# NextConsensus > NextConsensus estimates the probability that guideline bodies, regulators, and payers will act on changing medical evidence before your review deadline. NextConsensus provides dated evidence histories and registered forecasts for defined guideline, label, and coverage decisions. --- # What will FDA, NICE, or a payer decide? URL: https://nextconsensus.com/ ## What will FDA, NICE, or a payer decide? The probability that each body acts by the date you name, registered before the outcome is known. Request an estimate Explore forecasts Registered forecasts ### On the record 56 forecasts, made before the outcome is known. Snapshot 2026-10-26 . #### FDA FF-007 FDA Bepirovirsen · hepatitis B approval 84 % Oct 26, 2026 Unresolved FF-010 FDA INO-3107 · papillomatosis approval 45 % Oct 30, 2026 Unresolved #### NICE FF-016 NICE Epcoritamab combination · guidance publication 45 % Oct 28, 2026 Unresolved Deadlines by week, Oct–Dec 2026 · 35 of 56 registered Snapshot Oct 26 Oct Nov Dec - Unresolved - Resolved - Not scored - Expired Every forecast names an outcome and a deadline. The original estimate stays on the record after resolution. Registration counts and classes 56 registered · 56 unresolved · 0 resolved By class: FDA action by goal date (28), NICE guidance by scheduled date (24), NCCN guideline reclassification (2), FDA label revision (2). Read all 56 registered forecasts Add every deadline to your calendar The record ### What a registered record looks like Registered record specimen Durable ID: FF-011 · Structured Judgment Assessment specimen · FF-011 #### Ivonescimab · post-TKI NSCLC approval FDA approves ivonescimab for EGFR-mutated non-small cell lung cancer after EGFR TKI therapy on or before the disclosed PDUFA goal date of 2026-11-14 Institution FDA Action by Nov 14, 2026 Evidence cutoff 2026-09-26 Pivotal trial HARMONi (N=438) Registered estimate 15% Probability of the stated approval action by the deadline. Estimated base rate 70% Estimated at cutoff; not an enumerated historical rate. -55 points 55 percentage points below the estimated baseline. Both are estimates made at the same cutoff. ##### Evidence at the cutoff Primary endpoints dual primary endpoints: PFS, met (SRC-001); OS, primary analysis not statistically significant (HR 0.79, p=0.057, SRC-001) FDA review BLA submitted in the fourth quarter of 2025 and accepted for filing in January 2026; FDA noted that a statistically significant OS benefit is necessary in this setting (SRC-002) Later analysis June 2026 OS analysis made available to FDA (SRC-002); updated OS presented at WCLC 2026 on 2026-09-15 (SRC-001) Source record: SRC-001 · SRC-002 . Source descriptions and archived digests accompany the full record . ##### The planning question If your plan depends on approval by this date, compare the on-time and delayed-action cases using your own costs and deadlines. Case A: On-time action (15%) Approval action occurs on or before the stated deadline. Precedent indicates standard-review pathway timeline. Case B: Delay or Complete Response (85%) The remaining probability covers several outcomes: a complete response, a delay, withdrawal, or no action by the deadline. ##### When the evidence changes A new assessment requires a new registration. The original estimate and evidence cutoff stay on the record. The exact question and baseline The FDA takes an approval action on a Biologics License Application for ivonescimab (applicant Summit Therapeutics) for EGFR-mutated non-small cell lung cancer previously treated with an EGFR tyrosine kinase inhibitor, with an approval action date on or before 2026-11-14, the PDUFA goal action date disclosed in Summit Therapeutics' Form 8-K filed 2026-09-15. Read the complete resolution rule and its sources. Baseline basis: ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. First-cycle approval of original BLAs at the disclosed goal date, across review types. No enumerated count exists in this repository yet. Registered 2026-09-26 Content hash ledger 8a2d166c…c5de3c Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. Read the full record ### What are you waiting on? #### Commission an assessment. $9,500 · 10 business days For a question you commission, you receive: - Executive Briefing Memo: Decision timeline, estimate, and critical pivot points - Claim Vulnerability Matrix: Authority position redlines across FDA, NCCN, and payers - Evidence Gap Roadmap: Unaddressed endpoints and evidentiary exposure - Verifiable Audit Ledger: A dated SHA-256 record, frozen before the decision The forecasts on the record are free to read. The Asset Transition Ledger is available at $25,000. What the assessment includes The planning window ### Estimates registered before the decision Trailing notice #### Document & News Monitoring Reports what has already occurred. Evidence published Months prior Internal deliberation Closed to public Authority action Decision announced Post-hoc alert arrives After publication Post-publication notice Notice arrives after policy, pricing, and access terms are fixed. Internal review occurs reactively. Prospective forecast #### NextConsensus Transition Forecast Registers probability before the deadline. Evidence cutoff and ledger registration Cutoff frozen (SHA-256) Actionable planning window before authority action Authority deadline Stated date Independent outcome reading Pre-registered rule Window before the decision Compare structured estimates against historical base rates. Reallocate review and prepare positions before the public decision. Why the estimate moves ### When the estimate disagrees with the base rate An estimate that sits 15 points or more from its class base rate is scored separately , so a departure from precedent is never averaged in with the estimates that follow it. 22 of 56 sit there. Scored separately 22 of 56 Sit ≥15 points from their base rate Largest disagreement 55 pts Record FF-011, scored on the same terms Measured against Its own baseline Frozen at registration Each estimate carries its base rate. Open a record to see how the comparator was set. Base rate Registered estimate FF-011 FDA Base rate 70% · 55 points below Ivonescimab · post-TKI NSCLC approval 15 % Nov 14, 2026 Unresolved FF-009 FDA Base rate 85% · 50 points below IGALMI · at-home supplement approval 35 % Nov 14, 2026 Unresolved FF-020 NICE Base rate 50% · 45 points below Orforglipron · guidance publication 5 % Nov 18, 2026 Unresolved ### The record so far As decisions resolve, we compare each estimate with the outcome. We'll publish patterns in how institutions decide, once enough cases have resolved to support them. Registered 56 Resolved 0 Awaiting registration 7 Cohort Readout Window #### Upcoming Resolution Schedule Forecasts resolve automatically when their registered resolution window opens. Each record is read against its pre-committed rule. Nov 4, 2026 Read floor - FF-016 NICE Epcoritamab combination · guidance publication Nov 9, 2026 Read floor - FF-007 FDA Bepirovirsen · hepatitis B approval Nov 10, 2026 Read floor - FF-017 NICE Inavolisib combination · guidance publication 01 ##### Frozen Cutoff Sources, covariates, and propositions are sealed before the decision window opens. No retrospective edits. 02 ##### Cryptographic Hash Each registration is fingerprinted via SHA-256 and committed to an append-only public ledger. 03 ##### Automated Agreement Outcomes are read against the pre-registered rule by two independent machine readers. Both must agree before a result is posted, and the result is labelled machine-resolved. Phase 1 of the record: registry snapshot 2026-10-26 , outcomes pending. Next outcomes can be read from 2026-11-04 , 2026-11-09 and 2026-11-10 , each under its registered rule. How a forecast is scored Founded by Kanav Jain, who built products at Epic, Doximity, Transcarent, and CancerCompass. About the company --- # Registered forecasts URL: https://nextconsensus.com/forecast/ ## Registered forecasts The probability of a specific guideline, label, or coverage action by a deadline, registered before the outcome. Compare the registered questions and open any row to inspect its terms. 56 registered · 56 unresolved · 0 resolved · 0 expired Authority All authorities FDA NCCN NICE Forecast class All classes Guideline listing (NCCN, ESMO) Institutional ordering (FDA, NCCN) Regulatory action (FDA) Technology appraisal (NICE) Sort Soonest event deadline Highest estimate Group By authority By subject No grouping 56 forecasts All estimates use a shared 0–100% scale. Shared calendar: Oct 26, 2026 – Jul 31, 2027 Proposition Registered probability · 0–100% Event deadline · shared calendar Event by ### FDA 30 forecasts FF-007 FDA Bepirovirsen · hepatitis B approval 84 % 84% Oct 26, 2026 Unresolved The FDA takes an approval action on a New Drug Application for bepirovirsen (applicant GSK) for the treatment of chronic hepatitis B, with an approval action date on or before 2026-10-26, the PDUFA goal date disclosed in Ionis Pharmaceuticals' Form 10-Q filed 2026-07-29. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 84 % base-rate Authority base rate 85 % heuristic Calendar cycle 80 % expert Analyst proxy 85 % #### From cutoff to deadline Evidence cutoff Sep 26, 2026 Registered Sep 26, 2026 Event by Oct 26, 2026 Window closes Oct 26, 2026 Resolution rule, source, and archived material Resolves YES if the openFDA Drugs@FDA record returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22bepirovirsen%22 contains an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-10-26, and the Drugs@FDA approval letter or label for that application names chronic hepatitis B in its indication. An approval for a narrower chronic hepatitis B population than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2026-10-26: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-10-26 resolves NO as occurred_after_deadline. Read no earlier than 2026-11-09. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name bepirovirsen) governs. The application number was not public at the cutoff, so the rule reads by generic name; if the product carries a proprietary name, the generic name still identifies it. Resolves unresolvable only if neither source can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22bepirovirsen%22, https://www.accessdata.fda.gov/scripts/cder/daf/ 3 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-010 FDA INO-3107 · papillomatosis approval 45 % 45% Oct 30, 2026 Unresolved The FDA takes an approval action on Inovio's Biologics License Application for INO-3107 for the treatment of adults with recurrent respiratory papillomatosis, with an approval action date on or before 2026-10-30, the PDUFA target date disclosed in Inovio's Form 10-Q filed 2026-08-12. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 45 % base-rate Authority base rate 70 % heuristic Calendar cycle 65 % expert Analyst proxy 40 % #### From cutoff to deadline Evidence cutoff Sep 26, 2026 Registered Sep 26, 2026 Event by Oct 30, 2026 Window closes Oct 30, 2026 Resolution rule, source, and archived material INO-3107 is a CBER-regulated biologic, so openFDA's drugsfda endpoint does not list it. Resolves YES if FDA's Purple Book (https://purplebooksearch.fda.gov/) lists a licensed biological product that is INO-3107 under any proprietary name, with Inovio as licensee and an approval (license) date on or before 2026-10-30, and the CBER approval letter for that BLA names recurrent respiratory papillomatosis in adults in the indication. Approval under traditional rather than accelerated approval still resolves YES. Resolves NO if no approval action is dated on or before 2026-10-30: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; an approval dated after 2026-10-30 resolves NO as occurred_after_deadline. Read no earlier than 2026-11-13. If the Purple Book has not updated by then, the CBER approval letter or FDA's CBER list of approved products governs. Resolves unresolvable only if none of these can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://purplebooksearch.fda.gov/, https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products 1 source archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-012 FDA Mitapivat · sickle cell supplement approval 72 % 72% Nov 1, 2026 Unresolved The FDA takes an approval action on a supplement to NDA 216196 (mitapivat, PYRUKYND; applicant Agios) whose approved labeling includes sickle cell disease, with an approval action date on or before 2026-11-01, the PDUFA goal date disclosed in Agios' Form 10-Q filed 2026-07-30. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 72 % base-rate Authority base rate 85 % heuristic Calendar cycle 80 % expert Analyst proxy 70 % #### From cutoff to deadline Evidence cutoff Sep 26, 2026 Registered Sep 26, 2026 Event by Nov 1, 2026 Window closes Nov 1, 2026 Resolution rule, source, and archived material Resolves YES if the openFDA Drugs@FDA record for application NDA216196 (https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA216196%22) contains a submission with submission_type SUPPL, submission_status AP and a submission_status_date on or before 2026-11-01, and the Drugs@FDA label or letter for that supplement includes sickle cell disease in the indication. Approval under accelerated or traditional approval both count, as does a narrower sickle cell population. Resolves NO if no such supplement is approved on or before 2026-11-01: a complete response letter, a goal-date extension, withdrawal or no action. An approval dated after 2026-11-01 resolves NO as occurred_after_deadline. If the sickle cell indication is approved under a new NDA rather than a supplement, it still counts, read by the same fields. Read no earlier than 2026-11-15; if openFDA has not refreshed, the Drugs@FDA web record for NDA 216196 governs. At the cutoff the latest approved supplement was SUPPL 6, dated 2026-04-08 (SRC-002). Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA216196%22, https://www.accessdata.fda.gov/scripts/cder/daf/ 2 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-005 FDA Aficamten · MAPLE-HCM supplement approval 82 % 82% Nov 14, 2026 Unresolved The FDA takes an approval action on a supplement to NDA 219083 (aficamten, MYQORZO; applicant Cytokinetics) whose approved labeling includes the results of the MAPLE-HCM trial, with an approval action date on or before 2026-11-14, the PDUFA goal date disclosed in Cytokinetics' Form 10-Q filed 2026-08-06. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 82 % base-rate Authority base rate 85 % heuristic Calendar cycle 80 % expert Analyst proxy 85 % #### From cutoff to deadline Evidence cutoff Sep 26, 2026 Registered Sep 26, 2026 Event by Nov 14, 2026 Window closes Nov 14, 2026 Resolution rule, source, and archived material Resolves YES if the openFDA Drugs@FDA record for application NDA219083 (https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA219083%22) contains a submission with submission_type SUPPL, submission_status AP and a submission_status_date on or before 2026-11-14 that is this supplement. The supplement number was not known at the cutoff, so it is identified by two fields read together: submission_class_code EFFICACY in openFDA, and a Drugs@FDA approval letter or approved label for that supplement that names MAPLE-HCM or describes a randomized trial comparing aficamten with metoprolol. If the approval letter names MAPLE-HCM but openFDA carries another class code, the letter governs. Approval with labeling language about MAPLE-HCM narrower than the applicant sought still resolves YES. Resolves NO if no such supplement is approved on or before 2026-11-14: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-14 resolves NO as occurred_after_deadline. 2026-11-14 is a Saturday; an approval action dated that day still counts. Read no earlier than 2026-11-28; if openFDA has not refreshed, the Drugs@FDA web record for NDA 219083 (https://www.accessdata.fda.gov/scripts/cder/daf/) governs. At the cutoff the record held ORIG 1, approved 2025-12-19, and SUPPL 1, approved 2026-02-05 with a class code other than EFFICACY (SRC-002), and the only approved label named neither MAPLE-HCM nor metoprolol (SRC-003). Resolves unresolvable only if neither source can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA219083%22, https://www.accessdata.fda.gov/scripts/cder/daf/ 3 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-009 FDA IGALMI · at-home supplement approval 35 % 35% Nov 14, 2026 Unresolved The FDA takes an approval action on a supplement to NDA 215390 (dexmedetomidine sublingual film, IGALMI; applicant at the cutoff BioXcel Therapeutics) whose approved labeling permits IGALMI to be taken at home, without the supervision of a healthcare provider, for the acute treatment of agitation associated with schizophrenia or bipolar disorder, with an approval action date on or before 2026-11-14, the PDUFA target action date disclosed in BioXcel's Form 10-Q filed 2026-08-13. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 35 % base-rate Authority base rate 85 % heuristic Calendar cycle 80 % expert Analyst proxy 40 % #### From cutoff to deadline Evidence cutoff Sep 26, 2026 Registered Sep 26, 2026 Event by Nov 14, 2026 Window closes Nov 14, 2026 Resolution rule, source, and archived material Resolves YES if the openFDA Drugs@FDA record for application NDA215390 (https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA215390%22) contains a submission with submission_type SUPPL, submission_status AP and a submission_status_date on or before 2026-11-14, and either the Drugs@FDA approval letter for that supplement states that it provides for use at home, in the outpatient setting or without the supervision of a healthcare provider, or the label approved with it permits any dose to be taken without the supervision of a healthcare provider. The supplement is identified by that content, not by its number or class code. At the cutoff the approved label required administration under the supervision of a healthcare provider (SRC-001), and the latest approved supplement was SUPPL 2, approved 2025-11-19, which openFDA classes EFFICACY and Drugs@FDA lists as Efficacy-New Indication but which updated the prescribing information with a repeat-dosing study and is not this supplement (SRC-002, SRC-003, SRC-005). A label that keeps the first dose under supervision and permits later doses at home still resolves YES, as does an at-home approval narrower than the applicant sought (one of the two disorders, or one strength). An approval under a new holder of NDA 215390 counts. Resolves NO if no such supplement is approved on or before 2026-11-14: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-14 resolves NO as occurred_after_deadline. 2026-11-14 is a Saturday; an approval action dated that day still counts. Read no earlier than 2026-11-28; if openFDA has not refreshed, the Drugs@FDA web record for NDA 215390 (https://www.accessdata.fda.gov/scripts/cder/daf/) governs. Resolves unresolvable only if neither source can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA215390%22, https://www.accessdata.fda.gov/scripts/cder/daf/ 5 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-011 FDA Ivonescimab · post-TKI NSCLC approval 15 % 15% Nov 14, 2026 Unresolved The FDA takes an approval action on a Biologics License Application for ivonescimab (applicant Summit Therapeutics) for EGFR-mutated non-small cell lung cancer previously treated with an EGFR tyrosine kinase inhibitor, with an approval action date on or before 2026-11-14, the PDUFA goal action date disclosed in Summit Therapeutics' Form 8-K filed 2026-09-15. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 15 % base-rate Authority base rate 70 % heuristic Calendar cycle 65 % expert Analyst proxy 25 % #### From cutoff to deadline Evidence cutoff Sep 26, 2026 Registered Sep 26, 2026 Event by Nov 14, 2026 Window closes Nov 14, 2026 Resolution rule, source, and archived material Resolves YES if the openFDA Drugs@FDA record returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22ivonescimab%22 contains an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-11-14, and the Drugs@FDA approval letter or label for that application names in its indication EGFR-mutated (EGFR mutation-positive) non-small cell lung cancer that was previously treated with, or progressed on or after, an EGFR tyrosine kinase inhibitor. An approval for a narrower population than the applicant sought (for example non-squamous disease only, or only after a third-generation EGFR tyrosine kinase inhibitor) still resolves YES, as does an approval under accelerated approval. Resolves NO if no approval action is dated on or before 2026-11-14: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-14 resolves NO as occurred_after_deadline. 2026-11-14 is a Saturday; an approval action dated that day still counts. Read no earlier than 2026-11-28. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name ivonescimab) governs, and if neither lists the product, FDA's Purple Book (https://purplebooksearch.fda.gov/, searched by ivonescimab) governs for the licensure date, with the approval letter for the indication. The application number was not public at the cutoff, so the rule reads by name; a four-letter suffix on the nonproprietary name (ivonescimab-xxxx) or a proprietary name does not change the identification. At the cutoff ivonescimab was not approved in the United States (SRC-001). Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22ivonescimab%22, https://www.accessdata.fda.gov/scripts/cder/daf/, https://purplebooksearch.fda.gov/ 2 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-008 FDA Deramiocel · Duchenne approval 35 % 35% Nov 22, 2026 Unresolved The FDA takes an approval action on Capricor Therapeutics' Biologics License Application for deramiocel (CAP-1002) for the treatment of Duchenne muscular dystrophy, with an approval action date on or before 2026-11-22, the PDUFA target action date disclosed in Capricor's Form 8-K filed 2026-08-24. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 35 % base-rate Authority base rate 50 % heuristic Calendar cycle 60 % expert Analyst proxy 35 % #### From cutoff to deadline Evidence cutoff Sep 26, 2026 Registered Sep 26, 2026 Event by Nov 22, 2026 Window closes Nov 22, 2026 Resolution rule, source, and archived material Deramiocel is a CBER-regulated cell therapy, so openFDA's drugsfda endpoint does not list it. Resolves YES if FDA's Purple Book (https://purplebooksearch.fda.gov/) lists a licensed biological product that is deramiocel (CAP-1002) under any proprietary or proper name, with Capricor Therapeutics as licensee and an approval (license) date on or before 2026-11-22, and the CBER approval letter for that BLA names Duchenne muscular dystrophy in the indication. An indication for Duchenne muscular dystrophy as a whole, for a named part of it such as upper limb function or cardiomyopathy, or for a subpopulation of patients with it, resolves YES; so does accelerated rather than traditional approval. Resolves NO if no approval action is dated on or before 2026-11-22: a complete response letter, a further goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; an approval dated after 2026-11-22 resolves NO as occurred_after_deadline. 2026-11-22 is a Sunday; an approval action dated on or before it counts whatever the weekday. Read no earlier than 2026-12-06. If the Purple Book has not updated by then, the CBER approval letter or FDA's list of approved cellular and gene therapy products (https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products) governs. At the cutoff that list, content current as of 2026-09-17, did not include deramiocel (SRC-004). Resolves unresolvable only if none of these can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://purplebooksearch.fda.gov/, https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products 4 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-013 FDA Molgramostim · aPAP approval 75 % 75% Nov 22, 2026 Unresolved The FDA takes an approval action on Savara's Biologics License Application for molgramostim inhalation solution (proposed trade name MOLBREEVI) for the treatment of autoimmune pulmonary alveolar proteinosis, with an approval action date on or before 2026-11-22, the PDUFA target action date disclosed in Savara's Form 10-Q filed 2026-08-11. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 75 % base-rate Authority base rate 80 % heuristic Calendar cycle 75 % expert Analyst proxy 75 % #### From cutoff to deadline Evidence cutoff Sep 26, 2026 Registered Sep 26, 2026 Event by Nov 22, 2026 Window closes Nov 22, 2026 Resolution rule, source, and archived material Resolves YES if the openFDA Drugs@FDA record returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22molgramostim%22 (or, if that returns nothing, by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22molgramostim%22) contains an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-11-22, and the Drugs@FDA approval letter or label for that application names autoimmune pulmonary alveolar proteinosis in its indication. A proper name that adds a suffix to molgramostim still matches. An approval for a narrower autoimmune pulmonary alveolar proteinosis population than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2026-11-22: a complete response letter, a further goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-22 resolves NO as occurred_after_deadline. 2026-11-22 is a Sunday; an approval action dated on or before it counts whatever the weekday. Read no earlier than 2026-12-06. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name molgramostim) governs; if Drugs@FDA does not show the application either, FDA's Purple Book (https://purplebooksearch.fda.gov/) record of a licensed molgramostim product with Savara or a Savara subsidiary as licensee governs, read with the approval letter for the indication. The application number was not public at the cutoff, so the rule reads by generic name; if the product carries a proprietary name, MOLBREEVI or another, the generic name still identifies it. Savara expected CDER to hold primary jurisdiction (SRC-002); if CBER licenses the product instead, the Purple Book record and the CBER approval letter govern on the same terms. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22molgramostim%22, https://www.accessdata.fda.gov/scripts/cder/daf/, https://purplebooksearch.fda.gov/ 2 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-027 FDA Venglustat · type 3 Gaucher disease approval 75 % 75% Nov 25, 2026 Unresolved The FDA takes an approval action on Sanofi's New Drug Application for venglustat for the treatment of type 3 Gaucher disease, with an approval action date on or before 2026-11-25, the target action date disclosed in Sanofi's 2026 half-year management report, furnished on Form 6-K on 2026-07-30. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 75 % base-rate Authority base rate 85 % heuristic Calendar cycle 80 % expert Analyst proxy 75 % #### From cutoff to deadline Evidence cutoff Oct 6, 2026 Registered Oct 6, 2026 Event by Nov 25, 2026 Window closes Nov 25, 2026 Resolution rule, source, and archived material Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22venglustat%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22VENGLUSTAT%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-11-25, and the Drugs@FDA approval letter or label for that application names type 3 Gaucher disease in its indication, with Sanofi or a Sanofi subsidiary as applicant. An approval for a narrower type 3 Gaucher disease population, or for its neurological manifestations only, still resolves YES. Resolves NO if no approval action is dated on or before 2026-11-25: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-25 resolves NO as occurred_after_deadline. Read no earlier than 2026-12-09. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name venglustat) governs. The application number was not public at the cutoff, so the rule reads by name; a suffix on the nonproprietary name or a proprietary name does not change the identification. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22venglustat%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22VENGLUSTAT%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ 4 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-006 FDA BBP-418 · muscular dystrophy approval 85 % 85% Nov 27, 2026 Unresolved The FDA takes an approval action on BridgeBio Pharma's New Drug Application for oral BBP-418 for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), with an approval action date on or before 2026-11-27, the PDUFA target action date disclosed in BridgeBio's Form 8-K filed 2026-08-31. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 85 % base-rate Authority base rate 85 % heuristic Calendar cycle 80 % expert Analyst proxy 85 % #### From cutoff to deadline Evidence cutoff Sep 26, 2026 Registered Sep 26, 2026 Event by Nov 27, 2026 Window closes Nov 27, 2026 Resolution rule, source, and archived material The application number was not public at the cutoff, and no archived source gives an FDA established name for BBP-418; BridgeBio's own filings identify its compound as ribitol (SRC-004). The adjudicator therefore identifies the application by its indication plus its ingredient or its applicant, never by a name the adjudicator infers: the qualifying application is an NDA whose Drugs@FDA approval letter or label names limb-girdle muscular dystrophy type 2I/R9 (also written LGMD2I, LGMD R9 or FKRP-related limb-girdle muscular dystrophy) in its indication, and whose active ingredient is ribitol or whose applicant is BridgeBio Pharma or a BridgeBio subsidiary, under any proprietary name. Resolves YES if such an application appears in the openFDA Drugs@FDA endpoint, located by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22ribitol%22, with an ORIG submission whose submission_status is AP and whose submission_status_date is on or before 2026-11-27. An approval for a narrower LGMD2I/R9 population than the applicant sought (by age or genotype, for example) still resolves YES, as does accelerated rather than traditional approval. Resolves NO if no approval action is dated on or before 2026-11-27: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-27 resolves NO as occurred_after_deadline. 2026-11-27 is a Friday. Read no earlier than 2026-12-11. If openFDA has not refreshed by then, or the query returns nothing, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name ribitol or by the applicant) governs, under the same identification test. Resolves unresolvable only if neither source can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22ribitol%22, https://www.accessdata.fda.gov/scripts/cder/daf/ 4 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-025 FDA Neladalkib · ALK-positive NSCLC approval 85 % 85% Nov 27, 2026 Unresolved The FDA takes an approval action on Nuvalent's (a GSK company since July 2026) New Drug Application for neladalkib (NVL-655) for the treatment of tyrosine kinase inhibitor pre-treated advanced ALK-positive non-small cell lung cancer, with an approval action date on or before 2026-11-27, the target decision date disclosed in GSK's Form 6-K furnished 2026-07-22, and stated as the PDUFA date in Royalty Pharma's filing of 2026-08-05. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 85 % base-rate Authority base rate 70 % heuristic Calendar cycle 65 % expert Analyst proxy 85 % #### From cutoff to deadline Evidence cutoff Oct 6, 2026 Registered Oct 6, 2026 Event by Nov 27, 2026 Window closes Nov 27, 2026 Resolution rule, source, and archived material Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22neladalkib%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22NELADALKIB%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-11-27, and the Drugs@FDA approval letter or label for that application names ALK-positive non-small cell lung cancer in its indication. An approval for a narrower population than the applicant sought (for example after a specific prior ALK inhibitor) still resolves YES, as does accelerated rather than traditional approval. Resolves NO if no approval action is dated on or before 2026-11-27: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-27 resolves NO as occurred_after_deadline. Read no earlier than 2026-12-11. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name neladalkib) governs. The application number was not public at the cutoff, so the rule reads by name; a suffix on the nonproprietary name or a proprietary name does not change the identification. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22neladalkib%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22NELADALKIB%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ 7 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-024 FDA D-PLEX100 · colorectal surgical site infection approval 55 % 55% Nov 28, 2026 Unresolved The FDA takes an approval action on PolyPid's New Drug Application for D-PLEX100 (doxycycline in an extended-release polymer-lipid matrix) for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery, with an approval action date on or before 2026-11-28, the PDUFA goal date disclosed in Exhibit 99.1 to PolyPid's Form 6-K furnished 2026-08-12. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 55 % base-rate Authority base rate 85 % heuristic Calendar cycle 80 % expert Analyst proxy 55 % #### From cutoff to deadline Evidence cutoff Oct 6, 2026 Registered Oct 6, 2026 Event by Nov 28, 2026 Window closes Nov 28, 2026 Resolution rule, source, and archived material Doxycycline is marketed under many applications, so this one is identified by holder and indication. At the cutoff openFDA listed no PolyPid application (SRC-007, SRC-008). Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=sponsor_name:POLYPID*&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=sponsor_name:AZURITY*&limit=100, read together, contain an NDA held by PolyPid, or by Azurity or another holder to which PolyPid has assigned it (SRC-004), whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-11-28, and whose Drugs@FDA approval letter or label indicates the product for preventing or reducing surgical site infections. An approval for a narrower surgical population than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2026-11-28: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-28 resolves NO as occurred_after_deadline. 2026-11-28 is a Saturday; an approval action dated that day still counts. Read no earlier than 2026-12-12. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by PolyPid, Azurity or D-PLEX) governs, under the same holder and indication test. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=sponsor_name:POLYPID*&limit=100, https://api.fda.gov/drug/drugsfda.json?search=sponsor_name:AZURITY*&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ 8 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-023 FDA Bezuclastinib · GIST approval 85 % 85% Nov 30, 2026 Unresolved The FDA takes an approval action on Cogent Biosciences' New Drug Application for bezuclastinib in combination with sunitinib for the treatment of patients with gastrointestinal stromal tumor who have received prior treatment with imatinib, with an approval action date on or before 2026-11-30, the PDUFA target action date disclosed in Cogent Biosciences' Form 10-Q filed 2026-08-10. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 85 % base-rate Authority base rate 85 % heuristic Calendar cycle 80 % expert Analyst proxy 85 % #### From cutoff to deadline Evidence cutoff Oct 6, 2026 Registered Oct 6, 2026 Event by Nov 30, 2026 Window closes Nov 30, 2026 Resolution rule, source, and archived material Cogent has separate bezuclastinib applications for systemic mastocytosis (SRC-001); an approval for mastocytosis does not count. Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22bezuclastinib%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22BEZUCLASTINIB%22&limit=100, read together (openFDA does not always fill the generic-name field for a second application), contain a submission, original or supplement, with submission_status AP and a submission_status_date on or before 2026-11-30, and the Drugs@FDA approval letter or label for that submission names gastrointestinal stromal tumor in its indication. An approval for a narrower GIST population than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2026-11-30: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-30 resolves NO as occurred_after_deadline. Read no earlier than 2026-12-14. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name bezuclastinib) governs. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22bezuclastinib%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22BEZUCLASTINIB%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ 6 sources archived with the registration. #### Also asked about Bezuclastinib These share an evidence context. They are not independent cases, and they are not independent evidence. - FF-031 Bezuclastinib · nonadvanced systemic mastocytosis approval Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-026 FDA Povetacicept · IgA nephropathy approval 85 % 85% Nov 30, 2026 Unresolved The FDA takes an approval action on Vertex's Biologics License Application for povetacicept, submitted for accelerated approval, for the treatment of adults with IgA nephropathy, with an approval action date on or before 2026-11-30, the PDUFA target action date disclosed in Vertex's Form 10-Q filed 2026-08-04. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 85 % base-rate Authority base rate 70 % heuristic Calendar cycle 65 % expert Analyst proxy 85 % #### From cutoff to deadline Evidence cutoff Oct 6, 2026 Registered Oct 6, 2026 Event by Nov 30, 2026 Window closes Nov 30, 2026 Resolution rule, source, and archived material Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22povetacicept%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22POVETACICEPT%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-11-30, and the Drugs@FDA approval letter or label for that application names IgA nephropathy in its indication, with Vertex or a Vertex subsidiary as applicant. An approval for a narrower IgA nephropathy population than the applicant sought still resolves YES, as does accelerated rather than traditional approval. Resolves NO if no approval action is dated on or before 2026-11-30: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-30 resolves NO as occurred_after_deadline. Read no earlier than 2026-12-14. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name povetacicept) governs. If neither lists the product, FDA's Purple Book (https://purplebooksearch.fda.gov/, searched by povetacicept) governs for the licensure date, with the approval letter for the indication. The application number was not public at the cutoff, so the rule reads by name; a suffix on the nonproprietary name or a proprietary name does not change the identification. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22povetacicept%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22POVETACICEPT%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/, https://purplebooksearch.fda.gov/ 7 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-032 FDA Imsidolimab · generalized pustular psoriasis approval 70 % 70% Dec 12, 2026 Unresolved The FDA takes an approval action on Vanda Pharmaceuticals' Biologics License Application for imsidolimab (proposed name Quimilza) for the treatment of generalized pustular psoriasis, with an approval action date on or before 2026-12-12, the target action date disclosed in AnaptysBio's Form 10-KT filed 2026-09-21. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 70 % base-rate Authority base rate 85 % heuristic Calendar cycle 80 % expert Analyst proxy 70 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Dec 12, 2026 Window closes Dec 12, 2026 Resolution rule, source, and archived material Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22imsidolimab%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22IMSIDOLIMAB%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-12-12, and the Drugs@FDA approval letter or label for that application names generalized pustular psoriasis in its indication, with Vanda or a Vanda subsidiary as applicant. An approval for a narrower generalized pustular psoriasis population than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2026-12-12: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-12-12 resolves NO as occurred_after_deadline. 2026-12-12 is a Saturday; an approval action dated that day still counts. Read no earlier than 2026-12-26. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name imsidolimab) governs. If neither lists the product, FDA's Purple Book (https://purplebooksearch.fda.gov/, searched by imsidolimab) governs for the licensure date, with the approval letter for the indication. The application number was not public at the cutoff, so the rule reads by name; a suffix on the nonproprietary name or a proprietary name does not change the identification. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22imsidolimab%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22IMSIDOLIMAB%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/, https://purplebooksearch.fda.gov/ 6 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-034 FDA Relacorilant · Cushing's syndrome approval 45 % 45% Dec 17, 2026 Unresolved The FDA takes an approval action on Corcept Therapeutics' resubmitted New Drug Application for relacorilant for the treatment of patients with Cushing's syndrome (endogenous hypercortisolism), with an approval action date on or before 2026-12-17, the PDUFA date disclosed in Exhibit 99.1 to Corcept's Form 8-K filed 2026-07-29. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 45 % base-rate Authority base rate 50 % heuristic Calendar cycle 60 % expert Analyst proxy 45 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Dec 17, 2026 Window closes Dec 17, 2026 Resolution rule, source, and archived material Relacorilant was already approved for another indication at the cutoff: openFDA lists NDA220641 (LIFYORLI, platinum-resistant ovarian cancer), ORIG 1 approved 2026-03-25 (SRC-005). The Cushing's application is identified by its indication, not by application number. Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22relacorilant%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22RELACORILANT%22&limit=100, read together, contain a submission, original or supplement, with submission_status AP and a submission_status_date on or before 2026-12-17, and the Drugs@FDA approval letter or label for that submission names Cushing's syndrome or endogenous hypercortisolism (including a sign of it such as hyperglycaemia or hypertension secondary to hypercortisolism) in its indication, with Corcept or a Corcept subsidiary as applicant. An approval for a narrower Cushing's syndrome population, or for one manifestation of hypercortisolism, still resolves YES. Resolves NO if no approval action is dated on or before 2026-12-17: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-12-17 resolves NO as occurred_after_deadline. Read no earlier than 2026-12-31. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name relacorilant) governs. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22relacorilant%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22RELACORILANT%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ 6 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-033 FDA Lorundrostat · hypertension approval 82 % 82% Dec 22, 2026 Unresolved The FDA takes an approval action on Mineralys Therapeutics' New Drug Application for lorundrostat for the treatment of adults with hypertension in combination with other antihypertensive drugs, with an approval action date on or before 2026-12-22, the PDUFA target date disclosed in Exhibit 99.1 to Mineralys Therapeutics' Form 8-K filed 2026-08-11. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 82 % base-rate Authority base rate 85 % heuristic Calendar cycle 80 % expert Analyst proxy 85 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Dec 22, 2026 Window closes Dec 22, 2026 Resolution rule, source, and archived material Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22lorundrostat%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22LORUNDROSTAT%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-12-22, and the Drugs@FDA approval letter or label for that application names hypertension in its indication. An approval for a narrower hypertension population than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2026-12-22: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-12-22 resolves NO as occurred_after_deadline. Read no earlier than 2027-01-05. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name lorundrostat) governs. The application number was not public at the cutoff, so the rule reads by name; a suffix on the nonproprietary name or a proprietary name does not change the identification. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22lorundrostat%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22LORUNDROSTAT%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ 8 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-030 FDA Anito-cel · multiple myeloma approval 75 % 75% Dec 23, 2026 Unresolved The FDA takes an approval action on the Biologics License Application for anitocabtagene autoleucel (anito-cel; applicant Arcellx, a Gilead Sciences subsidiary since April 2026) for the treatment of patients with relapsed or refractory multiple myeloma in the fourth line or later, with an approval action date on or before 2026-12-23, the PDUFA target action date disclosed in Gilead Sciences' Form 10-Q filed 2026-08-06. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 75 % base-rate Authority base rate 70 % heuristic Calendar cycle 65 % expert Analyst proxy 75 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Dec 23, 2026 Window closes Dec 23, 2026 Resolution rule, source, and archived material Anitocabtagene autoleucel is a CBER-regulated biologic, so openFDA's drugsfda endpoint does not list it. Resolves YES if FDA's Purple Book (https://purplebooksearch.fda.gov/) lists a licensed biological product that is anitocabtagene autoleucel (anito-cel) under any proprietary or proper name, with Arcellx, Kite or another Gilead Sciences subsidiary as licensee and an approval (license) date on or before 2026-12-23, and the CBER approval letter for that BLA names relapsed or refractory multiple myeloma in the indication. An approval after a different number of prior lines than the applicant sought, or for a narrower relapsed or refractory multiple myeloma population, still resolves YES. Resolves NO if no approval action is dated on or before 2026-12-23: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-12-23 resolves NO as occurred_after_deadline. Read no earlier than 2027-01-06. If the Purple Book has not updated by then, the CBER approval letter or FDA's list of approved products (https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products) governs. Resolves unresolvable only if none of these can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://purplebooksearch.fda.gov/, https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products 6 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-035 FDA Relutrigine · SCN2A/SCN8A epilepsy approval 80 % 80% Dec 27, 2026 Unresolved The FDA takes an approval action on Praxis' New Drug Application for relutrigine for the treatment of SCN2A and SCN8A developmental and epileptic encephalopathies, with an approval action date on or before 2026-12-27, the PDUFA target action date, as extended by a major amendment, disclosed in Exhibit 99.1 to Praxis' Form 8-K filed 2026-08-06. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 80 % base-rate Authority base rate 85 % heuristic Calendar cycle 80 % expert Analyst proxy 80 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Dec 27, 2026 Window closes Dec 27, 2026 Resolution rule, source, and archived material Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22relutrigine%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22RELUTRIGINE%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-12-27, and the Drugs@FDA approval letter or label for that application names SCN2A or SCN8A developmental and epileptic encephalopathy in its indication. An approval for one of the two genotypes, or a narrower population than the applicant sought, still resolves YES. Resolves NO if no approval action is dated on or before 2026-12-27: a complete response letter, a further goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-12-27 resolves NO as occurred_after_deadline. 2026-12-27 is a Sunday; an approval action dated that day still counts. Read no earlier than 2027-01-10. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name relutrigine) governs. The application number was not public at the cutoff, so the rule reads by name; a suffix on the nonproprietary name or a proprietary name does not change the identification. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22relutrigine%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22RELUTRIGINE%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ 7 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-047 FDA Fast-acting meloxicam · acute pain approval 78 % 78% Dec 27, 2026 Unresolved The FDA takes an approval action on Viatris' New Drug Application for MR-107A-02, a fast-acting formulation of meloxicam, for the treatment of moderate-to-severe acute pain, with an approval action date on or before 2026-12-27, the PDUFA goal date disclosed in Exhibit 99.1 to Viatris' Form 8-K filed 2026-08-06. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 78 % base-rate Authority base rate 85 % heuristic Calendar cycle 80 % expert Analyst proxy 75 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Dec 27, 2026 Window closes Dec 27, 2026 Resolution rule, source, and archived material Meloxicam is already marketed under several applications, so this one is identified by applicant and indication, not by ingredient alone. At the cutoff openFDA listed no meloxicam NDA held by Viatris or Mylan (SRC-003, SRC-005). Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22MELOXICAM%22&limit=100 contain an NDA held by Viatris, Mylan or another Viatris subsidiary whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-12-27, and the Drugs@FDA approval letter or label for that application indicates the product for acute pain. An approval for a narrower acute-pain population or a narrower setting than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2026-12-27: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-12-27 resolves NO as occurred_after_deadline. 2026-12-27 is a Sunday; an approval action dated that day still counts. Read no earlier than 2027-01-10. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name meloxicam) governs, under the same applicant and indication test. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22MELOXICAM%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ 5 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-031 FDA Bezuclastinib · nonadvanced systemic mastocytosis approval 80 % 80% Dec 30, 2026 Unresolved The FDA takes an approval action on Cogent Biosciences' New Drug Application for bezuclastinib for the treatment of patients with nonadvanced systemic mastocytosis, with an approval action date on or before 2026-12-30, the PDUFA date disclosed in Exhibit 99.1 to Cogent Biosciences' Form 8-K filed 2026-08-10. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 80 % base-rate Authority base rate 85 % heuristic Calendar cycle 80 % expert Analyst proxy 80 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Dec 30, 2026 Window closes Dec 30, 2026 Resolution rule, source, and archived material Cogent has separate bezuclastinib applications for gastrointestinal stromal tumour, with an earlier goal date (SRC-001), and for advanced systemic mastocytosis (SRC-002), so this approval is identified by its indication, not by being the first bezuclastinib approval; an approval only for GIST or advanced systemic mastocytosis does not count. Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22bezuclastinib%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22BEZUCLASTINIB%22&limit=100, read together (openFDA does not always fill the generic-name field for a second application), contain a submission, original or supplement, with submission_status AP and a submission_status_date on or before 2026-12-30, and the Drugs@FDA approval letter or label for that submission names nonadvanced systemic mastocytosis (or indolent or smoldering systemic mastocytosis) in its indication. An approval for indolent systemic mastocytosis only, or another narrower nonadvanced population, still resolves YES. Resolves NO if no approval action is dated on or before 2026-12-30: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-12-30 resolves NO as occurred_after_deadline. Read no earlier than 2027-01-13. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name bezuclastinib) governs. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22bezuclastinib%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22BEZUCLASTINIB%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ 8 sources archived with the registration. #### Also asked about Bezuclastinib These share an evidence context. They are not independent cases, and they are not independent evidence. - FF-023 Bezuclastinib · GIST approval Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-037 FDA Z-rostudirsen · Duchenne exon 51 approval 70 % 70% Jan 21, 2027 Unresolved The FDA takes an approval action on Dyne Therapeutics' Biologics License Application for zeleciment rostudirsen (z-rostudirsen, DYNE-251) for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping, with an approval action date on or before 2027-01-21, the PDUFA target action date disclosed in Dyne Therapeutics' Form 10-Q filed 2026-07-29. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 70 % base-rate Authority base rate 70 % heuristic Calendar cycle 65 % expert Analyst proxy 70 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Jan 21, 2027 Window closes Jan 21, 2027 Resolution rule, source, and archived material Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22zeleciment%20rostudirsen%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22ZELECIMENT%20ROSTUDIRSEN%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2027-01-21, and the Drugs@FDA approval letter or label for that application names Duchenne muscular dystrophy amenable to exon 51 skipping in its indication. An approval for a narrower Duchenne muscular dystrophy amenable to exon 51 skipping population than the applicant sought still resolves YES, as does accelerated rather than traditional approval. Resolves NO if no approval action is dated on or before 2027-01-21: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2027-01-21 resolves NO as occurred_after_deadline. Read no earlier than 2027-02-04. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name zeleciment rostudirsen) governs. If neither lists the product, FDA's Purple Book (https://purplebooksearch.fda.gov/, searched by zeleciment rostudirsen) governs for the licensure date, with the approval letter for the indication. The application number was not public at the cutoff, so the rule reads by name; a suffix on the nonproprietary name or a proprietary name does not change the identification. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22zeleciment%20rostudirsen%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22ZELECIMENT%20ROSTUDIRSEN%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/, https://purplebooksearch.fda.gov/ 7 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-036 FDA Ulixacaltamide · essential tremor approval 80 % 80% Jan 29, 2027 Unresolved The FDA takes an approval action on Praxis' New Drug Application for ulixacaltamide hydrochloride for the treatment of essential tremor in adults, with an approval action date on or before 2027-01-29, the PDUFA date disclosed in Exhibit 99.1 to Praxis' Form 8-K filed 2026-08-06. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 80 % base-rate Authority base rate 85 % heuristic Calendar cycle 80 % expert Analyst proxy 80 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Jan 29, 2027 Window closes Jan 29, 2027 Resolution rule, source, and archived material Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22ulixacaltamide%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22ULIXACALTAMIDE%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2027-01-29, and the Drugs@FDA approval letter or label for that application names essential tremor in its indication. An approval for a narrower essential tremor population than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2027-01-29: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2027-01-29 resolves NO as occurred_after_deadline. Read no earlier than 2027-02-12. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name ulixacaltamide) governs. The application number was not public at the cutoff, so the rule reads by name; a suffix on the nonproprietary name or a proprietary name does not change the identification. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22ulixacaltamide%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22ULIXACALTAMIDE%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ 7 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-046 FDA Leniolisib · APDS children 13–27 kg supplement approval 85 % 85% Jan 30, 2027 Unresolved The FDA takes an approval action on a supplement to NDA 217759 (leniolisib, JOENJA; applicant Pharming) whose approved labeling provides dosing for patients with activated phosphoinositide 3-kinase delta syndrome (APDS) weighing 13 kg to less than 27 kg, with an approval action date on or before 2027-01-30, the PDUFA target action date disclosed in Pharming's Form 6-K furnished 2026-09-25. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 85 % base-rate Authority base rate 85 % heuristic Calendar cycle 80 % expert Analyst proxy 85 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Jan 30, 2027 Window closes Jan 30, 2027 Resolution rule, source, and archived material Resolves YES if the openFDA Drugs@FDA record for application NDA217759 (https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA217759%22) contains a submission with submission_type SUPPL, submission_status AP and a submission_status_date on or before 2027-01-30, and the Drugs@FDA approval letter or label for that supplement provides dosing for patients with APDS weighing 13 kg to less than 27 kg. The supplement is identified by that content, not by its number or class code. At the cutoff the latest approved supplement was SUPPL 6, approved 2026-09-11, which added dosing for children aged 4 to 11 weighing 27 kg or more and is not this supplement (SRC-003). An approval covering part of the 13 kg to 27 kg range, or a narrower age range, still resolves YES. Resolves NO if no approval action is dated on or before 2027-01-30: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2027-01-30 resolves NO as occurred_after_deadline. 2027-01-30 is a Saturday; an approval action dated that day still counts. Read no earlier than 2027-02-13; if openFDA has not refreshed, the Drugs@FDA web record for NDA217759 (https://www.accessdata.fda.gov/scripts/cder/daf/) governs. Resolves unresolvable only if neither source can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA217759%22, https://www.accessdata.fda.gov/scripts/cder/daf/ 4 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-045 FDA Lenacapavir · once-weekly oral PrEP approval 70 % 70% Feb 2, 2027 Unresolved The FDA takes an approval action on Gilead Sciences' supplemental New Drug Application for YEZTUGO (lenacapavir) 300-mg tablets as a once-weekly oral regimen for HIV-1 pre-exposure prophylaxis, with an approval action date on or before 2027-02-02, the PDUFA target action date disclosed in Gilead's Form 10-Q filed 2026-08-06. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 70 % base-rate Authority base rate 85 % heuristic Calendar cycle 80 % expert Analyst proxy 70 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Feb 2, 2027 Window closes Feb 2, 2027 Resolution rule, source, and archived material The filings do not give the application number; openFDA lists YEZTUGO 300 mg tablets under NDA220020 (SRC-003), so the approval is identified by content, applicant and date. The label approved with NDA220020 ORIG 1 on 2025-06-18 already permits oral lenacapavir 300 mg once every 7 days on an interim basis while injections are delayed (SRC-005); that does not count. Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22lenacapavir%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22LENACAPAVIR%20SODIUM%22&limit=100, read together, contain a Gilead application with a submission, original or supplement, whose submission_status is AP and whose submission_status_date is after 2026-10-01 and on or before 2027-02-02, and whose Drugs@FDA approval letter or label provides once-weekly oral lenacapavir as a regimen for HIV-1 pre-exposure prophylaxis in its own right, not only as interim dosing while injections are delayed. An approval for a narrower PrEP population than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2027-02-02: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2027-02-02 resolves NO as occurred_after_deadline. Read no earlier than 2027-02-16. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name lenacapavir) governs, under the same content test. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22lenacapavir%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22LENACAPAVIR%20SODIUM%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ 5 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-044 FDA Infigratinib · achondroplasia approval 80 % 80% Feb 4, 2027 Unresolved The FDA takes an approval action on BridgeBio Pharma's New Drug Application for oral infigratinib for the treatment of children with achondroplasia, with an approval action date on or before 2027-02-04, the PDUFA target action date disclosed in Exhibit 99.1 to BridgeBio's Form 8-K filed 2026-10-13. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 80 % base-rate Authority base rate 85 % heuristic Calendar cycle 80 % expert Analyst proxy 80 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Feb 4, 2027 Window closes Feb 4, 2027 Resolution rule, source, and archived material The application number was not public at the cutoff, and the ingredient already has an approval that is not this one: openFDA lists NDA214622 (TRUSELTIQ, infigratinib phosphate, applicant Helsinn Healthcare, both strengths discontinued), whose ORIG-1 was approved 2021-05-28 for an oncology indication (SRC-005). That approval does not count. The adjudicator identifies the qualifying approval by its indication plus its ingredient, never by a name the adjudicator infers: an approval action whose Drugs@FDA approval letter or label names achondroplasia in its indication, for a product whose active ingredient is infigratinib or a salt of it (infigratinib phosphate, for example), under any applicant (BridgeBio Pharma, its subsidiary QED Therapeutics, or another BridgeBio subsidiary) and any proprietary name. Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22INFIGRATINIB%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22infigratinib%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain such an approval: an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2027-02-04, or, if FDA acts on the achondroplasia indication as a supplement to an existing infigratinib application, an efficacy supplement with submission_status AP and a submission_status_date on or before 2027-02-04 whose letter or label adds achondroplasia. An approval for a narrower achondroplasia population than the applicant sought (by age, for example) still resolves YES, as does accelerated rather than traditional approval. Resolves NO if no approval action is dated on or before 2027-02-04: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2027-02-04 resolves NO as occurred_after_deadline. 2027-02-04 is a Thursday. Read no earlier than 2027-02-18. If openFDA has not refreshed by then, or both queries return nothing new, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name infigratinib) governs, under the same identification test. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22infigratinib%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22INFIGRATINIB%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ 6 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-053 FDA Tinlarebant · Stargardt disease approval 70 % 70% Feb 12, 2027 Unresolved The FDA takes an approval action on Belite Bio's New Drug Application for oral tinlarebant for the treatment of Stargardt disease type 1 (STGD1), with an approval action date on or before 2027-02-12, the PDUFA target action date disclosed in Exhibit 99.1 to Belite Bio's Form 6-K filed 2026-08-13. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 70 % base-rate Authority base rate 80 % heuristic Calendar cycle 80 % expert Analyst proxy 70 % #### From cutoff to deadline Evidence cutoff Oct 21, 2026 Registered Oct 21, 2026 Event by Feb 12, 2027 Window closes Feb 12, 2027 Resolution rule, source, and archived material The application number was not public at the cutoff, and openFDA held no record for the ingredient (SRC-004, SRC-005). The adjudicator identifies the qualifying approval by its indication plus its ingredient, never by a name the adjudicator infers: an approval action whose Drugs@FDA approval letter or label names Stargardt disease (STGD1, or Stargardt disease caused by ABCA4 mutations) in its indication, for a product whose active ingredient is tinlarebant (LBS-008) or a salt of it, under any applicant (Belite Bio, Inc or a Belite Bio subsidiary) and any proprietary name. Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22TINLAREBANT%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22tinlarebant%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain such an approval: an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2027-02-12. An approval for a narrower STGD1 population than the applicant sought (by age, for example) still resolves YES, as does accelerated rather than traditional approval. Resolves NO if no approval action is dated on or before 2027-02-12: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2027-02-12 resolves NO as occurred_after_deadline. 2027-02-12 is a Friday. Read no earlier than 2027-02-26. If openFDA has not refreshed by then, or both queries return nothing, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name tinlarebant) governs, under the same identification test. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22tinlarebant%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22TINLAREBANT%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ 6 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-056 FDA Roflumilast cream · infant atopic dermatitis supplement approval 88 % 88% Feb 23, 2027 Unresolved The FDA takes an approval action on a supplement to NDA 215985 (roflumilast, ZORYVE cream; applicant Arcutis Biotherapeutics) whose approved labeling extends ZORYVE cream 0.05% to the treatment of mild to moderate atopic dermatitis in infants younger than 2 years, with an approval action date on or before 2027-02-23, the PDUFA target action date disclosed in Arcutis’s Form 10-Q filed 2026-08-05. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 88 % base-rate Authority base rate 85 % heuristic Calendar cycle 80 % expert Analyst proxy 85 % #### From cutoff to deadline Evidence cutoff Oct 26, 2026 Registered Oct 26, 2026 Event by Feb 23, 2027 Window closes Feb 23, 2027 Resolution rule, source, and archived material Resolves YES if the openFDA Drugs@FDA record for application NDA215985 (https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA215985%22) contains a submission with submission_type SUPPL, submission_status AP and a submission_status_date on or before 2027-02-23, and the Drugs@FDA approval letter or label for that supplement extends the ZORYVE cream 0.05% atopic dermatitis indication to patients younger than 2 years. The supplement is identified by that content, not by its number or class code. At the cutoff the latest approved supplement was SUPPL 15, approved 2026-06-29 (SRC-004), which is not this one: the 0.05% cream was then labeled for children 2 to 5 years old, and Arcutis described the infant supplement as under review after that date (SRC-001, SRC-002). An approval whose lower age bound is above 3 months but below 2 years still resolves YES. Resolves NO if no approval action is dated on or before 2027-02-23: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2027-02-23 resolves NO as occurred_after_deadline. 2027-02-23 is a Tuesday. Read no earlier than 2027-03-09; if openFDA has not refreshed, the Drugs@FDA web record for NDA215985 (https://www.accessdata.fda.gov/scripts/cder/daf/) governs. Resolves unresolvable only if neither source can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Resolution source https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA215985%22, https://www.accessdata.fda.gov/scripts/cder/daf/ 4 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a PDUFA goal date commits FDA to FF-003 FDA Sunvozertinib · first-line approval by March 55 % 55% Mar 31, 2027 Unresolved The FDA approves a first-line / initial-treatment indication for sunvozertinib (ZEGFROVY) in EGFR exon 20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer — expected as an efficacy supplement to NDA 219839, held by Dizal at the cutoff — with an approval action dated on or before 2027-03-31. The resolution window closes 2027-07-31 so that this record is read at the same sitting as FF-002's; an approval action dated 2027-04-01 or later resolves this proposition NO. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 55 % base-rate Authority base rate 60 % heuristic Calendar cycle 40 % expert Analyst proxy 65 % #### From cutoff to deadline Evidence cutoff Sep 22, 2026 Registered Sep 22, 2026 Event by Mar 31, 2027 Window closes Jul 31, 2027 Resolution rule, source, and archived material Resolves YES if the openFDA Drugs@FDA record for application number NDA219839 — queried as https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA219839%22 , by application number and not brand name, so that a rebrand after the AstraZeneca licence cannot empty the query — contains a submission with submission_type SUPPL (or, if the supplement literal in the live record differs from SUPPL, any submission whose submission_type is not ORIG), submission_status AP, and submission_status_date on or before 20270331 (the field is YYYYMMDD), whose approved labeling covers the first-line / initial-treatment (previously untreated) setting for EGFR exon 20 insertion mutation-positive locally advanced or metastatic NSCLC. The indication is read from Section 1 (INDICATIONS AND USAGE) of the label PDF linked from that submission's application_docs entry of type Label or, if that link is absent, from the current label on the Drugs@FDA web record for NDA 219839 at https://www.accessdata.fda.gov/scripts/cder/daf/ ; a labeling supplement that adds WU-KONG28 to Section 14 (CLINICAL STUDIES) without changing Section 1 does NOT count. An action dated exactly 2027-03-31 counts. The date read is submission_status_date; if openFDA has not refreshed by the reading date (meta.last_updated earlier than the approval), the Action Date shown for that supplement on the Drugs@FDA web record governs, and if the two disagree the date on the approval letter (application_docs type Letter) governs. Adjudication floor: read no earlier than 2027-08-31 and no later than 2027-10-31, at the same sitting as FF-002. Resolves NO if no such approval action is dated on or before 2027-03-31 — including the case where the same indication is approved between 2027-04-01 and 2027-07-31, which resolves FF-002 YES and this record NO, by design. Resolves VOID, with the reason recorded, only if FDA restructures Drugs@FDA or withdraws the openFDA drugsfda endpoint so that no per-supplement action date can be read from either the JSON or the Drugs@FDA web record; while either source publishes the date, the rule stands. If the sponsor withdraws the supplement, or receives a complete response and does not obtain an approval by 2027-03-31, the record resolves NO on plain terms, not VOID. A change of application holder from Dizal to AstraZeneca, or of brand name, has no effect: the rule matches on application number NDA219839 and the query is by application number. Exclusions carried unchanged from FF-002: a supplement approved only for a later-line, maintenance or non-NSCLC indication does NOT count; conversion of the existing accelerated approval in the previously treated setting to traditional approval does NOT count; a first-line indication restricted to a narrower population than the full exon 20 insertion group (for example nonsquamous histology only) DOES count, provided it is first-line. A first-line indication approved under a new NDA rather than a supplement to 219839 DOES count, provided the labeling covers the specified population and setting; the adjudicator then reads that NDA's ORIG submission by the same fields. Both sources are public and unauthenticated; the JSON is machine-readable, the label is a PDF read by a person; no oncology judgement is needed. An approval action dated on or before the availability cutoff means the proposition was resolved before it was frozen: VOID as ill-posed, not YES. Resolution source openFDA Drugs@FDA record for NDA 219839, with the Drugs@FDA web record and the approval letter as fallbacks for the action date 7 sources archived with the registration, plus 1 held in the ledger. #### Also asked about Sunvozertinib · first-line NSCLC These share an evidence context. They are not independent cases, and they are not independent evidence. - FF-001 Sunvozertinib · first-line guideline listing - FF-002 Sunvozertinib · first-line approval - FF-004 Sunvozertinib · FDA approval before NCCN listing Full record, sources, and baseline rationale Verify this record FF-002 FDA Sunvozertinib · first-line approval 88 % 88% Jul 31, 2027 Unresolved The FDA approves a first-line / initial-treatment indication for sunvozertinib (ZEGFROVY) in EGFR exon 20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer, expected as a supplement to NDA 219839, with an approval action dated on or before 2027-07-31. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 88 % base-rate Authority base rate 85 % heuristic Calendar cycle 70 % expert Analyst proxy 90 % #### From cutoff to deadline Evidence cutoff Sep 22, 2026 Registered Sep 22, 2026 Event by Jul 31, 2027 Window closes Jul 31, 2027 Resolution rule, source, and archived material Resolves YES if the openFDA Drugs@FDA record for application NDA219839 contains a submission with submission_type SUPPL and submission_status AP, whose submission_status_date is on or before 2027-07-31, and whose approved labeling includes EGFR exon 20 insertion mutation-positive NSCLC in the first-line / initial-treatment setting. The adjudicator queries https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA219839%22 and reads the submissions array, then confirms the indication against the Drugs@FDA label for that supplement at https://www.accessdata.fda.gov/scripts/cder/daf/. Resolves NO if no such supplement is approved by that date. Read no earlier than 2027-08-31. If the openFDA record has not refreshed, the Drugs@FDA web record governs. Resolves VOID, with the reason recorded, only if FDA restructures Drugs@FDA such that supplement-level approval actions are no longer published per application and the openFDA drugsfda endpoint is withdrawn without an equivalent public successor, so that no approval action for a supplement to NDA219839 can be read from either source; while either source publishes it, the rule stands. Withdrawal of the application by the sponsor is NO on its plain terms, not VOID: no approval can occur. A brand-name change following the AstraZeneca license, or a transfer of the application holder from Dizal to AstraZeneca, does not void the record: the rule matches on application number NDA219839, which survives both. A supplement approved only for a later-line, maintenance, or non-NSCLC indication does NOT count. Approval of a first-line indication restricted to a narrower population than the full exon20ins group DOES count, provided it is first-line. Conversion of the existing accelerated approval to full approval in the previously approved later-line setting does NOT count. No oncology judgement is needed to apply this rule: both sources are public and unauthenticated; the indication is read from Section 1 (Indications and Usage) of the approved label PDF that the Drugs@FDA record links for the supplement. A first-line indication approved under a new NDA rather than a supplement to 219839 DOES count, provided the labeling covers the specified population and setting; the adjudicator then reads that NDA's ORIG submission by the same fields. Resolution source openFDA Drugs@FDA record for NDA 219839, with the Drugs@FDA web record and the approval letter as fallbacks for the action date 3 sources archived with the registration, plus 1 held in the ledger. #### Also asked about Sunvozertinib · first-line NSCLC These share an evidence context. They are not independent cases, and they are not independent evidence. - FF-003 Sunvozertinib · first-line approval by March - FF-001 Sunvozertinib · first-line guideline listing - FF-004 Sunvozertinib · FDA approval before NCCN listing Full record, sources, and baseline rationale Verify this record ### NCCN 2 forecasts FF-001 NCCN Sunvozertinib · first-line guideline listing 75 % 75% Jul 31, 2027 Unresolved A version of the NCCN Clinical Practice Guidelines in Oncology for Non-Small Cell Lung Cancer carrying a version date on or before 2027-07-31 lists sunvozertinib (ZEGFROVY) as a first-line / initial systemic therapy option, at any NCCN category, for EGFR exon 20 insertion mutation-positive metastatic non-squamous NSCLC. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 75 % base-rate Authority base rate 62 % heuristic Calendar cycle 40 % expert Analyst proxy 80 % #### From cutoff to deadline Evidence cutoff Jul 31, 2026 Registered Aug 17, 2026 Event by Jul 31, 2027 Window closes Jul 31, 2027 Resolution rule, source, and archived material Resolves YES if any NCCN NSCLC guideline version dated on or before 2027-07-31 names sunvozertinib (or ZEGFROVY) anywhere in the initial-systemic-therapy recommendation set for EGFR exon 20 insertion mutation-positive metastatic non-squamous NSCLC, at any category (1, 2A, 2B, or 3) and whether or not it is marked preferred. The adjudicator reads the NSCLC algorithm page for initial systemic therapy in EGFR exon 20 insertion mutation-positive disease and the corresponding systemic therapy tables, in the latest version dated on or before 2027-07-31. Resolves NO if no such version names it there. Listing confined to subsequent-line or post-progression therapy does NOT count. Access requires free NCCN registration; no clinical judgement about the drug is needed to apply this rule. Resolution source NCCN NSCLC guideline — initial systemic therapy algorithm and tables for EGFR exon 20 insertion mutation-positive disease, latest version dated on or before 2027-07-31 6 sources archived with the registration. #### Also asked about Sunvozertinib · first-line NSCLC These share an evidence context. They are not independent cases, and they are not independent evidence. - FF-003 Sunvozertinib · first-line approval by March - FF-002 Sunvozertinib · first-line approval - FF-004 Sunvozertinib · FDA approval before NCCN listing Full record, sources, and baseline rationale Verify this record FF-004 NCCN Sunvozertinib · FDA approval before NCCN listing 45 % 45% Jul 31, 2027 Unresolved On or before 2027-07-31 both of the following occur: (a) the FDA approves a first-line / initial-treatment indication for sunvozertinib (ZEGFROVY) in EGFR exon 20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer, expected as a supplement to NDA 219839 (the event FF-002 scores); and (b) a version of the NCCN Clinical Practice Guidelines in Oncology for Non-Small Cell Lung Cancer lists sunvozertinib (ZEGFROVY) as a first-line / initial systemic therapy option, at any NCCN category, for EGFR exon 20 insertion mutation-positive metastatic non-squamous NSCLC (the event FF-001 scores) — and the date of the FDA approval action is strictly earlier than the version date of the earliest NCCN NSCLC version carrying that listing. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 45 % base-rate Authority base rate 50 % heuristic Calendar cycle 15 % expert Analyst proxy 55 % #### From cutoff to deadline Evidence cutoff Sep 22, 2026 Registered Sep 22, 2026 Event by Jul 31, 2027 Window closes Jul 31, 2027 Resolution rule, source, and archived material Two dates are read, each under its sibling's rule as amended by workspace/reviews/2026-09-05-ff-001-ff-002-falsification.md §3d, and compared at day precision, the finest either record carries. D_FDA: the submission_status_date (YYYYMMDD) of the earliest submission in the openFDA Drugs@FDA record for application number NDA219839 — queried as https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA219839%22 — whose submission_type is SUPPL (or, if the live literal differs, is not ORIG), whose submission_status is AP, and whose approved labeling, read from Section 1 (INDICATIONS AND USAGE) of the label PDF linked in that submission's application_docs (type Label) or from the Drugs@FDA web record at https://www.accessdata.fda.gov/scripts/cder/daf/ , covers the first-line / initial-treatment setting for EGFR exon 20 insertion mutation-positive locally advanced or metastatic NSCLC. If openFDA has not refreshed by the reading date, the Action Date on the Drugs@FDA web record governs; if the two disagree, the date on the approval letter governs. A first-line approval under a new NDA counts, read from that NDA's ORIG row. Exclusions as in FF-002: later-line, maintenance, non-NSCLC, or conversion of the existing accelerated approval do not count; a narrower first-line population does. D_NCCN: the version date printed on the earliest version of the NCCN NSCLC guideline, dated on or before 2027-07-31, that names sunvozertinib or ZEGFROVY in the initial-systemic-therapy recommendation set for EGFR exon 20 insertion mutation-positive metastatic non-squamous NSCLC, at any category (1, 2A, 2B or 3), whether or not marked preferred, on the algorithm page for initial systemic therapy or in the corresponding systemic-therapy table; footnotes attached to that first-line options block count, footnotes on testing, discussion text and 'Principles of' pages do not; a listing confined to subsequent-line therapy does not count. The version date is the date NCCN prints beside the version number on the guideline's cover; if a version prints a number but its date appears only in its Updates section, that date governs. NCCN distributes only its current version, so the adjudicator reads captured copies of every NSCLC version issued inside the window (the repository is to capture each with its date and digest as it appears — an operational task, not a rule change). Bracket rule when the earliest listing version was not captured: let L be the version date of the latest version known not to carry the listing and U the version date of the earliest version known to carry it; if the exact D_NCCN cannot be established, resolve YES if D_FDA is on or before L, NO if D_FDA is on or after U, and VOID with the reason 'earliest listing version date not recoverable' if D_FDA falls strictly between L and U. Resolution: YES if and only if both D_FDA and D_NCCN exist on or before 2027-07-31 and D_FDA is strictly earlier than D_NCCN. NO if D_NCCN is earlier than or equal to D_FDA — a same-day tie resolves NO, is recorded as a tie, and is not broken by appeal to the hypothesised mechanism — or if either event has not occurred by 2027-07-31. NCCN versions dated after 2027-07-31 and FDA actions dated after 2027-07-31 are ignored. Adjudication floor: read no earlier than 2027-08-31 and no later than 2027-10-31, at the same sitting as FF-001 and FF-002. Access: openFDA and Drugs@FDA are public and unauthenticated; NCCN requires free registration. No clinical judgement about the drug is needed. VOID, with the reason recorded, if a first-line recommendation set for exon 20 insertion disease is distinguishable in no version issued inside the window, or if neither openFDA nor the Drugs@FDA web record publishes per-supplement action dates at the reading date; VOID as ill-posed if the earliest listing version is dated on or before the availability cutoff. Resolution source FDA action date from openFDA Drugs@FDA for NDA 219839; NCCN listing date from the version date of the earliest captured NCCN NSCLC version carrying the listing; compared at day precision 8 sources archived with the registration, plus 1 held in the ledger. #### Also asked about Sunvozertinib · first-line NSCLC These share an evidence context. They are not independent cases, and they are not independent evidence. - FF-003 Sunvozertinib · first-line approval by March - FF-001 Sunvozertinib · first-line guideline listing - FF-002 Sunvozertinib · first-line approval Full record, sources, and baseline rationale Verify this record ### NICE 24 forecasts FF-016 NICE Epcoritamab combination · guidance publication 45 % 45% Oct 28, 2026 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Epcoritamab with rituximab and lenalidomide for treating relapsed or refractory follicular lymphoma after 1 or more systemic treatments' [ID6586], with a publication date on or before 2026-10-28, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11768) on 2026-09-22. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 45 % base-rate Authority base rate 50 % heuristic Calendar cycle 55 % expert Analyst proxy 45 % #### From cutoff to deadline Evidence cutoff Sep 26, 2026 Registered Sep 26, 2026 Event by Oct 28, 2026 Window closes Oct 28, 2026 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID6586 shows a publication date ('Published: ') on or before 2026-10-28, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6586. Resolves NO if the guidance is published after 2026-10-28, if the expected date is revised and nothing is published by 2026-10-28, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-11-04. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11768, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 1 source archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-017 NICE Inavolisib combination · guidance publication 50 % 50% Nov 3, 2026 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Inavolisib with palbociclib and fulvestrant for treating recurrent hormone receptor-positive HER2-negative PIK3CA-positive advanced breast cancer after adjuvant endocrine treatment' [ID6425], with a publication date on or before 2026-11-03, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11519) on 2026-09-22. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 50 % base-rate Authority base rate 50 % heuristic Calendar cycle 60 % expert Analyst proxy 50 % #### From cutoff to deadline Evidence cutoff Sep 26, 2026 Registered Sep 26, 2026 Event by Nov 3, 2026 Window closes Nov 3, 2026 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID6425 shows a publication date ('Published: ') on or before 2026-11-03, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6425. Resolves NO if the guidance is published after 2026-11-03, if the expected date is revised and nothing is published by 2026-11-03, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-11-10. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11519, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 1 source archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-019 NICE Nivolumab + ipilimumab · guidance publication 45 % 45% Nov 11, 2026 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Nivolumab with ipilimumab for untreated advanced hepatocellular carcinoma' [ID6239], with a publication date on or before 2026-11-11, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11116) on 2026-09-22. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 45 % base-rate Authority base rate 50 % heuristic Calendar cycle 55 % expert Analyst proxy 45 % #### From cutoff to deadline Evidence cutoff Sep 26, 2026 Registered Sep 26, 2026 Event by Nov 11, 2026 Window closes Nov 11, 2026 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID6239 shows a publication date ('Published: ') on or before 2026-11-11, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6239. Resolves NO if the guidance is published after 2026-11-11, if the expected date is revised and nothing is published by 2026-11-11, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-11-18. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11116, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 1 source archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-022 NICE Zuranolone · guidance publication 50 % 50% Nov 12, 2026 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Zuranolone for treating postnatal depression' [ID6431], with a publication date on or before 2026-11-12, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11356) on 2026-09-24. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 50 % base-rate Authority base rate 50 % heuristic Calendar cycle 60 % expert Analyst proxy 50 % #### From cutoff to deadline Evidence cutoff Sep 26, 2026 Registered Sep 26, 2026 Event by Nov 12, 2026 Window closes Nov 12, 2026 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID6431 shows a publication date ('Published: ') on or before 2026-11-12, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6431. Resolves NO if the guidance is published after 2026-11-12, if the expected date is revised and nothing is published by 2026-11-12, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-11-19. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11356, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 4 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-014 NICE Beremagene geperpavec · guidance publication 35 % 35% Nov 18, 2026 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Beremagene geperpavec for treating skin wounds associated with dystrophic epidermolysis bullosa' [ID3959], with a publication date on or before 2026-11-18, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta10868) on 2026-09-24. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 35 % base-rate Authority base rate 50 % heuristic Calendar cycle 60 % expert Analyst proxy 40 % #### From cutoff to deadline Evidence cutoff Sep 26, 2026 Registered Sep 26, 2026 Event by Nov 18, 2026 Window closes Nov 18, 2026 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID3959 shows a publication date ('Published: ') on or before 2026-11-18, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID3959. Resolves NO if the guidance is published after 2026-11-18, if the expected date is revised and nothing is published by 2026-11-18, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-11-25. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta10868, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 4 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-015 NICE Efgartigimod · CIDP guidance publication 45 % 45% Nov 18, 2026 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Efgartigimod for treating chronic inflammatory demyelinating polyneuropathy' [ID6409], with a publication date on or before 2026-11-18, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11508) on 2026-09-24. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 45 % base-rate Authority base rate 50 % heuristic Calendar cycle 60 % expert Analyst proxy 45 % #### From cutoff to deadline Evidence cutoff Sep 26, 2026 Registered Sep 26, 2026 Event by Nov 18, 2026 Window closes Nov 18, 2026 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID6409 shows a publication date ('Published: ') on or before 2026-11-18, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6409. Resolves NO if the guidance is published after 2026-11-18, if the expected date is revised and nothing is published by 2026-11-18, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-11-25. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11508, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 4 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-018 NICE Larotrectinib · guidance publication 55 % 55% Nov 18, 2026 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Larotrectinib for treating NTRK fusion-positive advanced solid tumours (MA review of TA630)' [ID6292], the new guidance this managed access review produces and not TA630 itself, with a publication date on or before 2026-11-18, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11565) on 2026-09-24. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 55 % base-rate Authority base rate 50 % heuristic Calendar cycle 60 % expert Analyst proxy 50 % #### From cutoff to deadline Evidence cutoff Sep 26, 2026 Registered Sep 26, 2026 Event by Nov 18, 2026 Window closes Nov 18, 2026 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID6292 shows a publication date ('Published: ') on or before 2026-11-18, whatever the guidance recommends. That page is the new guidance this managed access review produces, not TA630: TA630's own publication date never counts. If NICE instead publishes the review's final guidance as an update to the TA630 page, the date that page gives for that update (its 'Last updated' date, with an update entry naming this review or ID6292) is the publication date, and TA630's original publication date still does not count. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6292. Resolves NO if the guidance is published after 2026-11-18, if the expected date is revised and nothing is published by 2026-11-18, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-11-25. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11565, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance, https://www.nice.org.uk/guidance/ta630 3 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-020 NICE Orforglipron · guidance publication 5 % 5% Nov 18, 2026 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Orforglipron for managing overweight and obesity' [ID6516], with a publication date on or before 2026-11-18, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11650) on 2026-09-24. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 5 % base-rate Authority base rate 50 % heuristic Calendar cycle 25 % expert Analyst proxy 10 % #### From cutoff to deadline Evidence cutoff Sep 26, 2026 Registered Sep 26, 2026 Event by Nov 18, 2026 Window closes Nov 18, 2026 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID6516 shows a publication date ('Published: ') on or before 2026-11-18, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6516. Resolves NO if the guidance is published after 2026-11-18, if the expected date is revised and nothing is published by 2026-11-18, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-11-25. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11650, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 3 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-021 NICE Pembrolizumab combination · guidance publication 50 % 50% Nov 18, 2026 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Pembrolizumab with chemotherapy with or without bevacizumab for treating platinum-resistant recurrent ovarian cancer after 1 or 2 treatments' [ID6363], with a publication date on or before 2026-11-18, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11422) on 2026-09-24. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 50 % base-rate Authority base rate 50 % heuristic Calendar cycle 60 % expert Analyst proxy 50 % #### From cutoff to deadline Evidence cutoff Sep 26, 2026 Registered Sep 26, 2026 Event by Nov 18, 2026 Window closes Nov 18, 2026 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID6363 shows a publication date ('Published: ') on or before 2026-11-18, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6363. Resolves NO if the guidance is published after 2026-11-18, if the expected date is revised and nothing is published by 2026-11-18, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-11-25. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11422, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 3 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-028 NICE Obicetrapib · hypercholesterolaemia guidance publication 40 % 40% Nov 25, 2026 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Obicetrapib and obicetrapib–ezetimibe for treating primary hypercholesterolaemia or mixed dyslipidaemia' [ID6519], with a publication date on or before 2026-11-25, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11649) on 2026-10-01. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 40 % base-rate Authority base rate 50 % heuristic Calendar cycle 55 % expert Analyst proxy 40 % #### From cutoff to deadline Evidence cutoff Oct 6, 2026 Registered Oct 6, 2026 Event by Nov 25, 2026 Window closes Nov 25, 2026 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID6519 shows a publication date ('Published: ') on or before 2026-11-25, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6519. Searching for GID-TA11649 finds the same project. Resolves NO if the guidance is published after 2026-11-25, if the expected date is revised and nothing is published by 2026-11-25, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-12-02. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11649, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 5 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-029 NICE Polihexanide · acanthamoeba keratitis guidance publication 35 % 35% Nov 25, 2026 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Polihexanide 0.8 mg/ml eye drops for treating acanthamoeba keratitis in people 12 years and over' [ID6497], with a publication date on or before 2026-11-25, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11643) on 2026-10-01. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 35 % base-rate Authority base rate 50 % heuristic Calendar cycle 55 % expert Analyst proxy 35 % #### From cutoff to deadline Evidence cutoff Oct 6, 2026 Registered Oct 6, 2026 Event by Nov 25, 2026 Window closes Nov 25, 2026 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID6497 shows a publication date ('Published: ') on or before 2026-11-25, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6497. Searching for GID-TA11643 finds the same project. Resolves NO if the guidance is published after 2026-11-25, if the expected date is revised and nothing is published by 2026-11-25, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-12-02. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11643, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 6 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-048 NICE Onasemnogene abeparvovec (intrathecal) · SMA guidance publication 35 % 35% Nov 25, 2026 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Intrathecal onasemnogene abeparvovec for treating spinal muscular atrophy in people 2 years and over' [ID6556], with a publication date on or before 2026-11-25, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11733) on 2026-10-01. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 35 % base-rate Authority base rate 50 % heuristic Calendar cycle 55 % expert Analyst proxy 35 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Nov 25, 2026 Window closes Nov 25, 2026 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID6556 shows a publication date ('Published: ') on or before 2026-11-25, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6556. Searching for GID-TA11733 finds the same project. Resolves NO if the guidance is published after 2026-11-25, if the expected date is revised and nothing is published by 2026-11-25, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-12-02. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11733, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 5 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-050 NICE Resmetirom · MASH guidance publication 35 % 35% Dec 9, 2026 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Resmetirom for treating non-alcoholic steatohepatitis and liver fibrosis' [ID6529], with a publication date on or before 2026-12-09, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11414) on 2026-10-01. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 35 % base-rate Authority base rate 50 % heuristic Calendar cycle 55 % expert Analyst proxy 35 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Dec 9, 2026 Window closes Dec 9, 2026 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID6529 shows a publication date ('Published: ') on or before 2026-12-09, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6529. Searching for GID-TA11414 finds the same project. Resolves NO if the guidance is published after 2026-12-09, if the expected date is revised and nothing is published by 2026-12-09, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-12-16. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11414, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 6 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-040 NICE Retifanlimab · anal cancer guidance publication 30 % 30% Dec 16, 2026 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Retifanlimab with platinum-based chemotherapy for treating inoperable, locally recurrent or metastatic squamous cell anal canal cancer untreated with systemic chemotherapy' [ID6482], with a publication date on or before 2026-12-16, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11625) on 2026-10-01. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 30 % base-rate Authority base rate 50 % heuristic Calendar cycle 45 % expert Analyst proxy 30 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Dec 16, 2026 Window closes Dec 16, 2026 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID6482 shows a publication date ('Published: ') on or before 2026-12-16, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6482. Searching for GID-TA11625 finds the same project. Resolves NO if the guidance is published after 2026-12-16, if the expected date is revised and nothing is published by 2026-12-16, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-12-23. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11625, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 5 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-051 NICE Semaglutide · MASH guidance publication 25 % 25% Jan 7, 2027 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Semaglutide for treating moderate to advanced liver fibrosis (without cirrhosis) caused by metabolic dysfunction-associated steatohepatitis' [ID6458], with a publication date on or before 2027-01-07, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11477) on 2026-10-01. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 25 % base-rate Authority base rate 50 % heuristic Calendar cycle 45 % expert Analyst proxy 25 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Jan 7, 2027 Window closes Jan 7, 2027 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID6458 shows a publication date ('Published: ') on or before 2027-01-07, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6458. Searching for GID-TA11477 finds the same project. Resolves NO if the guidance is published after 2027-01-07, if the expected date is revised and nothing is published by 2027-01-07, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2027-01-14. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11477, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 7 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-041 NICE Tarlatamab · small-cell lung cancer guidance publication 30 % 30% Jan 13, 2027 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Tarlatamab for treating extensive stage small-cell lung cancer that has progressed after platinum-based chemotherapy' [ID6617], with a publication date on or before 2027-01-13, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11812) on 2026-10-01. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 30 % base-rate Authority base rate 50 % heuristic Calendar cycle 45 % expert Analyst proxy 30 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Jan 13, 2027 Window closes Jan 13, 2027 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID6617 shows a publication date ('Published: ') on or before 2027-01-13, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6617. Searching for GID-TA11812 finds the same project. Resolves NO if the guidance is published after 2027-01-13, if the expected date is revised and nothing is published by 2027-01-13, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2027-01-20. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11812, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 4 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-042 NICE Toripalimab · nasopharyngeal cancer guidance publication 40 % 40% Jan 13, 2027 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Toripalimab with chemotherapy for untreated recurrent or metastatic nasopharyngeal cancer' [ID6406], with a publication date on or before 2027-01-13, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11341) on 2026-10-01. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 40 % base-rate Authority base rate 50 % heuristic Calendar cycle 55 % expert Analyst proxy 40 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Jan 13, 2027 Window closes Jan 13, 2027 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID6406 shows a publication date ('Published: ') on or before 2027-01-13, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6406. Searching for GID-TA11341 finds the same project. Resolves NO if the guidance is published after 2027-01-13, if the expected date is revised and nothing is published by 2027-01-13, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2027-01-20. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11341, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 6 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-039 NICE Nerandomilast · pulmonary fibrosis guidance publication 40 % 40% Jan 20, 2027 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Nerandomilast for treating idiopathic pulmonary fibrosis or progressive pulmonary fibrosis' [ID6446], with a publication date on or before 2027-01-20, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11552) on 2026-10-01. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 40 % base-rate Authority base rate 50 % heuristic Calendar cycle 55 % expert Analyst proxy 40 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Jan 20, 2027 Window closes Jan 20, 2027 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID6446 shows a publication date ('Published: ') on or before 2027-01-20, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6446. Searching for GID-TA11552 finds the same project. Resolves NO if the guidance is published after 2027-01-20, if the expected date is revised and nothing is published by 2027-01-20, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2027-01-27. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11552, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 7 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-043 NICE Trastuzumab deruxtecan · gastric cancer guidance publication 30 % 30% Jan 27, 2027 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Trastuzumab deruxtecan for treating HER2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma after trastuzumab-based treatment (review of TA879)' [ID6680], with a publication date on or before 2027-01-27, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11963) on 2026-10-01. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 30 % base-rate Authority base rate 50 % heuristic Calendar cycle 45 % expert Analyst proxy 30 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Jan 27, 2027 Window closes Jan 27, 2027 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID6680 shows a publication date ('Published: ') on or before 2027-01-27, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6680. Searching for GID-TA11963 finds the same project. This appraisal reviews TA879; the original publication date of TA879 does not count. If NICE publishes the review by updating TA879 in place, the date that page gives for this update is the publication date read. Resolves NO if the guidance is published after 2027-01-27, if the expected date is revised and nothing is published by 2027-01-27, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2027-02-03. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11963, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 4 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-038 NICE Elranatamab · myeloma guidance publication 30 % 30% Jan 28, 2027 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Elranatamab for treating relapsed and refractory multiple myeloma after 3 or more treatments (managed access review of TA1023)' [ID6653], with a publication date on or before 2027-01-28, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11956) on 2026-10-01. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 30 % base-rate Authority base rate 50 % heuristic Calendar cycle 45 % expert Analyst proxy 30 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Jan 28, 2027 Window closes Jan 28, 2027 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID6653 shows a publication date ('Published: ') on or before 2027-01-28, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6653. Searching for GID-TA11956 finds the same project. This appraisal reviews TA1023; the original publication date of TA1023 does not count. If NICE publishes the review by updating TA1023 in place, the date that page gives for this update is the publication date read. Resolves NO if the guidance is published after 2027-01-28, if the expected date is revised and nothing is published by 2027-01-28, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2027-02-04. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11956, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 3 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-049 NICE Pembrolizumab · muscle-invasive bladder cancer guidance publication 35 % 35% Feb 10, 2027 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Pembrolizumab with enfortumab vedotin for neoadjuvant and adjuvant treatment of muscle-invasive bladder cancer' [ID6607], with a publication date on or before 2027-02-10, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11694) on 2026-10-13. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 35 % base-rate Authority base rate 50 % heuristic Calendar cycle 50 % expert Analyst proxy 35 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Feb 10, 2027 Window closes Feb 10, 2027 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID6607 shows a publication date ('Published: ') on or before 2027-02-10, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6607. Searching for GID-TA11694 finds the same project. The project page records that ID6301 was combined into this appraisal, which continues under ID6607 with the title "Enfortumab vedotin with pembrolizumab for neoadjuvant and adjuvant treatment of muscle-invasive bladder cancer"; guidance published from project ID6607 under either title counts. Resolves NO if the guidance is published after 2027-02-10, if the expected date is revised and nothing is published by 2027-02-10, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2027-02-17. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11694, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 4 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-052 NICE Tislelizumab · oesophageal cancer guidance publication 45 % 45% Feb 10, 2027 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Tislelizumab with chemotherapy for untreated advanced oesophageal squamous cell cancer' [ID5113], with a publication date on or before 2027-02-10, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11025) on 2026-10-13. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 45 % base-rate Authority base rate 50 % heuristic Calendar cycle 55 % expert Analyst proxy 45 % #### From cutoff to deadline Evidence cutoff Oct 15, 2026 Registered Oct 15, 2026 Event by Feb 10, 2027 Window closes Feb 10, 2027 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID5113 shows a publication date ('Published: ') on or before 2027-02-10, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID5113. Searching for GID-TA11025 finds the same project. Resolves NO if the guidance is published after 2027-02-10, if the expected date is revised and nothing is published by 2027-02-10, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2027-02-17. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11025, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 4 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-055 NICE Setmelanotide · hypothalamic obesity guidance publication 30 % 30% Feb 10, 2027 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Setmelanotide for treating acquired hypothalamic obesity in people 4 years and over' [ID6542], with a publication date on or before 2027-02-10, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11525) as of the 2026-10-26 cutoff. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 30 % base-rate Authority base rate 50 % heuristic Calendar cycle 50 % expert Analyst proxy 30 % #### From cutoff to deadline Evidence cutoff Oct 26, 2026 Registered Oct 26, 2026 Event by Feb 10, 2027 Window closes Feb 10, 2027 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID6542 shows a publication date ('Published: ') on or before 2027-02-10, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6542. Searching for GID-TA11525 finds the same project. Resolves NO if the guidance is published after 2027-02-10, if the expected date is revised and nothing is published by 2027-02-10, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2027-02-17. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11525, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 4 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to FF-054 NICE Linvoseltamab · myeloma guidance publication 35 % 35% Feb 17, 2027 Unresolved NICE publishes final technology appraisal guidance for the appraisal 'Linvoseltamab for treating relapsed or refractory multiple myeloma after 3 or more treatments' [ID6609], with a publication date on or before 2027-02-17, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11052) on 2026-10-20. #### The frozen estimate, and the baselines beside it Every marker is on the same 0–100% scale. A baseline is a competing estimate frozen at the same cutoff, not an observed result. Registered estimate 35 % base-rate Authority base rate 50 % heuristic Calendar cycle 50 % expert Analyst proxy 35 % #### From cutoff to deadline Evidence cutoff Oct 21, 2026 Registered Oct 21, 2026 Event by Feb 17, 2027 Window closes Feb 17, 2027 Resolution rule, source, and archived material Resolves YES if the NICE technology appraisal guidance page published from project ID6609 shows a publication date ('Published: ') on or before 2027-02-17, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6609. Resolves NO if the guidance is published after 2027-02-17, if the expected date is revised and nothing is published by 2027-02-17, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2027-02-24. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Resolution source https://www.nice.org.uk/guidance/indevelopment/gid-ta11052, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance 4 sources archived with the registration. Full record, sources, and baseline rationale Verify this record What a NICE scheduled date commits NICE to ### Aficamten 1 forecast ### Anitocabtagene autoleucel 1 forecast ### BBP-418 1 forecast ### Bepirovirsen 1 forecast ### Beremagene geperpavec 1 forecast ### Bezuclastinib 2 forecasts ### Deramiocel 1 forecast ### Doxycycline (D-PLEX100) 1 forecast ### Efgartigimod 1 forecast ### Elranatamab 1 forecast ### Epcoritamab 1 forecast ### IGALMI 1 forecast ### Imsidolimab 1 forecast ### Inavolisib 1 forecast ### Infigratinib 1 forecast ### INO-3107 1 forecast ### Ivonescimab 1 forecast ### Larotrectinib 1 forecast ### Lenacapavir 1 forecast ### Leniolisib 1 forecast ### Linvoseltamab 1 forecast ### Lorundrostat 1 forecast ### Meloxicam (MR-107A-02) 1 forecast ### Mitapivat 1 forecast ### Molgramostim 1 forecast ### Neladalkib 1 forecast ### Nerandomilast 1 forecast ### Nivolumab + ipilimumab 1 forecast ### Obicetrapib 1 forecast ### Onasemnogene abeparvovec 1 forecast ### Orforglipron 1 forecast ### Pembrolizumab 1 forecast ### Pembrolizumab with enfortumab vedotin 1 forecast ### Polihexanide 1 forecast ### Povetacicept 1 forecast ### Relacorilant 1 forecast ### Relutrigine 1 forecast ### Resmetirom 1 forecast ### Retifanlimab 1 forecast ### Roflumilast 1 forecast ### Semaglutide 1 forecast ### Setmelanotide 1 forecast ### Sunvozertinib · first-line NSCLC 4 forecasts ### Tarlatamab 1 forecast ### Tinlarebant 1 forecast ### Tislelizumab with chemotherapy 1 forecast ### Toripalimab 1 forecast ### Trastuzumab deruxtecan 1 forecast ### Ulixacaltamide 1 forecast ### Venglustat 1 forecast ### Zeleciment rostudirsen 1 forecast ### Zuranolone 1 forecast No forecasts match these filters. Every registered forecast, by class NCCN guideline reclassification FDA label revision FDA action by goal date NICE guidance by scheduled date - Unresolved 56 - Resolved 0 - Not scored 0 - Expired 0 Registry snapshot 2026-10-26. Verify a record The FDA goal dates and NICE expected dates by month: PDUFA calendar · NICE appraisal calendar . Every deadline as a calendar file: dates and links, no estimates. Add to calendar Every registration, and every adjudication when it is recorded. RSS feed The registry as one file, exactly as exported: registry.json , with its SHA-256 in the manifest . Each probability is the estimate that the named action is taken by the stated deadline. The full resolution rule is attached to every record. --- # PDUFA calendar 2026–2027: FDA goal dates with registered forecasts URL: https://nextconsensus.com/pdufa-calendar/ ## PDUFA calendar 2026–2027: FDA goal dates with registered forecasts This calendar lists the FDA goal dates NextConsensus has registered a forecast on, month by month. Each row gives the drug, the applicant, the FDA review center and the registered probability. Follow a row to its record for the terms that settle it. A row's probability is the estimate that FDA approves the application by its goal date. It was frozen at registration. A complete response letter, an extension, a withdrawal, no action, or an approval after the date resolves the record NO. FDA does not publish goal dates, so each date is the one the sponsor or its partner disclosed in a filing. The PDUFA date guide covers where the dates come from and what each outcome means for a plan. FDA action by goal date: 28 registered · 28 unresolved · 0 resolved. Registry snapshot 2026-10-26. ### PDUFA dates in October 2026 Goal date Drug and application Applicant Reviewed by Registered probability Oct 26, 2026 Bepirovirsen · hepatitis B approval FF-007 GSK FDA · CDER 84% Unresolved Oct 30, 2026 INO-3107 · papillomatosis approval FF-010 Inovio FDA · CBER 45% Unresolved ### PDUFA dates in November 2026 Goal date Drug and application Applicant Reviewed by Registered probability Nov 1, 2026 Mitapivat · sickle cell supplement approval FF-012 Agios FDA · CDER 72% Unresolved Nov 14, 2026 Aficamten · MAPLE-HCM supplement approval FF-005 Cytokinetics FDA · CDER 82% Unresolved Nov 14, 2026 IGALMI · at-home supplement approval FF-009 BioXcel Therapeutics (applicant at the cutoff) FDA · CDER 35% Unresolved Nov 14, 2026 Ivonescimab · post-TKI NSCLC approval FF-011 Summit Therapeutics FDA · CDER 15% Unresolved Nov 22, 2026 Deramiocel · Duchenne approval FF-008 Capricor Therapeutics FDA · CBER 35% Unresolved Nov 22, 2026 Molgramostim · aPAP approval FF-013 Savara FDA · CDER 75% Unresolved Nov 25, 2026 Venglustat · type 3 Gaucher disease approval FF-027 Sanofi FDA · CDER 75% Unresolved Nov 27, 2026 BBP-418 · muscular dystrophy approval FF-006 BridgeBio Pharma FDA · CDER 85% Unresolved Nov 27, 2026 Neladalkib · ALK-positive NSCLC approval FF-025 Nuvalent (a GSK company since July 2026) FDA · CDER 85% Unresolved Nov 28, 2026 D-PLEX100 · colorectal surgical site infection approval FF-024 PolyPid FDA · CDER 55% Unresolved Nov 30, 2026 Bezuclastinib · GIST approval FF-023 Cogent Biosciences FDA · CDER 85% Unresolved Nov 30, 2026 Povetacicept · IgA nephropathy approval FF-026 Vertex FDA · CDER 85% Unresolved ### PDUFA dates in December 2026 Goal date Drug and application Applicant Reviewed by Registered probability Dec 12, 2026 Imsidolimab · generalized pustular psoriasis approval FF-032 Vanda Pharmaceuticals FDA · CDER 70% Unresolved Dec 17, 2026 Relacorilant · Cushing's syndrome approval FF-034 Corcept Therapeutics FDA · CDER 45% Unresolved Dec 22, 2026 Lorundrostat · hypertension approval FF-033 Mineralys Therapeutics FDA · CDER 82% Unresolved Dec 23, 2026 Anito-cel · multiple myeloma approval FF-030 Arcellx (a Gilead Sciences subsidiary since April 2026) FDA · CBER 75% Unresolved Dec 27, 2026 Relutrigine · SCN2A/SCN8A epilepsy approval FF-035 Praxis FDA · CDER 80% Unresolved Dec 27, 2026 Fast-acting meloxicam · acute pain approval FF-047 Viatris FDA · CDER 78% Unresolved Dec 30, 2026 Bezuclastinib · nonadvanced systemic mastocytosis approval FF-031 Cogent Biosciences FDA · CDER 80% Unresolved ### PDUFA dates in January 2027 Goal date Drug and application Applicant Reviewed by Registered probability Jan 21, 2027 Z-rostudirsen · Duchenne exon 51 approval FF-037 Dyne Therapeutics FDA · CDER 70% Unresolved Jan 29, 2027 Ulixacaltamide · essential tremor approval FF-036 Praxis FDA · CDER 80% Unresolved Jan 30, 2027 Leniolisib · APDS children 13–27 kg supplement approval FF-046 Pharming FDA · CDER 85% Unresolved ### PDUFA dates in February 2027 Goal date Drug and application Applicant Reviewed by Registered probability Feb 2, 2027 Lenacapavir · once-weekly oral PrEP approval FF-045 Gilead Sciences FDA · CDER 70% Unresolved Feb 4, 2027 Infigratinib · achondroplasia approval FF-044 BridgeBio Pharma FDA · CDER 80% Unresolved Feb 12, 2027 Tinlarebant · Stargardt disease approval FF-053 Belite Bio FDA · CDER 70% Unresolved Feb 23, 2027 Roflumilast cream · infant atopic dermatitis supplement approval FF-056 Arcutis Biotherapeutics FDA · CDER 88% Unresolved Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. ### Other registered dates - NICE appraisal calendar: expected publication dates with registered forecasts - Every registered forecast, by authority and deadline - Every registered deadline as one calendar file ### Bring the application and your deadline Name the application, its goal date, and the decision your team makes on it. Start with one claim --- # NICE appraisal calendar 2026–2027: expected dates with registered forecasts URL: https://nextconsensus.com/nice-appraisal-calendar/ ## NICE appraisal calendar 2026–2027: expected dates with registered forecasts This calendar lists the NICE technology appraisals NextConsensus has registered a forecast on, by expected publication month. Each row gives NICE's title for the appraisal, the project ID, the committee and the registered probability. Follow a row to its record for the terms that settle it. A row's probability is the estimate that NICE publishes the appraisal's final guidance by the expected date, whatever the guidance recommends. It was frozen at registration. A revised date with nothing published, a pause, a suspension or a termination resolves the record NO. Each date is the one the appraisal's in-development page on nice.org.uk showed at the record's cutoff; a later revision does not move it. The NICE scheduled-dates guide covers what the date commits NICE to and what each outcome means for a plan. NICE guidance by scheduled date: 24 registered · 24 unresolved · 0 resolved. Registry snapshot 2026-10-26. ### Expected NICE publication dates in October 2026 Expected date Appraisal Project ID Committee Registered probability Oct 28, 2026 Epcoritamab with rituximab and lenalidomide for treating relapsed or refractory follicular lymphoma after 1 or more systemic treatments FF-016 ID6586 Technology Appraisal Committee 45% Unresolved ### Expected NICE publication dates in November 2026 Expected date Appraisal Project ID Committee Registered probability Nov 3, 2026 Inavolisib with palbociclib and fulvestrant for treating recurrent hormone receptor-positive HER2-negative PIK3CA-positive advanced breast cancer after adjuvant endocrine treatment FF-017 ID6425 Technology Appraisal Committee 50% Unresolved Nov 11, 2026 Nivolumab with ipilimumab for untreated advanced hepatocellular carcinoma FF-019 ID6239 Technology Appraisal Committee 45% Unresolved Nov 12, 2026 Zuranolone for treating postnatal depression FF-022 ID6431 Technology Appraisal Committee 50% Unresolved Nov 18, 2026 Beremagene geperpavec for treating skin wounds associated with dystrophic epidermolysis bullosa FF-014 ID3959 Highly Specialised Technologies Evaluation Committee 35% Unresolved Nov 18, 2026 Efgartigimod for treating chronic inflammatory demyelinating polyneuropathy FF-015 ID6409 Highly Specialised Technologies Evaluation Committee 45% Unresolved Nov 18, 2026 Larotrectinib for treating NTRK fusion-positive advanced solid tumours (MA review of TA630) FF-018 ID6292 Technology Appraisal Committee 55% Unresolved Nov 18, 2026 Orforglipron for managing overweight and obesity FF-020 ID6516 Technology Appraisal Committee 5% Unresolved Nov 18, 2026 Pembrolizumab with chemotherapy with or without bevacizumab for treating platinum-resistant recurrent ovarian cancer after 1 or 2 treatments FF-021 ID6363 Technology Appraisal Committee 50% Unresolved Nov 25, 2026 Obicetrapib and obicetrapib–ezetimibe for treating primary hypercholesterolaemia or mixed dyslipidaemia FF-028 ID6519 Technology Appraisal Committee C 40% Unresolved Nov 25, 2026 Polihexanide 0.8 mg/ml eye drops for treating acanthamoeba keratitis in people 12 years and over FF-029 ID6497 Highly Specialised Technologies Evaluation Committee 35% Unresolved Nov 25, 2026 Intrathecal onasemnogene abeparvovec for treating spinal muscular atrophy in people 2 years and over FF-048 ID6556 Technology Appraisal Committee C 35% Unresolved ### Expected NICE publication dates in December 2026 Expected date Appraisal Project ID Committee Registered probability Dec 9, 2026 Resmetirom for treating non-alcoholic steatohepatitis and liver fibrosis FF-050 ID6529 Technology Appraisal Committee B 35% Unresolved Dec 16, 2026 Retifanlimab with platinum-based chemotherapy for treating inoperable, locally recurrent or metastatic squamous cell anal canal cancer untreated with systemic chemotherapy FF-040 ID6482 Technology Appraisal Committee A 30% Unresolved ### Expected NICE publication dates in January 2027 Expected date Appraisal Project ID Committee Registered probability Jan 7, 2027 Semaglutide for treating moderate to advanced liver fibrosis (without cirrhosis) caused by metabolic dysfunction-associated steatohepatitis FF-051 ID6458 Technology Appraisal Committee 25% Unresolved Jan 13, 2027 Tarlatamab for treating extensive stage small-cell lung cancer that has progressed after platinum-based chemotherapy FF-041 ID6617 Technology Appraisal Committee 30% Unresolved Jan 13, 2027 Toripalimab with chemotherapy for untreated recurrent or metastatic nasopharyngeal cancer FF-042 ID6406 Technology Appraisal Committee D 40% Unresolved Jan 20, 2027 Nerandomilast for treating idiopathic pulmonary fibrosis or progressive pulmonary fibrosis FF-039 ID6446 Technology Appraisal Committee B 40% Unresolved Jan 27, 2027 Trastuzumab deruxtecan for treating HER2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma after trastuzumab-based treatment (review of TA879) FF-043 ID6680 Committee not named in the archived sources 30% Unresolved Jan 28, 2027 Elranatamab for treating relapsed and refractory multiple myeloma after 3 or more treatments (managed access review of TA1023) FF-038 ID6653 Technology Appraisal Committee 30% Unresolved ### Expected NICE publication dates in February 2027 Expected date Appraisal Project ID Committee Registered probability Feb 10, 2027 Pembrolizumab with enfortumab vedotin for neoadjuvant and adjuvant treatment of muscle-invasive bladder cancer FF-049 ID6607 Technology Appraisal Committee 35% Unresolved Feb 10, 2027 Tislelizumab with chemotherapy for untreated advanced oesophageal squamous cell cancer FF-052 ID5113 Technology Appraisal Committee 45% Unresolved Feb 10, 2027 Setmelanotide for treating acquired hypothalamic obesity in people 4 years and over FF-055 ID6542 Technology Appraisal Committee 30% Unresolved Feb 17, 2027 Linvoseltamab for treating relapsed or refractory multiple myeloma after 3 or more treatments FF-054 ID6609 Technology Appraisal Committee 35% Unresolved Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. ### Other registered dates - PDUFA calendar: FDA goal dates with registered forecasts - Every registered forecast, by authority and deadline - Every registered deadline as one calendar file ### Bring the appraisal and your deadline Name the appraisal, its expected publication date, and the decision your team makes on it. Start with one claim --- # 75% forecast: NCCN lists sunvozertinib as a first-line option in EGFR exon 20 insertion NSCLC URL: https://nextconsensus.com/forecast/ff-001/ Registered forecast 75% registered probability event by 2027-07-31 Unresolved ## NCCN lists sunvozertinib as a first-line option in EGFR exon 20 insertion NSCLC FF-001 Registered · Unresolved Registered probability 75% Event by 2027-07-31 Resolution window 2026-08-01 → 2027-07-31 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 62% - Calendar cycle 40% - Analyst proxy 80% nextconsensus.com/forecast/ff-001/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-08-17. It is one of 56 registered forecasts . The proposition ### What was claimed A version of the NCCN Clinical Practice Guidelines in Oncology for Non-Small Cell Lung Cancer carrying a version date on or before 2027-07-31 lists sunvozertinib (ZEGFROVY) as a first-line / initial systemic therapy option, at any NCCN category, for EGFR exon 20 insertion mutation-positive metastatic non-squamous NSCLC. Authority National Comprehensive Cancer Network (NCCN), NSCLC Guidelines Panel (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 5: Guideline action — Formal recommendation change by a recognized guideline body: grade shift, new/retracted endorsement, population expansion/restriction. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NCCN guideline reclassification Scope EGFR exon 20 insertion mutation-positive metastatic non-squamous NSCLC The estimate ### The number and the baselines it has to beat 75% probability, method v0.1.0 · frozen at the 2026-07-31 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-001 · registered 75% Authority base rate +13 pts 62% Calendar cycle +35 pts 40% Analyst proxy −5 pts 80% Authority base rate 62% Reference class: agents with a positive randomized phase 3 in a molecularly defined NSCLC subset appearing in an NCCN NSCLC line-of-therapy recommendation within 12 months of publication. Recent precedent in this guideline (alectinib adjuvant post-ALINA, amivantamab first-line post-PAPILLON, sevabertinib in ERBB2) is consistently fast. Estimate from precedent, not an enumerated count — the enumerated corpus is the object of the external-transition-forecast-v1 study and does not yet exist. Recorded as the honest state of this baseline at the cutoff. Calendar cycle 40% A model that knows only NCCN's revision cadence. The NSCLC guideline is revised several times a year, so the probability that at least one revision opportunity falls inside a 12-month window is approximately 1.0. Having no evidence input, such a model cannot discriminate between pending candidates and defaults to the unconditional per-candidate incorporation rate, which is well below the phase-3-conditioned rate above. The output is the product of opportunity and that unconditional rate, recorded as the model's value at the cutoff. Analyst proxy 80% A thoracic-oncology analyst reading the same public record on 2026-07-31 — NEJM-published positive phase 3, Breakthrough Therapy Designation, first-line sNDA submitted, a $600m upfront global license — would call listing highly likely and treat FDA review timing as the only serious question. Estimated by reconstructing that read, not by surveying analysts. Guideline listing (NCCN, ESMO): offered on judgment, with no calibration figure until 15 in the class have resolved. Comparator: Rung 6: Regulatory action (FDA sNDA approval). Date the FDA approves the first-line supplemental NDA, or a publicly announced decision that ends that pathway. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-07-31 Registered 2026-08-17 Window opens 2026-08-01 Deadline 2027-07-31 Evidence cutoff 2026-07-31 Registered 2026-08-17 Window opens 2026-08-01 Deadline 2027-07-31 Evidence cutoff 2026-07-31 Nothing after this date informed the estimate. Registered 2026-08-17 Frozen and hashed. Resolution window 2026-08-01 → 2027-07-31 When the outcome can be read against the rule. Event by 2027-07-31 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger ad43205978351a4affaeb1d6b2cbe00dd6aa0bdf3ac78fd24f9d7259ca3f34fd · operator record jc-1786944950479-571589a7 ### Around this record Sunvozertinib · first-line NSCLC - FF-003 · Sunvozertinib · first-line approval by March event by 2027-03-31 - FF-002 · Sunvozertinib · first-line approval event by 2027-07-31 - FF-004 · Sunvozertinib · FDA approval before NCCN listing event by 2027-07-31 This kind of deadline - Every registered forecast, by authority and deadline The evidence - The evidence ledger: every dated, sourced act on this asset - The subject dossier: evidence, institutional sequence, and preparation by team Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NCCN for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if any NCCN NSCLC guideline version dated on or before 2027-07-31 names sunvozertinib (or ZEGFROVY) anywhere in the initial-systemic-therapy recommendation set for EGFR exon 20 insertion mutation-positive metastatic non-squamous NSCLC, at any category (1, 2A, 2B, or 3) and whether or not it is marked preferred. The adjudicator reads the NSCLC algorithm page for initial systemic therapy in EGFR exon 20 insertion mutation-positive disease and the corresponding systemic therapy tables, in the latest version dated on or before 2027-07-31. Resolves NO if no such version names it there. Listing confined to subsequent-line or post-progression therapy does NOT count. Access requires free NCCN registration; no clinical judgement about the drug is needed to apply this rule. Source the rule names: NCCN NSCLC guideline — initial systemic therapy algorithm and tables for EGFR exon 20 insertion mutation-positive disease, latest version dated on or before 2027-07-31 Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NCCN guideline reclassification): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 75% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### Why this number, and what would break it #### Mechanism Hypothesis, not access — NCCN panel deliberation is closed. Primary path: the US supplemental NDA for the first-line indication, submitted on or before 2026-07-14 and carrying FDA Breakthrough Therapy Designation in this setting, is granted priority review and approved inside the window; NCCN then incorporates the new indication at its normal post-approval cadence, which for this guideline has historically been one to two versions. Secondary path: the panel lists the agent ahead of FDA action on the strength of the NEJM-published randomized phase 3, which it does occasionally for breakthrough-designated agents in molecularly defined subsets. The two paths are not independent — both are driven by the same evidence event — which is why the forecast sits below the ceiling implied by the regulatory path alone. #### Against The WU-KONG28 control arm was platinum doublet alone, not the category-1 preferred regimen the guideline already lists; the guideline requires registration and version dates were unconfirmed at cutoff #### When the proposition would be ill-posed The proposition would be ill-posed if: NCCN restructures the EGFR exon 20 insertion pages such that 'initial systemic therapy' is no longer a distinguishable recommendation set; NCCN withdraws public version-dated distribution of the NSCLC guideline; or the agent is withdrawn from the US market, in which case no listing can occur and the proposition resolves NO on its plain terms rather than being voided. A brand-name change following the AstraZeneca license does not void it — the rule matches on the INN 'sunvozertinib' as well as the brand. Listing restricted to a narrower first-line population than the full exon20ins group still counts as YES, provided it is a first-line recommendation. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-07-31, including the 3 fields whose values were unknown then. Those are left unknown rather than filled in. review pathway FDA Breakthrough Therapy Designation granted for the first-line setting (per AstraZeneca release, 2026-07-14); the forecast object itself is an NCCN panel revision, which follows NCCN's continuous-update process rather than a statutory clock submission type supplemental New Drug Application — efficacy supplement for a new line of therapy in an already-approved molecule evidence class randomized, open-label, multinational phase 3 (WU-KONG28), published in the New England Journal of Medicine 2026-05-29 and presented as an ASCO late-breaking abstract pivotal n 324 randomized 1:1 endpoint type progression-free survival by blinded independent central review (primary; 10.3 vs 7.5 months per BICR, HR 0.65, p=0.0008); overall survival not reported as mature at the 2026-01-16 data cutoff approved competitors in class 1 — amivantamab plus carboplatin/pemetrexed, FDA-approved first-line for EGFR exon20ins on PAPILLON, and widely reported as the NCCN category 1 preferred first-line option for this subset. The category claim is from secondary reporting, NOT from a primary source archived here: the guideline requires registration and was not retrievable for archiving at the cutoff. Load-bearing either way — the WU-KONG28 control arm was platinum doublet alone rather than this regimen, so the trial does not establish superiority over the standard the guideline already recommends, which is the main argument for a lower category or a slower listing. months since last guideline revision unknown — NCCN NSCLC version dates could not be confirmed against a primary source at the cutoff; the guideline itself requires registration and public secondary reporting of 2026 version dates was mutually inconsistent panel cycle position unknown — see months_since_last_guideline_revision. The NSCLC guideline is revised several times per year, so procedural opportunity within the window is effectively certain; where the window falls in the cycle is not known. sponsor request status unknown — NCCN does not publish manufacturer submission requests odac referral none announced as of the availability cutoff sponsor state change AstraZeneca took an exclusive global license from Dizal on 2026-07-14, with $600m upfront and up to $900m in milestones — a change in the commercial capacity behind guideline and reimbursement engagement, occurring 17 days before this cutoff Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-07-31 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Dizal press release announcing WU-KONG28 phase 3 results (2026-05-29): PFS 10.3 vs 7.5 months per the release; HR 0.65, p=0.0008; confirms prior US and China accelerated approvals in relapsed/refractory disease https://www.prnewswire.com/news-releases/dizal-announces-phase-3-wu-kong28-results-zegfrovy-sunvozertinib-outperforms-platinum-doublet-chemotherapy-in-first-line-egfr-exon-20-insertion-mutation-positive-non-small-cell-lung-cancer-302785656.html Retrieved 2026-07-31 · sha256 8d36a5ba14efa04cbdbbc0ea3ceda931828048f5dfdeed0c9621ed5fdd394489 SRC-002 PubMed record for the NEJM primary publication (PMID 42212913, doi 10.1056/NEJMoa2604461, 2026-05-29), 'First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations'. Archived via PubMed rather than the publisher: nejm.org served a bot-challenge page, not the article. https://pubmed.ncbi.nlm.nih.gov/42212913/ Retrieved 2026-07-31 · sha256 a8b05e1e6f2c03013cad238c9404d0f10d28437e26d60251c01d55052a61a6fe SRC-003 AstraZeneca press release (2026-07-14) announcing the exclusive global license from Dizal. Load-bearing: the only archived primary source confirming the first-line supplemental NDA to the US FDA and FDA Breakthrough Therapy Designation in this setting. Both facts drive the probability. https://www.astrazeneca.com/media-centre/press-releases/2026/astrazeneca-licenses-novel-egfr-inhibitor.html Retrieved 2026-07-31 · sha256 56e8ee9aceb9ca38a075dc5b969135c71e2b48cc9f82487f39a0c49d35697f0f SRC-004 Dizal press release: China NMPA accepted the first-line NDA with Priority Review https://www.prnewswire.com/news-releases/dizals-zegfrovy-sunvozertinib-new-drug-application-accepted-and-granted-priority-review-by-china-national-medical-products-administration-for-first-line-treatment-of-egfr-exon-20-insertion-mutated-non-small-cell-lung-cancer-302783017.html Retrieved 2026-07-31 · sha256 6dc5663822dd9950c749c765045abe4c3ce4d8f6f632251106d222c577549214 SRC-005 ASCO Post coverage of the WU-KONG28 first-line results (June 2026) — independent secondary reporting of the same readout https://ascopost.com/news/june-2026/sunvozertinib-in-nsclc-with-egfr-exon-20-insertion-mutations/ Retrieved 2026-07-31 · sha256 81a89a602bfbc251e80c5cf06192df596808daa1d552db12ff7475987b5dda2b SRC-006 PubMed record for the Cancer Discovery commentary 'Rare EGFRm NSCLC: More First-Line Options Emerge' (PMID 42224429, 2026-07-01) — contemporaneous field read of the first-line landscape in this subset https://pubmed.ncbi.nlm.nih.gov/42224429/ Retrieved 2026-07-31 · sha256 d8898e1c83e58d791ef7466d371ccf1728f120b1c0aa46a61c0bac75571f0098 --- # 88% forecast: FDA approves a first-line indication for sunvozertinib in EGFR exon 20 insertion NSCLC URL: https://nextconsensus.com/forecast/ff-002/ Registered forecast 88% registered probability event by 2027-07-31 Unresolved ## FDA approves a first-line indication for sunvozertinib in EGFR exon 20 insertion NSCLC FF-002 Registered · Unresolved Registered probability 88% Event by 2027-07-31 Resolution window 2026-09-23 → 2027-07-31 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 85% - Calendar cycle 70% - Analyst proxy 90% nextconsensus.com/forecast/ff-002/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-09-22. It is one of 56 registered forecasts . The proposition ### What was claimed The FDA approves a first-line / initial-treatment indication for sunvozertinib (ZEGFROVY) in EGFR exon 20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer, expected as a supplement to NDA 219839, with an approval action dated on or before 2027-07-31. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research, Office of Oncologic Diseases (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA label revision Scope EGFR exon 20 insertion mutation-positive locally advanced or metastatic NSCLC The estimate ### The number and the baselines it has to beat 88% probability, method v0.1.0 · frozen at the 2026-09-22 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-002 · registered 88% Authority base rate +3 pts 85% Calendar cycle +18 pts 70% Analyst proxy −2 pts 90% Authority base rate 85% Reference class: FDA efficacy supplements adding a line of therapy, supported by a randomized phase 3 that met its primary endpoint and carrying Breakthrough Therapy Designation, approved within eleven months of acceptance. Supplements that reach filing are approved at a high rate and the large majority act within one goal-date cycle. Estimated from the shape of that reference class, not from an enumerated count — the enumerated corpus for rung 6 is the object of the proof cycle and, per the repo's own fda-label-v1-invalidation review under workspace/reviews/ (a review of this repo's backtest, not a source fact), the one that existed was not usable. Recorded as the honest state of this baseline at the cutoff. Calendar cycle 70% A model that knows only PDUFA clocks and nothing about the evidence. An accepted efficacy supplement has a goal date 6 months (priority) or 10 months (standard) from the 60-day filing date; from an acceptance no later than 2026-09-01 both land before 2027-07-31, so the probability that a decision of some kind falls inside the window is near 1. Having no evidence input, such a model cannot discriminate between a strong and a weak application and defaults to the unconditional probability that a filed efficacy supplement is approved at its first goal date. The output is the product of those two. Analyst proxy 90% A thoracic-oncology analyst reading the same public record on 2026-09-04 — NEJM-published positive phase 3 against platinum doublet, Breakthrough Therapy Designation in this setting, supplement accepted, and a large pharmaceutical company paying $600m upfront for global rights seven weeks before the license completed and the acceptance was announced — would call first-line approval highly likely and treat the goal date as the only real question. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-09-22 Registered 2026-09-22 Window opens 2026-09-23 Deadline 2027-07-31 Evidence cutoff 2026-09-22 Registered 2026-09-22 Window opens 2026-09-23 Deadline 2027-07-31 Evidence cutoff 2026-09-22 Nothing after this date informed the estimate. Registered 2026-09-22 Frozen and hashed. Resolution window 2026-09-23 → 2027-07-31 When the outcome can be read against the rule. Event by 2027-07-31 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 56015937eab42488ee1a6706401594c56146be557f1536688ff27c3835e0b2c5 · operator record jc-1790109834676-bf6924d6 ### Around this record Sunvozertinib · first-line NSCLC - FF-003 · Sunvozertinib · first-line approval by March event by 2027-03-31 - FF-001 · Sunvozertinib · first-line guideline listing event by 2027-07-31 - FF-004 · Sunvozertinib · FDA approval before NCCN listing event by 2027-07-31 This kind of deadline - Every registered forecast, by authority and deadline The evidence - The evidence ledger: every dated, sourced act on this asset - The subject dossier: evidence, institutional sequence, and preparation by team Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the openFDA Drugs@FDA record for application NDA219839 contains a submission with submission_type SUPPL and submission_status AP, whose submission_status_date is on or before 2027-07-31, and whose approved labeling includes EGFR exon 20 insertion mutation-positive NSCLC in the first-line / initial-treatment setting. The adjudicator queries https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA219839%22 and reads the submissions array, then confirms the indication against the Drugs@FDA label for that supplement at https://www.accessdata.fda.gov/scripts/cder/daf/. Resolves NO if no such supplement is approved by that date. Read no earlier than 2027-08-31. If the openFDA record has not refreshed, the Drugs@FDA web record governs. Resolves VOID, with the reason recorded, only if FDA restructures Drugs@FDA such that supplement-level approval actions are no longer published per application and the openFDA drugsfda endpoint is withdrawn without an equivalent public successor, so that no approval action for a supplement to NDA219839 can be read from either source; while either source publishes it, the rule stands. Withdrawal of the application by the sponsor is NO on its plain terms, not VOID: no approval can occur. A brand-name change following the AstraZeneca license, or a transfer of the application holder from Dizal to AstraZeneca, does not void the record: the rule matches on application number NDA219839, which survives both. A supplement approved only for a later-line, maintenance, or non-NSCLC indication does NOT count. Approval of a first-line indication restricted to a narrower population than the full exon20ins group DOES count, provided it is first-line. Conversion of the existing accelerated approval to full approval in the previously approved later-line setting does NOT count. No oncology judgement is needed to apply this rule: both sources are public and unauthenticated; the indication is read from Section 1 (Indications and Usage) of the approved label PDF that the Drugs@FDA record links for the supplement. A first-line indication approved under a new NDA rather than a supplement to 219839 DOES count, provided the labeling covers the specified population and setting; the adjudicator then reads that NDA's ORIG submission by the same fields. Source the rule names: openFDA Drugs@FDA record for NDA 219839, with the Drugs@FDA web record and the approval letter as fallbacks for the action date Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA label revision): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 88% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-09-22. review pathway FDA Breakthrough Therapy Designation granted for the first-line setting (AstraZeneca release, 2026-09-01; also recorded in the 2026-07-14 license release). Whether the supplement carries priority or standard review is not disclosed; the original NDA 219839 was reviewed under PRIORITY (openFDA, ORIG-1, AP 2025-07-02). A separate, earlier Breakthrough Therapy Designation was reported in April 2024 (SRC-004, citing targetedonc.com, 9 April 2024: 'FDA Grants Breakthrough Therapy Designation to Sunvozertinib in EGFR Exon20+ NSCLC'); the archived copy does not state its setting, but it predates the first-line phase 3 readout. Two designations therefore exist, and the first-line one is reported only by sponsor releases. submission type supplemental New Drug Application — efficacy supplement adding a new line of therapy to an already-approved molecule evidence class randomized, open-label, multinational phase 3 (WU-KONG28), published in the New England Journal of Medicine 2026-05-29 and presented as an ASCO late-breaking abstract pivotal n 324 randomized 1:1 endpoint type progression-free survival by blinded independent central review (primary; 10.3 vs 7.5 months, HR 0.65, p=0.0008); overall survival not reported as mature at the 2026-01-16 data cutoff approved competitors in class 1 — amivantamab plus carboplatin/pemetrexed, FDA-approved first-line for EGFR exon20ins on PAPILLON. Load-bearing against this forecast in the same way it is against FF-001: the WU-KONG28 control arm was platinum doublet alone rather than this regimen, so the trial does not establish superiority over the standard already available in the setting. That is an argument about the strength of the approval, not about whether an approval occurs, since the comparator chosen was an accepted control for the population. months since last guideline revision not applicable — the forecast object is an FDA approval action, which follows PDUFA goal dates rather than a guideline revision cadence panel cycle position not applicable for the same reason. No ODAC meeting has been announced for this application, so no advisory-committee calendar position exists to record. sponsor request status supplemental NDA accepted by FDA, per the AstraZeneca release of 2026-09-01: 'A supplemental New Drug Application for approval of ZEGFROVY in the 1st-line setting has been accepted by the US Food and Drug Administration (FDA).' The acceptance date itself is not disclosed, and no PDUFA goal date is public. odac referral none announced as of the availability cutoff sponsor state change AstraZeneca completed its exclusive global license from Dizal, announced 2026-09-01, following the 2026-07-14 agreement ($600m upfront, up to $900m in milestones). The regulatory holder of record in openFDA at the cutoff is still DIZAL. Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-09-22 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 AstraZeneca press release (2026-09-01) announcing completion of the global license from Dizal. Load-bearing: the primary archived source confirming that the first-line supplemental NDA has been ACCEPTED by FDA, and that Breakthrough Therapy Designation was granted in this setting. Neither the acceptance date nor a PDUFA goal date is disclosed, which is why the probability is not higher. Cross-reference: this file says only that the supplement 'has been accepted'; the 2026-07-14 submission date used in the mechanism and covariates rests on registry/archive/nccn-nsclc-sunvozertinib-1l/SRC-003-az-license.html (FF-001's archive, retrieved 2026-07-31: 'has been submitted to the US Food and Drug Administration'), not on any file in this draft's own archive. https://www.biospace.com/press-releases/astrazeneca-completes-global-license-agreement-for-oral-egfr-inhibitor-zegfrovy-sunvozertinib-for-lung-cancer Retrieved 2026-09-04 · sha256 779b724b7d2e236b854b931f41c5ed63d59aebe6cbbb481bebe6cf8a49b55332 SRC-002 PubMed record for the NEJM primary publication (PMID 42212913, 2026-05-29), 'First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations'. The efficacy evidence the supplement rests on. Archived via the PubMed E-utilities XML rather than the publisher: nejm.org serves a bot-challenge page, not the article. Cross-reference: this record reads 'P<0.001' and carries no data-cutoff date and no design label; the 'p=0.0008', the '2026-01-16' date, and 'open-label' in the covariates rest on registry/archive/nccn-nsclc-sunvozertinib-1l/SRC-001-dizal-wukong28.html (FF-001's archive, retrieved 2026-07-31: 'As of January 16, 2026, 324 patients were randomized', 'HR=0.65; P=0.0008', 'multinational, open-label, randomized confirmatory phase 3 study'). This draft's own archive cannot be extended to hold that file without a retrieved_at after the cutoff. https://eutils.ncbi.nlm.nih.gov/entrez/eutils/efetch.fcgi?db=pubmed&id=42212913&retmode=xml Retrieved 2026-09-04 · sha256 fdf43f48643ab11e991f9b089d2bce0f45675bf6a15f20be067355715688809e SRC-003 openFDA Drugs@FDA record for NDA219839 (ZEGFROVY, sponsor DIZAL) as of the cutoff. Establishes the pre-registration state the proposition is measured against: exactly one submission, ORIG-1, submission_status AP dated 2025-07-02, review_priority PRIORITY. No SUPPL of any kind is present, so the first-line indication is not approved at registration. This is also the resolution source, which makes the starting state and the finishing state readings of the same public endpoint. https://api.fda.gov/drug/drugsfda.json?search=products.brand_name:%22ZEGFROVY%22&limit=5 Retrieved 2026-09-04 · sha256 9dc982bddee2169e1df1b7fdbb7182de826569802f9601ed15b434dd5a4f2b05 One more archived source, a secondary summary the record does not rely on, is held in the ledger and not listed here. --- # 55% forecast: FDA approves first-line sunvozertinib in EGFR exon 20 insertion NSCLC on or before 2027-03-31 URL: https://nextconsensus.com/forecast/ff-003/ Registered forecast 55% registered probability event by 2027-03-31 Unresolved ## FDA approves first-line sunvozertinib in EGFR exon 20 insertion NSCLC on or before 2027-03-31 FF-003 Registered · Unresolved Registered probability 55% Event by 2027-03-31 Resolution window 2026-09-23 → 2027-07-31 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 60% - Calendar cycle 40% - Analyst proxy 65% nextconsensus.com/forecast/ff-003/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-09-22. It is one of 56 registered forecasts . The proposition ### What was claimed The FDA approves a first-line / initial-treatment indication for sunvozertinib (ZEGFROVY) in EGFR exon 20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer — expected as an efficacy supplement to NDA 219839, held by Dizal at the cutoff — with an approval action dated on or before 2027-03-31. The resolution window closes 2027-07-31 so that this record is read at the same sitting as FF-002's; an approval action dated 2027-04-01 or later resolves this proposition NO. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research, Office of Oncologic Diseases (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA label revision Scope EGFR exon 20 insertion mutation-positive locally advanced or metastatic NSCLC The estimate ### The number and the baselines it has to beat 55% probability, method v0.1.0 · frozen at the 2026-09-22 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-003 · registered 55% Authority base rate −5 pts 60% Calendar cycle +15 pts 40% Analyst proxy −10 pts 65% Authority base rate 60% Reference class: FDA efficacy supplements adding a line of therapy to an approved oncology drug, supported by a randomized phase 3 that met its primary endpoint and carrying Breakthrough Therapy Designation, acted on within eight and a half months of submission (2026-07-14 to 2027-03-31 here). To my understanding most such supplements receive priority review and are approved at or before the goal date, and a minority run on the standard clock or take an extension; that shape gives roughly 0.6. ESTIMATE FROM PRECEDENT, NOT AN ENUMERATED COUNT — the enumerated corpus for rung 6 is the object of the proof cycle and, per the repo's own fda-label-v1-invalidation review under workspace/reviews/ (a review of this repo's backtest, not a source fact), the one that existed was not usable. Recorded as the honest state of this baseline at the cutoff. Calendar cycle 40% A model that knows only clocks and nothing about the evidence, with its rule stated: receipt on or before 2026-07-14 (SRC-004); review designation unknown, so priority and standard each 0.5; goal 6 or 10 months from receipt, so on or before 2027-01-14 (inside the deadline) or 2027-05-14 (outside it); approval at the first goal date with prior 0.85 (first-cycle approval of a filed efficacy supplement — a prior, not a count); under priority, a major-amendment extension that carries the action past the deadline with prior 0.15; under standard, an action at least six weeks early with prior 0.1. 0.5 x 0.85 x 0.85 + 0.5 x 0.85 x 0.1 = 0.40. Every input except the receipt bound is a prior and is labelled as one. Analyst proxy 65% A regulatory or thoracic-oncology analyst reading the same public record on 2026-09-05 — Breakthrough Therapy Designation in the setting, the original NDA reviewed under priority, an NEJM-published positive phase 3, a supplement accepted by 2026-09-01, and a $600m upfront licence completed the same day — would most likely assume priority review, pencil a goal date in the first quarter of 2027, and discount for the absence of any announced designation or goal date and for the crossover-confounded survival data. Reconstructed as about 0.65; estimated by reconstructing that read, not by surveying analysts. The draft's own number sits below it because the draft gives more weight to the silence about the designation. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-09-22 Registered 2026-09-22 Window opens 2026-09-23 Deadline 2027-03-31 Evidence cutoff 2026-09-22 Registered 2026-09-22 Window opens 2026-09-23 Deadline 2027-03-31 Evidence cutoff 2026-09-22 Nothing after this date informed the estimate. Registered 2026-09-22 Frozen and hashed. Resolution window 2026-09-23 → 2027-07-31 When the outcome can be read against the rule. Event by 2027-03-31 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger c1f038e701df6f687ad521494d0f0e5fec7c39b3f565f3e38732de1317ea768a · operator record jc-1790109835059-8d38c270 ### Around this record Sunvozertinib · first-line NSCLC - FF-001 · Sunvozertinib · first-line guideline listing event by 2027-07-31 - FF-002 · Sunvozertinib · first-line approval event by 2027-07-31 - FF-004 · Sunvozertinib · FDA approval before NCCN listing event by 2027-07-31 This kind of deadline - Every registered forecast, by authority and deadline The evidence - The evidence ledger: every dated, sourced act on this asset - The subject dossier: evidence, institutional sequence, and preparation by team Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the openFDA Drugs@FDA record for application number NDA219839 — queried as https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA219839%22 , by application number and not brand name, so that a rebrand after the AstraZeneca licence cannot empty the query — contains a submission with submission_type SUPPL (or, if the supplement literal in the live record differs from SUPPL, any submission whose submission_type is not ORIG), submission_status AP, and submission_status_date on or before 20270331 (the field is YYYYMMDD), whose approved labeling covers the first-line / initial-treatment (previously untreated) setting for EGFR exon 20 insertion mutation-positive locally advanced or metastatic NSCLC. The indication is read from Section 1 (INDICATIONS AND USAGE) of the label PDF linked from that submission's application_docs entry of type Label or, if that link is absent, from the current label on the Drugs@FDA web record for NDA 219839 at https://www.accessdata.fda.gov/scripts/cder/daf/ ; a labeling supplement that adds WU-KONG28 to Section 14 (CLINICAL STUDIES) without changing Section 1 does NOT count. An action dated exactly 2027-03-31 counts. The date read is submission_status_date; if openFDA has not refreshed by the reading date (meta.last_updated earlier than the approval), the Action Date shown for that supplement on the Drugs@FDA web record governs, and if the two disagree the date on the approval letter (application_docs type Letter) governs. Adjudication floor: read no earlier than 2027-08-31 and no later than 2027-10-31, at the same sitting as FF-002. Resolves NO if no such approval action is dated on or before 2027-03-31 — including the case where the same indication is approved between 2027-04-01 and 2027-07-31, which resolves FF-002 YES and this record NO, by design. Resolves VOID, with the reason recorded, only if FDA restructures Drugs@FDA or withdraws the openFDA drugsfda endpoint so that no per-supplement action date can be read from either the JSON or the Drugs@FDA web record; while either source publishes the date, the rule stands. If the sponsor withdraws the supplement, or receives a complete response and does not obtain an approval by 2027-03-31, the record resolves NO on plain terms, not VOID. A change of application holder from Dizal to AstraZeneca, or of brand name, has no effect: the rule matches on application number NDA219839 and the query is by application number. Exclusions carried unchanged from FF-002: a supplement approved only for a later-line, maintenance or non-NSCLC indication does NOT count; conversion of the existing accelerated approval in the previously treated setting to traditional approval does NOT count; a first-line indication restricted to a narrower population than the full exon 20 insertion group (for example nonsquamous histology only) DOES count, provided it is first-line. A first-line indication approved under a new NDA rather than a supplement to 219839 DOES count, provided the labeling covers the specified population and setting; the adjudicator then reads that NDA's ORIG submission by the same fields. Both sources are public and unauthenticated; the JSON is machine-readable, the label is a PDF read by a person; no oncology judgement is needed. An approval action dated on or before the availability cutoff means the proposition was resolved before it was frozen: VOID as ill-posed, not YES. Source the rule names: openFDA Drugs@FDA record for NDA 219839, with the Drugs@FDA web record and the approval letter as fallbacks for the action date Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA label revision): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 55% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-09-22. review pathway Two Breakthrough Therapy Designations are in the archive: one for the first-line setting, reported only by sponsor releases (SRC-002 and SRC-004: 'in this setting'; SRC-006: 'for this treatment-naive patient population'), and an earlier one in the platinum-pretreated setting reported in April 2024 (SRC-008, secondary). The original NDA 219839 was reviewed under PRIORITY (SRC-001, ORIG-1, AP 20250702). The review designation of the first-line supplement — priority or standard — is in no archived file; the 2026-09-01 release says only 'accepted'. This is the hinge of the proposition; see mechanism. submission type supplemental New Drug Application (efficacy supplement adding a new line of therapy to an approved molecule), per sponsor releases only: 'has been submitted' (SRC-004, 2026-07-14) and 'has been accepted' (SRC-002, 2026-09-01). openFDA shows no supplement row of any kind as of its 2026-09-02 refresh (SRC-001). evidence class randomized, open-label, multinational phase 3 (WU-KONG28, NCT05668988) versus carboplatin-pemetrexed: 'phase 3, international' per the NEJM abstract (SRC-003); 'open-label' per the sponsor release (SRC-005) and The ASCO Post (SRC-007); enrolled December 2022 to May 2025 (SRC-007); 15 countries per SRC-005 and 16 per SRC-006; presented as ASCO late-breaking abstract LBA8500 and published in NEJM on 2026-05-29 (SRC-003, SRC-005). pivotal n 324 randomized 1:1 (163 sunvozertinib, 161 chemotherapy) per the NEJM abstract (SRC-003) endpoint type primary: progression-free survival by blinded independent central review, 10.3 vs 7.5 months, HR 0.65 (95% CI 0.50 to 0.85), P<0.001 (SRC-003; the sponsor release gives P=0.0008, SRC-005); 12-month PFS 46.1% vs 26.7%; objective response 58.9% vs 31.1%; overall survival immature at 38.9% maturity (SRC-003) with 101 of 112 (90.2%) chemotherapy patients crossed over (SRC-007); grade 3 or higher adverse events 75.5% vs 56.7% (SRC-003); serious adverse events 45.4% vs 26.7% (SRC-007). Data cutoff read as 2026-01-16 from 'As of January 16, 2026, 324 patients were randomized' (SRC-005), which the release states as a randomization-count date; the NEJM abstract gives no cutoff date. approved competitors in class No archived file names an approved first-line regimen for this population. What the archive supports: the sponsor's statement that 'no oral targeted therapies have been approved for the first-line treatment of EGFR exon20ins NSCLC' and that first-line treatment 'largely relies on chemotherapy-based regimens' (SRC-006, 2026-05-27). FF-001 and FF-002 record one approved first-line regimen, amivantamab with carboplatin/pemetrexed, from secondary reporting archived nowhere in this repo; if that record is right, priority review is less automatic than the sponsor's framing suggests, because WU-KONG28's control arm was carboplatin-pemetrexed alone (SRC-003). Load-bearing for the designation question and unresolved by the archive; the founder should archive the Rybrevant Drugs@FDA record before any public evidence story leans on it. months since last guideline revision not applicable — the forecast object is an FDA approval action on a PDUFA clock, not a guideline revision. For the record, the sponsor cites NCCN NSCLC Version 6.2026, accessed July 2026, in both the 2026-07-14 and the 2026-09-01 release (SRC-004, SRC-002). panel cycle position not applicable for the same reason. No ODAC meeting is mentioned in any archived file; the FDA advisory-committee calendar itself is not archived, so this is an absence claim. sponsor request status supplemental NDA submitted to FDA on or before 2026-07-14 (SRC-004: 'has been submitted') and accepted on or before 2026-09-01 (SRC-002: 'has been accepted by the US Food and Drug Administration (FDA)'). Receipt date, filing date, review designation and goal date are all undisclosed. Press release only: openFDA lists approved actions and cannot corroborate a pending submission (SRC-001). odac referral none announced in any archived file as of the availability cutoff; the advisory-committee calendar is not archived (absence claim) sponsor state change AstraZeneca entered an exclusive global licence with Dizal on 2026-07-14 ($600m upfront, up to $900m in milestones, tiered royalties; SRC-004) and announced its completion on 2026-09-01, four days before this cutoff, with a US launch of the second-line indication planned for the fourth quarter of 2026 (SRC-002). The application holder of record in openFDA is still DIZAL as of the 2026-09-02 refresh (SRC-001). Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-09-22 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 openFDA Drugs@FDA record for application NDA219839 (ZEGFROVY, sponsor DIZAL), meta.last_updated 2026-09-02. Establishes the starting state this proposition is measured against: exactly one submission, ORIG-1, submission_status AP dated 20250702, review_priority PRIORITY, submission_class TYPE 1 (New Molecular Entity); no supplement of any kind is present, so no first-line indication is approved at the cutoff. Also the resolution source; this copy was queried by brand name, the resolution rule queries by application_number. Bytes retrieved from the network 2026-09-04 for the fda-nsclc-sunvozertinib-first-line-approval draft (its SRC-003) and copied here unchanged on 2026-09-05, so the starting state is read one day before this draft's cutoff — see contingency_notes. https://api.fda.gov/drug/drugsfda.json?search=products.brand_name:%22ZEGFROVY%22&limit=5 Retrieved 2026-09-05 · sha256 9dc982bddee2169e1df1b7fdbb7182de826569802f9601ed15b434dd5a4f2b05 SRC-002 AstraZeneca press release dated 2026-09-01 (BUSINESS WIRE, BioSpace carriage) announcing completion of the global licence from Dizal. Load-bearing: the only archived statement that the first-line supplemental NDA 'has been accepted by the US Food and Drug Administration (FDA)' and that 'the US FDA and China's CDE both granted Breakthrough Therapy Designation to ZEGFROVY in this setting'. It gives no acceptance date, no filing date, no review designation and no goal date — the word 'priority' does not appear in it. Also records that AstraZeneca will launch the second-line indication in the US in the fourth quarter of 2026, and cites NCCN NSCLC Version 6.2026 (accessed July 2026) for a subsequent-therapy listing. Bytes retrieved 2026-09-04 for the fda-nsclc-sunvozertinib-first-line-approval draft (its SRC-001); copied here unchanged 2026-09-05. https://www.biospace.com/press-releases/astrazeneca-completes-global-license-agreement-for-oral-egfr-inhibitor-zegfrovy-sunvozertinib-for-lung-cancer Retrieved 2026-09-05 · sha256 779b724b7d2e236b854b931f41c5ed63d59aebe6cbbb481bebe6cf8a49b55332 SRC-003 PubMed E-utilities XML for the NEJM primary publication (PMID 42212913, doi 10.1056/NEJMoa2604461, published online 2026-05-29), 'First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations'. Source for n=324 (163 vs 161), carboplatin-pemetrexed control, PFS 10.3 vs 7.5 months by BICR, HR 0.65 (95% CI 0.50 to 0.85), P<0.001, overall survival immature (38.9% maturity), objective response 58.9% vs 31.1%, grade 3 or higher adverse events 75.5% vs 56.7%, and the accelerated-approval status of the later-line indication. Archived via PubMed because nejm.org serves a bot-challenge page. Bytes retrieved 2026-09-04 for the fda-nsclc-sunvozertinib-first-line-approval draft (its SRC-002); copied here unchanged 2026-09-05. https://eutils.ncbi.nlm.nih.gov/entrez/eutils/efetch.fcgi?db=pubmed&id=42212913&retmode=xml Retrieved 2026-09-05 · sha256 fdf43f48643ab11e991f9b089d2bce0f45675bf6a15f20be067355715688809e SRC-004 AstraZeneca press release dated 2026-07-14 announcing the exclusive global licence agreement with Dizal. Load-bearing for the review clock: it states that a supplemental NDA for the first-line setting 'has been submitted to the US Food and Drug Administration (FDA)', which fixes FDA receipt on or before 2026-07-14 — the earliest archived upper bound on the clock start — and that FDA granted Breakthrough Therapy Designation in this setting. Footnote 1 cites NCCN NSCLC Version 6.2026, accessed July 2026, for a Category 2A subsequent-therapy listing. Bytes retrieved 2026-07-31 for the registered nccn-nsclc-sunvozertinib-first-line draft (FF-001, its SRC-003); copied here unchanged 2026-09-05 — a copy retrieved before the cutoff is available at the cutoff. https://www.astrazeneca.com/media-centre/press-releases/2026/astrazeneca-licenses-novel-egfr-inhibitor.html Retrieved 2026-09-05 · sha256 56e8ee9aceb9ca38a075dc5b969135c71e2b48cc9f82487f39a0c49d35697f0f SRC-005 Dizal press release dated 2026-05-29 announcing the WU-KONG28 results. Source for 'As of January 16, 2026, 324 patients were randomized in a 1:1 ratio', the byte from which the 2026-01-16 date in covariates.endpoint_type and clocks.t_evidence is read (as FF-002 read it, as the data cutoff and t_evidence), P=0.0008, the 'open-label' design, enrolment across 15 countries, and — load-bearing for this proposition by contrast — that China's NMPA 'accepted and granted Priority Review designation' to the first-line NDA, a form of words no archived file uses for the US supplement. Bytes retrieved 2026-07-31 for FF-001 (its SRC-001); copied here unchanged 2026-09-05. https://www.prnewswire.com/news-releases/dizal-announces-phase-3-wu-kong28-results-zegfrovy-sunvozertinib-outperforms-platinum-doublet-chemotherapy-in-first-line-egfr-exon-20-insertion-mutation-positive-non-small-cell-lung-cancer-302785656.html Retrieved 2026-09-05 · sha256 8d36a5ba14efa04cbdbbc0ea3ceda931828048f5dfdeed0c9621ed5fdd394489 SRC-006 Dizal press release dated 2026-05-27 announcing China NMPA acceptance with priority review of the first-line NDA. Source for the statement that ZEGFROVY 'has received Breakthrough Therapy Designations (BTDs) from both the U.S. FDA and China's CDE for this treatment-naive patient population' and that 'globally, no oral targeted therapies have been approved for the first-line treatment of EGFR exon20ins NSCLC' — the sponsor's framing of available therapy, which is what a priority-review determination turns on. Says 16 countries where the 2026-05-29 release says 15. Bytes retrieved 2026-07-31 for FF-001 (its SRC-004); copied here unchanged 2026-09-05. https://www.prnewswire.com/news-releases/dizals-zegfrovy-sunvozertinib-new-drug-application-accepted-and-granted-priority-review-by-china-national-medical-products-administration-for-first-line-treatment-of-egfr-exon-20-insertion-mutated-non-small-cell-lung-cancer-302783017.html Retrieved 2026-09-05 · sha256 6dc5663822dd9950c749c765045abe4c3ce4d8f6f632251106d222c577549214 SRC-007 The ASCO Post report (posted 2026-06-08) on the WU-KONG28 NEJM paper. Independent secondary reporting; source for enrolment between December 2022 and May 2025, median follow-up 24.0 vs 18.0 months, crossover of 101 of 112 (90.2%) chemotherapy patients, serious adverse events in 45.4% vs 26.7%, and one treatment-related death in the chemotherapy group. These are the facts a complete response or a major amendment would most plausibly rest on. Bytes retrieved 2026-07-31 for FF-001 (its SRC-005); copied here unchanged 2026-09-05. https://ascopost.com/news/june-2026/sunvozertinib-in-nsclc-with-egfr-exon-20-insertion-mutations/ Retrieved 2026-09-05 · sha256 81a89a602bfbc251e80c5cf06192df596808daa1d552db12ff7475987b5dda2b One more archived source, a secondary summary the record does not rely on, is held in the ledger and not listed here. --- # 45% forecast: FDA first-line approval of sunvozertinib precedes the NCCN first-line listing URL: https://nextconsensus.com/forecast/ff-004/ Registered forecast 45% registered probability event by 2027-07-31 Unresolved ## FDA first-line approval of sunvozertinib precedes the NCCN first-line listing FF-004 Registered · Unresolved Registered probability 45% Event by 2027-07-31 Resolution window 2026-09-23 → 2027-07-31 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 15% - Analyst proxy 55% nextconsensus.com/forecast/ff-004/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-09-22. It is one of 56 registered forecasts . The proposition ### What was claimed On or before 2027-07-31 both of the following occur: (a) the FDA approves a first-line / initial-treatment indication for sunvozertinib (ZEGFROVY) in EGFR exon 20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer, expected as a supplement to NDA 219839 (the event FF-002 scores); and (b) a version of the NCCN Clinical Practice Guidelines in Oncology for Non-Small Cell Lung Cancer lists sunvozertinib (ZEGFROVY) as a first-line / initial systemic therapy option, at any NCCN category, for EGFR exon 20 insertion mutation-positive metastatic non-squamous NSCLC (the event FF-001 scores) — and the date of the FDA approval action is strictly earlier than the version date of the earliest NCCN NSCLC version carrying that listing. Authority National Comprehensive Cancer Network (NCCN) and US Food and Drug Administration (FDA), NSCLC Guidelines Panel (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 5: Guideline action — Formal recommendation change by a recognized guideline body: grade shift, new/retracted endorsement, population expansion/restriction. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NCCN guideline reclassification Scope EGFR exon 20 insertion mutation-positive metastatic non-squamous NSCLC The estimate ### The number and the baselines it has to beat 45% probability, method v0.1.0 · frozen at the 2026-09-22 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-004 · registered 45% Authority base rate −5 pts 50% Calendar cycle +30 pts 15% Analyst proxy −10 pts 55% Authority base rate 50% Reference class: new FDA indications in molecularly defined NSCLC subsets, supported by a positive randomized phase 3, paired with the NCCN NSCLC panel's listing of the same indication, ordered by date. To my understanding the panel most often lists after the FDA acts, within one or two versions, and lists ahead of the FDA for a minority of high-profile datasets; roughly 0.7 regulator-first among pairs where both occur within a year, times roughly 0.7 that both occur inside this eleven-month window, gives about 0.5. ESTIMATE FROM PRECEDENT, NOT AN ENUMERATED COUNT — no dated corpus pairing NCCN version dates with FDA action dates exists in this repo, and the one backtest that touched rung 6 was invalidated by the repo's own fda-label-v1-invalidation review under workspace/reviews/ (a review of this repo's backtest, not a source fact). Recorded as the honest state of this baseline at the cutoff. Calendar cycle 15% A model that knows only clocks and cadences, with its rule stated: FDA receipt on or before 2026-07-14 (SRC-006); designation unknown, priority and standard each 0.5; goal 6 or 10 months from receipt, so the FDA date is 2027-01-14 or 2027-05-14; an action at the goal with prior 0.85. NCCN: six or more versions by July 2026 (SRC-006), so roughly monthly; with no evidence input the model treats the listing as arriving at a uniformly random version in the window with total in-window probability 0.45 (FF-001's calendar baseline used 0.4 for a twelve-month window — the same prior, not a count). Probability that the FDA date precedes a uniform NCCN date over 2026-09-06 to 2027-07-31: 6.5/11 under priority, 2.5/11 under standard, average 0.41. 0.41 x 0.85 x 0.45 = 0.16, recorded as 0.15. Every input except the receipt bound and the version count is a prior and is labelled as one. Analyst proxy 55% A thoracic-oncology or market-access analyst reading the same public record on 2026-09-05 would say the panel will follow the label, as it usually does; that the FDA will act in the first half of 2027; that a panel-first listing on the NEJM data is possible but not the base case; and would not price the window censoring or the tie rule. Reconstructed as about 0.55; estimated by reconstructing that read, not by surveying analysts. The draft's own number sits below it because the draft prices the late-approval censoring and the tie. Institutional ordering (FDA, NCCN): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-09-22 Registered 2026-09-22 Window opens 2026-09-23 Deadline 2027-07-31 Evidence cutoff 2026-09-22 Registered 2026-09-22 Window opens 2026-09-23 Deadline 2027-07-31 Evidence cutoff 2026-09-22 Nothing after this date informed the estimate. Registered 2026-09-22 Frozen and hashed. Resolution window 2026-09-23 → 2027-07-31 When the outcome can be read against the rule. Event by 2027-07-31 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 114dae9f9853bf368b35569c63d28c9aa3f183dbd10bebe9c4f5654b63d86f84 · operator record jc-1790109835432-125b0ac6 ### Around this record Sunvozertinib · first-line NSCLC - FF-003 · Sunvozertinib · first-line approval by March event by 2027-03-31 - FF-001 · Sunvozertinib · first-line guideline listing event by 2027-07-31 - FF-002 · Sunvozertinib · first-line approval event by 2027-07-31 This kind of deadline - Every registered forecast, by authority and deadline The evidence - The evidence ledger: every dated, sourced act on this asset - The subject dossier: evidence, institutional sequence, and preparation by team Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NCCN and the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Two dates are read, each under its sibling's rule as amended by workspace/reviews/2026-09-05-ff-001-ff-002-falsification.md §3d, and compared at day precision, the finest either record carries. D_FDA: the submission_status_date (YYYYMMDD) of the earliest submission in the openFDA Drugs@FDA record for application number NDA219839 — queried as https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA219839%22 — whose submission_type is SUPPL (or, if the live literal differs, is not ORIG), whose submission_status is AP, and whose approved labeling, read from Section 1 (INDICATIONS AND USAGE) of the label PDF linked in that submission's application_docs (type Label) or from the Drugs@FDA web record at https://www.accessdata.fda.gov/scripts/cder/daf/ , covers the first-line / initial-treatment setting for EGFR exon 20 insertion mutation-positive locally advanced or metastatic NSCLC. If openFDA has not refreshed by the reading date, the Action Date on the Drugs@FDA web record governs; if the two disagree, the date on the approval letter governs. A first-line approval under a new NDA counts, read from that NDA's ORIG row. Exclusions as in FF-002: later-line, maintenance, non-NSCLC, or conversion of the existing accelerated approval do not count; a narrower first-line population does. D_NCCN: the version date printed on the earliest version of the NCCN NSCLC guideline, dated on or before 2027-07-31, that names sunvozertinib or ZEGFROVY in the initial-systemic-therapy recommendation set for EGFR exon 20 insertion mutation-positive metastatic non-squamous NSCLC, at any category (1, 2A, 2B or 3), whether or not marked preferred, on the algorithm page for initial systemic therapy or in the corresponding systemic-therapy table; footnotes attached to that first-line options block count, footnotes on testing, discussion text and 'Principles of' pages do not; a listing confined to subsequent-line therapy does not count. The version date is the date NCCN prints beside the version number on the guideline's cover; if a version prints a number but its date appears only in its Updates section, that date governs. NCCN distributes only its current version, so the adjudicator reads captured copies of every NSCLC version issued inside the window (the repository is to capture each with its date and digest as it appears — an operational task, not a rule change). Bracket rule when the earliest listing version was not captured: let L be the version date of the latest version known not to carry the listing and U the version date of the earliest version known to carry it; if the exact D_NCCN cannot be established, resolve YES if D_FDA is on or before L, NO if D_FDA is on or after U, and VOID with the reason 'earliest listing version date not recoverable' if D_FDA falls strictly between L and U. Resolution: YES if and only if both D_FDA and D_NCCN exist on or before 2027-07-31 and D_FDA is strictly earlier than D_NCCN. NO if D_NCCN is earlier than or equal to D_FDA — a same-day tie resolves NO, is recorded as a tie, and is not broken by appeal to the hypothesised mechanism — or if either event has not occurred by 2027-07-31. NCCN versions dated after 2027-07-31 and FDA actions dated after 2027-07-31 are ignored. Adjudication floor: read no earlier than 2027-08-31 and no later than 2027-10-31, at the same sitting as FF-001 and FF-002. Access: openFDA and Drugs@FDA are public and unauthenticated; NCCN requires free registration. No clinical judgement about the drug is needed. VOID, with the reason recorded, if a first-line recommendation set for exon 20 insertion disease is distinguishable in no version issued inside the window, or if neither openFDA nor the Drugs@FDA web record publishes per-supplement action dates at the reading date; VOID as ill-posed if the earliest listing version is dated on or before the availability cutoff. Source the rule names: FDA action date from openFDA Drugs@FDA for NDA 219839; NCCN listing date from the version date of the earliest captured NCCN NSCLC version carrying the listing; compared at day precision Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NCCN guideline reclassification): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 45% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-09-22, including the 2 fields whose values were unknown then. Those are left unknown rather than filled in. review pathway FDA leg: Breakthrough Therapy Designation for the first-line setting, reported only by sponsor releases (SRC-001 and SRC-006: 'in this setting'; SRC-007: 'for this treatment-naive patient population'); the original NDA 219839 was reviewed under PRIORITY (SRC-003, ORIG-1, AP 20250702); the supplement's designation, priority or standard, is in no archived file. A separate April 2024 designation in the platinum-pretreated setting is reported secondarily (SRC-004). NCCN leg: no statutory clock; the panel's continuous-update process, at a cadence the archive bounds at six or more versions in the first seven months of 2026 (SRC-006). The forecast object is the ordering of the two. submission type FDA leg: supplemental New Drug Application, efficacy supplement for a new line of therapy, per sponsor releases only (submitted, SRC-006; accepted, SRC-001); no supplement row in openFDA as of 2026-09-02 (SRC-003). NCCN leg: none — NCCN does not publish manufacturer submission requests. evidence class randomized, open-label, multinational phase 3 (WU-KONG28, NCT05668988) versus carboplatin-pemetrexed: 'phase 3, international' per the NEJM abstract (SRC-002); 'open-label' per the sponsor release (SRC-005) and The ASCO Post (SRC-008); enrolled December 2022 to May 2025 (SRC-008); 15 countries per SRC-005 and 16 per SRC-007; presented as ASCO late-breaking abstract LBA8500 and published in NEJM on 2026-05-29 (SRC-002, SRC-005). pivotal n 324 randomized 1:1 (163 sunvozertinib, 161 chemotherapy) per the NEJM abstract (SRC-002) endpoint type primary: progression-free survival by blinded independent central review, 10.3 vs 7.5 months, HR 0.65 (95% CI 0.50 to 0.85), P<0.001 (SRC-002; the sponsor release gives P=0.0008, SRC-005); 12-month PFS 46.1% vs 26.7%; objective response 58.9% vs 31.1%; overall survival immature at 38.9% maturity (SRC-002) with 101 of 112 (90.2%) chemotherapy patients crossed over (SRC-008); grade 3 or higher adverse events 75.5% vs 56.7% (SRC-002); serious adverse events 45.4% vs 26.7% (SRC-008). Data cutoff read as 2026-01-16 from 'As of January 16, 2026, 324 patients were randomized' (SRC-005), which the release states as a randomization-count date; the NEJM abstract gives no cutoff date. approved competitors in class No archived file names an approved first-line regimen for this population, and no archived file states the current NCCN first-line recommendation set for it. What the archive supports: the sponsor's 'no oral targeted therapies have been approved for the first-line treatment' and 'first-line treatment ... largely relies on chemotherapy-based regimens' (SRC-007); the Cancer Discovery news item names amivantamab with lazertinib for atypical EGFR mutations and nothing for exon 20 insertions first-line (SRC-009). FF-001 records amivantamab with carboplatin/pemetrexed as FDA-approved first-line and widely reported as the NCCN category 1 preferred option, from secondary sources archived nowhere in this repo. Load-bearing on both legs if right — a preferred regimen already in place is the main argument for a slower listing (FF-001) and for a standard review clock (FF-002) — and unverified by the archive. months since last guideline revision unknown in months. The archive fixes a lower bound on version count, not a date: NCCN NSCLC Version 6.2026 existed by July 2026 (SRC-006 footnote 1, 'Accessed July 2026'; repeated in SRC-001 dated 2026-09-01). Six or more versions in seven months is a cadence of roughly one a month; the date of the latest version at the cutoff, and whether any version after 6.2026 exists, are not in the archive. panel cycle position unknown — see months_since_last_guideline_revision. At the cadence the archive implies, ten or more NSCLC versions fall inside the eleven-month window, so procedural opportunity for the NCCN leg after any in-window FDA action is close to certain; the position of the window in the cycle is not known. sponsor request status FDA leg: supplemental NDA submitted on or before 2026-07-14 (SRC-006) and accepted on or before 2026-09-01 (SRC-001); receipt date, filing date, designation and goal date undisclosed; press release only. NCCN leg: unknown — NCCN does not publish manufacturer submission requests. odac referral none announced in any archived file as of the availability cutoff; the advisory-committee calendar is not archived (absence claim) sponsor state change AstraZeneca entered an exclusive global licence with Dizal on 2026-07-14 ($600m upfront, up to $900m in milestones; SRC-006) and announced its completion on 2026-09-01, four days before this cutoff, with a US launch of the second-line indication planned for the fourth quarter of 2026 (SRC-001) — a change in the commercial capacity behind both regulatory and guideline engagement. The application holder of record in openFDA is still DIZAL as of 2026-09-02 (SRC-003). Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-09-22 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 AstraZeneca press release dated 2026-09-01 (BUSINESS WIRE, BioSpace carriage) announcing completion of the global licence from Dizal. Load-bearing for both legs of the ordering. FDA leg: the only archived statement that the first-line supplemental NDA 'has been accepted by the US Food and Drug Administration (FDA)', with no acceptance date, review designation or goal date. NCCN leg: the latest archived statement of the guideline state — sunvozertinib 'is recommended as a subsequent therapy option' in the NCCN NSCLC guideline, footnoted to Version 6.2026 accessed July 2026 — so no first-line listing had appeared in the version the sponsor read in July 2026, two months after the NEJM publication. Also: Breakthrough Therapy Designation 'in this setting' from FDA and China's CDE; US launch of the second-line indication planned for Q4 2026. Bytes retrieved 2026-09-04 for the fda-nsclc-sunvozertinib-first-line-approval draft (its SRC-001); copied here unchanged 2026-09-05. https://www.biospace.com/press-releases/astrazeneca-completes-global-license-agreement-for-oral-egfr-inhibitor-zegfrovy-sunvozertinib-for-lung-cancer Retrieved 2026-09-05 · sha256 779b724b7d2e236b854b931f41c5ed63d59aebe6cbbb481bebe6cf8a49b55332 SRC-002 PubMed E-utilities XML for the NEJM primary publication (PMID 42212913, doi 10.1056/NEJMoa2604461, published online 2026-05-29), 'First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations'. The evidence event both legs respond to: n=324 (163 vs 161), carboplatin-pemetrexed control, PFS 10.3 vs 7.5 months by BICR, HR 0.65 (95% CI 0.50 to 0.85), P<0.001, overall survival immature (38.9% maturity), grade 3 or higher adverse events 75.5% vs 56.7%. Archived via PubMed because nejm.org serves a bot-challenge page. FF-001 holds an earlier retrieval (2026-07-31) of the same record with different bytes under nccn-nsclc-sunvozertinib-1l/SRC-002; this is the 2026-09-04 retrieval made for the fda-nsclc-sunvozertinib-first-line-approval draft (its SRC-002), copied here unchanged 2026-09-05. https://eutils.ncbi.nlm.nih.gov/entrez/eutils/efetch.fcgi?db=pubmed&id=42212913&retmode=xml Retrieved 2026-09-05 · sha256 fdf43f48643ab11e991f9b089d2bce0f45675bf6a15f20be067355715688809e SRC-003 openFDA Drugs@FDA record for application NDA219839 (ZEGFROVY, sponsor DIZAL), meta.last_updated 2026-09-02. Starting state of the FDA leg: exactly one submission, ORIG-1, submission_status AP dated 20250702, review_priority PRIORITY; no supplement is present, so the FDA event has not occurred at the cutoff. Also the resolution source for the FDA date; this copy was queried by brand name, the resolution rule queries by application_number. Bytes retrieved 2026-09-04 for the fda-nsclc-sunvozertinib-first-line-approval draft (its SRC-003) and copied here unchanged 2026-09-05, so the FDA starting state is read one day before this draft's cutoff — see contingency_notes. https://api.fda.gov/drug/drugsfda.json?search=products.brand_name:%22ZEGFROVY%22&limit=5 Retrieved 2026-09-05 · sha256 9dc982bddee2169e1df1b7fdbb7182de826569802f9601ed15b434dd5a4f2b05 SRC-005 Dizal press release dated 2026-05-29 announcing the WU-KONG28 results at ASCO with simultaneous NEJM publication — the date the evidence became detectable (t_detectable). Source for 'As of January 16, 2026, 324 patients were randomized in a 1:1 ratio', the byte from which the 2026-01-16 date in covariates.endpoint_type and clocks.t_evidence is read (as the data cutoff, t_evidence), P=0.0008, the 'open-label' design, 15 countries, prior US and China accelerated approvals in relapsed/refractory disease, and that China's NMPA 'accepted and granted Priority Review designation' to the first-line NDA — wording no archived file uses for the US supplement, which matters for when the FDA leg lands. Bytes retrieved 2026-07-31 for FF-001 (its SRC-001); copied here unchanged 2026-09-05. https://www.prnewswire.com/news-releases/dizal-announces-phase-3-wu-kong28-results-zegfrovy-sunvozertinib-outperforms-platinum-doublet-chemotherapy-in-first-line-egfr-exon-20-insertion-mutation-positive-non-small-cell-lung-cancer-302785656.html Retrieved 2026-09-05 · sha256 8d36a5ba14efa04cbdbbc0ea3ceda931828048f5dfdeed0c9621ed5fdd394489 SRC-006 AstraZeneca press release dated 2026-07-14 announcing the exclusive global licence agreement with Dizal. FDA leg: a supplemental NDA for the first-line setting 'has been submitted' to FDA, fixing receipt on or before 2026-07-14, with Breakthrough Therapy Designation in this setting. NCCN leg: sunvozertinib 'is included in the NCCN Clinical Practice Guidelines in Oncology for NSCLC as a Category 2A recommended subsequent therapy option', footnote 1 citing Version 6.2026 accessed July 2026 — the only archived statement of the category, and evidence that at least six NSCLC versions were issued in 2026 by July. Bytes retrieved 2026-07-31 for FF-001 (its SRC-003); copied here unchanged 2026-09-05. https://www.astrazeneca.com/media-centre/press-releases/2026/astrazeneca-licenses-novel-egfr-inhibitor.html Retrieved 2026-09-05 · sha256 56e8ee9aceb9ca38a075dc5b969135c71e2b48cc9f82487f39a0c49d35697f0f SRC-007 Dizal press release dated 2026-05-27 announcing China NMPA acceptance with priority review of the first-line NDA. Source for FDA Breakthrough Therapy Designation 'for this treatment-naive patient population' and for the sponsor's statement that 'no oral targeted therapies have been approved for the first-line treatment of EGFR exon20ins NSCLC' and that first-line treatment 'largely relies on chemotherapy-based regimens' — the sponsor's account of what the guideline and the regulator each have in front of them. Bytes retrieved 2026-07-31 for FF-001 (its SRC-004); copied here unchanged 2026-09-05. https://www.prnewswire.com/news-releases/dizals-zegfrovy-sunvozertinib-new-drug-application-accepted-and-granted-priority-review-by-china-national-medical-products-administration-for-first-line-treatment-of-egfr-exon-20-insertion-mutated-non-small-cell-lung-cancer-302783017.html Retrieved 2026-09-05 · sha256 6dc5663822dd9950c749c765045abe4c3ce4d8f6f632251106d222c577549214 SRC-008 The ASCO Post report (posted 2026-06-08) on the WU-KONG28 NEJM paper. Independent secondary reporting; source for enrolment December 2022 to May 2025, median follow-up 24.0 vs 18.0 months, crossover of 101 of 112 (90.2%) chemotherapy patients, serious adverse events 45.4% vs 26.7%. The facts a slow FDA review or a cautious panel would most plausibly cite. Bytes retrieved 2026-07-31 for FF-001 (its SRC-005); copied here unchanged 2026-09-05. https://ascopost.com/news/june-2026/sunvozertinib-in-nsclc-with-egfr-exon-20-insertion-mutations/ Retrieved 2026-09-05 · sha256 81a89a602bfbc251e80c5cf06192df596808daa1d552db12ff7475987b5dda2b SRC-009 PubMed record for the Cancer Discovery news item 'Rare EGFRm NSCLC: More First-Line Options Emerge' (PMID 42224429, 2026-07-01). Contemporaneous field read: sunvozertinib, 'an approved later-line option', 'also looks effective up front, besting chemotherapy'; the only other agent it names is amivantamab with lazertinib for atypical EGFR mutations. It says nothing about any guideline or regulatory timetable and names no approved first-line exon 20 insertion regimen. Bytes retrieved 2026-07-31 for FF-001 (its SRC-006); copied here unchanged 2026-09-05. https://pubmed.ncbi.nlm.nih.gov/42224429/ Retrieved 2026-09-05 · sha256 d8898e1c83e58d791ef7466d371ccf1728f120b1c0aa46a61c0bac75571f0098 One more archived source, a secondary summary the record does not rely on, is held in the ledger and not listed here. --- # 82% forecast: FDA approves the aficamten MAPLE-HCM supplement to NDA 219083 on or before the disclosed PDUFA goal date of 2026-11-14 URL: https://nextconsensus.com/forecast/ff-005/ Registered forecast 82% registered probability event by 2026-11-14 Unresolved ## FDA approves the aficamten MAPLE-HCM supplement to NDA 219083 on or before the disclosed PDUFA goal date of 2026-11-14 FF-005 Registered · Unresolved Registered probability 82% Event by 2026-11-14 Resolution window 2026-09-27 → 2026-11-14 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 85% - Calendar cycle 80% - Analyst proxy 85% nextconsensus.com/forecast/ff-005/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-09-26. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on a supplement to NDA 219083 (aficamten, MYQORZO; applicant Cytokinetics) whose approved labeling includes the results of the MAPLE-HCM trial, with an approval action date on or before 2026-11-14, the PDUFA goal date disclosed in Cytokinetics' Form 10-Q filed 2026-08-06. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope Obstructive hypertrophic cardiomyopathy (MAPLE-HCM trial population) The estimate ### The number and the baselines it has to beat 82% probability, method v0.1.0 · frozen at the 2026-09-26 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-005 · registered 82% Authority base rate −3 pts 85% Calendar cycle +2 pts 80% Analyst proxy −3 pts 85% Authority base rate 85% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Efficacy supplements to approved drugs are approved at their first goal date more often than original applications. The calendar's own count does not exist yet. Calendar cycle 80% A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle supplement actions are approvals. Analyst proxy 85% An analyst reading the same public record on 2026-09-24 would weigh a positive randomized phase 3 trial, a drug already approved and sold, a standard-review supplement and a well-funded sponsor against the chance of a late labeling negotiation or an extension like the one on the original NDA. The analyst would call approval by the date likely. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-14 Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-14 Evidence cutoff 2026-09-26 Nothing after this date informed the estimate. Registered 2026-09-26 Frozen and hashed. Resolution window 2026-09-27 → 2026-11-14 When the outcome can be read against the rule. Event by 2026-11-14 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger a5cceddb217f50728de0be9b274908b92398542751b2c1e5f5aac2647294e93c · operator record jc-1790461082252-bcaed08e ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the openFDA Drugs@FDA record for application NDA219083 (https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA219083%22) contains a submission with submission_type SUPPL, submission_status AP and a submission_status_date on or before 2026-11-14 that is this supplement. The supplement number was not known at the cutoff, so it is identified by two fields read together: submission_class_code EFFICACY in openFDA, and a Drugs@FDA approval letter or approved label for that supplement that names MAPLE-HCM or describes a randomized trial comparing aficamten with metoprolol. If the approval letter names MAPLE-HCM but openFDA carries another class code, the letter governs. Approval with labeling language about MAPLE-HCM narrower than the applicant sought still resolves YES. Resolves NO if no such supplement is approved on or before 2026-11-14: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-14 resolves NO as occurred_after_deadline. 2026-11-14 is a Saturday; an approval action dated that day still counts. Read no earlier than 2026-11-28; if openFDA has not refreshed, the Drugs@FDA web record for NDA 219083 (https://www.accessdata.fda.gov/scripts/cder/daf/) governs. At the cutoff the record held ORIG 1, approved 2025-12-19, and SUPPL 1, approved 2026-02-05 with a class code other than EFFICACY (SRC-002), and the only approved label named neither MAPLE-HCM nor metoprolol (SRC-003). Resolves unresolvable only if neither source can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA219083%22, https://www.accessdata.fda.gov/scripts/cder/daf/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 82% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-09-26, including the one field whose value was unknown then. It is left unknown rather than filled in. review pathway standard review (SRC-001) submission type efficacy supplement to NDA 219083, asking to add trial results to the label of an approved new molecular entity (SRC-001, SRC-002) evidence class completed randomized, double-blind, active-comparator phase 3 trial, MAPLE-HCM (SRC-001) pivotal n unknown — not stated in the archived sources endpoint type change in peak oxygen uptake (pVO2) from baseline to week 24, aficamten against metoprolol (SRC-001) approved competitors in class not named in the archive — Cytokinetics describes MYQORZO as competing among cardiac myosin inhibitors in the United States (SRC-001) months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status sNDA submitted January 2026, accepted for filing with standard review (SRC-001) odac referral none announced in the archived sources sponsor state change latest approved supplement to NDA 219083 is SUPPL 1, 2026-02-05, not an efficacy supplement (SRC-002); MYQORZO approved by the European Commission in February 2026 and in the United Kingdom in July 2026 (SRC-001) Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-09-26 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Cytokinetics 10-Q for the quarter ended 2026-06-30, filed 2026-08-06. States that Cytokinetics submitted in January 2026, and FDA accepted for filing, a supplemental NDA for MYQORZO requesting to include in the label the results of MAPLE-HCM, a phase 3 randomized, double-blind, active-comparator trial of aficamten monotherapy against metoprolol monotherapy in obstructive HCM, with a standard review classification and a PDUFA date of November 14, 2026. States that MAPLE-HCM showed a statistically significant improvement in peak oxygen uptake from baseline to week 24 against metoprolol, that FDA approved MYQORZO in December 2025, and that the original NDA's PDUFA action date was extended once. https://www.sec.gov/Archives/edgar/data/1061983/000119312526338217/cytk-20260630.htm Retrieved 2026-09-24 · sha256 98c96b81eacc3370a7815e4a9ed93292dd1dd82e1ec3e61add5956acea07c652 SRC-002 openFDA Drugs@FDA record for NDA219083 (MYQORZO, aficamten) retrieved at the cutoff. The starting state: ORIG 1 approved 2025-12-19 and SUPPL 1 approved 2026-02-05, whose submission_class_code is not EFFICACY; no efficacy supplement is approved. https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA219083%22 Retrieved 2026-09-24 · sha256 2bcfe382f9442970adad23e6654153c8a352fc99ef56a69e611bedf928e5b89d SRC-003 Drugs@FDA prescribing information for MYQORZO approved with ORIG 1 (2025-12-19), the only label posted for NDA 219083 at the cutoff. Its clinical studies section describes SEQUOIA-HCM; it does not name MAPLE-HCM or metoprolol. This is what makes a label naming MAPLE-HCM a change an adjudicator can see. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219083s000lbl.pdf Retrieved 2026-09-24 · sha256 d90aed5fdec2ba10979194c950d9ca10444976b658156ac07847fe0be073f753 --- # 85% forecast: FDA approves BBP-418 for limb-girdle muscular dystrophy type 2I/R9 on or before the disclosed PDUFA goal date of 2026-11-27 URL: https://nextconsensus.com/forecast/ff-006/ Registered forecast 85% registered probability event by 2026-11-27 Unresolved ## FDA approves BBP-418 for limb-girdle muscular dystrophy type 2I/R9 on or before the disclosed PDUFA goal date of 2026-11-27 FF-006 Registered · Unresolved Registered probability 85% Event by 2026-11-27 Resolution window 2026-09-27 → 2026-11-27 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 85% - Calendar cycle 80% - Analyst proxy 85% nextconsensus.com/forecast/ff-006/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-09-26. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on BridgeBio Pharma's New Drug Application for oral BBP-418 for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), with an approval action date on or before 2026-11-27, the PDUFA target action date disclosed in BridgeBio's Form 8-K filed 2026-08-31. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope Limb-girdle muscular dystrophy type 2I/R9 The estimate ### The number and the baselines it has to beat 85% probability, method v0.1.0 · frozen at the 2026-09-26 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-006 · registered 85% Authority base rate 0 pts 85% Calendar cycle +5 pts 80% Analyst proxy 0 pts 85% Authority base rate 85% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Original NDAs under Priority Review with a positive phase 3 trial are approved at their first goal date in a large majority of cases. The calendar's own met-goal-date share for disclosed PDUFA dates does not exist yet (docs/foundations/short-horizon-reference-classes.md §4.1). Calendar cycle 80% A model that knows only the clock. The goal date falls inside the window; FDA meets the large majority of PDUFA goal dates; the share of first-cycle actions on original NDAs that are approvals is the rest. With no evidence input it cannot tell a strong application from a weak one. Analyst proxy 85% A neuromuscular-focused analyst reading the same public record on 2026-09-24 — a phase 3 trial that met every pre-specified endpoint at interim, Priority Review, no advisory committee planned, no approved alternative, a sponsor with an approved product and cash for a launch — would call approval by the goal date likely, with FDA's view of an interim-analysis submission as the main risk. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-27 Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-27 Evidence cutoff 2026-09-26 Nothing after this date informed the estimate. Registered 2026-09-26 Frozen and hashed. Resolution window 2026-09-27 → 2026-11-27 When the outcome can be read against the rule. Event by 2026-11-27 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 56a534eeec5d40e039a81e7783a01a2d1661afbbb6bb11f9b30d64fd36dbdf25 · operator record jc-1790461082259-3f5083f6 ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast The application number was not public at the cutoff, and no archived source gives an FDA established name for BBP-418; BridgeBio's own filings identify its compound as ribitol (SRC-004). The adjudicator therefore identifies the application by its indication plus its ingredient or its applicant, never by a name the adjudicator infers: the qualifying application is an NDA whose Drugs@FDA approval letter or label names limb-girdle muscular dystrophy type 2I/R9 (also written LGMD2I, LGMD R9 or FKRP-related limb-girdle muscular dystrophy) in its indication, and whose active ingredient is ribitol or whose applicant is BridgeBio Pharma or a BridgeBio subsidiary, under any proprietary name. Resolves YES if such an application appears in the openFDA Drugs@FDA endpoint, located by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22ribitol%22, with an ORIG submission whose submission_status is AP and whose submission_status_date is on or before 2026-11-27. An approval for a narrower LGMD2I/R9 population than the applicant sought (by age or genotype, for example) still resolves YES, as does accelerated rather than traditional approval. Resolves NO if no approval action is dated on or before 2026-11-27: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-27 resolves NO as occurred_after_deadline. 2026-11-27 is a Friday. Read no earlier than 2026-12-11. If openFDA has not refreshed by then, or the query returns nothing, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name ribitol or by the applicant) governs, under the same identification test. Resolves unresolvable only if neither source can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22ribitol%22, https://www.accessdata.fda.gov/scripts/cder/daf/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 85% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-09-26, including the 2 fields whose values were unknown then. Those are left unknown rather than filled in. review pathway Priority Review (SRC-001, SRC-002); Orphan Drug, Fast Track and Rare Pediatric Disease designations (SRC-002) submission type original NDA; oral small molecule, identified by BridgeBio as ribitol (SRC-004); application number not public evidence class placebo-controlled phase 3 trial, FORTIFY, at a pre-specified 12-month interim analysis (SRC-002, SRC-003) pivotal n unknown — not stated in the archived sources endpoint type unknown in the archive — FORTIFY met all pre-specified primary and secondary endpoints at interim, which the archived sources do not name; the drug is meant to restore alpha-dystroglycan glycosylation (SRC-002) approved competitors in class none — BridgeBio states BBP-418 would be the first approved therapy for LGMD2I/R9 and for any form of LGMD (SRC-002) months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status NDA accepted for filing with Priority Review on 2026-05-27 (SRC-002) odac referral none planned — FDA said at filing it was not currently planning an advisory committee meeting; restated 2026-08-10 (SRC-002, SRC-003) sponsor state change none recorded in the archived sources since NDA acceptance Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-09-26 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Exhibit 99.1 to BridgeBio Pharma's 8-K filed 2026-08-31: press release of that date on an agreement with the U.S. government. States BridgeBio has three additional medicines under FDA review, including BBP-418 for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), with a PDUFA date with Priority Review of November 27, 2026. Gives no generic name and no application number for BBP-418. https://www.sec.gov/Archives/edgar/data/1743881/000114036126035055/ef20081330_ex99-1.htm Retrieved 2026-09-24 · sha256 c78b0e3280c74846acea00c04e8448f0bca08a07e64ecc27928383f1f85feec4 SRC-002 Exhibit 99.1 to BridgeBio's 8-K filed 2026-05-27: press release of that date. States the FDA accepted for filing BridgeBio's New Drug Application (NDA) for oral BBP-418 for the treatment of LGMD2I/R9 with Priority Review and a PDUFA target action date of November 27, 2026, and notified BridgeBio it is not currently planning to hold an advisory committee meeting. States the phase 3 FORTIFY trial met all primary and secondary endpoints at its pre-specified 12-month interim analysis; that BBP-418 is an oral glycosylation substrate intended to enhance residual FKRP enzyme function and restore glycosylation of alpha-dystroglycan; that it holds FDA Orphan Drug, Fast Track and Rare Pediatric Disease designations; and that no therapy is approved for LGMD2I/R9 or any form of LGMD. https://www.sec.gov/Archives/edgar/data/1743881/000114036126022979/ef20074977_ex99-1.htm Retrieved 2026-09-24 · sha256 881c2fa35fe7c4f598eafea0ebc48a79b2fa1c0a169164b56d20b69f8d1119b3 SRC-003 Exhibit 99.1 to BridgeBio's 8-K filed 2026-08-10: second-quarter 2026 results release. Restates that on May 27, 2026 the FDA accepted the NDA for BBP-418 with Priority Review and a PDUFA target action date of November 27, 2026, and that no advisory committee meeting is currently planned; restates that FORTIFY met all pre-specified primary and secondary endpoints of its 12-month interim analysis. Reports cash, cash equivalents and marketable securities of 720.2 million dollars at 2026-06-30 and one approved product, Attruby. https://www.sec.gov/Archives/edgar/data/1743881/000174388126000026/bbio-20260630xex991.htm Retrieved 2026-09-24 · sha256 6cef45e0d6e9073c53860de1d58a578291bf2e563b7906882f1beb99b6847b08 SRC-004 Exhibit 10.1 to BridgeBio's 8-K filed 2026-07-02 (a financing agreement). Its definitions identify BBP-418 as a product containing the compound (2R,3S,4S)-pentane-1,2,3,4,5-pentol, also known as ribitol. The one archived source that names BBP-418's active compound; it is a contract definition, not an FDA established name. https://www.sec.gov/Archives/edgar/data/1743881/000114036126027445/ef20077282_ex10-1.htm Retrieved 2026-09-24 · sha256 e274807a0e380067c019d228fb47bcd40688387c99f77e8ea886505e0831a549 --- # 84% forecast: FDA approves bepirovirsen for chronic hepatitis B on or before the disclosed PDUFA goal date of 2026-10-26 URL: https://nextconsensus.com/forecast/ff-007/ Registered forecast 84% registered probability event by 2026-10-26 Unresolved ## FDA approves bepirovirsen for chronic hepatitis B on or before the disclosed PDUFA goal date of 2026-10-26 FF-007 Registered · Unresolved Registered probability 84% Event by 2026-10-26 Resolution window 2026-09-27 → 2026-10-26 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 85% - Calendar cycle 80% - Analyst proxy 85% nextconsensus.com/forecast/ff-007/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-09-26. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on a New Drug Application for bepirovirsen (applicant GSK) for the treatment of chronic hepatitis B, with an approval action date on or before 2026-10-26, the PDUFA goal date disclosed in Ionis Pharmaceuticals' Form 10-Q filed 2026-07-29. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope Chronic hepatitis B The estimate ### The number and the baselines it has to beat 84% probability, method v0.1.0 · frozen at the 2026-09-26 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-007 · registered 84% Authority base rate −1 pts 85% Calendar cycle +4 pts 80% Analyst proxy −1 pts 85% Authority base rate 85% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Original NDAs under Priority Review with positive randomised phase 3 trials are approved at their first goal date in a large majority of cases. The calendar's own met-goal-date share for disclosed PDUFA dates does not exist yet (docs/foundations/short-horizon-reference-classes.md §4.1); this is the honest state of the baseline at the cutoff. Calendar cycle 80% A model that knows only the clock. The goal date falls inside the window; FDA meets the large majority of PDUFA goal dates; the share of first-cycle actions on original NDAs that are approvals is the rest. With no evidence input it cannot tell a strong application from a weak one. Analyst proxy 85% A hepatology-focused analyst reading the same public record on 2026-09-22 — two positive phase 3 trials in NEJM, Breakthrough designation, Priority Review, approval in Japan a month earlier, a large sponsor — would call approval by the goal date likely, with manufacturing of a novel oligonucleotide as the main risk. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-10-26 Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-10-26 Evidence cutoff 2026-09-26 Nothing after this date informed the estimate. Registered 2026-09-26 Frozen and hashed. Resolution window 2026-09-27 → 2026-10-26 When the outcome can be read against the rule. Event by 2026-10-26 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 7a94b79fadc84e089049a64c530c032a32cfc876c966e1f24e37683f016a66e8 · operator record jc-1790461077721-b6900ecd ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the openFDA Drugs@FDA record returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22bepirovirsen%22 contains an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-10-26, and the Drugs@FDA approval letter or label for that application names chronic hepatitis B in its indication. An approval for a narrower chronic hepatitis B population than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2026-10-26: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-10-26 resolves NO as occurred_after_deadline. Read no earlier than 2026-11-09. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name bepirovirsen) governs. The application number was not public at the cutoff, so the rule reads by generic name; if the product carries a proprietary name, the generic name still identifies it. Resolves unresolvable only if neither source can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22bepirovirsen%22, https://www.accessdata.fda.gov/scripts/cder/daf/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 84% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-09-26, including the one field whose value was unknown then. It is left unknown rather than filled in. review pathway Priority Review (SRC-001); US Breakthrough Therapy and Fast Track designations (SRC-002) submission type original NDA; new molecular entity (antisense oligonucleotide) evidence class two randomised, double-blind, placebo-controlled phase 3 trials, B-Well 1 and B-Well 2 (SRC-002, SRC-003) pivotal n unknown — not stated in the archived sources endpoint type functional cure of chronic hepatitis B (HBsAg loss with HBV DNA suppression) as GSK describes it (SRC-003); the exact primary-endpoint wording is not in the archive approved competitors in class none — GSK describes it as the first functional cure approved (Japan, SRC-002) months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status filed Q1 2026 (SRC-003); accepted with Priority Review (SRC-001) odac referral none announced in the archived sources sponsor state change first global approval, Japan, 2026-08-24 (SRC-002) Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-09-26 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Ionis Pharmaceuticals 10-Q for the quarter ended 2026-06-30, filed 2026-07-29. States that GSK is developing bepirovirsen for chronic hepatitis B and that the FDA granted Priority Review with a PDUFA action date of October 26, 2026. The disclosure is the licensor's; GSK is the applicant. https://www.sec.gov/Archives/edgar/data/874015/000087401526000251/form10q.htm Retrieved 2026-09-22 · sha256 4e22f26cda9ad6efbdb70f60fc29f45de76d9e57cf708dd2974538c15d50f7d7 SRC-002 GSK plc 6-K dated 2026-08-24: Japan's MHLW approved Hibsago (bepirovirsen) for chronic hepatitis B, described as the first global approval. A regulatory decision in another jurisdiction; it says nothing about the FDA action. https://www.sec.gov/Archives/edgar/data/1131399/000165495426007800/a8443r.htm Retrieved 2026-09-22 · sha256 92a1488d92b33b2cd78e9b27504d7130b568dcbd5b59e2f2ee5ec12ba23a5bc6 SRC-003 GSK plc 6-K dated 2026-09-08 (results release): pipeline table lists bepirovirsen B-WELL 1/2 with 'Regulatory decision (US, JP)' still ahead, and states bepirovirsen was filed in Q1 2026. https://www.sec.gov/Archives/edgar/data/1131399/000119312526384439/d331501d6k.htm Retrieved 2026-09-22 · sha256 1d246b55a9181829ff3f53f0446c244603ee67467b6e650c8b16e94c49593d23 --- # 35% forecast: FDA approves deramiocel for Duchenne muscular dystrophy on or before the disclosed PDUFA goal date of 2026-11-22 URL: https://nextconsensus.com/forecast/ff-008/ Registered forecast 35% registered probability event by 2026-11-22 Unresolved ## FDA approves deramiocel for Duchenne muscular dystrophy on or before the disclosed PDUFA goal date of 2026-11-22 FF-008 Registered · Unresolved Registered probability 35% Event by 2026-11-22 Resolution window 2026-09-27 → 2026-11-22 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 60% - Analyst proxy 35% nextconsensus.com/forecast/ff-008/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-09-26. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on Capricor Therapeutics' Biologics License Application for deramiocel (CAP-1002) for the treatment of Duchenne muscular dystrophy, with an approval action date on or before 2026-11-22, the PDUFA target action date disclosed in Capricor's Form 8-K filed 2026-08-24. Authority US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope Duchenne muscular dystrophy The estimate ### The number and the baselines it has to beat 35% probability, method v0.1.0 · frozen at the 2026-09-26 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-008 · registered 35% Authority base rate −15 pts 50% Calendar cycle −25 pts 60% Analyst proxy 0 pts 35% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Approval at the goal date for resubmitted original BLAs whose first cycle ended in a complete response on effectiveness, across review types. No enumerated count exists in this repository yet. Calendar cycle 60% A clock-only model: the goal date is inside the window and FDA meets most goal dates, discounted because this is a resubmission whose goal date has already been extended once. Analyst proxy 35% An analyst reading the same public record on 2026-09-24 would weigh a met primary endpoint on upper limb function, CBER's acceptance of an amendment toward that indication and the unmet need in DMD against a prior complete response on effectiveness, a 3 to 9 advisory committee vote, a key secondary endpoint no longer significant, an inspection finding on trial conduct and a sponsor with no approved product. Such an analyst would call approval by the goal date less likely than not. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-22 Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-22 Evidence cutoff 2026-09-26 Nothing after this date informed the estimate. Registered 2026-09-26 Frozen and hashed. Resolution window 2026-09-27 → 2026-11-22 When the outcome can be read against the rule. Event by 2026-11-22 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 53dcbd72a686d5c74158eebc1b0aca044cd2fa9b317017ce1645fe902cdcb6ec · operator record jc-1790461082264-68c58ac7 ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Deramiocel is a CBER-regulated cell therapy, so openFDA's drugsfda endpoint does not list it. Resolves YES if FDA's Purple Book (https://purplebooksearch.fda.gov/) lists a licensed biological product that is deramiocel (CAP-1002) under any proprietary or proper name, with Capricor Therapeutics as licensee and an approval (license) date on or before 2026-11-22, and the CBER approval letter for that BLA names Duchenne muscular dystrophy in the indication. An indication for Duchenne muscular dystrophy as a whole, for a named part of it such as upper limb function or cardiomyopathy, or for a subpopulation of patients with it, resolves YES; so does accelerated rather than traditional approval. Resolves NO if no approval action is dated on or before 2026-11-22: a complete response letter, a further goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; an approval dated after 2026-11-22 resolves NO as occurred_after_deadline. 2026-11-22 is a Sunday; an approval action dated on or before it counts whatever the weekday. Read no earlier than 2026-12-06. If the Purple Book has not updated by then, the CBER approval letter or FDA's list of approved cellular and gene therapy products (https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products) governs. At the cutoff that list, content current as of 2026-09-17, did not include deramiocel (SRC-004). Resolves unresolvable only if none of these can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://purplebooksearch.fda.gov/, https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 35% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-09-26, including the one field whose value was unknown then. It is left unknown rather than filled in. review pathway Class 2 resubmission; the first cycle had Priority Review; goal date extended three months by a major amendment (SRC-001, SRC-003); RMAT, Orphan Drug and Rare Pediatric Disease designations (SRC-002) submission type original BLA, Class 2 resubmission after a complete response letter (allogeneic cell therapy; CBER) evidence class one placebo-controlled phase 3 trial, HOPE-3, with the phase 2 HOPE-2 trial and open-label extensions (SRC-003) pivotal n unknown — not stated in the archived sources endpoint type upper limb function on PUL 2.0, the HOPE-3 primary endpoint, met at p=0.029; key secondary LVEF at p=0.09 after a model update (SRC-003) approved competitors in class none named in the archived sources; Capricor says several therapies address certain DMD genetic mutations and that unmet need remains in established skeletal and cardiac muscle disease (SRC-003) months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status BLA amended with 24-month HOPE-3 open-label extension data and a refined proposed indication focused on upper limb function; CBER accepted it and moved the goal date from August 22, 2026 to November 22, 2026 (SRC-001, SRC-002) odac referral Cellular, Tissue and Gene Therapies Advisory Committee met 2026-07-29 and voted 3 for, 9 against on effectiveness for cardiomyopathy in DMD; no vote on upper limb function or overall benefit-risk (SRC-003) sponsor state change complete response letter July 2025; Form 483 with one observation on HOPE-3 trial conduct after a July 2026 BIMO inspection, response submitted (SRC-003) Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-09-26 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Capricor Therapeutics 8-K filed 2026-08-24 (Item 8.01). States the FDA extended the PDUFA target action date for Capricor's BLA for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD), from August 22, 2026 to November 22, 2026, after classifying a submission as a major amendment that extends the review period by three months. The amendment includes 24-month open-label extension data from the Phase 3 HOPE-3 study and asks FDA to review the data in support of a refined proposed indication focused on upper limb function, the HOPE-3 primary endpoint. https://www.sec.gov/Archives/edgar/data/1133869/000110465926100071/capr-20260824x8k.htm Retrieved 2026-09-24 · sha256 9f970ba2e4ae130fbf072fb42f55123c8679756ef3089edc99fdd147870d8601 SRC-002 Exhibit 99.1 to the same 8-K: Capricor press release dated 2026-08-24. States the amendment followed the July 2026 Advisory Committee meeting; that FDA's Center for Biologics Evaluation and Research (CBER) accepted the amendment for review, citing the significant unmet medical need in DMD; that the new PDUFA target action date is November 22, 2026; and that Deramiocel (CAP-1002) is allogeneic cardiosphere-derived cells holding Orphan Drug, RMAT and Rare Pediatric Disease designations in the U.S. https://www.sec.gov/Archives/edgar/data/1133869/000110465926100071/capr-20260824xex99d1.htm Retrieved 2026-09-24 · sha256 496a2e83537e57e2e95b943e9e25caf54f4a4f88649550aac7dc3a23675935fe SRC-003 Capricor 10-Q for the quarter ended 2026-06-30, filed 2026-08-14. Records the BLA history: submitted late 2024 for the treatment of DMD, Priority Review, a Complete Response Letter in July 2025 finding the application did not meet the statutory requirement for substantial evidence of effectiveness, and a Class 2 resubmission with HOPE-3 data given a PDUFA date of August 22, 2026. Records HOPE-3 results: primary endpoint PUL 2.0 met (least squares mean difference 4.55 percentage points, p=0.029); key secondary endpoint LVEF revised to p=0.09 under an updated statistical model, so later hierarchical endpoints are nominal only. Records a July 2026 BIMO inspection ending with a Form 483 citing one observation on HOPE-3 trial conduct, answered by Capricor. Records the 2026-07-29 Cellular, Tissue and Gene Therapies Advisory Committee vote of 3 for and 9 against on whether the evidence supports effectiveness for cardiomyopathy in DMD, a narrower indication than Capricor proposed, with no vote on upper limb function or overall benefit-risk, and Capricor's plan to amend the BLA toward a refined indication focused on the HOPE-3 primary endpoint. https://www.sec.gov/Archives/edgar/data/1133869/000110465926097294/capr-20260630x10q.htm Retrieved 2026-09-24 · sha256 a55e830f12123306d9b5744dc67ad80f339368b1dd71dce0f60dd51aaaf3317e SRC-004 FDA page 'Approved Cellular and Gene Therapy Products' (licensed products from CBER's Office of Therapeutic Products), content current as of 2026-09-17, retrieved at the cutoff. The starting state: it does not list Deramiocel or any Capricor product. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products Retrieved 2026-09-24 · sha256 b2104a789deaaa3322b5366766d5b314a1cdbbf7930cc3a6dae389e8013be439 --- # 35% forecast: FDA approves the IGALMI at-home use supplement to NDA 215390 on or before the disclosed PDUFA goal date of 2026-11-14 URL: https://nextconsensus.com/forecast/ff-009/ Registered forecast 35% registered probability event by 2026-11-14 Unresolved ## FDA approves the IGALMI at-home use supplement to NDA 215390 on or before the disclosed PDUFA goal date of 2026-11-14 FF-009 Registered · Unresolved Registered probability 35% Event by 2026-11-14 Resolution window 2026-09-27 → 2026-11-14 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 85% - Calendar cycle 80% - Analyst proxy 40% nextconsensus.com/forecast/ff-009/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-09-26. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on a supplement to NDA 215390 (dexmedetomidine sublingual film, IGALMI; applicant at the cutoff BioXcel Therapeutics) whose approved labeling permits IGALMI to be taken at home, without the supervision of a healthcare provider, for the acute treatment of agitation associated with schizophrenia or bipolar disorder, with an approval action date on or before 2026-11-14, the PDUFA target action date disclosed in BioXcel's Form 10-Q filed 2026-08-13. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope Agitation associated with bipolar disorder or schizophrenia (at-home use) The estimate ### The number and the baselines it has to beat 35% probability, method v0.1.0 · frozen at the 2026-09-26 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-009 · registered 35% Authority base rate −50 pts 85% Calendar cycle −45 pts 80% Analyst proxy −5 pts 40% Authority base rate 85% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Efficacy supplements to approved drugs are approved at their first goal date more often than original applications. The calendar's own count does not exist yet. Calendar cycle 80% A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle supplement actions are approvals. With no input beyond the clock it cannot see the package request, the supplier facility or the sponsor's bankruptcy. Analyst proxy 40% An analyst reading the same public record on 2026-09-24 would weigh a completed phase 3 safety trial and positive pre-sNDA feedback against an FDA request to redesign the package during the review, an OAI classification at the sole active-ingredient supplier, and an applicant in Chapter 11 selling itself with milestones tied to the timing of this action. Such an analyst would call approval by the date less likely than not. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-14 Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-14 Evidence cutoff 2026-09-26 Nothing after this date informed the estimate. Registered 2026-09-26 Frozen and hashed. Resolution window 2026-09-27 → 2026-11-14 When the outcome can be read against the rule. Event by 2026-11-14 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 132037f290c965911776fecf29f898a2e433a4794ebee5b18eb54c6e3c04a89d · operator record jc-1790461082269-0a69cc40 ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the openFDA Drugs@FDA record for application NDA215390 (https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA215390%22) contains a submission with submission_type SUPPL, submission_status AP and a submission_status_date on or before 2026-11-14, and either the Drugs@FDA approval letter for that supplement states that it provides for use at home, in the outpatient setting or without the supervision of a healthcare provider, or the label approved with it permits any dose to be taken without the supervision of a healthcare provider. The supplement is identified by that content, not by its number or class code. At the cutoff the approved label required administration under the supervision of a healthcare provider (SRC-001), and the latest approved supplement was SUPPL 2, approved 2025-11-19, which openFDA classes EFFICACY and Drugs@FDA lists as Efficacy-New Indication but which updated the prescribing information with a repeat-dosing study and is not this supplement (SRC-002, SRC-003, SRC-005). A label that keeps the first dose under supervision and permits later doses at home still resolves YES, as does an at-home approval narrower than the applicant sought (one of the two disorders, or one strength). An approval under a new holder of NDA 215390 counts. Resolves NO if no such supplement is approved on or before 2026-11-14: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-14 resolves NO as occurred_after_deadline. 2026-11-14 is a Saturday; an approval action dated that day still counts. Read no earlier than 2026-11-28; if openFDA has not refreshed, the Drugs@FDA web record for NDA 215390 (https://www.accessdata.fda.gov/scripts/cder/daf/) governs. Resolves unresolvable only if neither source can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA215390%22, https://www.accessdata.fda.gov/scripts/cder/daf/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 35% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-09-26. review pathway not stated in the archived sources; ten months from submission to goal date is consistent with standard review (drafter's understanding, unverified) submission type efficacy supplement to NDA 215390, a 505(b)(2) application for a new dosage form (SRC-002, SRC-003); seeks a new setting of use, not a new disorder (SRC-001) evidence class randomized, placebo-controlled 12-week phase 3 trial, SERENITY At-Home, with safety as the primary objective and exploratory efficacy (SRC-001) pivotal n 246 randomized; 208 patients treated 2,437 agitation episodes (SRC-001) endpoint type primary objective safety and tolerability of the 120 mcg dose at home; exploratory efficacy on a modified CGI-S scale scored by patients or caregivers (SRC-001) approved competitors in class none for at-home use, as BioXcel states: no FDA-approved options for the at-home population (SRC-001) months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status sNDA submitted 2026-01-14 and accepted with a PDUFA target action date; FDA requested a change to the child-resistant package feature during review, and a new design was planned (SRC-001) odac referral none announced in the archived sources sponsor state change Chapter 11 petition 2026-08-27; stalking-horse sale of substantially all assets to Teva pending court approval (SRC-004); latest approved supplement SUPPL 2, 2025-11-19, a prescribing-information update that is not the at-home supplement (SRC-002, SRC-003) Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-09-26 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 BioXcel Therapeutics 10-Q for the quarter ended 2026-06-30, filed 2026-08-13. States that IGALMI is approved for self-administration under the supervision of a health care provider; that an sNDA for IGALMI for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia, based on the SERENITY At-Home phase 3 safety trial and designed to remove the healthcare supervision requirement, was submitted on January 14, 2026 and accepted with a PDUFA target action date of November 14, 2026. Also states that during the review FDA requested a change to the child-resistant feature of the primary package, which BioXcel planned to answer with a new package design, and that a facility of the sole active-ingredient supplier is under an FDA official action indicated (OAI) classification that BioXcel says could delay the action. https://www.sec.gov/Archives/edgar/data/1720893/000110465926095965/btai-20260630x10q.htm Retrieved 2026-09-24 · sha256 173f85ad5aa7287dd25b92a9319bd3b59130b13d89a3ad0e869522bdf2152e10 SRC-002 openFDA Drugs@FDA record for NDA215390 (IGALMI, dexmedetomidine sublingual film) retrieved at the cutoff. The starting state: ORIG 1 approved 2022-04-05, SUPPL 1 (LABELING) approved 2022-10-24, SUPPL 2 (EFFICACY) approved 2025-11-19. No supplement is pending in the record; SUPPL 2 predates the at-home sNDA's 2026-01-14 submission (SRC-001). https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA215390%22 Retrieved 2026-09-24 · sha256 9e916cb5cdd269efb4240a67f2b86ce2b2a5d3055377b5de04fc66faf001e07a SRC-003 FDA approval letter for NDA 215390/S-002, signed 2025-11-19. S-002 is a prior-approval supplement updating Sections 5.4, 5.5 and 9 of the prescribing information with the results of Study BXCL501-404, a repeat-dosing study intended to fulfil a postmarketing requirement. It is not the at-home supplement, although openFDA classes it EFFICACY and Drugs@FDA lists it as Efficacy-New Indication. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215390Orig1s002ltr.pdf Retrieved 2026-09-24 · sha256 bd1dd3514d78f1ea06db10ca289c4110ec3d29a4dc663ab1ba2bcf34e2b77d19 SRC-004 BioXcel Therapeutics 8-K filed 2026-08-28. States that BioXcel and two subsidiaries filed voluntary Chapter 11 petitions on 2026-08-27 and continue to operate as debtors-in-possession, and that they signed a stalking-horse asset purchase agreement with Teva for substantially all assets: 57.5 million dollars upfront plus up to 67.5 million dollars in development milestones tied to the outcome and timing of the pending IGALMI at-home sNDA, subject to higher bids and court approval, with a termination right if the sale is not consummated by 2026-10-30. https://www.sec.gov/Archives/edgar/data/1720893/000110465926102570/tm2624233d1_8k.htm Retrieved 2026-09-24 · sha256 e688c22ae1c98f41cb03d4bca77017978f3ce99971dda8eb1a22bea5d85453fb SRC-005 Drugs@FDA web record for NDA 215390 retrieved at the cutoff. Lists ORIG-1 (2022-04-05), SUPPL-1 (2022-10-24, Labeling-Container/Carton Labels) and SUPPL-2 (2025-11-19, Efficacy-New Indication) with their letters and labels. The category Drugs@FDA gives SUPPL-2 is why the resolution rule identifies the at-home supplement by the content of its letter or label, not by its category or class code. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215390 Retrieved 2026-09-24 · sha256 57fe572eddd80e4e04007e5621c40ff4e5bf2f0bafe8a97208f84a34d8b82bf7 --- # 45% forecast: FDA approves INO-3107 for recurrent respiratory papillomatosis on or before the disclosed PDUFA goal date of 2026-10-30 URL: https://nextconsensus.com/forecast/ff-010/ Registered forecast 45% registered probability event by 2026-10-30 Unresolved ## FDA approves INO-3107 for recurrent respiratory papillomatosis on or before the disclosed PDUFA goal date of 2026-10-30 FF-010 Registered · Unresolved Registered probability 45% Event by 2026-10-30 Resolution window 2026-09-27 → 2026-10-30 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 70% - Calendar cycle 65% - Analyst proxy 40% nextconsensus.com/forecast/ff-010/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-09-26. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on Inovio's Biologics License Application for INO-3107 for the treatment of adults with recurrent respiratory papillomatosis, with an approval action date on or before 2026-10-30, the PDUFA target date disclosed in Inovio's Form 10-Q filed 2026-08-12. Authority US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope Recurrent respiratory papillomatosis in adults The estimate ### The number and the baselines it has to beat 45% probability, method v0.1.0 · frozen at the 2026-09-26 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-010 · registered 45% Authority base rate −25 pts 70% Calendar cycle −20 pts 65% Analyst proxy +5 pts 40% Authority base rate 70% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. First-cycle approval of original BLAs at the disclosed goal date, across review types. No enumerated count exists in this repository yet. Calendar cycle 65% A clock-only model: the goal date is inside the window and FDA meets most goal dates, discounted for the lower first-cycle approval share of standard-review original applications. Analyst proxy 40% An analyst reading the same public record on 2026-09-22 would weigh the filing-letter concern on accelerated-approval eligibility, an approved competitor, a single-arm trial of about thirty patients and a small sponsor against completed late-cycle milestones and talk of a confirmatory design. Such an analyst would call it close to a coin flip, leaning no. Estimated by reconstructing that read. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-10-30 Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-10-30 Evidence cutoff 2026-09-26 Nothing after this date informed the estimate. Registered 2026-09-26 Frozen and hashed. Resolution window 2026-09-27 → 2026-10-30 When the outcome can be read against the rule. Event by 2026-10-30 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 9c6197a7bfbb4b11603222825b467a6fa2ee4e9aba0ce2f6bfaedde7d7b30a28 · operator record jc-1790461077734-ded9d6e3 ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast INO-3107 is a CBER-regulated biologic, so openFDA's drugsfda endpoint does not list it. Resolves YES if FDA's Purple Book (https://purplebooksearch.fda.gov/) lists a licensed biological product that is INO-3107 under any proprietary name, with Inovio as licensee and an approval (license) date on or before 2026-10-30, and the CBER approval letter for that BLA names recurrent respiratory papillomatosis in adults in the indication. Approval under traditional rather than accelerated approval still resolves YES. Resolves NO if no approval action is dated on or before 2026-10-30: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; an approval dated after 2026-10-30 resolves NO as occurred_after_deadline. Read no earlier than 2026-11-13. If the Purple Book has not updated by then, the CBER approval letter or FDA's CBER list of approved products governs. Resolves unresolvable only if none of these can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://purplebooksearch.fda.gov/, https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 45% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-09-26. review pathway standard review; FDA denied priority review; accelerated approval program (SRC-001) submission type original BLA (DNA medicine; CBER) evidence class single-arm phase 1/2 trial (SRC-001) pivotal n 32 patients at year 1, 28 evaluable at year 2, as Inovio reports (SRC-001) endpoint type reduction in surgical interventions for RRP (SRC-001) approved competitors in class PAPZIMEOS, approved for adults with RRP (SRC-001) months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status FDA's filing letter raised a potential review issue on accelerated-approval eligibility; mid-cycle and late-cycle meetings and inspections completed by early August 2026 (SRC-001) odac referral none announced in the archived source sponsor state change none recorded in the archived source Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-09-26 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Inovio 10-Q for the quarter ended 2026-06-30, filed 2026-08-12. States the FDA accepted the BLA for INO-3107 in adults with recurrent respiratory papillomatosis under the accelerated approval program, denied priority review, and set a PDUFA target date of October 30, 2026. Also records that the FDA's filing letter noted a potential review issue, and that PAPZIMEOS was already approved for adults with RRP. https://www.sec.gov/Archives/edgar/data/1055726/000105572626000023/ino-20260630.htm Retrieved 2026-09-22 · sha256 9937745f338108a6f24c7cae2fcab37c62d8b5c181914c6eeaca51fd8487e215 --- # 15% forecast: FDA approves ivonescimab for EGFR-mutated non-small cell lung cancer after EGFR TKI therapy on or before the disclosed PDUFA goal date of 2026-11-14 URL: https://nextconsensus.com/forecast/ff-011/ Registered forecast 15% registered probability event by 2026-11-14 Unresolved ## FDA approves ivonescimab for EGFR-mutated non-small cell lung cancer after EGFR TKI therapy on or before the disclosed PDUFA goal date of 2026-11-14 FF-011 Registered · Unresolved Registered probability 15% Event by 2026-11-14 Resolution window 2026-09-27 → 2026-11-14 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 70% - Calendar cycle 65% - Analyst proxy 25% nextconsensus.com/forecast/ff-011/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-09-26. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on a Biologics License Application for ivonescimab (applicant Summit Therapeutics) for EGFR-mutated non-small cell lung cancer previously treated with an EGFR tyrosine kinase inhibitor, with an approval action date on or before 2026-11-14, the PDUFA goal action date disclosed in Summit Therapeutics' Form 8-K filed 2026-09-15. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope EGFR-mutated non-small cell lung cancer after EGFR TKI therapy The estimate ### The number and the baselines it has to beat 15% probability, method v0.1.0 · frozen at the 2026-09-26 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-011 · registered 15% Authority base rate −55 pts 70% Calendar cycle −50 pts 65% Analyst proxy −10 pts 25% Authority base rate 70% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. First-cycle approval of original BLAs at the disclosed goal date, across review types. No enumerated count exists in this repository yet. Calendar cycle 65% A clock-only model: the goal date is inside the window and FDA meets most goal dates, discounted for the lower first-cycle approval share of standard-review original applications. With no evidence input it cannot see the OS result. Analyst proxy 25% An analyst reading the same public record on 2026-09-24 would weigh FDA's stated need for a statistically significant OS benefit and a primary OS analysis that missed it against a strong PFS result, later OS analyses pointing the same way, a positive OS trial in China and a sponsor still working toward approval. Such an analyst would call a complete response the likely outcome, with a real minority chance of approval. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-14 Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-14 Evidence cutoff 2026-09-26 Nothing after this date informed the estimate. Registered 2026-09-26 Frozen and hashed. Resolution window 2026-09-27 → 2026-11-14 When the outcome can be read against the rule. Event by 2026-11-14 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 8a2d166c0ea14aa76d0a28312995a97f845fb8289237dadc0a520404c5c5de3c · operator record jc-1790461082276-da68aed0 ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the openFDA Drugs@FDA record returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22ivonescimab%22 contains an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-11-14, and the Drugs@FDA approval letter or label for that application names in its indication EGFR-mutated (EGFR mutation-positive) non-small cell lung cancer that was previously treated with, or progressed on or after, an EGFR tyrosine kinase inhibitor. An approval for a narrower population than the applicant sought (for example non-squamous disease only, or only after a third-generation EGFR tyrosine kinase inhibitor) still resolves YES, as does an approval under accelerated approval. Resolves NO if no approval action is dated on or before 2026-11-14: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-14 resolves NO as occurred_after_deadline. 2026-11-14 is a Saturday; an approval action dated that day still counts. Read no earlier than 2026-11-28. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name ivonescimab) governs, and if neither lists the product, FDA's Purple Book (https://purplebooksearch.fda.gov/, searched by ivonescimab) governs for the licensure date, with the approval letter for the indication. The application number was not public at the cutoff, so the rule reads by name; a four-letter suffix on the nonproprietary name (ivonescimab-xxxx) or a proprietary name does not change the identification. At the cutoff ivonescimab was not approved in the United States (SRC-001). Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22ivonescimab%22, https://www.accessdata.fda.gov/scripts/cder/daf/, https://purplebooksearch.fda.gov/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 15% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-09-26. review pathway not stated in the archived sources; about twelve months from a fourth-quarter 2025 submission to the goal date is consistent with standard review (drafter's understanding, unverified) submission type original BLA; PD-1 and VEGF bispecific antibody not approved in the United States (SRC-001) evidence class one multiregional, double-blind, placebo-controlled phase 3 trial, HARMONi (SRC-001, SRC-002); supporting single-region phase 3 trial in China, HARMONi-A, which also enrolled HARMONi's patients from China (SRC-002) pivotal n 219 per arm in the intention-to-treat population; 83 and 82 western patients (SRC-001) endpoint type dual primary endpoints: PFS, met (SRC-001); OS, primary analysis not statistically significant (HR 0.79, p=0.057, SRC-001) approved competitors in class no FDA-approved regimen in this setting has shown a statistically significant OS benefit, as Summit states (SRC-002); the approved options are not named in the archive months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status BLA submitted in the fourth quarter of 2025 and accepted for filing in January 2026; FDA noted that a statistically significant OS benefit is necessary in this setting (SRC-002) odac referral none announced in the archived sources sponsor state change June 2026 OS analysis made available to FDA (SRC-002); updated OS presented at WCLC 2026 on 2026-09-15 (SRC-001) Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-09-26 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Summit Therapeutics press release filed as Exhibit 99.1 to its 8-K of 2026-09-15 (the text layer under the slide images of the exhibit). States that Summit's BLA, based on the phase 3 HARMONi trial of ivonescimab plus chemotherapy in EGFR-mutated non-squamous NSCLC after a third-generation EGFR TKI, was accepted for filing in January 2026 with a PDUFA goal action date of November 14, 2026; that the primary OS analysis (April 2025) gave HR 0.79 (95% CI 0.62-1.01; p=0.057), not statistically significant; that later analyses with June 2026 data gave HR 0.76 (nominal p=0.0151); and that ivonescimab is not approved by any regulatory authority in Summit's territories, including the United States. https://www.sec.gov/Archives/edgar/data/1599298/000159929826000081/a2026_prx0915xharmoniltf.htm Retrieved 2026-09-24 · sha256 02b7c0c9d77ab1f02674b813049c8c1b3e17f9f646db09ead2fb31a10bb4f720 SRC-002 Summit Therapeutics 10-Q for the quarter ended 2026-06-30, filed 2026-07-23. States that Summit submitted the BLA in the fourth quarter of 2025, that FDA accepted it for filing in January 2026 with a PDUFA goal action date of November 14, 2026, and that FDA noted a statistically significant OS benefit is necessary to support marketing authorization in this setting and the PFS results may not be sufficient. Also states that the June 2026 OS results were made available to FDA. https://www.sec.gov/Archives/edgar/data/1599298/000159929826000068/smmt-20260630.htm Retrieved 2026-09-24 · sha256 2ffdd38a96669e03a23de08b12561e4f18fef1f88a10948194340c802d823d1b --- # 72% forecast: FDA approves the mitapivat sickle cell disease supplement to NDA 216196 on or before the disclosed PDUFA goal date of 2026-11-01 URL: https://nextconsensus.com/forecast/ff-012/ Registered forecast 72% registered probability event by 2026-11-01 Unresolved ## FDA approves the mitapivat sickle cell disease supplement to NDA 216196 on or before the disclosed PDUFA goal date of 2026-11-01 FF-012 Registered · Unresolved Registered probability 72% Event by 2026-11-01 Resolution window 2026-09-27 → 2026-11-01 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 85% - Calendar cycle 80% - Analyst proxy 70% nextconsensus.com/forecast/ff-012/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-09-26. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on a supplement to NDA 216196 (mitapivat, PYRUKYND; applicant Agios) whose approved labeling includes sickle cell disease, with an approval action date on or before 2026-11-01, the PDUFA goal date disclosed in Agios' Form 10-Q filed 2026-07-30. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope Sickle cell disease The estimate ### The number and the baselines it has to beat 72% probability, method v0.1.0 · frozen at the 2026-09-26 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-012 · registered 72% Authority base rate −13 pts 85% Calendar cycle −8 pts 80% Analyst proxy +2 pts 70% Authority base rate 85% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Efficacy supplements to approved drugs are approved at their first goal date more often than original applications. The calendar's own count does not exist yet. Calendar cycle 80% A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle supplement actions are approvals. Analyst proxy 70% An analyst reading the same public record on 2026-09-22 would weigh an established drug and a confirmatory trial already running against the uncertainty of accelerated approval in sickle cell disease on a surrogate endpoint. The analyst would call approval by the date more likely than not. Estimated by reconstructing that read. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-01 Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-01 Evidence cutoff 2026-09-26 Nothing after this date informed the estimate. Registered 2026-09-26 Frozen and hashed. Resolution window 2026-09-27 → 2026-11-01 When the outcome can be read against the rule. Event by 2026-11-01 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger d9729672f768800f59c0828a962a9f8b7911e1225296817037a10b5de6b5049d · operator record jc-1790461077743-76b89c3f ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the openFDA Drugs@FDA record for application NDA216196 (https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA216196%22) contains a submission with submission_type SUPPL, submission_status AP and a submission_status_date on or before 2026-11-01, and the Drugs@FDA label or letter for that supplement includes sickle cell disease in the indication. Approval under accelerated or traditional approval both count, as does a narrower sickle cell population. Resolves NO if no such supplement is approved on or before 2026-11-01: a complete response letter, a goal-date extension, withdrawal or no action. An approval dated after 2026-11-01 resolves NO as occurred_after_deadline. If the sickle cell indication is approved under a new NDA rather than a supplement, it still counts, read by the same fields. Read no earlier than 2026-11-15; if openFDA has not refreshed, the Drugs@FDA web record for NDA 216196 governs. At the cutoff the latest approved supplement was SUPPL 6, dated 2026-04-08 (SRC-002). Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA216196%22, https://www.accessdata.fda.gov/scripts/cder/daf/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 72% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-09-26, including the 3 fields whose values were unknown then. Those are left unknown rather than filled in. review pathway Priority Review; accelerated approval pathway (SRC-001) submission type efficacy supplement to NDA 216196 evidence class completed double-blind phase 3 study, RISE UP (SRC-001); confirmatory phase 3 REIGNITE initiated pivotal n unknown — not stated in the archived sources endpoint type unknown in the archive — accelerated approval implies a surrogate endpoint; REIGNITE measures transfusion burden (SRC-001) approved competitors in class unknown in the archive months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status sNDA submitted May 2026, accepted with Priority Review (SRC-001) odac referral none announced in the archived sources sponsor state change latest approved supplement to NDA 216196 is SUPPL 6, 2026-04-08 (SRC-002) Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-09-26 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Agios 10-Q for the quarter ended 2026-06-30, filed 2026-07-30. States Agios submitted an sNDA for U.S. accelerated approval of mitapivat in sickle cell disease in May 2026, accepted with priority review and a PDUFA goal date of November 1, 2026. https://www.sec.gov/Archives/edgar/data/1439222/000143922226000118/agio-20260630.htm Retrieved 2026-09-22 · sha256 93e8f8e3d816c875d38743d9fb5267afe7c5a0daf907957980e7bb12e1d662b5 SRC-002 openFDA Drugs@FDA record for NDA216196 (PYRUKYND, mitapivat) retrieved at the cutoff. The starting state: the latest approved supplement is SUPPL 6, AP 2026-04-08; no sickle cell supplement is approved. https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA216196%22 Retrieved 2026-09-22 · sha256 f01a4f0f049e552a6c9abf63c7fe8a10757d92435cf635d8eba0ba9d32363f13 --- # 75% forecast: FDA approves molgramostim (MOLBREEVI) for autoimmune pulmonary alveolar proteinosis on or before the disclosed PDUFA goal date of 2026-11-22 URL: https://nextconsensus.com/forecast/ff-013/ Registered forecast 75% registered probability event by 2026-11-22 Unresolved ## FDA approves molgramostim (MOLBREEVI) for autoimmune pulmonary alveolar proteinosis on or before the disclosed PDUFA goal date of 2026-11-22 FF-013 Registered · Unresolved Registered probability 75% Event by 2026-11-22 Resolution window 2026-09-27 → 2026-11-22 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 80% - Calendar cycle 75% - Analyst proxy 75% nextconsensus.com/forecast/ff-013/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-09-26. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on Savara's Biologics License Application for molgramostim inhalation solution (proposed trade name MOLBREEVI) for the treatment of autoimmune pulmonary alveolar proteinosis, with an approval action date on or before 2026-11-22, the PDUFA target action date disclosed in Savara's Form 10-Q filed 2026-08-11. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope Autoimmune pulmonary alveolar proteinosis The estimate ### The number and the baselines it has to beat 75% probability, method v0.1.0 · frozen at the 2026-09-26 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-013 · registered 75% Authority base rate −5 pts 80% Calendar cycle 0 pts 75% Analyst proxy 0 pts 75% Authority base rate 80% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Original BLAs under Priority Review with a positive randomised phase 3 trial are approved at their first goal date in a large majority of cases. A Refusal to File does not, to the drafter's understanding, start a review cycle, so this is read as a first cycle. The calendar's own met-goal-date share for disclosed PDUFA dates does not exist yet (docs/foundations/short-horizon-reference-classes.md §4.1). Calendar cycle 75% A clock-only model: the goal date is inside the window and FDA meets most goal dates, discounted because the date has already been extended once by a major amendment. Analyst proxy 75% An analyst reading the same public record on 2026-09-24 — a positive phase 3 trial published in the New England Journal of Medicine, Breakthrough designation and Priority Review, no approved alternative, a sponsor building a launch — would call approval by the goal date likely, with the drug-substance transfer, the nebulizer and whatever the April major amendment answered as the main risks. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-22 Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-22 Evidence cutoff 2026-09-26 Nothing after this date informed the estimate. Registered 2026-09-26 Frozen and hashed. Resolution window 2026-09-27 → 2026-11-22 When the outcome can be read against the rule. Event by 2026-11-22 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 0b638dd5666d29fd6769192cbf9068ceb940dba70bb0e7bfe01b84028d705d81 · operator record jc-1790461082283-30eda9c2 ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the openFDA Drugs@FDA record returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22molgramostim%22 (or, if that returns nothing, by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22molgramostim%22) contains an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-11-22, and the Drugs@FDA approval letter or label for that application names autoimmune pulmonary alveolar proteinosis in its indication. A proper name that adds a suffix to molgramostim still matches. An approval for a narrower autoimmune pulmonary alveolar proteinosis population than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2026-11-22: a complete response letter, a further goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-22 resolves NO as occurred_after_deadline. 2026-11-22 is a Sunday; an approval action dated on or before it counts whatever the weekday. Read no earlier than 2026-12-06. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name molgramostim) governs; if Drugs@FDA does not show the application either, FDA's Purple Book (https://purplebooksearch.fda.gov/) record of a licensed molgramostim product with Savara or a Savara subsidiary as licensee governs, read with the approval letter for the indication. The application number was not public at the cutoff, so the rule reads by generic name; if the product carries a proprietary name, MOLBREEVI or another, the generic name still identifies it. Savara expected CDER to hold primary jurisdiction (SRC-002); if CBER licenses the product instead, the Purple Book record and the CBER approval letter govern on the same terms. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22molgramostim%22, https://www.accessdata.fda.gov/scripts/cder/daf/, https://purplebooksearch.fda.gov/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 75% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-09-26. review pathway Priority Review; Breakthrough Therapy and Fast Track designations (SRC-001, SRC-002); goal date extended three months by a major amendment (SRC-001) submission type original BLA, resubmitted after a Refusal to File and filed February 2026 (inhaled GM-CSF with a nebulizer; CDER, as Savara expects, SRC-002) evidence class one randomized, double-blind, placebo-controlled phase 3 trial, IMPALA-2 (SRC-002); the earlier phase 2/3 IMPALA trial missed its primary endpoint (SRC-002) pivotal n 164 patients enrolled in IMPALA-2 (SRC-002) endpoint type change from baseline in DLCO (gas exchange) at Week 24; secondary endpoints on SGRQ and exercise capacity (SRC-002) approved competitors in class none — no medicine is approved for autoimmune PAP in the U.S.; whole lung lavage is the current procedure (SRC-002) months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status BLA filed February 2026 with Priority Review; responses to FDA information requests classed as a major amendment in April 2026 (SRC-001) odac referral none announced in the archived sources sponsor state change drug substance manufacture moved from GEMA to Fujifilm before resubmission; some vendors not yet FDA-inspected as of the 10-K filed 2026-03-13 (SRC-002) Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-09-26 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Savara 10-Q for the quarter ended 2026-06-30, filed 2026-08-11. States that MOLBREEVI is the proposed trade name for molgramostim inhalation solution, an inhaled GM-CSF and Savara's sole program, not approved in any indication; that in February 2026 the FDA formally filed the BLA for MOLBREEVI in autoimmune pulmonary alveolar proteinosis (autoimmune PAP) and granted Priority Review; and that in April 2026 the FDA determined Savara's responses to information requests constituted a major amendment, extending the PDUFA target action date by three months to November 22, 2026. Also records Fast Track, Breakthrough Therapy and Orphan Drug designations, an EMA marketing authorisation application validated in March 2026, and a royalty agreement paying Savara on FDA approval on or before 2027-03-31. https://www.sec.gov/Archives/edgar/data/1160308/000119312526344585/svra-20260630.htm Retrieved 2026-09-24 · sha256 7ddac76471031d362faa84f71cd3d6c0e29fc0831323d5a140eb22625534d137 SRC-002 Savara 10-K for the year ended 2025-12-31, filed 2026-03-13. States Savara believes MOLBREEVI, a drug-device combination with PARI's eFlow nebulizer, will be regulated as a drug under the primary jurisdiction of FDA's Center for Drug Evaluation and Research (CDER), with CDRH reviewing the nebulizer. Records the BLA history: submitted March 2025; a Refusal to File letter in May 2025, which Savara says did not request or recommend additional efficacy studies; a Type A meeting aligning with FDA on drug substance comparability between GEMA and Fujifilm; resubmission in December 2025 with Fujifilm as the drug substance supplier; and filing with Priority Review in February 2026. Records IMPALA-2, a randomized, double-blind, placebo-controlled phase 3 trial that enrolled 164 patients and met its primary endpoint (change from baseline in DLCO at Week 24), with statistically significant secondary results, published in the New England Journal of Medicine in August 2025; that no medicines are approved for autoimmune PAP in the U.S.; and that certain manufacturing and supply vendors had not yet received an FDA inspection. https://www.sec.gov/Archives/edgar/data/1160308/000119312526105076/svra-20251231.htm Retrieved 2026-09-24 · sha256 901f9daef540ef8dab9a4fe2fe5031d779cdb5ed39af17ce1f3fa9c3d1a2508c --- # 35% forecast: NICE publishes technology appraisal guidance on Beremagene geperpavec for treating skin wounds associated with dystrophic epidermolysis bullosa [ID3959] on or before 2026-11-18 URL: https://nextconsensus.com/forecast/ff-014/ Registered forecast 35% registered probability event by 2026-11-18 Unresolved ## NICE publishes technology appraisal guidance on Beremagene geperpavec for treating skin wounds associated with dystrophic epidermolysis bullosa [ID3959] on or before 2026-11-18 FF-014 Registered · Unresolved Registered probability 35% Event by 2026-11-18 Resolution window 2026-09-27 → 2026-11-18 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 60% - Analyst proxy 40% nextconsensus.com/forecast/ff-014/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-09-26. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Beremagene geperpavec for treating skin wounds associated with dystrophic epidermolysis bullosa' [ID3959], with a publication date on or before 2026-11-18, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta10868) on 2026-09-24. Authority National Institute for Health and Care Excellence (NICE), Highly Specialised Technologies Evaluation Committee, appraising under the technology appraisal (STA) process (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope Dystrophic epidermolysis bullosa wounds The estimate ### The number and the baselines it has to beat 35% probability, method v0.1.0 · frozen at the 2026-09-26 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-014 · registered 35% Authority base rate −15 pts 50% Calendar cycle −25 pts 60% Analyst proxy −5 pts 40% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown about eight weeks earlier is not yet counted (docs/foundations/short-horizon-reference-classes.md §4.6 names it as the census the calendar builds). Expected dates are revised often, especially when a committee meeting does not reach a final recommendation. Calendar cycle 60% A clock-only model: NICE sets a provisional publication date a few weeks after a committee meeting that assumes the meeting reaches a final recommendation. A second committee meeting more often reaches a final recommendation than a first, which favours the date. Eight weeks from the second meeting to expected publication is on schedule if that meeting is final. Analyst proxy 40% A market-access analyst reading the same project pages on 2026-09-24 would weigh the stage of the appraisal, the negative draft guidance and the history of delays. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-18 Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-18 Evidence cutoff 2026-09-26 Nothing after this date informed the estimate. Registered 2026-09-26 Frozen and hashed. Resolution window 2026-09-27 → 2026-11-18 When the outcome can be read against the rule. Event by 2026-11-18 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 669bf39db23b33d8c6a6d624bcf63ac8d7517ed44c4226e27f6a7f975fd9f9a8 · operator record jc-1790461082288-50191d82 ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID3959 shows a publication date ('Published: ') on or before 2026-11-18, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID3959. Resolves NO if the guidance is published after 2026-11-18, if the expected date is revised and nothing is published by 2026-11-18, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-11-25. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta10868, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 35% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-09-26. review pathway single technology appraisal (STA), standard (SRC-001); second meeting heard by the highly specialised technologies evaluation committee (SRC-004) submission type new technology appraisal evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class comparator company named on the page: Chiesi (birch bark extract), participating (SRC-001) months since last guideline revision not applicable panel cycle position committee meeting 2 dated 24 September 2026, the cutoff day, on the highly specialised technologies evaluation committee's draft agenda with ID6409 (SRC-001, SRC-004); draft guidance consultation 26 June to 10 August 2026 (SRC-001) sponsor request status rescheduled on 02 September 2025 following advice from the company, to align with latest regulatory expectations; start delayed in 2023 by a company routing challenge (SRC-001) odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change none recorded in the archived sources Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-09-26 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development page for ID3959, beremagene geperpavec for treating skin wounds associated with dystrophic epidermolysis bullosa, retrieved at the cutoff. Fixes the expected publication date the proposition freezes (18 November 2026), status In progress, process STA Standard, and the project history: scoping from May 2022; a 2023 note that a company routing challenge delayed the start; a restart with a second scope consultation in December 2024; a note of 02 September 2025 that the appraisal was rescheduled, following advice from the company, to align with latest regulatory expectations; committee meeting 1 on 21 May 2026; draft guidance consultation 26 June 2026 to 10 August 2026; committee meeting 2 dated 24 September 2026. https://www.nice.org.uk/guidance/indevelopment/gid-ta10868 Retrieved 2026-09-24 · sha256 1b10739cf2cf9c2faf2db4125dc129985d9072e363eef4945786da0bbc093fc8 SRC-002 NICE project documents page for ID3959, retrieved at the cutoff. Lists the draft guidance with its committee papers and public committee slides, each published 26 June 2026, and the three project notes; lists no final draft guidance. https://www.nice.org.uk/guidance/indevelopment/gid-ta10868/documents Retrieved 2026-09-24 · sha256 aaad523d0513af2bb755a50c123e2d591f3b0626762bab5c834bb3e3e4bb89bb SRC-003 NICE consultation on the ID3959 draft guidance, section 1 (Recommendations), retrieved at the cutoff. The draft's recommendation 1.1 reads 'Beremagene geperpavec should not be used to treat skin wounds associated with dystrophic epidermolysis bullosa (DEB) in people of all ages who have mutations in the collagen type 7 alpha 1 chain (COL7A1) gene.' It gives cost-effectiveness estimates substantially above the range NICE normally considers acceptable, and says the company has not submitted a managed access proposal. The consultation ended on 10 August 2026. https://www.nice.org.uk/consultations/3376/1/recommendations Retrieved 2026-09-24 · sha256 1bff15ba1b7a17e1761054c58761c38f82fbdc7ba983d4ef8b796c7647356719 SRC-004 Draft agenda of the NICE highly specialised technologies evaluation committee (HSTEC) for 24 September 2026, retrieved at the cutoff. Lists the appraisal of beremagene geperpavec [ID3959], with agreement on the content of the draft guidance or final draft guidance in closed session, after the appraisal of efgartigimod for chronic inflammatory demyelinating polyneuropathy [ID6409]. States the agenda is subject to change. https://www.nice.org.uk/event/HSTEC-Sept-2026 Retrieved 2026-09-24 · sha256 942e30159eb7d14fbfecb321fd163e59e5caa0e3ac202b0ee77f1e518f30f71d --- # 45% forecast: NICE publishes technology appraisal guidance on Efgartigimod for treating chronic inflammatory demyelinating polyneuropathy [ID6409] on or before 2026-11-18 URL: https://nextconsensus.com/forecast/ff-015/ Registered forecast 45% registered probability event by 2026-11-18 Unresolved ## NICE publishes technology appraisal guidance on Efgartigimod for treating chronic inflammatory demyelinating polyneuropathy [ID6409] on or before 2026-11-18 FF-015 Registered · Unresolved Registered probability 45% Event by 2026-11-18 Resolution window 2026-09-27 → 2026-11-18 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 60% - Analyst proxy 45% nextconsensus.com/forecast/ff-015/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-09-26. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Efgartigimod for treating chronic inflammatory demyelinating polyneuropathy' [ID6409], with a publication date on or before 2026-11-18, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11508) on 2026-09-24. Authority National Institute for Health and Care Excellence (NICE), Highly Specialised Technologies Evaluation Committee, appraising under the technology appraisal (STA) process (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope Chronic inflammatory demyelinating polyneuropathy The estimate ### The number and the baselines it has to beat 45% probability, method v0.1.0 · frozen at the 2026-09-26 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-015 · registered 45% Authority base rate −5 pts 50% Calendar cycle −15 pts 60% Analyst proxy 0 pts 45% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown about eight weeks earlier is not yet counted (docs/foundations/short-horizon-reference-classes.md §4.6 names it as the census the calendar builds). Expected dates are revised often, especially when a committee meeting does not reach a final recommendation. Calendar cycle 60% A clock-only model: NICE sets a provisional publication date a few weeks after a committee meeting that assumes the meeting reaches a final recommendation. A second committee meeting more often reaches a final recommendation than a first, which favours the date. Eight weeks from the second meeting to expected publication is on schedule if that meeting is final. Analyst proxy 45% A market-access analyst reading the same project pages on 2026-09-24 would weigh the stage of the appraisal, the negative draft guidance and the history of delays. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-18 Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-18 Evidence cutoff 2026-09-26 Nothing after this date informed the estimate. Registered 2026-09-26 Frozen and hashed. Resolution window 2026-09-27 → 2026-11-18 When the outcome can be read against the rule. Event by 2026-11-18 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger e715bfe2a8099aa2162258d2a6d0d934776705ce86bdf980ef67ca4d9312c55c · operator record jc-1790461082293-0fd9e9c4 ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID6409 shows a publication date ('Published: ') on or before 2026-11-18, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6409. Resolves NO if the guidance is published after 2026-11-18, if the expected date is revised and nothing is published by 2026-11-18, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-11-25. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11508, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 45% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-09-26. review pathway single technology appraisal (STA), standard (SRC-001); second meeting heard by the highly specialised technologies evaluation committee (SRC-004) submission type new technology appraisal evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class comparator companies named on the page: Grifols UK, Octapharma and Takeda UK (human immunoglobulin) (SRC-001) months since last guideline revision not applicable panel cycle position committee meeting 2 dated 24 September 2026, the cutoff day, on the highly specialised technologies evaluation committee's draft agenda with ID3959 (SRC-001, SRC-004); draft guidance consultation 24 April to 18 May 2026 (SRC-001) sponsor request status next committee meeting rescheduled to 24 September 2026 to allow the company additional time to submit its draft guidance consultation response (note of 09 June 2026, SRC-001) odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change none recorded in the archived sources Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-09-26 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development page for ID6409, efgartigimod for treating chronic inflammatory demyelinating polyneuropathy, retrieved at the cutoff. Fixes the expected publication date the proposition freezes (18 November 2026), status In progress, process STA Standard, and the project history: invitation to participate 14 August 2025; committee meeting 1 on 19 March 2026; draft guidance consultation 24 April 2026 to 18 May 2026; a note of 09 June 2026 that the next committee meeting was rescheduled to 24 September 2026 to allow the company additional time to submit its draft guidance consultation response; committee meeting 2 dated 24 September 2026. https://www.nice.org.uk/guidance/indevelopment/gid-ta11508 Retrieved 2026-09-24 · sha256 a65c9fb6d1ae0de41cd72f82b68f00739290106af71b4164f8a3d0e00b0e3143 SRC-002 NICE project documents page for ID6409, retrieved at the cutoff. Lists the draft guidance with the first meeting's committee papers (ACM1) and public committee slides (ACM1), each published 24 April 2026; lists no final draft guidance. https://www.nice.org.uk/guidance/indevelopment/gid-ta11508/documents Retrieved 2026-09-24 · sha256 4d3aa6ec911e98898519a2c984da5948bfba209be716ae70b69260f63e1c4b8c SRC-003 NICE consultation on the ID6409 draft guidance, section 1 (Recommendations), retrieved at the cutoff. The draft's recommendation 1.1 reads 'Efgartigimod should not be used to treat progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) in adults after corticosteroids or immunoglobulins.' It says that, because of the uncertainties in the economic model, it is not possible to determine the most likely cost-effectiveness estimates. The consultation closed on 18 May 2026. https://www.nice.org.uk/consultations/3308/1/recommendations Retrieved 2026-09-24 · sha256 8b39000afd9d5a716866cac3be7fc442cdc1dff881705f32af01e97bd7324c03 SRC-004 Draft agenda of the NICE highly specialised technologies evaluation committee (HSTEC) for 24 September 2026, retrieved at the cutoff. Lists the appraisal of efgartigimod for treating chronic inflammatory demyelinating polyneuropathy [ID6409], with agreement on the content of the draft guidance or final draft guidance in closed session, followed by the appraisal of beremagene geperpavec [ID3959]. States the agenda is subject to change. https://www.nice.org.uk/event/HSTEC-Sept-2026 Retrieved 2026-09-24 · sha256 942e30159eb7d14fbfecb321fd163e59e5caa0e3ac202b0ee77f1e518f30f71d --- # 45% forecast: NICE publishes technology appraisal guidance on Epcoritamab with rituximab and lenalidomide for treating relapsed or refractory follicular lymphoma after 1 or more systemic treatments [ID6586] on or before 2026-10-28 URL: https://nextconsensus.com/forecast/ff-016/ Registered forecast 45% registered probability event by 2026-10-28 Unresolved ## NICE publishes technology appraisal guidance on Epcoritamab with rituximab and lenalidomide for treating relapsed or refractory follicular lymphoma after 1 or more systemic treatments [ID6586] on or before 2026-10-28 FF-016 Registered · Unresolved Registered probability 45% Event by 2026-10-28 Resolution window 2026-09-27 → 2026-10-28 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 55% - Analyst proxy 45% nextconsensus.com/forecast/ff-016/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-09-26. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Epcoritamab with rituximab and lenalidomide for treating relapsed or refractory follicular lymphoma after 1 or more systemic treatments' [ID6586], with a publication date on or before 2026-10-28, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11768) on 2026-09-22. Authority National Institute for Health and Care Excellence (NICE), Technology Appraisal Committee (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope Relapsed or refractory follicular lymphoma after 1+ systemic therapies The estimate ### The number and the baselines it has to beat 45% probability, method v0.1.0 · frozen at the 2026-09-26 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-016 · registered 45% Authority base rate −5 pts 50% Calendar cycle −10 pts 55% Analyst proxy 0 pts 45% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown about five weeks earlier is not yet counted (docs/foundations/short-horizon-reference-classes.md §4.6 names it as the census the calendar builds). Expected dates are revised often, especially when a first committee meeting does not reach a final recommendation. Calendar cycle 55% A clock-only model: NICE sets a provisional publication date a few weeks after a committee meeting that assumes the meeting reaches a final recommendation. Seven weeks from first meeting to expected publication is on schedule if the meeting was final. Analyst proxy 45% A market-access analyst reading the same project page on 2026-09-22 would weigh the stage of the appraisal and its history of delays. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-10-28 Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-10-28 Evidence cutoff 2026-09-26 Nothing after this date informed the estimate. Registered 2026-09-26 Frozen and hashed. Resolution window 2026-09-27 → 2026-10-28 When the outcome can be read against the rule. Event by 2026-10-28 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger f3dc7e9a0fd079f1f2cdf78b395ae1c89f8f451aca00d735ed257eedc8f2dee0 · operator record jc-1790461077758-ed871f1e ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID6586 shows a publication date ('Published: ') on or before 2026-10-28, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6586. Resolves NO if the guidance is published after 2026-10-28, if the expected date is revised and nothing is published by 2026-10-28, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-11-04. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11768, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 45% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-09-26. review pathway single technology appraisal (STA), standard submission type new technology appraisal evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class comparators named on the page include tafasitamab (Incyte) and lenalidomide (SRC-001) months since last guideline revision not applicable panel cycle position first committee meeting 8 September 2026, after a delay noted 15 April 2026 (SRC-001) sponsor request status none recorded beyond the delay (SRC-001) odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change none recorded in the archived source Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-09-26 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development page for ID6586, epcoritamab with rituximab and lenalidomide for relapsed or refractory follicular lymphoma, retrieved at the cutoff. Fixes the expected publication date the proposition freezes (28 October 2026), status In progress, process STA, and the project history, including that the appraisal was delayed to a committee meeting on 8 September 2026. https://www.nice.org.uk/guidance/indevelopment/gid-ta11768 Retrieved 2026-09-22 · sha256 deae7e614e87465821799063e409cb6da52fe157366d06d5c7711488e6a69b68 --- # 50% forecast: NICE publishes technology appraisal guidance on Inavolisib with palbociclib and fulvestrant for treating recurrent hormone receptor-positive HER2-negative PIK3CA-positive advanced breast cancer after adjuvant endocrine treatment [ID6425] on or before 2026-11-03 URL: https://nextconsensus.com/forecast/ff-017/ Registered forecast 50% registered probability event by 2026-11-03 Unresolved ## NICE publishes technology appraisal guidance on Inavolisib with palbociclib and fulvestrant for treating recurrent hormone receptor-positive HER2-negative PIK3CA-positive advanced breast cancer after adjuvant endocrine treatment [ID6425] on or before 2026-11-03 FF-017 Registered · Unresolved Registered probability 50% Event by 2026-11-03 Resolution window 2026-09-27 → 2026-11-03 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 60% - Analyst proxy 50% nextconsensus.com/forecast/ff-017/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-09-26. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Inavolisib with palbociclib and fulvestrant for treating recurrent hormone receptor-positive HER2-negative PIK3CA-positive advanced breast cancer after adjuvant endocrine treatment' [ID6425], with a publication date on or before 2026-11-03, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11519) on 2026-09-22. Authority National Institute for Health and Care Excellence (NICE), Technology Appraisal Committee (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope HR+/HER2- PIK3CA-positive advanced breast cancer The estimate ### The number and the baselines it has to beat 50% probability, method v0.1.0 · frozen at the 2026-09-26 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-017 · registered 50% Authority base rate 0 pts 50% Calendar cycle −10 pts 60% Analyst proxy 0 pts 50% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown about five weeks earlier is not yet counted (docs/foundations/short-horizon-reference-classes.md §4.6 names it as the census the calendar builds). Expected dates are revised often, especially when a first committee meeting does not reach a final recommendation. Calendar cycle 60% A clock-only model: NICE sets a provisional publication date a few weeks after a committee meeting that assumes the meeting reaches a final recommendation. A second committee meeting more often reaches a final recommendation than a first, which favours the date. Analyst proxy 50% A market-access analyst reading the same project page on 2026-09-22 would weigh the stage of the appraisal and its history of delays. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-03 Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-03 Evidence cutoff 2026-09-26 Nothing after this date informed the estimate. Registered 2026-09-26 Frozen and hashed. Resolution window 2026-09-27 → 2026-11-03 When the outcome can be read against the rule. Event by 2026-11-03 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger cdce96623d2c92f80738e1efa131809f0a4c32da26098ac171e673d16acdb1bf · operator record jc-1790461077768-fad31dc8 ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID6425 shows a publication date ('Published: ') on or before 2026-11-03, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6425. Resolves NO if the guidance is published after 2026-11-03, if the expected date is revised and nothing is published by 2026-11-03, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-11-10. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11519, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 50% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-09-26. review pathway single technology appraisal (STA), standard submission type new technology appraisal evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class not recorded in the archived page months since last guideline revision not applicable panel cycle position second committee meeting 15 September 2026, after draft guidance consultation 28 May to 18 June 2026 (SRC-001) sponsor request status paused 11 March 2026 at the company's request for commercial discussions and pending the new cost-effectiveness threshold (SRC-001) odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change none recorded in the archived source Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-09-26 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development page for ID6425, inavolisib with palbociclib and fulvestrant for PIK3CA-positive advanced breast cancer, retrieved at the cutoff. Fixes the expected publication date (3 November 2026), status In progress, process STA, draft guidance of 11 March 2026, and a project-history entry that the appraisal was paused at the company's request for commercial discussions. https://www.nice.org.uk/guidance/indevelopment/gid-ta11519 Retrieved 2026-09-22 · sha256 d1774ee7064e1af6efb564c31af6486d22f2987b99d1e3e02ce40f7ff2268099 --- # 55% forecast: NICE publishes technology appraisal guidance on Larotrectinib for treating NTRK fusion-positive advanced solid tumours (MA review of TA630) [ID6292] on or before 2026-11-18 URL: https://nextconsensus.com/forecast/ff-018/ Registered forecast 55% registered probability event by 2026-11-18 Unresolved ## NICE publishes technology appraisal guidance on Larotrectinib for treating NTRK fusion-positive advanced solid tumours (MA review of TA630) [ID6292] on or before 2026-11-18 FF-018 Registered · Unresolved Registered probability 55% Event by 2026-11-18 Resolution window 2026-09-27 → 2026-11-18 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 60% - Analyst proxy 50% nextconsensus.com/forecast/ff-018/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-09-26. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Larotrectinib for treating NTRK fusion-positive advanced solid tumours (MA review of TA630)' [ID6292], the new guidance this managed access review produces and not TA630 itself, with a publication date on or before 2026-11-18, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11565) on 2026-09-24. Authority National Institute for Health and Care Excellence (NICE), Technology Appraisal Committee (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope NTRK fusion-positive advanced solid tumours (MA review) The estimate ### The number and the baselines it has to beat 55% probability, method v0.1.0 · frozen at the 2026-09-26 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-018 · registered 55% Authority base rate +5 pts 50% Calendar cycle −5 pts 60% Analyst proxy +5 pts 50% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown about eight weeks earlier is not yet counted (docs/foundations/short-horizon-reference-classes.md §4.6 names it as the census the calendar builds). Expected dates are revised often, especially when a first committee meeting does not reach a final recommendation. Calendar cycle 60% A clock-only model: NICE sets a provisional publication date a few weeks after a committee meeting that assumes the meeting reaches a final recommendation. A second committee meeting more often reaches a final recommendation than a first, and ten weeks from the second meeting to expected publication is on schedule if it was final. Analyst proxy 50% A market-access analyst reading the same project page and draft guidance on 2026-09-24 would weigh the second meeting against the negative draft and the appeal risk of a managed access review. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-18 Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-18 Evidence cutoff 2026-09-26 Nothing after this date informed the estimate. Registered 2026-09-26 Frozen and hashed. Resolution window 2026-09-27 → 2026-11-18 When the outcome can be read against the rule. Event by 2026-11-18 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 735f8ef595baeaab7844eb785692fe6d897f514e5ab3ec702c5fbe5eede0a5d9 · operator record jc-1790461082298-14d0cc7a ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID6292 shows a publication date ('Published: ') on or before 2026-11-18, whatever the guidance recommends. That page is the new guidance this managed access review produces, not TA630: TA630's own publication date never counts. If NICE instead publishes the review's final guidance as an update to the TA630 page, the date that page gives for that update (its 'Last updated' date, with an update entry naming this review or ID6292) is the publication date, and TA630's original publication date still does not count. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6292. Resolves NO if the guidance is published after 2026-11-18, if the expected date is revised and nothing is published by 2026-11-18, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-11-25. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11565, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance, https://www.nice.org.uk/guidance/ta630 Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 55% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-09-26. review pathway single technology appraisal (STA), standard submission type managed access review of an existing technology appraisal (TA630) (SRC-001, SRC-002) evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class none named: the page lists comparator companies as None (SRC-001), and the draft guidance says there is no standard treatment for NTRK fusion-positive solid tumours (SRC-002) months since last guideline revision not applicable panel cycle position second committee meeting 9 September 2026, after draft guidance consultation 1 to 24 April 2026 (SRC-001) sponsor request status a note of 13 June 2024 says further information on timelines would follow advice received from the company (SRC-001); none recorded since odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change none recorded in the archived sources Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-09-26 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development page for ID6292 (GID-TA11565), larotrectinib for treating NTRK fusion-positive advanced solid tumours, managed access review of TA630, retrieved at the cutoff. Fixes the expected publication date the proposition freezes (18 November 2026), status In progress, process STA Standard, company Bayer, and the timeline: committee meeting 1 on 4 March 2026, draft guidance 1 to 24 April 2026, committee meeting 2 on 9 September 2026, no final draft guidance entry, and a note of 13 June 2024 that further information on timelines would follow advice received from the company. https://www.nice.org.uk/guidance/indevelopment/gid-ta11565 Retrieved 2026-09-24 · sha256 8a23a5aad07e48a7cb4aa7e4d67f8385bbeaaea7020bf580249d85c5c0d95009 SRC-002 NICE draft guidance consultation document for ID6292 (PDF linked from the project documents, published 1 April 2026). Section 1 does not recommend larotrectinib; it reviews TA630 and the evidence collected during the managed access period; the key dates give the second committee meeting as TBC; after consultation the committee prepares final draft guidance, subject to any appeal; section 2.1 states the marketing authorisation indication (Vitrakvi, Bayer). https://www.nice.org.uk/guidance/gid-ta11565/documents/draft-guidance Retrieved 2026-09-24 · sha256 1a594f57d4f4b5d4cd8aa779f89c2523865c6cf5c821ea55d64038abc19cdf5e SRC-003 NICE technology appraisal committee D, 9 September 2026, draft agenda. Lists this appraisal [ID6292] with ID6474 (cabozantinib, not a Q4 calendar row). https://www.nice.org.uk/event/TACD-Sept-2026 Retrieved 2026-09-24 · sha256 1621cdf44c4ec7803e87a01fb70c5cac33c6eb1f370dd363ad82f94f495c67fd --- # 45% forecast: NICE publishes technology appraisal guidance on Nivolumab with ipilimumab for untreated advanced hepatocellular carcinoma [ID6239] on or before 2026-11-11 URL: https://nextconsensus.com/forecast/ff-019/ Registered forecast 45% registered probability event by 2026-11-11 Unresolved ## NICE publishes technology appraisal guidance on Nivolumab with ipilimumab for untreated advanced hepatocellular carcinoma [ID6239] on or before 2026-11-11 FF-019 Registered · Unresolved Registered probability 45% Event by 2026-11-11 Resolution window 2026-09-27 → 2026-11-11 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 55% - Analyst proxy 45% nextconsensus.com/forecast/ff-019/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-09-26. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Nivolumab with ipilimumab for untreated advanced hepatocellular carcinoma' [ID6239], with a publication date on or before 2026-11-11, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11116) on 2026-09-22. Authority National Institute for Health and Care Excellence (NICE), Technology Appraisal Committee (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope Untreated advanced hepatocellular carcinoma The estimate ### The number and the baselines it has to beat 45% probability, method v0.1.0 · frozen at the 2026-09-26 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-019 · registered 45% Authority base rate −5 pts 50% Calendar cycle −10 pts 55% Analyst proxy 0 pts 45% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown about five weeks earlier is not yet counted (docs/foundations/short-horizon-reference-classes.md §4.6 names it as the census the calendar builds). Expected dates are revised often, especially when a first committee meeting does not reach a final recommendation. Calendar cycle 55% A clock-only model: NICE sets a provisional publication date a few weeks after a committee meeting that assumes the meeting reaches a final recommendation. Eight weeks from first meeting to expected publication is on schedule if the meeting was final. Analyst proxy 45% A market-access analyst reading the same project page on 2026-09-22 would weigh the stage of the appraisal and its history of delays. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-11 Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-11 Evidence cutoff 2026-09-26 Nothing after this date informed the estimate. Registered 2026-09-26 Frozen and hashed. Resolution window 2026-09-27 → 2026-11-11 When the outcome can be read against the rule. Event by 2026-11-11 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 110ca8dcc7a2c2ab6b417d5a355b88cdffff103181b3503873d10c7a1b251019 · operator record jc-1790461077781-dfc7a04a ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID6239 shows a publication date ('Published: ') on or before 2026-11-11, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6239. Resolves NO if the guidance is published after 2026-11-11, if the expected date is revised and nothing is published by 2026-11-11, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-11-18. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11116, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 45% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-09-26. review pathway single technology appraisal (STA), standard submission type new technology appraisal evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class comparator companies named on the page: AstraZeneca (durvalumab, tremelimumab), Roche (atezolizumab, bevacizumab), Eisai (lenvatinib), Bayer (sorafenib) (SRC-001) months since last guideline revision not applicable panel cycle position first committee meeting 16 September 2026 (SRC-001) sponsor request status timelines revised once at the company's request (SRC-001) odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change none recorded in the archived source Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-09-26 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development page for ID6239, nivolumab with ipilimumab for untreated advanced hepatocellular carcinoma, retrieved at the cutoff. Fixes the expected publication date (11 November 2026), status In progress, process STA, and the project history, including a committee meeting on 16 February 2026 and a stakeholder notice following a company request. https://www.nice.org.uk/guidance/indevelopment/gid-ta11116 Retrieved 2026-09-22 · sha256 22185e14edc41e1dca29f0c320c0ae4e09fd27892e32ea387ce1e7904b94c445 --- # 5% forecast: NICE publishes technology appraisal guidance on Orforglipron for managing overweight and obesity [ID6516] on or before 2026-11-18 URL: https://nextconsensus.com/forecast/ff-020/ Registered forecast 5% registered probability event by 2026-11-18 Unresolved ## NICE publishes technology appraisal guidance on Orforglipron for managing overweight and obesity [ID6516] on or before 2026-11-18 FF-020 Registered · Unresolved Registered probability 5% Event by 2026-11-18 Resolution window 2026-09-27 → 2026-11-18 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 25% - Analyst proxy 10% nextconsensus.com/forecast/ff-020/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-09-26. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Orforglipron for managing overweight and obesity' [ID6516], with a publication date on or before 2026-11-18, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11650) on 2026-09-24. Authority National Institute for Health and Care Excellence (NICE), Technology Appraisal Committee (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope Overweight and obesity management The estimate ### The number and the baselines it has to beat 5% probability, method v0.1.0 · frozen at the 2026-09-26 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-020 · registered 5% Authority base rate −45 pts 50% Calendar cycle −20 pts 25% Analyst proxy −5 pts 10% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown about eight weeks earlier is not yet counted (docs/foundations/short-horizon-reference-classes.md §4.6 names it as the census the calendar builds). Expected dates are revised often, especially when a first committee meeting does not reach a final recommendation. Calendar cycle 25% A clock-only model: NICE sets a provisional publication date a few weeks after a committee meeting that assumes the meeting reaches a final recommendation. Eighteen weeks from the only meeting to the expected date would be ample if that meeting had been final, but ten weeks after it the timeline shows no draft or final draft guidance and no further meeting, which a clock reads as off schedule. Analyst proxy 10% A market-access analyst reading the same project page and the 5 August note on 2026-09-24 would read a further meeting not yet scheduled as a slip, and would weigh the status of the marketing authorisation. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-18 Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-18 Evidence cutoff 2026-09-26 Nothing after this date informed the estimate. Registered 2026-09-26 Frozen and hashed. Resolution window 2026-09-27 → 2026-11-18 When the outcome can be read against the rule. Event by 2026-11-18 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 4fe0cbed9b8443dea2133c8f88dd3c452aac74eeec41fe93439f55fabfe997fd · operator record jc-1790461082304-acec9f66 ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID6516 shows a publication date ('Published: ') on or before 2026-11-18, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6516. Resolves NO if the guidance is published after 2026-11-18, if the expected date is revised and nothing is published by 2026-11-18, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-11-25. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11650, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 5% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-09-26. review pathway single technology appraisal (STA), standard submission type new technology appraisal evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class comparators in the final scope: tirzepatide (TA1026), semaglutide (TA875), liraglutide (TA664), prescription-dose orlistat, and standard management (SRC-003) months since last guideline revision not applicable panel cycle position one committee meeting, 14 July 2026, without a full conclusion; a further meeting is to follow and none is listed at the cutoff (SRC-001, SRC-002) sponsor request status none recorded; the committee will ask the company for additional evidence (SRC-002) odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change no UK marketing authorisation for this use at the December 2025 final scope (SRC-003); status at the cutoff unverified Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-09-26 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development page for ID6516 (GID-TA11650), orforglipron for managing overweight and obesity, retrieved at the cutoff. Fixes the expected publication date the proposition freezes (18 November 2026), status In progress, process STA Standard, the suggested remit 'within its marketing authorisation' (the page does not say whether one has been granted), and the timeline: invitation to participate 1 December 2025, one committee meeting on 14 July 2026, a Topic Update note added on 5 August 2026, no draft or final draft guidance entry and no further committee meeting listed. https://www.nice.org.uk/guidance/indevelopment/gid-ta11650 Retrieved 2026-09-24 · sha256 f4f22d8f383246e9c900c7dfe85f0d48371756a7238581030cdd2a1bf29d2f75 SRC-002 NICE Topic Update note for ID6516, linked from the project documents and dated 5 August 2026 in the SRC-001 timeline. Says the committee discussed the appraisal on Tuesday 14 July 2026 but was unable to reach a full conclusion because more information is needed from the company; the company will be asked to submit additional evidence, which the committee will discuss at a further committee meeting. https://www.nice.org.uk/guidance/gid-ta11650/documents/html-content-7 Retrieved 2026-09-24 · sha256 ff1800c68d302e33404689541bca3842020e66396b16b1665b6066306d46b795 SRC-003 NICE final scope for ID6516 (PDF, issue date December 2025, published 1 December 2025). States that orforglipron (Eli Lilly) does not have a marketing authorisation in the UK for managing overweight and obesity, and that guidance will only be issued in accordance with the marketing authorisation. Says nothing about the authorisation's status after December 2025. https://www.nice.org.uk/guidance/gid-ta11650/documents/final-scope Retrieved 2026-09-24 · sha256 68e011225e58e35f449f3ad2455b5bff073c3f5572eda4bd29a16e67cde1fb79 --- # 50% forecast: NICE publishes technology appraisal guidance on Pembrolizumab with chemotherapy with or without bevacizumab for treating platinum-resistant recurrent ovarian cancer after 1 or 2 treatments [ID6363] on or before 2026-11-18 URL: https://nextconsensus.com/forecast/ff-021/ Registered forecast 50% registered probability event by 2026-11-18 Unresolved ## NICE publishes technology appraisal guidance on Pembrolizumab with chemotherapy with or without bevacizumab for treating platinum-resistant recurrent ovarian cancer after 1 or 2 treatments [ID6363] on or before 2026-11-18 FF-021 Registered · Unresolved Registered probability 50% Event by 2026-11-18 Resolution window 2026-09-27 → 2026-11-18 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 60% - Analyst proxy 50% nextconsensus.com/forecast/ff-021/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-09-26. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Pembrolizumab with chemotherapy with or without bevacizumab for treating platinum-resistant recurrent ovarian cancer after 1 or 2 treatments' [ID6363], with a publication date on or before 2026-11-18, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11422) on 2026-09-24. Authority National Institute for Health and Care Excellence (NICE), Technology Appraisal Committee (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope Platinum-resistant recurrent ovarian cancer The estimate ### The number and the baselines it has to beat 50% probability, method v0.1.0 · frozen at the 2026-09-26 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-021 · registered 50% Authority base rate 0 pts 50% Calendar cycle −10 pts 60% Analyst proxy 0 pts 50% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown about eight weeks earlier is not yet counted (docs/foundations/short-horizon-reference-classes.md §4.6 names it as the census the calendar builds). Expected dates are revised often, especially when a first committee meeting does not reach a final recommendation. Calendar cycle 60% A clock-only model: NICE sets a provisional publication date a few weeks after a committee meeting that assumes the meeting reaches a final recommendation. A second committee meeting more often reaches a final recommendation than a first, and nine weeks from the second meeting to expected publication is on schedule if it was final. Analyst proxy 50% A market-access analyst reading the same project page and draft guidance on 2026-09-24 would weigh the second meeting, held on schedule, against the negative draft and the size of the cost-effectiveness gap. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-18 Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-18 Evidence cutoff 2026-09-26 Nothing after this date informed the estimate. Registered 2026-09-26 Frozen and hashed. Resolution window 2026-09-27 → 2026-11-18 When the outcome can be read against the rule. Event by 2026-11-18 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 80d14b258192d4b4d16dabc0f47be5dc510901f559ce701020f11b39224e5e22 · operator record jc-1790461082310-50e7fe60 ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID6363 shows a publication date ('Published: ') on or before 2026-11-18, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6363. Resolves NO if the guidance is published after 2026-11-18, if the expected date is revised and nothing is published by 2026-11-18, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-11-25. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11422, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 50% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-09-26. review pathway single technology appraisal (STA), standard submission type new technology appraisal evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class usual treatment named in the draft guidance: paclitaxel or pegylated liposomal doxorubicin, with mirvetuximab soravtansine an option for folate receptor-alpha-positive cancer (SRC-002) months since last guideline revision not applicable panel cycle position second committee meeting 15 September 2026, after draft guidance consultation 4 to 25 August 2026 (SRC-001) sponsor request status none recorded since the invitation to participate on 1 December 2025; a note added to the project documents on 5 July 2024 predates it, and its text is not archived (SRC-001) odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change none recorded in the archived sources Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-09-26 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development page for ID6363 (GID-TA11422), pembrolizumab with chemotherapy with or without bevacizumab for platinum-resistant recurrent ovarian cancer after 1 or 2 treatments, retrieved at the cutoff. Fixes the expected publication date the proposition freezes (18 November 2026), status In progress, process STA Standard, and the timeline: invitation to participate 1 December 2025, committee meeting 1 on 14 July 2026, draft guidance 4 to 25 August 2026, committee meeting 2 on 15 September 2026, no final draft guidance entry, and a note added to the project documents on 5 July 2024 (its text is not on this page). https://www.nice.org.uk/guidance/indevelopment/gid-ta11422 Retrieved 2026-09-24 · sha256 1fcac6b4fc01e27ba98dbc3d29419238c0d4a97bbb1f7390b0bb3612e38de71e SRC-002 NICE draft guidance consultation document for ID6363 (PDF linked from the project documents; issue date July 2026). Section 1 says pembrolizumab plus paclitaxel, with or without bevacizumab, should not be used for this population; the key dates give comments closing 25 August 2026 and the second committee meeting on 15 September 2026; after consultation the committee prepares final draft guidance, subject to any appeal; section 2.1 states the marketing authorisation indication (Keytruda, MSD); section 3.15 says the cost-effectiveness estimates were considerably higher than the range normally considered acceptable. https://www.nice.org.uk/guidance/gid-ta11422/documents/consultation-document Retrieved 2026-09-24 · sha256 71d3de8d2d70e65f36fa49232c880e07a51e4224d0c4acbbc63dd222d0a00bfb SRC-003 NICE technology appraisal committee A, 15 September 2026, final agenda. Lists this appraisal [ID6363] for its second meeting, with ID6425 (inavolisib, CAL-NICE-006) and ID6325 on the same agenda. https://www.nice.org.uk/event/TACA-Sept-2026 Retrieved 2026-09-24 · sha256 4b9680efac5ce7db0f81aa113a91b7171be9ee2d0dd34fba43559e6ab3564cf6 --- # 50% forecast: NICE publishes technology appraisal guidance on Zuranolone for treating postnatal depression [ID6431] on or before 2026-11-12 URL: https://nextconsensus.com/forecast/ff-022/ Registered forecast 50% registered probability event by 2026-11-12 Unresolved ## NICE publishes technology appraisal guidance on Zuranolone for treating postnatal depression [ID6431] on or before 2026-11-12 FF-022 Registered · Unresolved Registered probability 50% Event by 2026-11-12 Resolution window 2026-09-27 → 2026-11-12 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 60% - Analyst proxy 50% nextconsensus.com/forecast/ff-022/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-09-26. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Zuranolone for treating postnatal depression' [ID6431], with a publication date on or before 2026-11-12, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11356) on 2026-09-24. Authority National Institute for Health and Care Excellence (NICE), Technology Appraisal Committee (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope Postnatal depression The estimate ### The number and the baselines it has to beat 50% probability, method v0.1.0 · frozen at the 2026-09-26 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-022 · registered 50% Authority base rate 0 pts 50% Calendar cycle −10 pts 60% Analyst proxy 0 pts 50% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown about seven weeks earlier is not yet counted (docs/foundations/short-horizon-reference-classes.md §4.6 names it as the census the calendar builds). Expected dates are revised often, especially when a committee meeting does not reach a final recommendation. Calendar cycle 60% A clock-only model: NICE sets a provisional publication date a few weeks after a committee meeting that assumes the meeting reaches a final recommendation. A second committee meeting more often reaches a final recommendation than a first, which favours the date. Eight weeks from the second meeting to expected publication is on schedule if that meeting was final. Analyst proxy 50% A market-access analyst reading the same project pages on 2026-09-24 would weigh the stage of the appraisal, the negative draft guidance and the history of delays. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-12 Evidence cutoff 2026-09-26 Registered 2026-09-26 Window opens 2026-09-27 Deadline 2026-11-12 Evidence cutoff 2026-09-26 Nothing after this date informed the estimate. Registered 2026-09-26 Frozen and hashed. Resolution window 2026-09-27 → 2026-11-12 When the outcome can be read against the rule. Event by 2026-11-12 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger f8ceb2e7f05c5212e38731e78252d5bace74d5a31bc67309afabc65c3ba0d2e4 · operator record jc-1790461082315-806175cd ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID6431 shows a publication date ('Published: ') on or before 2026-11-12, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6431. Resolves NO if the guidance is published after 2026-11-12, if the expected date is revised and nothing is published by 2026-11-12, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-11-19. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11356, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 50% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-09-26. review pathway single technology appraisal (STA), standard (SRC-001); technology appraisal committee B (SRC-004) submission type new technology appraisal evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class comparator companies named on the page supply antidepressants (among them citalopram, sertraline and venlafaxine) and a digital therapy (SilverCloud, Space from Depression); each is marked not participating (SRC-001) months since last guideline revision not applicable panel cycle position committee meeting 2 dated 16 September 2026, on technology appraisal committee B's draft agenda with ID6239 (SRC-001, SRC-004); draft guidance consultation 28 August to 18 September 2025 (SRC-001) sponsor request status the company requested additional time to respond to the draft guidance and the second committee meeting was delayed (note of 28 August 2025, SRC-001) odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change none recorded in the archived sources Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-09-26 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development page for ID6431, zuranolone for treating postnatal depression, retrieved at the cutoff. Fixes the expected publication date the proposition freezes (12 November 2026), status In progress, process STA Standard, and the project history: committee meeting on 06 August 2025; a note of 28 August 2025 that the company requested additional time to respond to the draft guidance and that the second committee meeting will be delayed; draft guidance consultation 28 August 2025 to 18 September 2025; committee meeting 2 dated 16 September 2026. https://www.nice.org.uk/guidance/indevelopment/gid-ta11356 Retrieved 2026-09-24 · sha256 f50ac146f45e74ea7ebddfe689daf36298e95e64984e02654e671754568024ef SRC-002 NICE project documents page for ID6431, retrieved at the cutoff. Lists draft guidance 1 with its committee papers and public committee slides, each published 28 August 2025, and the note on the company's request for additional time; lists no final draft guidance. https://www.nice.org.uk/guidance/indevelopment/gid-ta11356/documents Retrieved 2026-09-24 · sha256 e7c87a9a4563c22eed0e6906198222f3de58d61cba7a2654a6ac2ea07889af8e SRC-003 NICE consultation on the ID6431 draft guidance, section 1 (Recommendations), retrieved at the cutoff. The draft's recommendation 1.1 reads 'Zuranolone should not be used to treat postnatal depression in adults.' The consultation ended on 18 September 2025. https://www.nice.org.uk/consultations/3061/1/recommendations Retrieved 2026-09-24 · sha256 f75ef9b7c7a171f5e94a3b42428019488ac1d037f0b6c9446955d64dfa9cefd0 SRC-004 Draft agenda of NICE technology appraisal committee B for 16 September 2026, retrieved at the cutoff. Lists the appraisal of zuranolone for treating postnatal depression [ID6431], with agreement on the content of the draft guidance or final draft guidance in closed session, after the appraisal of nivolumab with ipilimumab for untreated advanced hepatocellular carcinoma [ID6239]. States the agenda is subject to change. https://www.nice.org.uk/event/TACB-Sept-2026 Retrieved 2026-09-24 · sha256 be1c644dd287879311e4b161f0834945f933cea9edca24e7428b98e3b810ea8a --- # 85% forecast: FDA approves bezuclastinib with sunitinib for gastrointestinal stromal tumor after imatinib on or before the disclosed PDUFA goal date of 2026-11-30 URL: https://nextconsensus.com/forecast/ff-023/ Registered forecast 85% registered probability event by 2026-11-30 Unresolved ## FDA approves bezuclastinib with sunitinib for gastrointestinal stromal tumor after imatinib on or before the disclosed PDUFA goal date of 2026-11-30 FF-023 Registered · Unresolved Registered probability 85% Event by 2026-11-30 Resolution window 2026-10-07 → 2026-11-30 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 85% - Calendar cycle 80% - Analyst proxy 85% nextconsensus.com/forecast/ff-023/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-06. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on Cogent Biosciences' New Drug Application for bezuclastinib in combination with sunitinib for the treatment of patients with gastrointestinal stromal tumor who have received prior treatment with imatinib, with an approval action date on or before 2026-11-30, the PDUFA target action date disclosed in Cogent Biosciences' Form 10-Q filed 2026-08-10. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope GIST after imatinib, in combination with sunitinib The estimate ### The number and the baselines it has to beat 85% probability, method v0.1.0 · frozen at the 2026-10-06 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-023 · registered 85% Authority base rate 0 pts 85% Calendar cycle +5 pts 80% Analyst proxy 0 pts 85% Authority base rate 85% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Applications built on positive randomized controlled trials are approved at their first goal date in a large majority of cases. The calendar's own met-goal-date share for disclosed PDUFA dates does not exist yet. Calendar cycle 80% A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle actions on applications like this are approvals. With no evidence input it cannot tell a strong application from a weak one. Analyst proxy 85% An oncology analyst reading the same filings on 2026-10-01 would weigh priority review under Real-Time Oncology Review, Breakthrough designation and a randomized phase 3 that halved the hazard of progression, against immature overall survival and added liver toxicity. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-06 Registered 2026-10-06 Window opens 2026-10-07 Deadline 2026-11-30 Evidence cutoff 2026-10-06 Registered 2026-10-06 Window opens 2026-10-07 Deadline 2026-11-30 Evidence cutoff 2026-10-06 Nothing after this date informed the estimate. Registered 2026-10-06 Frozen and hashed. Resolution window 2026-10-07 → 2026-11-30 When the outcome can be read against the rule. Event by 2026-11-30 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 7fa4097d054e825b3e0895600217f1b711f8a49430c6b2980b9d0233e9cd659a · operator record jc-1791309827087-bd33806e ### Around this record Bezuclastinib - FF-031 · Bezuclastinib · nonadvanced systemic mastocytosis approval event by 2026-12-30 This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Cogent has separate bezuclastinib applications for systemic mastocytosis (SRC-001); an approval for mastocytosis does not count. Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22bezuclastinib%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22BEZUCLASTINIB%22&limit=100, read together (openFDA does not always fill the generic-name field for a second application), contain a submission, original or supplement, with submission_status AP and a submission_status_date on or before 2026-11-30, and the Drugs@FDA approval letter or label for that submission names gastrointestinal stromal tumor in its indication. An approval for a narrower GIST population than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2026-11-30: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-30 resolves NO as occurred_after_deadline. Read no earlier than 2026-12-14. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name bezuclastinib) governs. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22bezuclastinib%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22BEZUCLASTINIB%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 85% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-06. review pathway priority review; Real-Time Oncology Review (RTOR); Breakthrough Therapy Designation (January 2026) (SRC-001) submission type original NDA (SRC-001) evidence class one randomized, open-label, global Phase 3 trial (PEAK) of bezuclastinib + sunitinib vs sunitinib alone (SRC-001, SRC-003) pivotal n 204 (bezuclastinib + sunitinib) vs 209 (sunitinib) randomized 1:1 (SRC-004) endpoint type progression-free survival by blinded independent central review: median 16.5 vs 9.2 months, HR 0.50 (95% CI 0.39–0.65); overall survival immature at the top-line analysis (SRC-003) approved competitors in class sunitinib monotherapy is the current second-line therapy for most patients (SRC-001); the PEAK deck benchmarks the approved agents imatinib, sunitinib, regorafenib and ripretinib from their labels (SRC-004) months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status NDA submitted March 2026 under RTOR; accepted with Priority Review May 2026 (SRC-001) odac referral none announced in the archived sources sponsor state change none recorded; commercial supply agreement with Hovione signed September 1, 2026 (SRC-005) Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-06 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Cogent Biosciences, Inc. Form 10-Q for the quarter ended June 30, 2026, filed 2026-08-10 (latest filing found that states the date). States that the GIST NDA for bezuclastinib plus sunitinib was submitted in March 2026 under RTOR, accepted with Priority Review in May 2026, with a PDUFA target action date of November 30, 2026; Breakthrough Therapy Designation in January 2026; PEAK results; and a separate NonAdvSM NDA with a PDUFA date of December 30, 2026. https://www.sec.gov/Archives/edgar/data/1622229/000119312526342393/cogt-20260630.htm Retrieved 2026-10-01 · sha256 0cad67b994f18f1f4566e7b6e9d299584e8d127f092019c3a8c60d2b470bc2d3 SRC-002 Cogent Form 8-K Exhibit 99.1 (Q2 2026 results press release), filed 2026-08-10. Headline: potential approval of bezuclastinib for GIST patients (PDUFA November 30) and NonAdvSM patients (PDUFA December 30); lists 'Potential FDA approval of bezuclastinib in GIST – PDUFA date of November 30, 2026'. https://www.sec.gov/Archives/edgar/data/1622229/000119312526341315/cogt-ex99_1.htm Retrieved 2026-10-01 · sha256 b6f61d423831a083e76308a4f061f380cdee7726161949ca0c217bde11ad9882 SRC-003 Cogent Form 8-K filed 2025-11-10 (Item 8.01) reporting PEAK Phase 3 top-line results: PFS HR 0.50 (95% CI 0.39–0.65), median PFS 16.5 vs 9.2 months by blinded independent central review, ORR 46% vs 26%, overall survival immature, and Grade 3+ adverse event rates. https://www.sec.gov/Archives/edgar/data/1622229/000119312525273315/d54064d8k.htm Retrieved 2026-10-01 · sha256 d26ccb857f5dfe2a0e7d4b8d4cd494c53a05bbb94e89158d896e31b182273838 SRC-004 Cogent Form 8-K Exhibit 99.1 (PEAK top-line investor presentation), filed 2025-11-10. Gives randomization (bezuclastinib + sunitinib n=204; sunitinib n=209) and benchmarks for approved GIST agents. https://www.sec.gov/Archives/edgar/data/1622229/000119312525273315/d54064dex991.htm Retrieved 2026-10-01 · sha256 d31f164cf90f0401c19110eaf0845f0a00fe5eb0c6e09cf9940085e5ffbc3250 SRC-005 Cogent Form 8-K filed 2026-09-02 (latest Cogent filing before cutoff), Item 1.01: Commercial Supply Agreement with Hovione FarmaCiencia S.A. to manufacture bezuclastinib spray-dried dispersion and tablets. Reports no change to the review. https://www.sec.gov/Archives/edgar/data/1622229/000119312526380194/d184156d8k.htm Retrieved 2026-10-01 · sha256 bfd0128cf4afa7c90d9da1327efcc6a68571fff2e6fdbe9b1fde8070ca4e15c0 SRC-006 openFDA drugsfda API response for generic name 'bezuclastinib', retrieved 2026-10-01: 404 NOT_FOUND 'No matches found!'. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22bezuclastinib%22 Retrieved 2026-10-01 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da --- # 55% forecast: FDA approves D-PLEX100 (extended-release doxycycline) for prevention of surgical site infections in colorectal surgery on or before the disclosed PDUFA goal date of 2026-11-28 URL: https://nextconsensus.com/forecast/ff-024/ Registered forecast 55% registered probability event by 2026-11-28 Unresolved ## FDA approves D-PLEX100 (extended-release doxycycline) for prevention of surgical site infections in colorectal surgery on or before the disclosed PDUFA goal date of 2026-11-28 FF-024 Registered · Unresolved Registered probability 55% Event by 2026-11-28 Resolution window 2026-10-07 → 2026-11-28 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 85% - Calendar cycle 80% - Analyst proxy 55% nextconsensus.com/forecast/ff-024/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-06. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on PolyPid's New Drug Application for D-PLEX100 (doxycycline in an extended-release polymer-lipid matrix) for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery, with an approval action date on or before 2026-11-28, the PDUFA goal date disclosed in Exhibit 99.1 to PolyPid's Form 6-K furnished 2026-08-12. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope Prevention of surgical site infections in abdominal colorectal surgery The estimate ### The number and the baselines it has to beat 55% probability, method v0.1.0 · frozen at the 2026-10-06 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-024 · registered 55% Authority base rate −30 pts 85% Calendar cycle −25 pts 80% Analyst proxy 0 pts 55% Authority base rate 85% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Applications built on positive randomized controlled trials are approved at their first goal date in a large majority of cases. The calendar's own met-goal-date share for disclosed PDUFA dates does not exist yet. Calendar cycle 80% A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle actions on applications like this are approvals. With no evidence input it cannot tell a strong application from a weak one. Analyst proxy 55% An analyst reading the same filings on 2026-10-01 would weigh priority review, Breakthrough designation and a positive phase 3, against a single pivotal trial with a mid-study protocol change, the sponsor's own warning that FDA may not accept its 505(b)(2) route, a going-concern statement and a first-time applicant's manufacturing. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-06 Registered 2026-10-06 Window opens 2026-10-07 Deadline 2026-11-28 Evidence cutoff 2026-10-06 Registered 2026-10-06 Window opens 2026-10-07 Deadline 2026-11-28 Evidence cutoff 2026-10-06 Nothing after this date informed the estimate. Registered 2026-10-06 Frozen and hashed. Resolution window 2026-10-07 → 2026-11-28 When the outcome can be read against the rule. Event by 2026-11-28 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 78267586fe018127a09ef07cd55d477d78dbace1df7d6bdad0b43c4e4704ac9e · operator record jc-1791309827457-ff8e2936 ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Doxycycline is marketed under many applications, so this one is identified by holder and indication. At the cutoff openFDA listed no PolyPid application (SRC-007, SRC-008). Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=sponsor_name:POLYPID*&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=sponsor_name:AZURITY*&limit=100, read together, contain an NDA held by PolyPid, or by Azurity or another holder to which PolyPid has assigned it (SRC-004), whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-11-28, and whose Drugs@FDA approval letter or label indicates the product for preventing or reducing surgical site infections. An approval for a narrower surgical population than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2026-11-28: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-28 resolves NO as occurred_after_deadline. 2026-11-28 is a Saturday; an approval action dated that day still counts. Read no earlier than 2026-12-12. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by PolyPid, Azurity or D-PLEX) governs, under the same holder and indication test. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=sponsor_name:POLYPID*&limit=100, https://api.fda.gov/drug/drugsfda.json?search=sponsor_name:AZURITY*&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 55% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-06, including the one field whose value was unknown then. It is left unknown rather than filled in. review pathway priority review (SRC-001, SRC-002); Breakthrough Therapy Designation (SRC-002); Fast Track and rolling submission (SRC-006) submission type original NDA; company intends Section 505(b)(2) (SRC-006) evidence class one pivotal randomized Phase 3 trial, SHIELD II, D-PLEX100 plus standard of care vs standard of care alone (SRC-006) pivotal n 405 (D-PLEX100 + SoC) vs 393 (SoC) in the primary-endpoint analysis; 975 patients with incision >=7 cm in the overall population used for the second key secondary endpoint (SRC-006) endpoint type composite primary endpoint of deep and superficial SSI, all-cause mortality and reintervention at the index incision: 10.9% vs 18.1%, 40% reduction, p<0.005 (SRC-006) approved competitors in class unknown — not stated in the archived sources months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status NDA submission completed (rolling); FDA accepted it on July 27, 2026 with Priority Review and identified no filing review issues (SRC-001) odac referral none announced in the archived sources sponsor state change exclusive US/Canada license and supply agreement with Azurity effective July 17, 2026; PolyPid must assign the approved NDA to Azurity after approval (SRC-003, SRC-004) Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-06 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 PolyPid Ltd. Form 6-K Exhibit 99.1 (Q2 2026 corporate update and results press release), furnished 2026-08-12 (latest PolyPid filing before cutoff). States that on July 27, 2026 FDA accepted the D-PLEX100 NDA with Priority Review and a PDUFA goal date of November 28, 2026, that FDA identified no filing review issues, and that cash plus Azurity proceeds are expected to fund operations into 2028. https://www.sec.gov/Archives/edgar/data/1611842/000121390026088040/ea030152801ex99-1.htm Retrieved 2026-10-01 · sha256 d60e47844378a63ecc2acfce6b2fe5d727c95675f39c9ec08f8e8adcb8d0687a SRC-002 PolyPid Form 6-K Exhibit 99.1 furnished 2026-07-29: press release 'PolyPid Announces FDA Acceptance of NDA with Priority Review for D-PLEX100'. States the PDUFA target action date of November 28, 2026 (about one quarter ahead of prior Q1 2027 guidance), no filing review issues, Breakthrough Therapy Designation, and SHIELD II results. https://www.sec.gov/Archives/edgar/data/1611842/000121390026082564/ea029964201ex99-1.htm Retrieved 2026-10-01 · sha256 0a6eebd916671c1829e22973c19e140fb100954563df720383e053e044936d83 SRC-003 PolyPid Form 6-K furnished 2026-07-21 (cover report). States that on July 17, 2026 PolyPid entered a License and Supply Agreement granting Azurity Pharmaceuticals Ireland Ltd. exclusive rights to commercialize D-PLEX100 in the US and Canada, with a $15 million milestone payable on FDA acceptance of the NDA. https://www.sec.gov/Archives/edgar/data/1611842/000121390026079808/ea0298559-6k_polypid.htm Retrieved 2026-10-01 · sha256 0fb6dd6c06a9b0ec257f53311ac2d78f46888cb171ca99e50949ba5e16c91612 SRC-004 PolyPid Form 6-K Exhibit 10.1 (License and Supply Agreement with Azurity, dated July 17, 2026; redacted), furnished 2026-07-21. Section 3.02(a): PolyPid submits the NDA and shall assign the approved Product NDA to Azurity after final approval. https://www.sec.gov/Archives/edgar/data/1611842/000121390026079808/ea029855901ex10-1.htm Retrieved 2026-10-01 · sha256 18d69a3e30f813036853daa06d6c91d9a15c10819f68daf85ac92a618665d8e8 SRC-005 PolyPid Form 6-K Exhibit 99.1 (interim condensed consolidated financial statements as of June 30, 2026), furnished 2026-08-12. Note 1c states that these factors raise a substantial doubt about the company's ability to continue as a going concern. https://www.sec.gov/Archives/edgar/data/1611842/000121390026088439/ea030023101ex99-1.htm Retrieved 2026-10-01 · sha256 91b8b0d5894504d47790403b2afc7ea3ac911c27ed66158ac401096a01900954 SRC-006 PolyPid Form 20-F for fiscal 2025, filed 2026-02-25. Gives SHIELD II design and results (D-PLEX100 + SoC n=405 vs SoC n=393; primary endpoint 10.9% vs 18.1%, a 40% reduction, p<0.005), the intent to use the Section 505(b)(2) pathway, and plans to submit the NDA on a rolling basis using Fast Track and Breakthrough Therapy designations. https://www.sec.gov/Archives/edgar/data/1611842/000121390026020370/ea0276727-20f_polypid.htm Retrieved 2026-10-01 · sha256 784cec58a6d079bdd6ba7bcf8a2f030e50f82411eb6e843fa65d44ca40eb9cca SRC-007 openFDA drugsfda API response for sponsor_name POLYPID* (prefix search), retrieved 2026-10-01: 404 NOT_FOUND 'No matches found!' (no PolyPid application in Drugs@FDA data). https://api.fda.gov/drug/drugsfda.json?search=sponsor_name:POLYPID* Retrieved 2026-10-01 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da SRC-008 openFDA drugsfda API response for brand name 'D-PLEX100', retrieved 2026-10-01: 404 NOT_FOUND 'No matches found!'. https://api.fda.gov/drug/drugsfda.json?search=products.brand_name:%22D-PLEX100%22 Retrieved 2026-10-01 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da --- # 85% forecast: FDA approves neladalkib for ALK-positive non-small cell lung cancer after a prior ALK inhibitor on or before the disclosed PDUFA goal date of 2026-11-27 URL: https://nextconsensus.com/forecast/ff-025/ Registered forecast 85% registered probability event by 2026-11-27 Unresolved ## FDA approves neladalkib for ALK-positive non-small cell lung cancer after a prior ALK inhibitor on or before the disclosed PDUFA goal date of 2026-11-27 FF-025 Registered · Unresolved Registered probability 85% Event by 2026-11-27 Resolution window 2026-10-07 → 2026-11-27 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 70% - Calendar cycle 65% - Analyst proxy 85% nextconsensus.com/forecast/ff-025/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-06. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on Nuvalent's (a GSK company since July 2026) New Drug Application for neladalkib (NVL-655) for the treatment of tyrosine kinase inhibitor pre-treated advanced ALK-positive non-small cell lung cancer, with an approval action date on or before 2026-11-27, the target decision date disclosed in GSK's Form 6-K furnished 2026-07-22, and stated as the PDUFA date in Royalty Pharma's filing of 2026-08-05. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope ALK-positive NSCLC after a prior ALK inhibitor The estimate ### The number and the baselines it has to beat 85% probability, method v0.1.0 · frozen at the 2026-10-06 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-025 · registered 85% Authority base rate +15 pts 70% Calendar cycle +20 pts 65% Analyst proxy 0 pts 85% Authority base rate 70% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Applications resting on uncontrolled or early-phase trials, or on surrogate endpoints, often under accelerated approval, meet their first goal date less often than those built on completed randomized trials. The calendar's own count does not exist yet. Calendar cycle 65% A clock-only model: the goal date is inside the window and FDA meets most goal dates, but first-cycle approval is less common on uncontrolled, early-phase or surrogate evidence. Analyst proxy 85% A thoracic oncology analyst reading the same filings on 2026-10-01 would weigh priority review, Breakthrough Therapy designation and a registration-directed trial in a pre-treated population, against a phase 1/2 basis and an applicant that changed owners during review. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-06 Registered 2026-10-06 Window opens 2026-10-07 Deadline 2026-11-27 Evidence cutoff 2026-10-06 Registered 2026-10-06 Window opens 2026-10-07 Deadline 2026-11-27 Evidence cutoff 2026-10-06 Nothing after this date informed the estimate. Registered 2026-10-06 Frozen and hashed. Resolution window 2026-10-07 → 2026-11-27 When the outcome can be read against the rule. Event by 2026-11-27 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger a912641a8f1dfb783320fb6599a0e4d8f2aa1d9250f29ebb3abe316ffc6a68b0 · operator record jc-1791309827796-23e39d52 ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22neladalkib%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22NELADALKIB%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-11-27, and the Drugs@FDA approval letter or label for that application names ALK-positive non-small cell lung cancer in its indication. An approval for a narrower population than the applicant sought (for example after a specific prior ALK inhibitor) still resolves YES, as does accelerated rather than traditional approval. Resolves NO if no approval action is dated on or before 2026-11-27: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-27 resolves NO as occurred_after_deadline. Read no earlier than 2026-12-11. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name neladalkib) governs. The application number was not public at the cutoff, so the rule reads by name; a suffix on the nonproprietary name or a proprietary name does not change the identification. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22neladalkib%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22NELADALKIB%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 85% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-06, including the 3 fields whose values were unknown then. Those are left unknown rather than filled in. review pathway priority review (SRC-002); Breakthrough Therapy and Orphan Drug designations (SRC-005) submission type original NDA (SRC-002, SRC-004) evidence class registration-directed Phase 1/2 trial (ALKOVE-1) in TKI pre-treated patients; no randomized trial in this population cited (SRC-004) pivotal n unknown — not stated in the archived sources endpoint type unknown — primary endpoint not named in the archived sources; SRC-004 cites overall activity including intracranial responses approved competitors in class unknown — not stated in the archived sources (SRC-004 names alectinib as 'a front-line standard of care' and the comparator in the separate first-line ALKAZAR Phase 3) months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status NDA submitted (announced 2026-05-07, SRC-004); accepted for filing with Priority Review in May 2026 (SRC-002) odac referral none announced in the archived sources sponsor state change Nuvalent was acquired by GSK; acquisition completed (SRC-006, furnished 2026-07-15) Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-06 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 GSK plc Form 6-K furnished 2026-07-22 (press release on US approval of Jideytro). States that neladalkib (NVL-655) for ALK-altered NSCLC is 'currently under FDA review with a target decision date of 27 November 2026'. https://www.sec.gov/Archives/edgar/data/1131399/000165495426006789/a4747n.htm Retrieved 2026-10-01 · sha256 74018843a305c4532053912939453081e6c8665747c6db9a552f3650868b183f SRC-002 Royalty Pharma plc Form 8-K Exhibit 99.1 (Q2 2026 results), filed 2026-08-05 (latest filing found that states the exact date). States that in May 2026 Nuvalent announced FDA accepted its NDA for neladalkib for filing and granted Priority Review with a PDUFA date of November 27, 2026, and that GSK completed its acquisition of Nuvalent in July 2026. https://www.sec.gov/Archives/edgar/data/1802768/000180276826000014/rprx-20260630rpplcpressxre.htm Retrieved 2026-10-01 · sha256 c0bbf274a3d7dea2d9c2f4affe478f059ba7b9abf4f29204d7152d9b4024bdeb SRC-003 GSK plc Form 6-K furnished 2026-09-08 (Q2 2026 results report; latest GSK filing found that mentions neladalkib). States neladalkib is under FDA review for TKI pre-treated ALK-positive NSCLC 'with PDUFA date anticipated in November 2026' and lists 'neladalkib (PDUFA H2 2026)'. Consistent with SRC-001; does not state the day. https://www.sec.gov/Archives/edgar/data/1131399/000119312526384439/d331501d6k.htm Retrieved 2026-10-01 · sha256 3caaa636b58cb1fcf2d56c6e7e7340c104df489e30e5d51c5b1a17b1d7d9e717 SRC-004 Nuvalent, Inc. Form 8-K Exhibit 99.1 (Q1 2026 results), filed 2026-05-07. States Nuvalent submitted an NDA for neladalkib in TKI pre-treated advanced ALK-positive NSCLC based on the registration-directed ALKOVE-1 Phase 1/2 trial. https://www.sec.gov/Archives/edgar/data/1861560/000186156026000020/nuvl-ex99_1.htm Retrieved 2026-10-01 · sha256 478c168b9dc7f504088b3c724a83e1db9b94d1a1913f64f6b1c83a0ed23718e5 SRC-005 Nuvalent Form 8-K Exhibit 99.1, filed 2026-06-09 (GSK press release announcing agreement to acquire Nuvalent). States both zidesamtinib and neladalkib have FDA Breakthrough Therapy and Orphan Drug Designations and are in review with target decision dates of 18 September 2026 (zidesamtinib) and 27 November 2026 (neladalkib). https://www.sec.gov/Archives/edgar/data/1861560/000119312526262950/d137459dex991.htm Retrieved 2026-10-01 · sha256 eb7bad5ae48a93930e67e8c5d39365a7d61dd53548887c50c427d4f992b54b3e SRC-006 GSK plc Form 6-K furnished 2026-07-15 announcing completion of its acquisition of Nuvalent, Inc.; states neladalkib is under FDA review with a target decision date later this year. https://www.sec.gov/Archives/edgar/data/1131399/000165495426006663/a5060m.htm Retrieved 2026-10-01 · sha256 33f626b68e7a9a458e8307d7d367ed5623f85b2f5b4fe56629ec88feed095f76 SRC-007 openFDA drugsfda API response for generic name 'neladalkib', retrieved 2026-10-01: 404 NOT_FOUND 'No matches found!'. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22neladalkib%22 Retrieved 2026-10-01 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da --- # 85% forecast: FDA approves povetacicept for IgA nephropathy on or before the disclosed PDUFA goal date of 2026-11-30 URL: https://nextconsensus.com/forecast/ff-026/ Registered forecast 85% registered probability event by 2026-11-30 Unresolved ## FDA approves povetacicept for IgA nephropathy on or before the disclosed PDUFA goal date of 2026-11-30 FF-026 Registered · Unresolved Registered probability 85% Event by 2026-11-30 Resolution window 2026-10-07 → 2026-11-30 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 70% - Calendar cycle 65% - Analyst proxy 85% nextconsensus.com/forecast/ff-026/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-06. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on Vertex's Biologics License Application for povetacicept, submitted for accelerated approval, for the treatment of adults with IgA nephropathy, with an approval action date on or before 2026-11-30, the PDUFA target action date disclosed in Vertex's Form 10-Q filed 2026-08-04. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope IgA nephropathy in adults (accelerated approval) The estimate ### The number and the baselines it has to beat 85% probability, method v0.1.0 · frozen at the 2026-10-06 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-026 · registered 85% Authority base rate +15 pts 70% Calendar cycle +20 pts 65% Analyst proxy 0 pts 85% Authority base rate 70% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Applications resting on uncontrolled or early-phase trials, or on surrogate endpoints, often under accelerated approval, meet their first goal date less often than those built on completed randomized trials. The calendar's own count does not exist yet. Calendar cycle 65% A clock-only model: the goal date is inside the window and FDA meets most goal dates, but first-cycle approval is less common on uncontrolled, early-phase or surrogate evidence. Analyst proxy 85% A nephrology analyst reading the same filings on 2026-10-01 would weigh priority review and a pre-specified interim analysis of a randomized phase 3 that the sponsor reports positive on all endpoints, with another IgA nephropathy medicine granted accelerated approval in July 2026 (SRC-005). Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-06 Registered 2026-10-06 Window opens 2026-10-07 Deadline 2026-11-30 Evidence cutoff 2026-10-06 Registered 2026-10-06 Window opens 2026-10-07 Deadline 2026-11-30 Evidence cutoff 2026-10-06 Nothing after this date informed the estimate. Registered 2026-10-06 Frozen and hashed. Resolution window 2026-10-07 → 2026-11-30 When the outcome can be read against the rule. Event by 2026-11-30 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 3579c949d3f51f469db7d882ce86439cd190f53841739638ddb56b1413b12a61 · operator record jc-1791309828140-79ed1088 ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22povetacicept%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22POVETACICEPT%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-11-30, and the Drugs@FDA approval letter or label for that application names IgA nephropathy in its indication, with Vertex or a Vertex subsidiary as applicant. An approval for a narrower IgA nephropathy population than the applicant sought still resolves YES, as does accelerated rather than traditional approval. Resolves NO if no approval action is dated on or before 2026-11-30: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-30 resolves NO as occurred_after_deadline. Read no earlier than 2026-12-14. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name povetacicept) governs. If neither lists the product, FDA's Purple Book (https://purplebooksearch.fda.gov/, searched by povetacicept) governs for the licensure date, with the approval letter for the indication. The application number was not public at the cutoff, so the rule reads by name; a suffix on the nonproprietary name or a proprietary name does not change the identification. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22povetacicept%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22POVETACICEPT%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/, https://purplebooksearch.fda.gov/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 85% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-06, including the 2 fields whose values were unknown then. Those are left unknown rather than filled in. review pathway priority review via a priority review voucher (SRC-003, SRC-004); accelerated approval (SRC-001) submission type original BLA, rolling submission completed March 2026 (SRC-003) evidence class pre-specified Week 36 interim analysis of the ongoing Phase 3 RAINIER trial (SRC-002) pivotal n unknown — not stated in the archived sources endpoint type unknown — endpoints not named in the archived sources; Vertex reports positive interim results 'for the primary and all secondary endpoints' (SRC-004) approved competitors in class TRUTAKNA (atacicept-vymj, Vera Therapeutics) received FDA accelerated approval in IgA nephropathy (SRC-005, filed 2026-07-07; openFDA BLA761486 ORIG-1 approved 2026-07-07, SRC-007) months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status rolling BLA submission completed by 2026-03-31 (SRC-003); FDA accepted the BLA (SRC-001), acceptance date not stated odac referral none announced in the archived sources sponsor state change none recorded Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-06 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Vertex Pharmaceuticals Incorporated Form 10-Q for the quarter ended June 30, 2026, filed 2026-08-04 (latest Vertex filing found that discusses povetacicept). States FDA accepted the BLA for accelerated approval of povetacicept for adults with IgAN and assigned a PDUFA target action date of November 30, 2026. https://www.sec.gov/Archives/edgar/data/875320/000087532026000259/vrtx-20260630.htm Retrieved 2026-10-01 · sha256 9ef79476bd63bcf8b6f7abb266e9347a59276b501e4bcb7e353bb632ecca0461 SRC-002 Vertex Form 8-K Exhibit 99.1 (Q2 2026 results), filed 2026-08-03. Headline 'povetacicept PDUFA date November 30th'; states the BLA for accelerated approval was accepted with a PDUFA target action date of November 30, 2026 and is supported by a pre-specified Week 36 interim analysis of the ongoing Phase 3 RAINIER trial. https://www.sec.gov/Archives/edgar/data/875320/000087532026000256/ex-991_q22026.htm Retrieved 2026-10-01 · sha256 e4bd456a827ea131b8725def6f61d8f8ad64a5037ca7e69c2a6ae0f59d9fb648 SRC-003 Vertex Form 8-K filed 2026-03-31 (Item 8.01): completed the rolling BLA submission for potential accelerated approval of povetacicept in adults with IgAN and used a priority review voucher, expecting a six-month review from acceptance. https://www.sec.gov/Archives/edgar/data/875320/000087532026000147/vrtx-20260331.htm Retrieved 2026-10-01 · sha256 f0371f5420453ea32fcab52a43e4ab3dde66be5e3a8b367a8a7773510e8dccf4 SRC-004 Vertex Form 8-K Exhibit 99.1 (Q1 2026 results), filed 2026-05-04. States positive Week 36 interim analysis results for the primary and all secondary endpoints in RAINIER (reported March 2026) and use of a Priority Review Voucher. https://www.sec.gov/Archives/edgar/data/875320/000087532026000171/ex-991_q12026.htm Retrieved 2026-10-01 · sha256 0272eff5e133d1cb01893505fbe63fd826b9a99b248cc6f3f25ce4cfd749ee85 SRC-005 Vera Therapeutics, Inc. Form 8-K filed 2026-07-07 announcing FDA accelerated approval of TRUTAKNA (atacicept-vymj) to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression (an approved product with a related BAFF/APRIL mechanism — mechanism comparison is the drafter's, not the filing's). https://www.sec.gov/Archives/edgar/data/1831828/000119312526297211/vera-20260707.htm Retrieved 2026-10-01 · sha256 7c34316d2eb72e2226d70280fc31e634f76115acd11cfe1e6d091c2b4e7fec07 SRC-006 openFDA drugsfda API response for generic name 'povetacicept', retrieved 2026-10-01: 404 NOT_FOUND 'No matches found!'. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22povetacicept%22 Retrieved 2026-10-01 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da SRC-007 openFDA drugsfda API response for generic name 'atacicept', retrieved 2026-10-01 (meta last_updated 2026-09-29): BLA761486, TRUTAKNA, sponsor VERA THERAPEUTICS INC., ORIG-1 approved 2026-07-07 (review priority PRIORITY). https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22atacicept%22 Retrieved 2026-10-01 · sha256 24bd149d40db612596d544e9ab774186e072d590a7c478bd26d91968e0639b8c --- # 75% forecast: FDA approves venglustat for type 3 Gaucher disease on or before the disclosed PDUFA goal date of 2026-11-25 URL: https://nextconsensus.com/forecast/ff-027/ Registered forecast 75% registered probability event by 2026-11-25 Unresolved ## FDA approves venglustat for type 3 Gaucher disease on or before the disclosed PDUFA goal date of 2026-11-25 FF-027 Registered · Unresolved Registered probability 75% Event by 2026-11-25 Resolution window 2026-10-07 → 2026-11-25 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 85% - Calendar cycle 80% - Analyst proxy 75% nextconsensus.com/forecast/ff-027/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-06. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on Sanofi's New Drug Application for venglustat for the treatment of type 3 Gaucher disease, with an approval action date on or before 2026-11-25, the target action date disclosed in Sanofi's 2026 half-year management report, furnished on Form 6-K on 2026-07-30. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope Type 3 Gaucher disease The estimate ### The number and the baselines it has to beat 75% probability, method v0.1.0 · frozen at the 2026-10-06 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-027 · registered 75% Authority base rate −10 pts 85% Calendar cycle −5 pts 80% Analyst proxy 0 pts 75% Authority base rate 85% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Applications built on positive randomized controlled trials are approved at their first goal date in a large majority of cases. The calendar's own met-goal-date share for disclosed PDUFA dates does not exist yet. Calendar cycle 80% A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle actions on applications like this are approvals. With no evidence input it cannot tell a strong application from a weak one. Analyst proxy 75% A rare-disease analyst reading the same filings on 2026-10-01 would weigh priority review, Breakthrough Therapy designation and a phase 3 that met both neurological co-primary endpoints against an active comparator, against a small trial and failures of the same drug in Fabry disease. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-06 Registered 2026-10-06 Window opens 2026-10-07 Deadline 2026-11-25 Evidence cutoff 2026-10-06 Registered 2026-10-06 Window opens 2026-10-07 Deadline 2026-11-25 Evidence cutoff 2026-10-06 Nothing after this date informed the estimate. Registered 2026-10-06 Frozen and hashed. Resolution window 2026-10-07 → 2026-11-25 When the outcome can be read against the rule. Event by 2026-11-25 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger e47801540786a6fe2ed9a4a168e3e7923e30b1e5efe6a34cee6a64d3108081f8 · operator record jc-1791309828469-68a8e289 ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22venglustat%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22VENGLUSTAT%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-11-25, and the Drugs@FDA approval letter or label for that application names type 3 Gaucher disease in its indication, with Sanofi or a Sanofi subsidiary as applicant. An approval for a narrower type 3 Gaucher disease population, or for its neurological manifestations only, still resolves YES. Resolves NO if no approval action is dated on or before 2026-11-25: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-25 resolves NO as occurred_after_deadline. Read no earlier than 2026-12-09. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name venglustat) governs. The application number was not public at the cutoff, so the rule reads by name; a suffix on the nonproprietary name or a proprietary name does not change the identification. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22venglustat%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22VENGLUSTAT%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 75% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-06. review pathway priority review (SRC-001, SRC-002, SRC-003); Breakthrough Therapy and Fast Track designations and US orphan designation for GD3 (SRC-002) submission type original NDA for a new investigational molecule (SRC-002) evidence class one randomized, double-blind, double-dummy, active-comparator (ERT) Phase 3 study, LEAP2MONO (SRC-002) pivotal n 43 patients randomized 1:1 (SRC-002) endpoint type co-primary: change in SARA modified total score and in RBANS total scale index score vs ERT from baseline to week 52; both met, plus 3 of 4 key secondary endpoints (SRC-002) approved competitors in class Sanofi states there are currently no approved targeted treatments that specifically address the neurological symptoms of GD3 (SRC-002); Sanofi's Cerezyme and Cerdelga form its existing Gaucher disease franchise (SRC-001) months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status priority review granted May 2026 (SRC-001); NDA submission date not stated odac referral none announced in the archived sources sponsor state change none recorded Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-06 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Sanofi Form 6-K (furnished 2026-07-30), exhibit: 2026 half-year management report (latest Sanofi filing found that states the date). States that in May FDA granted priority review to the NDA for venglustat for type 3 Gaucher disease and that 'The target action date for the FDA decision is November 25, 2026'; also states venglustat did not meet the primary endpoint in the PERIDOT and CARAT Phase 3 studies in Fabry disease. https://www.sec.gov/Archives/edgar/data/1121404/000162828026050803/exhibit992-2026halfyearman.htm Retrieved 2026-10-01 · sha256 78c671041137febd93622e7c255ef797b21514547b08052e40a3f5fea5134254 SRC-002 Sanofi Form 6-K Exhibit 99.1, furnished 2026-06-08: press release dated May 28, 2026 'Sanofi's venglustat accepted for priority review in the US to treat type 3 Gaucher disease'. States the target action date (November 25, 2026), describes the LEAP2MONO Phase 3 study (43 patients randomized 1:1 vs ERT; both primary endpoints and three of four key secondary endpoints met) and prior Breakthrough Therapy, Fast Track and orphan designations. https://www.sec.gov/Archives/edgar/data/1121404/000119312526260613/d123884dex991.htm Retrieved 2026-10-01 · sha256 521965d2464588178b02140c05830c20821094d8343ca6c03a5393460d430d2a SRC-003 Sanofi Form 6-K (furnished 2026-07-30), Q2 2026 results press release. Lists 'venglustat – GD3 – priority review (US)' and states the target action date for the FDA decision is November 25, 2026. https://www.sec.gov/Archives/edgar/data/1121404/000112140426000008/pressreleaseq22026english.htm Retrieved 2026-10-01 · sha256 71db55bcf24f5a592b5c3720922d820b3d395e155c1bc5ea894afe2f6a16262e SRC-004 openFDA drugsfda API response for generic name 'venglustat', retrieved 2026-10-01: 404 NOT_FOUND 'No matches found!'. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22venglustat%22 Retrieved 2026-10-01 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da --- # 40% forecast: NICE publishes technology appraisal guidance on Obicetrapib and obicetrapib–ezetimibe for treating primary hypercholesterolaemia or mixed dyslipidaemia [ID6519] on or before 2026-11-25 URL: https://nextconsensus.com/forecast/ff-028/ Registered forecast 40% registered probability event by 2026-11-25 Unresolved ## NICE publishes technology appraisal guidance on Obicetrapib and obicetrapib–ezetimibe for treating primary hypercholesterolaemia or mixed dyslipidaemia [ID6519] on or before 2026-11-25 FF-028 Registered · Unresolved Registered probability 40% Event by 2026-11-25 Resolution window 2026-10-07 → 2026-11-25 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 55% - Analyst proxy 40% nextconsensus.com/forecast/ff-028/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-06. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Obicetrapib and obicetrapib–ezetimibe for treating primary hypercholesterolaemia or mixed dyslipidaemia' [ID6519], with a publication date on or before 2026-11-25, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11649) on 2026-10-01. Authority National Institute for Health and Care Excellence (NICE), Technology Appraisal Committee C (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope Primary hypercholesterolaemia or mixed dyslipidaemia The estimate ### The number and the baselines it has to beat 40% probability, method v0.1.0 · frozen at the 2026-10-06 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-028 · registered 40% Authority base rate −10 pts 50% Calendar cycle −15 pts 55% Analyst proxy 0 pts 40% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown at the cutoff is not yet counted; the calendar's census will count it. Expected dates are revised often, most when a committee meeting does not reach a final recommendation or a company asks for time. Calendar cycle 55% A clock-only model: a second committee meeting on 6 October, 50 days before the expected date, is treated as on schedule: the model assumes final draft guidance and an appeal period fit in that time. Analyst proxy 40% An analyst reading the project page and the draft guidance on 2026-10-01 would see negative draft guidance and a second meeting not yet held, and would weigh the chance that the committee asks for more evidence or the company for time. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-06 Registered 2026-10-06 Window opens 2026-10-07 Deadline 2026-11-25 Evidence cutoff 2026-10-06 Registered 2026-10-06 Window opens 2026-10-07 Deadline 2026-11-25 Evidence cutoff 2026-10-06 Nothing after this date informed the estimate. Registered 2026-10-06 Frozen and hashed. Resolution window 2026-10-07 → 2026-11-25 When the outcome can be read against the rule. Event by 2026-11-25 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 1e21419a5ead2a82d8f93717b1141df0883f93890b2fe56fa3a8b3ed2b5a1912 · operator record jc-1791309828794-32bf1a17 ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID6519 shows a publication date ('Published: ') on or before 2026-11-25, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6519. Searching for GID-TA11649 finds the same project. Resolves NO if the guidance is published after 2026-11-25, if the expected date is revised and nothing is published by 2026-11-25, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-12-02. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11649, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 40% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-06. review pathway STA by Technology Appraisal Committee C (SRC-001, SRC-003) submission type New appraisal of two technologies (obicetrapib; obicetrapib–ezetimibe); company A. Menarini Farmaceutica Internazionale (SRC-001) evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class Comparator companies include Novartis (inclisiran), Daiichi Sankyo (bempedoic acid) and AstraZeneca UK (rosuvastatin) - confidentiality agreements signed, participating; Amgen (evolocumab), Sanofi (alirocumab) and multiple statin/ezetimibe generic manufacturers - not participating (SRC-001) months since last guideline revision not applicable panel cycle position Committee meeting 1: 04 August 2026; draft guidance 25 August - 16 September 2026; second meeting per the draft guidance 6 October 2026, 50 days before the expected publication date of 25 November 2026 (SRC-001, SRC-003, SRC-005). sponsor request status No company request for more time or pause is recorded in the archived sources. odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change None recorded in the archived sources. Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-06 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development page (Project information tab) for GID-TA11649. Shows 'Expected publication date: 25 November 2026', status 'In progress', 'Process: STA Standard', provisional schedule (expected publication 25 November 2026 only; no second committee meeting listed), comparator companies and the timeline (committee meeting 1 on 04 August 2026; draft guidance 25 August - 16 September 2026). https://www.nice.org.uk/guidance/indevelopment/gid-ta11649 Retrieved 2026-10-01 · sha256 bdeeb6aef610c3a3ae3fecc4d148b1219e85b922c25d4fb0cee09fcfcf5070cd SRC-002 NICE Project documents tab for GID-TA11649. Latest documents: draft guidance, committee papers and public committee slides 'Published: 25 August 2026'; register of interests 'Published: 14 September 2026'. https://www.nice.org.uk/guidance/indevelopment/gid-ta11649/documents Retrieved 2026-10-01 · sha256 e5e996bc0e57c8f29f3b0ce232c1e49f90b43b38d6700cc1eceb42421e4ee89f SRC-003 Draft guidance consultation PDF (issue date August 2026). Recommendation 1.1 (should not be used), key dates (closing date for comments 16 September 2026; second evaluation committee meeting 6 October 2026) and 'This topic was considered by committee C.' https://www.nice.org.uk/guidance/gid-ta11649/documents/draft-guidance Retrieved 2026-10-01 · sha256 d915919423fbfef42c4e6446b77e36d22eef73679b7a44099c7b2e787ec9f1b7 SRC-004 Confirmed minutes of NICE Technology Appraisal Committee C, Tuesday 4 August 2026 (Word). Records the appraisal of obicetrapib and obicetrapib–ezetimibe [ID6519] with company A. Menarini Farmaceutica Internazionale and a discussion of the evidence. https://a.storyblok.com/f/243782/x/34d635e9e9/confirmed-tac-c-minutes-4-august-2026.docx Retrieved 2026-10-01 · sha256 0d2e5513db08e360bbf0ea1412a113d50029872a08a03042090bb100b670288d SRC-005 NICE Technology appraisal committees page. Lists next meeting dates including Committee C 'Tuesday 06 October 2026', 'Tuesday 03 November 2026' and 'Tuesday 01 December 2026'. https://www.nice.org.uk/get-involved/our-committees/nice-committee-meetings/technology-appraisal-committees Retrieved 2026-10-01 · sha256 8e6f62cd7fdf5be519f696bbeb8813e845b461e04dc894f32f2c57c49246c2a8 --- # 35% forecast: NICE publishes technology appraisal guidance on Polihexanide 0.8 mg/ml eye drops for treating acanthamoeba keratitis in people 12 years and over [ID6497] on or before 2026-11-25 URL: https://nextconsensus.com/forecast/ff-029/ Registered forecast 35% registered probability event by 2026-11-25 Unresolved ## NICE publishes technology appraisal guidance on Polihexanide 0.8 mg/ml eye drops for treating acanthamoeba keratitis in people 12 years and over [ID6497] on or before 2026-11-25 FF-029 Registered · Unresolved Registered probability 35% Event by 2026-11-25 Resolution window 2026-10-07 → 2026-11-25 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 55% - Analyst proxy 35% nextconsensus.com/forecast/ff-029/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-06. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Polihexanide 0.8 mg/ml eye drops for treating acanthamoeba keratitis in people 12 years and over' [ID6497], with a publication date on or before 2026-11-25, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11643) on 2026-10-01. Authority National Institute for Health and Care Excellence (NICE), Highly Specialised Technologies Evaluation Committee, appraising under the technology appraisal process (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope Acanthamoeba keratitis in people 12 years and over The estimate ### The number and the baselines it has to beat 35% probability, method v0.1.0 · frozen at the 2026-10-06 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-029 · registered 35% Authority base rate −15 pts 50% Calendar cycle −20 pts 55% Analyst proxy 0 pts 35% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown at the cutoff is not yet counted; the calendar's census will count it. Expected dates are revised often, most when a committee meeting does not reach a final recommendation or a company asks for time. Calendar cycle 55% A clock-only model: a second committee meeting 125 days before the expected date is treated as on schedule: the model assumes final draft guidance and an appeal period fit in that time. Analyst proxy 35% An analyst reading the project page on 2026-10-01 would note negative draft guidance and no final draft guidance 70 days after the second meeting, and would read the silence as a sign the schedule has slipped. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-06 Registered 2026-10-06 Window opens 2026-10-07 Deadline 2026-11-25 Evidence cutoff 2026-10-06 Registered 2026-10-06 Window opens 2026-10-07 Deadline 2026-11-25 Evidence cutoff 2026-10-06 Nothing after this date informed the estimate. Registered 2026-10-06 Frozen and hashed. Resolution window 2026-10-07 → 2026-11-25 When the outcome can be read against the rule. Event by 2026-11-25 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 6743177dc95da81113b18db16a14f1716ec4a7783c26571d1e8e3498debb1daa · operator record jc-1791309829118-41c6f966 ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID6497 shows a publication date ('Published: ') on or before 2026-11-25, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6497. Searching for GID-TA11643 finds the same project. Resolves NO if the guidance is published after 2026-11-25, if the expected date is revised and nothing is published by 2026-11-25, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-12-02. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11643, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 35% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-06. review pathway STA process considered by the highly specialised technologies evaluation committee (SRC-001, SRC-003, SRC-005) submission type New appraisal; company SIFI S.p.a. (SRC-001) evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class Comparator company: Thorton & Ross Ltd (propamidine) - confidentiality agreement not signed, not participating (SRC-001) months since last guideline revision not applicable panel cycle position Committee meeting 1: 22 January 2026; draft guidance 13 February - 06 March 2026; committee meeting 2: 23 July 2026, 125 days before the expected publication date of 25 November 2026; no FDG by 01 October 2026 (SRC-001, SRC-002). sponsor request status No company request for more time or pause is recorded in the archived sources. odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change None recorded in the archived sources. Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-06 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development page (Project information tab) for GID-TA11643. Shows 'Expected publication date: 25 November 2026', status 'In progress', 'Process: STA Standard', provisional schedule (expected publication 25 November 2026 only), comparator company and the timeline (committee meeting 1 on 22 January 2026; draft guidance 13 February - 06 March 2026; 22 May 2026 note scheduling the next meeting for 23 July 2026; committee meeting 2 on 23 July 2026). https://www.nice.org.uk/guidance/indevelopment/gid-ta11643 Retrieved 2026-10-01 · sha256 dda18f0ab4858ed0f2dd3f496f2de67fa513a9b99dd85fe8f376961c519e15a1 SRC-002 NICE Project documents tab for GID-TA11643. Latest document: register of interests 'Published: 03 August 2026'; draft guidance 'Published: 13 February 2026'; no final draft guidance listed at retrieval. https://www.nice.org.uk/guidance/indevelopment/gid-ta11643/documents Retrieved 2026-10-01 · sha256 64d8c5d852ea622d6fce14b399448a85ef2d38909f71638c23241f44b25775c9 SRC-003 Draft guidance consultation PDF (issue date February 2026). Recommendation 1.1 (should not be used), key dates (closing date for comments 06 March 2026; second evaluation committee meeting 'To be confirmed') and that the highly specialised technologies evaluation committee is the evaluating committee. https://www.nice.org.uk/guidance/gid-ta11643/documents/draft-guidance Retrieved 2026-10-01 · sha256 14d9fa19d8cf526e8dd63dd1a89ed9aa7996340f0ab11336d725b6c1e46db870 SRC-004 NICE note page (Project documents) for GID-TA11643 (undated): 'The appraisal committee meeting will now take place on 22 January 2026.' https://www.nice.org.uk/guidance/gid-ta11643/documents/html-content-4 Retrieved 2026-10-01 · sha256 4882d32ff27c28925c823ef651ad030e6992e9c879648a28b04eb24ac3ea3d10 SRC-005 Confirmed minutes of the NICE Highly Specialised Technologies Evaluation Committee, Thursday 22 January 2026 (Word). Records the appraisal of polihexanide eye drops [ID6497] with company SIFI SpA and a discussion of the evidence. https://a.storyblok.com/f/243782/x/34f29aa918/confirmed-minutes-hstec-22-january-2026.docx Retrieved 2026-10-01 · sha256 4b6536be4f49020253d8efa69230ab1ea1b941e59f864261262dd208ee3567c9 SRC-006 NICE Highly specialised technologies evaluation committee page. Lists next meeting dates (22 October, 19 November, 17 December 2026) and published minutes; the most recent 2026 minutes listed are for 21 May 2026 (none yet for 23 July 2026). https://www.nice.org.uk/get-involved/our-committees/nice-committee-meetings/highly-specialised-technologies-evaluation-committee Retrieved 2026-10-01 · sha256 34bbf46ef3258a8c0e30dc6dca8a9ec72f63b0bf7bebe267338fc66ec691d7ff --- # 75% forecast: FDA approves anitocabtagene autoleucel (anito-cel) for relapsed or refractory multiple myeloma after 3 or more lines on or before the disclosed PDUFA goal date of 2026-12-23 URL: https://nextconsensus.com/forecast/ff-030/ Registered forecast 75% registered probability event by 2026-12-23 Unresolved ## FDA approves anitocabtagene autoleucel (anito-cel) for relapsed or refractory multiple myeloma after 3 or more lines on or before the disclosed PDUFA goal date of 2026-12-23 FF-030 Registered · Unresolved Registered probability 75% Event by 2026-12-23 Resolution window 2026-10-16 → 2026-12-23 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 70% - Calendar cycle 65% - Analyst proxy 75% nextconsensus.com/forecast/ff-030/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on the Biologics License Application for anitocabtagene autoleucel (anito-cel; applicant Arcellx, a Gilead Sciences subsidiary since April 2026) for the treatment of patients with relapsed or refractory multiple myeloma in the fourth line or later, with an approval action date on or before 2026-12-23, the PDUFA target action date disclosed in Gilead Sciences' Form 10-Q filed 2026-08-06. Authority US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope Relapsed or refractory multiple myeloma after 3 or more lines The estimate ### The number and the baselines it has to beat 75% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-030 · registered 75% Authority base rate +5 pts 70% Calendar cycle +10 pts 65% Analyst proxy 0 pts 75% Authority base rate 70% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Applications resting on uncontrolled or early-phase trials, or on surrogate endpoints, often under accelerated approval, meet their first goal date less often than those built on completed randomized trials. The calendar's own count does not exist yet. Calendar cycle 65% A clock-only model: the goal date is inside the window and FDA meets most goal dates, but first-cycle approval is less common on uncontrolled, early-phase or surrogate evidence. Analyst proxy 75% A hematology analyst reading the same filings on 2026-10-01 would weigh single-arm response data on a primary endpoint agreed with FDA (SRC-003), two BCMA CAR-T therapies already on CBER's approved list (SRC-005), and Kite as manufacturing and commercial partner, against a pre-approval inspection and a change of control during review. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2026-12-23 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2026-12-23 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2026-12-23 When the outcome can be read against the rule. Event by 2026-12-23 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 9f476a053fbff5ae6708d1471fa3d3dedd96b3a9a3e75f53b0d346ae088a458b · operator record jc-1792036247345-3b14af2b ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Anitocabtagene autoleucel is a CBER-regulated biologic, so openFDA's drugsfda endpoint does not list it. Resolves YES if FDA's Purple Book (https://purplebooksearch.fda.gov/) lists a licensed biological product that is anitocabtagene autoleucel (anito-cel) under any proprietary or proper name, with Arcellx, Kite or another Gilead Sciences subsidiary as licensee and an approval (license) date on or before 2026-12-23, and the CBER approval letter for that BLA names relapsed or refractory multiple myeloma in the indication. An approval after a different number of prior lines than the applicant sought, or for a narrower relapsed or refractory multiple myeloma population, still resolves YES. Resolves NO if no approval action is dated on or before 2026-12-23: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-12-23 resolves NO as occurred_after_deadline. Read no earlier than 2027-01-06. If the Purple Book has not updated by then, the CBER approval letter or FDA's list of approved products (https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products) governs. Resolves unresolvable only if none of these can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://purplebooksearch.fda.gov/, https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 75% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15. review pathway Not stated in the archived sources. BLA submitted December 23, 2025 with an anticipated PDUFA date of December 23, 2026 (SRC-003); a 12-month timeline is consistent with a standard review (drafter's understanding, unverified). CBER center is the drafter's understanding for an autologous CAR-T product, unverified. submission type Original BLA (SRC-003). evidence class Single-arm pivotal Phase 2 iMMagine-1 in fourth-line-or-later rrMM, supported by a Phase 1 study (SRC-003, SRC-004). pivotal n iMMagine-1: 117 patients (ORR 96%, CR/sCR 74% as reported by Arcellx) (SRC-003). endpoint type Overall response rate, the primary endpoint of the single-arm iMMagine-1 trial, selected on CAR-T precedent and agreed with FDA (SRC-003); key secondary endpoints sCR/CR rate and duration of response (SRC-003). approved competitors in class Two FDA-approved BCMA-targeted CAR-T therapies: Abecma (idecabtagene vicleucel) and Carvykti (ciltacabtagene autoleucel) (SRC-003; both listed on the CBER approved products page, SRC-005). months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status BLA submitted December 23, 2025; FDA accepted it February 20, 2026 (SRC-003). odac referral none announced in the archived sources sponsor state change Gilead closed its acquisition of Arcellx in April 2026 (~$6.4 billion); Arcellx became a wholly-owned subsidiary (SRC-001). Gilead's Kite was already the co-development/co-commercialization partner (SRC-003). Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Gilead Sciences Form 10-Q for the quarter ended 2026-06-30, filed 2026-08-06 (latest filing stating the date). States the anito-cel BLA in 4L+ R/R MM was accepted with a PDUFA target action date of December 23, 2026, and that Gilead closed its acquisition of Arcellx in April 2026. https://www.sec.gov/Archives/edgar/data/882095/000088209526000031/gild-20260630.htm Retrieved 2026-10-01 · sha256 d5966689c4b6acc58b939e92e2dc798c9148549b34baf98187eb8c9c8d4a43f0 SRC-002 Gilead Form 8-K Exhibit 99.1 (Q1 2026 results), filed 2026-05-07. States the anito-cel BLA in 4L+ R/R MM was accepted with PDUFA target action date December 23, 2026. https://www.sec.gov/Archives/edgar/data/882095/000088209526000022/exhibit991earningspressrel.htm Retrieved 2026-10-01 · sha256 cdf7415bb9a4521d8daa239c680b967f0c495867c467d6e3873afa4ce4d71afc SRC-003 Arcellx Form 10-K for fiscal 2025, filed 2026-02-26. States BLA submitted December 23, 2025, accepted February 20, 2026 with anticipated PDUFA action date December 23, 2026; Fast Track, Orphan Drug and RMAT designations; iMMagine-1 data (117 patients); approved BCMA CAR-Ts Abecma and Carvykti. https://www.sec.gov/Archives/edgar/data/1786205/000119312526076876/aclx-20251231.htm Retrieved 2026-10-01 · sha256 c7a117052af78a2c234af4e0c075f5b7843e6de5edd9d217c1de42671026e57f SRC-004 Arcellx Form 8-K Exhibit 99.1 (merger announcement with Gilead), filed 2026-02-23. States the anito-cel BLA has been accepted with an anticipated PDUFA action date of December 23, 2026. https://www.sec.gov/Archives/edgar/data/1786205/000119312526063955/d112937dex991.htm Retrieved 2026-10-01 · sha256 a612e92e312f8559d724fe1dab98128aa134573a04f9bc5aaa9d439af685bc86 SRC-005 FDA CBER "Approved Cellular and Gene Therapy Products" web page, retrieved 2026-10-01 (content current as of 09/17/2026). Lists ABECMA and CARVYKTI; does not list anitocabtagene autoleucel. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products Retrieved 2026-10-01 · sha256 23a506795a2d33ea05b428430abf4cff39e49fa3dfc4818297ff4e1dc5a88ed0 SRC-006 openFDA drugsfda products.active_ingredients.name:"ANITOCABTAGENE AUTOLEUCEL", retrieved 2026-10-01: 404 No matches found (openFDA drugsfda does not cover CBER products; included for completeness). https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22ANITOCABTAGENE%20AUTOLEUCEL%22&limit=100 Retrieved 2026-10-01 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da --- # 80% forecast: FDA approves bezuclastinib for nonadvanced systemic mastocytosis on or before the disclosed PDUFA goal date of 2026-12-30 URL: https://nextconsensus.com/forecast/ff-031/ Registered forecast 80% registered probability event by 2026-12-30 Unresolved ## FDA approves bezuclastinib for nonadvanced systemic mastocytosis on or before the disclosed PDUFA goal date of 2026-12-30 FF-031 Registered · Unresolved Registered probability 80% Event by 2026-12-30 Resolution window 2026-10-16 → 2026-12-30 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 85% - Calendar cycle 80% - Analyst proxy 80% nextconsensus.com/forecast/ff-031/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on Cogent Biosciences' New Drug Application for bezuclastinib for the treatment of patients with nonadvanced systemic mastocytosis, with an approval action date on or before 2026-12-30, the PDUFA date disclosed in Exhibit 99.1 to Cogent Biosciences' Form 8-K filed 2026-08-10. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope Nonadvanced systemic mastocytosis The estimate ### The number and the baselines it has to beat 80% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-031 · registered 80% Authority base rate −5 pts 85% Calendar cycle 0 pts 80% Analyst proxy 0 pts 80% Authority base rate 85% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Applications built on positive randomized controlled trials are approved at their first goal date in a large majority of cases. The calendar's own met-goal-date share for disclosed PDUFA dates does not exist yet. Calendar cycle 80% A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle actions on applications like this are approvals. With no evidence input it cannot tell a strong application from a weak one. Analyst proxy 80% A hematology analyst reading the same filings on 2026-10-01 would weigh a placebo-controlled registration-directed trial that met its symptom endpoint and Breakthrough designation in patients previously treated with avapritinib (SRC-004), against liver-enzyme elevations reported in SUMMIT (SRC-005). Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2026-12-30 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2026-12-30 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2026-12-30 When the outcome can be read against the rule. Event by 2026-12-30 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger ee048aedc9382c734fe3af3f5a44247c1270bba9983104a3991026af98262a61 · operator record jc-1792036247689-1020905b ### Around this record Bezuclastinib - FF-023 · Bezuclastinib · GIST approval event by 2026-11-30 This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Cogent has separate bezuclastinib applications for gastrointestinal stromal tumour, with an earlier goal date (SRC-001), and for advanced systemic mastocytosis (SRC-002), so this approval is identified by its indication, not by being the first bezuclastinib approval; an approval only for GIST or advanced systemic mastocytosis does not count. Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22bezuclastinib%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22BEZUCLASTINIB%22&limit=100, read together (openFDA does not always fill the generic-name field for a second application), contain a submission, original or supplement, with submission_status AP and a submission_status_date on or before 2026-12-30, and the Drugs@FDA approval letter or label for that submission names nonadvanced systemic mastocytosis (or indolent or smoldering systemic mastocytosis) in its indication. An approval for indolent systemic mastocytosis only, or another narrower nonadvanced population, still resolves YES. Resolves NO if no approval action is dated on or before 2026-12-30: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-12-30 resolves NO as occurred_after_deadline. Read no earlier than 2027-01-13. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name bezuclastinib) governs. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22bezuclastinib%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22BEZUCLASTINIB%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 80% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15. review pathway Not stated for the NonAdvSM NDA in the archived sources (the separate GIST NDA is stated to be under Priority Review/RTOR, SRC-002). Submitted December 2025 with PDUFA December 30, 2026 (SRC-002): a ~12-month timeline is consistent with a standard review of a new molecular entity (drafter's understanding, unverified). submission type Original NDA (SRC-002). evidence class Registration-directed randomized, double-blind, placebo-controlled Phase 2 SUMMIT (Part 2) (SRC-002, SRC-005). pivotal n SUMMIT Part 2: 118 bezuclastinib + 60 placebo (SRC-005). endpoint type Patient-reported symptom score: mean change in total symptom score (TSS, Mastocytosis Symptom Severity Daily Diary) at 24 weeks (SRC-005). approved competitors in class Blueprint Medicines' (a Sanofi company) avapritinib is approved for Non-AdvSM; avapritinib and midostaurin approved for AdvSM (SRC-004). months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status NDA for NonAdvSM submitted December 2025, accepted March 2026 (SRC-002). odac referral none announced in the archived sources sponsor state change None reported. Cogent signed a commercial supply agreement with Hovione for bezuclastinib on September 1, 2026 (SRC-006). Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Cogent Form 8-K Exhibit 99.1 (Q2 2026 results), filed 2026-08-10. Lists "Potential FDA approval of bezuclastinib in NonAdvSM – PDUFA date of December 30, 2026" and GIST PDUFA November 30, 2026. https://www.sec.gov/Archives/edgar/data/1622229/000119312526341315/cogt-ex99_1.htm Retrieved 2026-10-01 · sha256 b6f61d423831a083e76308a4f061f380cdee7726161949ca0c217bde11ad9882 SRC-002 Cogent Form 10-Q for the quarter ended 2026-06-30, filed 2026-08-10. States the first NDA (NonAdvSM) was submitted December 2025, accepted March 2026, PDUFA December 30, 2026; AdvSM NDA submitted June 2026; GIST NDA accepted with Priority Review (PDUFA November 30, 2026); BTD (October 2025) and orphan designation. https://www.sec.gov/Archives/edgar/data/1622229/000119312526342393/cogt-20260630.htm Retrieved 2026-10-01 · sha256 0cad67b994f18f1f4566e7b6e9d299584e8d127f092019c3a8c60d2b470bc2d3 SRC-003 Cogent Form 8-K Exhibit 99.1 (Q1 2026 results), filed 2026-05-05. Announces FDA accepted the NonAdvSM NDA and assigned a PDUFA target action date of December 30, 2026. https://www.sec.gov/Archives/edgar/data/1622229/000119312526205124/cogt-ex99_1.htm Retrieved 2026-10-01 · sha256 67bb286415005a1720e57425501848cc6a0fcc6de307400c4448401a34ada393 SRC-004 Cogent Form 10-K for fiscal 2025, filed 2026-02-17. Competition section: avapritinib approved for Non-AdvSM; avapritinib/midostaurin/imatinib approved for AdvSM; BTD and orphan designations. https://www.sec.gov/Archives/edgar/data/1622229/000119312526053334/cogt-20251231.htm Retrieved 2026-10-01 · sha256 78ed5cf0bec467c81bf95732c9a5e56c9b93342647e6e2248705f2227fde0073 SRC-005 Cogent Form 8-K, filed 2025-12-08. Full SUMMIT Part 2 results: 118 bezuclastinib vs 60 placebo; TSS primary endpoint at 24 weeks met (p<0.001); safety including ALT/AST elevations. https://www.sec.gov/Archives/edgar/data/1622229/000119312525311217/d81277d8k.htm Retrieved 2026-10-01 · sha256 8b3f107f13d33cbca316d36d733c5293b06f56e326970285df2f363e6a386e4b SRC-006 Cogent Form 8-K (Item 1.01), filed 2026-09-02 (latest Cogent filing before cutoff). Commercial Supply Agreement with Hovione for bezuclastinib dated September 1, 2026; no change to review status. https://www.sec.gov/Archives/edgar/data/1622229/000119312526380194/d184156d8k.htm Retrieved 2026-10-01 · sha256 bfd0128cf4afa7c90d9da1327efcc6a68571fff2e6fdbe9b1fde8070ca4e15c0 SRC-007 openFDA drugsfda products.active_ingredients.name:"BEZUCLASTINIB", retrieved 2026-10-01: 404 No matches found. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22BEZUCLASTINIB%22&limit=100 Retrieved 2026-10-01 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da SRC-008 openFDA drugsfda openfda.generic_name:"bezuclastinib", retrieved 2026-10-01: 404 No matches found. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22bezuclastinib%22&limit=100 Retrieved 2026-10-01 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da --- # 70% forecast: FDA approves imsidolimab for generalized pustular psoriasis on or before the disclosed PDUFA goal date of 2026-12-12 URL: https://nextconsensus.com/forecast/ff-032/ Registered forecast 70% registered probability event by 2026-12-12 Unresolved ## FDA approves imsidolimab for generalized pustular psoriasis on or before the disclosed PDUFA goal date of 2026-12-12 FF-032 Registered · Unresolved Registered probability 70% Event by 2026-12-12 Resolution window 2026-10-16 → 2026-12-12 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 85% - Calendar cycle 80% - Analyst proxy 70% nextconsensus.com/forecast/ff-032/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on Vanda Pharmaceuticals' Biologics License Application for imsidolimab (proposed name Quimilza) for the treatment of generalized pustular psoriasis, with an approval action date on or before 2026-12-12, the target action date disclosed in AnaptysBio's Form 10-KT filed 2026-09-21. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope Generalized pustular psoriasis The estimate ### The number and the baselines it has to beat 70% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-032 · registered 70% Authority base rate −15 pts 85% Calendar cycle −10 pts 80% Analyst proxy 0 pts 70% Authority base rate 85% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Applications built on positive randomized controlled trials are approved at their first goal date in a large majority of cases. The calendar's own met-goal-date share for disclosed PDUFA dates does not exist yet. Calendar cycle 80% A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle actions on applications like this are approvals. With no evidence input it cannot tell a strong application from a weak one. Analyst proxy 70% A dermatology analyst reading the same filings on 2026-10-01 would weigh a positive randomized phase 3 in a rare disease with an approved competitor (SRC-004), against a pivotal dataset of 45 patients and a maintenance study of 16. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2026-12-12 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2026-12-12 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2026-12-12 When the outcome can be read against the rule. Event by 2026-12-12 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 41c59f846806fdd51750606007d7d5861960bd532e5b23f07b3ba897880a15b7 · operator record jc-1792036248042-45adc42c ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22imsidolimab%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22IMSIDOLIMAB%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-12-12, and the Drugs@FDA approval letter or label for that application names generalized pustular psoriasis in its indication, with Vanda or a Vanda subsidiary as applicant. An approval for a narrower generalized pustular psoriasis population than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2026-12-12: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-12-12 resolves NO as occurred_after_deadline. 2026-12-12 is a Saturday; an approval action dated that day still counts. Read no earlier than 2026-12-26. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name imsidolimab) governs. If neither lists the product, FDA's Purple Book (https://purplebooksearch.fda.gov/, searched by imsidolimab) governs for the licensure date, with the approval letter for the indication. The application number was not public at the cutoff, so the rule reads by name; a suffix on the nonproprietary name or a proprietary name does not change the identification. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22imsidolimab%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22IMSIDOLIMAB%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/, https://purplebooksearch.fda.gov/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 70% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15, including the one field whose value was unknown then. It is left unknown rather than filled in. review pathway unknown — not stated in the archived sources (BLA submitted December 2025 with a December 12, 2026 target date, consistent with a standard review — drafter's understanding from dates, unverified); FDA Orphan Drug Designation for GPP (SRC-004) submission type original BLA (SRC-001) evidence class two Phase 3 trials: GEMINI-1 (randomized, placebo-controlled, single IV dose) and GEMINI-2 (randomized maintenance in GEMINI-1 responders) (SRC-004) pivotal n GEMINI-1: 45 patients; GEMINI-2: 16 GEMINI-1 responders re-randomized (SRC-004) endpoint type GEMINI-1 primary endpoint: GPPPGA 0/1 (clear or almost clear) at Week 4 — 53% (750 mg IV) vs 13% placebo, p=0.0131 (SRC-004) approved competitors in class SPEVIGO (spesolimab, Boehringer Ingelheim), an anti-IL-36 receptor antibody approved for GPP (SRC-004; openFDA BLA761244 ORIG-1 approved 2022-09-01, SRC-006) months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status BLA submitted December 2025; accepted February 2026 (SRC-001) odac referral none announced in the archived sources sponsor state change AnaptysBio licensed global rights to Vanda on January 31, 2025 and now manages its Jemperli and Quimilza royalties as a virtual company (SRC-001) Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 AnaptysBio, Inc. Form 10-KT (transition report for the period ended June 30, 2026), filed 2026-09-21 (latest filing found that states the date). States that Vanda submitted a BLA for Quimilza (formerly imsidolimab) in GPP in December 2025 and that FDA accepted it in February 2026 with a target action date of December 12, 2026; describes the January 31, 2025 license to Vanda. https://www.sec.gov/Archives/edgar/data/1370053/000119312526396696/anab-20260630.htm Retrieved 2026-10-01 · sha256 c08410809e565bf4f02fb654a0af52cf6e91c96ee0a90e2f07c5aaef0da89224 SRC-002 Vanda Pharmaceuticals Inc. Form 10-Q for the quarter ended June 30, 2026, filed 2026-08-06 (latest Vanda filing before cutoff). States the BLA for Quimilza in GPP is under FDA review with a PDUFA target action date of December 12, 2026. https://www.sec.gov/Archives/edgar/data/1347178/000162828026053855/vnda-20260630.htm Retrieved 2026-10-01 · sha256 dd893b5e99cc3a6359a98f5b434b6366cef982f0303cee1fd6653eaf956ffec2 SRC-003 Vanda Form 8-K Exhibit 99.1 (Q2 2026 results), filed 2026-08-05. States 'Quimilza TM (imsidolimab) BLA for GPP under review by the FDA; PDUFA target action date of December 12, 2026'. https://www.sec.gov/Archives/edgar/data/1347178/000162828026053308/vnda8-k852026exhibit991.htm Retrieved 2026-10-01 · sha256 5e526a9827d27635e187e0202102cf7d37705edf7067261df3736b8911a5c557 SRC-004 AnaptysBio Form 10-Q for the quarter ended September 30, 2024, filed 2024-11-05. Describes GEMINI-1 (45 patients; primary endpoint GPPPGA 0/1 at Week 4: 53% vs 13% placebo, p=0.0131 at 750 mg IV) and GEMINI-2 (16 responders re-randomized), FDA Orphan Drug Designation (July 2020), and names SPEVIGO (spesolimab) as an approved anti-IL-36 receptor competitor for GPP. https://www.sec.gov/Archives/edgar/data/1370053/000137005324000054/anab-20240930.htm Retrieved 2026-10-01 · sha256 962b9b00702d17965082a84dc139ee3a460fe07cde55eb2b7d8f94048ed02963 SRC-005 openFDA drugsfda API response for generic name 'imsidolimab', retrieved 2026-10-01: 404 NOT_FOUND 'No matches found!'. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22imsidolimab%22 Retrieved 2026-10-01 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da SRC-006 openFDA drugsfda API response for generic name 'spesolimab', retrieved 2026-10-01 (meta last_updated 2026-09-29): BLA761244, SPEVIGO, sponsor BOEHRINGER INGELHEIM PHARMACEUTICALS INC, ORIG-1 approved 2022-09-01, with later efficacy supplements approved 2024-03-18 and 2025-05-28. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22spesolimab%22 Retrieved 2026-10-01 · sha256 31fc75f0c56c7c2f1db4defa203a63d42298e945e9de6d8728d911bee8b024d1 --- # 82% forecast: FDA approves lorundrostat for hypertension on or before the disclosed PDUFA goal date of 2026-12-22 URL: https://nextconsensus.com/forecast/ff-033/ Registered forecast 82% registered probability event by 2026-12-22 Unresolved ## FDA approves lorundrostat for hypertension on or before the disclosed PDUFA goal date of 2026-12-22 FF-033 Registered · Unresolved Registered probability 82% Event by 2026-12-22 Resolution window 2026-10-16 → 2026-12-22 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 85% - Calendar cycle 80% - Analyst proxy 85% nextconsensus.com/forecast/ff-033/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on Mineralys Therapeutics' New Drug Application for lorundrostat for the treatment of adults with hypertension in combination with other antihypertensive drugs, with an approval action date on or before 2026-12-22, the PDUFA target date disclosed in Exhibit 99.1 to Mineralys Therapeutics' Form 8-K filed 2026-08-11. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope Hypertension, in combination with other antihypertensive drugs The estimate ### The number and the baselines it has to beat 82% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-033 · registered 82% Authority base rate −3 pts 85% Calendar cycle +2 pts 80% Analyst proxy −3 pts 85% Authority base rate 85% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Applications built on positive randomized controlled trials are approved at their first goal date in a large majority of cases. The calendar's own met-goal-date share for disclosed PDUFA dates does not exist yet. Calendar cycle 80% A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle actions on applications like this are approvals. With no evidence input it cannot tell a strong application from a weak one. Analyst proxy 85% A cardiovascular analyst reading the same filings on 2026-10-01 would weigh two positive placebo-controlled pivotal trials on blood pressure, no advisory committee anticipated, and FDA's approval in May 2026 of baxdrostat (BAXFENDY), an aldosterone synthase inhibitor with the same indication (SRC-007, SRC-008), against a first NDA from a company without a commercial product, and would call approval by the goal date likely. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2026-12-22 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2026-12-22 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2026-12-22 When the outcome can be read against the rule. Event by 2026-12-22 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 44b1dd75f68f58f6cbca5c7e8c96d7e47592152e153061faf20a6a112851d076 · operator record jc-1792036248384-a2c3e7b3 ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22lorundrostat%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22LORUNDROSTAT%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-12-22, and the Drugs@FDA approval letter or label for that application names hypertension in its indication. An approval for a narrower hypertension population than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2026-12-22: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-12-22 resolves NO as occurred_after_deadline. Read no earlier than 2027-01-05. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name lorundrostat) governs. The application number was not public at the cutoff, so the rule reads by name; a suffix on the nonproprietary name or a proprietary name does not change the identification. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22lorundrostat%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22LORUNDROSTAT%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 82% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15. review pathway Not stated in the archived sources. NDA submitted December 2025 with a PDUFA date of December 22, 2026 (SRC-004); a ~12-month timeline is consistent with a standard review of a new molecular entity (drafter's understanding, unverified). Center CDER is the drafter's understanding, unverified. submission type Original NDA (SRC-004). evidence class Two pivotal randomized, double-blind, placebo-controlled trials: Phase 3 Launch-HTN and Phase 2 Advance-HTN, plus Phase 2 Explore-CKD and Explore-OSA (SRC-003, SRC-002). pivotal n Launch-HTN n=1,083 randomized; Advance-HTN n=285 randomized (SRC-003). endpoint type Blood pressure (surrogate): Launch-HTN primary endpoint = change in automated office systolic BP vs placebo at week 6; Advance-HTN primary endpoint = change in 24-hour ambulatory systolic BP at week 12 (SRC-003). approved competitors in class BAXFENDY (baxdrostat; AstraZeneca), NDA219878, ORIG 1 approved 2026-05-15 (SRC-007), an aldosterone synthase inhibitor indicated, in combination with other antihypertensive drugs, for hypertension in adults not adequately controlled on other agents (SRC-008). The 10-K names competing programmes without naming it (SRC-003). months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status NDA submitted December 2025; FDA acceptance announced March 9, 2026 (SRC-002, SRC-004). odac referral Stated not anticipated: 10-Q lists "supporting a potential advisory committee meeting (not anticipated currently)" (SRC-004). sponsor state change None reported; Chief Medical Officer succession effective August 10, 2026 (SRC-001). Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Mineralys Form 8-K Exhibit 99.1 (Q2 2026 results), filed 2026-08-11. States FDA continues its review of the lorundrostat NDA with a PDUFA target date of December 22, 2026; CMO succession. https://www.sec.gov/Archives/edgar/data/1933414/000193341426000112/mlys2026q28kex991.htm Retrieved 2026-10-01 · sha256 a9d23afc19a185fc9fee98c2553985999bcc31e5b36afe1e4bf6cc0b1fc8b940 SRC-002 Mineralys Form 8-K Exhibit 99.1, filed 2026-03-09. Announces FDA acceptance of the lorundrostat NDA (hypertension, in combination with other antihypertensive drugs) with a PDUFA target action date of December 22, 2026; Explore-OSA topline results. https://www.sec.gov/Archives/edgar/data/1933414/000193341426000048/mlys202603068kex991.htm Retrieved 2026-10-01 · sha256 a1d57f438f7a72454cee4af4f70f0d43e3021af261f33e4af3c0ddde222c0e92 SRC-003 Mineralys Form 10-K for fiscal 2025, filed 2026-03-12. Describes Launch-HTN (n=1,083) and Advance-HTN (n=285) designs, primary endpoints and results; competition section. https://www.sec.gov/Archives/edgar/data/1933414/000193341426000056/mlys-20251231.htm Retrieved 2026-10-01 · sha256 10b8bf4d6ebd2944543ec31222fd4633d3049b85db14bd341ba77108dc07f599 SRC-004 Mineralys Form 10-Q for the quarter ended 2026-06-30, filed 2026-08-11. States the NDA was submitted December 2025 and assigned a PDUFA target date of December 22, 2026; lists "a potential advisory committee meeting (not anticipated currently)". https://www.sec.gov/Archives/edgar/data/1933414/000193341426000114/mlys-20260630.htm Retrieved 2026-10-01 · sha256 d94e031862d483f46248759c2ce9e9c625c128f77767d764a03e84f6a4e063d4 SRC-005 openFDA drugsfda products.active_ingredients.name:"LORUNDROSTAT", retrieved 2026-10-01: 404 No matches found. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22LORUNDROSTAT%22&limit=100 Retrieved 2026-10-01 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da SRC-006 openFDA drugsfda openfda.generic_name:"lorundrostat", retrieved 2026-10-01: 404 No matches found. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22lorundrostat%22&limit=100 Retrieved 2026-10-01 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da SRC-007 openFDA Drugs@FDA record for BAXFENDY (baxdrostat), NDA219878, AstraZeneca, retrieved at the cutoff: ORIG 1 approved 2026-05-15. The record has no openfda generic-name block. https://api.fda.gov/drug/drugsfda.json?search=products.brand_name:%22BAXFENDY%22&limit=100 Retrieved 2026-10-01 · sha256 60e948a396f6822ae182dd1bc641ef95d72b55979518ac31e2b85b5cd4371f69 SRC-008 openFDA drug label record for baxdrostat (BAXFENDY), retrieved at the cutoff: 'BAXFENDY is an aldosterone synthase inhibitor indicated for the treatment of hypertension in combination with other antihypertensive drugs'. https://api.fda.gov/drug/label.json?search=baxdrostat Retrieved 2026-10-01 · sha256 4740f3a33aa3a819befa11de5d12a3928ec502daa421027f24c3388a5c2ccf60 --- # 45% forecast: FDA approves relacorilant for Cushing's syndrome (resubmission) on or before the disclosed PDUFA goal date of 2026-12-17 URL: https://nextconsensus.com/forecast/ff-034/ Registered forecast 45% registered probability event by 2026-12-17 Unresolved ## FDA approves relacorilant for Cushing's syndrome (resubmission) on or before the disclosed PDUFA goal date of 2026-12-17 FF-034 Registered · Unresolved Registered probability 45% Event by 2026-12-17 Resolution window 2026-10-16 → 2026-12-17 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 60% - Analyst proxy 45% nextconsensus.com/forecast/ff-034/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on Corcept Therapeutics' resubmitted New Drug Application for relacorilant for the treatment of patients with Cushing's syndrome (endogenous hypercortisolism), with an approval action date on or before 2026-12-17, the PDUFA date disclosed in Exhibit 99.1 to Corcept's Form 8-K filed 2026-07-29. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope Cushing's syndrome (endogenous hypercortisolism) The estimate ### The number and the baselines it has to beat 45% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-034 · registered 45% Authority base rate −5 pts 50% Calendar cycle −15 pts 60% Analyst proxy 0 pts 45% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Resubmissions after a complete response letter are approved on the next cycle about as often as not, depending on whether the deficiency was evidence or process. The calendar's own count does not exist yet. Calendar cycle 60% A clock-only model: FDA meets most resubmission goal dates, and a second cycle that answers the letter's request is often approved. Analyst proxy 45% An endocrine-focused analyst reading the same filings on 2026-10-01 would weigh a complete response letter that asked for more evidence of efficacy against a resubmission built on analyses FDA itself requested, and would call the second cycle roughly even. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2026-12-17 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2026-12-17 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2026-12-17 When the outcome can be read against the rule. Event by 2026-12-17 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger fc3ac1610959707a4812d77bb108b55de1f4cd352bd231e60d6d3408aec5ddf8 · operator record jc-1792036248696-ed4247ab ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Relacorilant was already approved for another indication at the cutoff: openFDA lists NDA220641 (LIFYORLI, platinum-resistant ovarian cancer), ORIG 1 approved 2026-03-25 (SRC-005). The Cushing's application is identified by its indication, not by application number. Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22relacorilant%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22RELACORILANT%22&limit=100, read together, contain a submission, original or supplement, with submission_status AP and a submission_status_date on or before 2026-12-17, and the Drugs@FDA approval letter or label for that submission names Cushing's syndrome or endogenous hypercortisolism (including a sign of it such as hyperglycaemia or hypertension secondary to hypercortisolism) in its indication, with Corcept or a Corcept subsidiary as applicant. An approval for a narrower Cushing's syndrome population, or for one manifestation of hypercortisolism, still resolves YES. Resolves NO if no approval action is dated on or before 2026-12-17: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-12-17 resolves NO as occurred_after_deadline. Read no earlier than 2026-12-31. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name relacorilant) governs. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22relacorilant%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22RELACORILANT%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 45% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15. review pathway Resubmission review; Corcept stated it "expects the resubmission to receive a six-month review" (SRC-003). FDA classification (Class 1/Class 2) is not stated in the archived sources. Center CDER is the drafter's understanding (small-molecule NDA), unverified. submission type NDA resubmission after Complete Response Letter (SRC-002, SRC-003); the resubmission "includes additional analyses of data included in the original NDA submission" (SRC-003). evidence class Pivotal Phase 3 GRACE (open-label phase followed by double-blind randomized-withdrawal phase) with confirmatory evidence from Phase 3 GRADIENT, a Phase 3 long-term extension study and a Phase 2 study (SRC-004, SRC-002). CRL stated additional evidence of effectiveness was required (SRC-002). pivotal n GRACE: 152 patients enrolled in the open-label phase (SRC-002); randomized-withdrawal phase size not stated in the archived sources. endpoint type GRACE primary endpoint: number of patients who lost blood pressure control on relacorilant vs placebo in the randomized-withdrawal phase (SRC-002). approved competitors in class Korlym (mifepristone) 300 mg, approved 2012 for hyperglycemia secondary to hypercortisolism in adults with endogenous Cushing’s syndrome with type 2 diabetes or glucose intolerance, and its authorized generic, both sold by Corcept (SRC-002). Other approved Cushing’s therapies are not named in the archived sources. months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status Original NDA submitted December 2024; accepted March 2025 with PDUFA date December 30, 2025 (SRC-004); CRL December 30, 2025; FDA asked for additional analyses in April 2026; NDA resubmitted June 17, 2026 (SRC-002, SRC-003). odac referral none announced in the archived sources sponsor state change None material reported. Corcept is commercial-stage; relacorilant was approved as Lifyorli for platinum-resistant ovarian cancer in March 2026 (SRC-002, SRC-005). The President of Corcept Endocrinology announced his retirement effective October 1, 2026 (SRC-006). Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Corcept Form 8-K Exhibit 99.1 (Q2 2026 results press release), filed 2026-07-29. States the relacorilant NDA for Cushing’s syndrome was resubmitted with a PDUFA date of December 17, 2026 and "We expect a decision on our NDA by December 17, 2026." https://www.sec.gov/Archives/edgar/data/1088856/000162828026050607/cort072926ex991pressrelease.htm Retrieved 2026-10-01 · sha256 b23525a8e915dcddee5776528082a3f112b83082632503f09aaee5ed1c3546ed SRC-002 Corcept Form 10-Q for the quarter ended 2026-06-30, filed 2026-07-29. States the December 30, 2025 CRL and its stated reason, the April 2026 FDA request for additional analyses, resubmission on June 17, 2026, the PDUFA target date of December 17, 2026, the GRACE design/primary endpoint/152 patients, Korlym approval history, and the March 2026 approval of Lifyorli (relacorilant) in ovarian cancer. https://www.sec.gov/Archives/edgar/data/1088856/000162828026050613/cort-20260630.htm Retrieved 2026-10-01 · sha256 0e0f148f001fc1af12e56b2efa89144b012236b07c0cc8138f0838ef761ed1e3 SRC-003 Corcept Form 8-K Exhibit 99.1, filed 2026-06-17. Announces the NDA resubmission for relacorilant in Cushing’s syndrome; resubmission includes additional analyses requested by FDA; Corcept expects a six-month review. https://www.sec.gov/Archives/edgar/data/1088856/000119312526274258/d159941dex991.htm Retrieved 2026-10-01 · sha256 458cb058dad40d993aa24ddf376f4ed50e70b5866ec41cbcd4d1eac046d48f60 SRC-004 Corcept Form 10-Q for the quarter ended 2025-09-30, filed 2025-11-04. States the original NDA for relacorilant in endogenous hypercortisolism was submitted in December 2024 and accepted in March 2025 with a PDUFA date of December 30, 2025, based on GRACE with confirmatory evidence from GRADIENT, a long-term extension study and a Phase 2 study. https://www.sec.gov/Archives/edgar/data/1088856/000162828025048841/cort-20250930.htm Retrieved 2026-10-01 · sha256 e46aac8a8d2f49eaa395a3d2666f8e46c78003b87c7f5e1598675cbc69cbe556 SRC-005 openFDA drugsfda query products.active_ingredients.name:"RELACORILANT", retrieved 2026-10-01 (meta last_updated 2026-09-29). Returns only NDA220641 LIFYORLI (COPACKAGED), ORIG-1 approved 2026-03-25; no Cushing’s approval. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22RELACORILANT%22&limit=100 Retrieved 2026-10-01 · sha256 8afded2d8ef93de7836d9593ea446fdcdb1e8cee3c029d8f956d239369e502f2 SRC-006 Corcept Form 8-K Exhibit 99.1, filed 2026-09-23 (latest Corcept filing before cutoff). Announces retirement of the President of Corcept Endocrinology and appointment of a successor effective October 1; contains no change to the relacorilant review. https://www.sec.gov/Archives/edgar/data/1088856/000119312526398561/d148256dex991.htm Retrieved 2026-10-01 · sha256 7d397485929fa2c7fbd9178ae03901b0e0588b908bd60a6796b02f6b5514ffae --- # 80% forecast: FDA approves relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies on or before the disclosed PDUFA goal date of 2026-12-27 URL: https://nextconsensus.com/forecast/ff-035/ Registered forecast 80% registered probability event by 2026-12-27 Unresolved ## FDA approves relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies on or before the disclosed PDUFA goal date of 2026-12-27 FF-035 Registered · Unresolved Registered probability 80% Event by 2026-12-27 Resolution window 2026-10-16 → 2026-12-27 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 85% - Calendar cycle 80% - Analyst proxy 80% nextconsensus.com/forecast/ff-035/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on Praxis' New Drug Application for relutrigine for the treatment of SCN2A and SCN8A developmental and epileptic encephalopathies, with an approval action date on or before 2026-12-27, the PDUFA target action date, as extended by a major amendment, disclosed in Exhibit 99.1 to Praxis' Form 8-K filed 2026-08-06. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope SCN2A and SCN8A developmental and epileptic encephalopathies The estimate ### The number and the baselines it has to beat 80% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-035 · registered 80% Authority base rate −5 pts 85% Calendar cycle 0 pts 80% Analyst proxy 0 pts 80% Authority base rate 85% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Applications built on positive randomized controlled trials are approved at their first goal date in a large majority of cases. The calendar's own met-goal-date share for disclosed PDUFA dates does not exist yet. Calendar cycle 80% A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle actions on applications like this are approvals. With no evidence input it cannot tell a strong application from a weak one. Analyst proxy 80% A neurology analyst reading the same filings on 2026-10-01 would weigh a registrational cohort stopped early for efficacy, priority review, a mid-cycle meeting with no major concerns, a clean BIMO inspection and no advisory committee, against an extension already taken and a phase 2 registrational basis. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2026-12-27 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2026-12-27 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2026-12-27 When the outcome can be read against the rule. Event by 2026-12-27 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 55d89291184e24857575879dca8c42900a4c1e7c2030d141349a63f201dde604 · operator record jc-1792036248979-1ca63aaa ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22relutrigine%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22RELUTRIGINE%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-12-27, and the Drugs@FDA approval letter or label for that application names SCN2A or SCN8A developmental and epileptic encephalopathy in its indication. An approval for one of the two genotypes, or a narrower population than the applicant sought, still resolves YES. Resolves NO if no approval action is dated on or before 2026-12-27: a complete response letter, a further goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-12-27 resolves NO as occurred_after_deadline. 2026-12-27 is a Sunday; an approval action dated that day still counts. Read no earlier than 2027-01-10. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name relutrigine) governs. The application number was not public at the cutoff, so the rule reads by name; a suffix on the nonproprietary name or a proprietary name does not change the identification. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22relutrigine%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22RELUTRIGINE%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 80% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15. review pathway Priority review (SRC-003), extended three months by major amendment (SRC-002). Center CDER is the drafter's understanding, unverified. submission type Original NDA (SRC-003, SRC-005). evidence class Registrational cohort of the randomized, double-blind, placebo-controlled Phase 2 EMBOLD study, stopped early for efficacy on Data Monitoring Committee recommendation (SRC-005). pivotal n EMBOLD registrational cohort: relutrigine-treated patients n=51 (SRC-005); placebo n not stated in the archived sources. endpoint type Motor seizure frequency (clinical): 53% placebo-adjusted seizure reduction over 16 weeks (SRC-005). approved competitors in class Not named in the archived sources; Praxis states relutrigine, if approved, "will be the first therapy for SCN2A and SCN8A DEEs" (SRC-001). months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status NDA submitted (stated as submitted in the 10-K filed 2026-02-19, SRC-005); accepted for priority review (announced by 2026-05-07, SRC-004); extension notified June 2026 (SRC-002). odac referral Stated not planned: "The agency confirmed that no advisory committee meeting is planned." (SRC-001, SRC-003). sponsor state change None reported (Praxis reported ~$1.4 billion cash and investments as of March 31, 2026, SRC-004). Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Praxis Form 8-K Exhibit 99.1 (Q2 2026 results), filed 2026-08-06. States the major-amendment extension to a PDUFA target action date of December 27, 2026, mid-cycle meeting with no major concerns, no advisory committee planned, BIMO inspections with no Form 483; BTD and ODD. https://www.sec.gov/Archives/edgar/data/1689548/000168954826000082/praxisq22026pr.htm Retrieved 2026-10-01 · sha256 bff42b02a8aad816b42e8753f8d38450f58824590384a117df588cff935a431c SRC-002 Praxis Form 8-K (Item 8.01), filed 2026-06-29. States FDA extended the relutrigine NDA review by three months from September 27, 2026 to December 27, 2026 following submission of additional sensitivity analyses deemed a major amendment; no new studies requested; no safety or manufacturing concerns cited. https://www.sec.gov/Archives/edgar/data/1689548/000168954826000069/prax-20260629.htm Retrieved 2026-10-01 · sha256 081fb76cd7f4b47f6a49dd8bef1a07db63f688f6f7aa40c7e3bc29c71ef4126b SRC-003 Praxis Form 10-Q for the quarter ended 2026-06-30, filed 2026-08-06. States the NDA was accepted for priority review with PDUFA date September 27, 2026, extended in June 2026 to December 27, 2026; no advisory committee planned; BIMO inspection with no Form 483. https://www.sec.gov/Archives/edgar/data/1689548/000168954826000083/prax-20260630.htm Retrieved 2026-10-01 · sha256 f62a98ce438254fda9ee738bd36efef3f2cb1f447b27e8eba9277791a3e1fc71 SRC-004 Praxis Form 8-K Exhibit 99.1 (Q1 2026 results), filed 2026-05-07. States FDA accepted the relutrigine NDA with priority review and a PDUFA target action date of September 27, 2026; cash of ~$1.4 billion. https://www.sec.gov/Archives/edgar/data/1689548/000168954826000049/praxisq12026pr.htm Retrieved 2026-10-01 · sha256 27d1e98176cd85483cc0ad92bd57b870f86604455500aad469b97bf75c184608 SRC-005 Praxis Form 10-K for fiscal 2025, filed 2026-02-19. States the relutrigine NDA was submitted based on EMBOLD; EMBOLD registrational cohort results (n=51 relutrigine, 53% placebo-adjusted seizure reduction) after DMC early stop for efficacy; ODD, RPD and BTD. https://www.sec.gov/Archives/edgar/data/1689548/000168954826000029/prax-20251231.htm Retrieved 2026-10-01 · sha256 e825ff049616bd8a8b9171130ce20cda971a1f3301bf968431f46aa855d9cd05 SRC-006 openFDA drugsfda products.active_ingredients.name:"RELUTRIGINE", retrieved 2026-10-01: 404 No matches found. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22RELUTRIGINE%22&limit=100 Retrieved 2026-10-01 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da SRC-007 openFDA drugsfda openfda.generic_name:"relutrigine", retrieved 2026-10-01: 404 No matches found. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22relutrigine%22&limit=100 Retrieved 2026-10-01 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da --- # 80% forecast: FDA approves ulixacaltamide for essential tremor on or before the disclosed PDUFA goal date of 2027-01-29 URL: https://nextconsensus.com/forecast/ff-036/ Registered forecast 80% registered probability event by 2027-01-29 Unresolved ## FDA approves ulixacaltamide for essential tremor on or before the disclosed PDUFA goal date of 2027-01-29 FF-036 Registered · Unresolved Registered probability 80% Event by 2027-01-29 Resolution window 2026-10-16 → 2027-01-29 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 85% - Calendar cycle 80% - Analyst proxy 80% nextconsensus.com/forecast/ff-036/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on Praxis' New Drug Application for ulixacaltamide hydrochloride for the treatment of essential tremor in adults, with an approval action date on or before 2027-01-29, the PDUFA date disclosed in Exhibit 99.1 to Praxis' Form 8-K filed 2026-08-06. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope Essential tremor in adults The estimate ### The number and the baselines it has to beat 80% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-036 · registered 80% Authority base rate −5 pts 85% Calendar cycle 0 pts 80% Analyst proxy 0 pts 80% Authority base rate 85% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Applications built on positive randomized controlled trials are approved at their first goal date in a large majority of cases. The calendar's own met-goal-date share for disclosed PDUFA dates does not exist yet. Calendar cycle 80% A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle actions on applications like this are approvals. With no evidence input it cannot tell a strong application from a weak one. Analyst proxy 80% A neurology analyst reading the same filings on 2026-10-01 would weigh two phase 3 studies, a mid-cycle meeting with no major concerns, a clean BIMO inspection and no advisory committee, and would call approval by the goal date likely. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-01-29 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-01-29 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2027-01-29 When the outcome can be read against the rule. Event by 2027-01-29 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 6cd7820ace1c35bc8346892f8b767d059fcb0e7d819a5fdef261a11e9b8aa51b · operator record jc-1792036249340-0a27ee0a ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22ulixacaltamide%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22ULIXACALTAMIDE%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2027-01-29, and the Drugs@FDA approval letter or label for that application names essential tremor in its indication. An approval for a narrower essential tremor population than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2027-01-29: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2027-01-29 resolves NO as occurred_after_deadline. Read no earlier than 2027-02-12. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name ulixacaltamide) governs. The application number was not public at the cutoff, so the rule reads by name; a suffix on the nonproprietary name or a proprietary name does not change the identification. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22ulixacaltamide%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22ULIXACALTAMIDE%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 80% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15, including the one field whose value was unknown then. It is left unknown rather than filled in. review pathway unknown — not stated in the archived sources (no priority review stated for this NDA, unlike relutrigine). Center CDER is the drafter's understanding, unverified. submission type Original NDA (SRC-002, SRC-003). evidence class Two Phase 3 pivotal studies in the Essential3 program: Study 1 (double-blind, placebo-controlled parallel-group) and Study 2 (randomized-withdrawal) (SRC-004). pivotal n Study 1: 473 patients randomized 1:1; Study 2: 238 patients enrolled (SRC-004). endpoint type Clinical/functional: change from baseline in modified Activities of Daily Living 11 (mADL11) at Week 8 (Study 1); proportion maintaining response (Study 2) (SRC-004). approved competitors in class Approved ET therapies such as propranolol; off-label primidone (SRC-004). Praxis states ulixacaltamide is the first investigational therapy with a positive Phase 3 program in ET (SRC-001). months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status NDA submitted (stated as submitted in the 10-K filed 2026-02-19, SRC-004); FDA acceptance announced April 14, 2026 (SRC-003). odac referral Stated not planned: FDA "is not planning to hold an advisory committee meeting" (SRC-003); "The agency confirmed that no advisory committee meeting is planned" (SRC-002). sponsor state change None reported. Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Praxis Form 8-K Exhibit 99.1 (Q2 2026 results), filed 2026-08-06. States ulixacaltamide NDA review progressing with PDUFA date January 29, 2027; mid-cycle meeting with no major concerns; no advisory committee planned; BIMO with no Form 483; BTD. https://www.sec.gov/Archives/edgar/data/1689548/000168954826000082/praxisq22026pr.htm Retrieved 2026-10-01 · sha256 bff42b02a8aad816b42e8753f8d38450f58824590384a117df588cff935a431c SRC-002 Praxis Form 10-Q for the quarter ended 2026-06-30, filed 2026-08-06. States the NDA for ulixacaltamide HCl for ET was accepted with a PDUFA target action date of January 29, 2027; mid-cycle meeting; no advisory committee planned. https://www.sec.gov/Archives/edgar/data/1689548/000168954826000083/prax-20260630.htm Retrieved 2026-10-01 · sha256 f62a98ce438254fda9ee738bd36efef3f2cb1f447b27e8eba9277791a3e1fc71 SRC-003 Praxis Form 8-K (Item 8.01), filed 2026-04-14. Announces FDA acceptance of the NDA for ulixacaltamide HCl for essential tremor in adults, PDUFA target action date January 29, 2027, and that FDA is not planning to hold an advisory committee meeting. https://www.sec.gov/Archives/edgar/data/1689548/000168954826000033/prax-20260414.htm Retrieved 2026-10-01 · sha256 6310b62dfa824816dcbe491340dbcfb958655cc6cace47270f06611ed6e386fc SRC-004 Praxis Form 10-K for fiscal 2025, filed 2026-02-19. Essential3 design (Study 1: 473 patients; Study 2: 238 patients), endpoints and results; BTD; NDA submitted; competition (propranolol, primidone). https://www.sec.gov/Archives/edgar/data/1689548/000168954826000029/prax-20251231.htm Retrieved 2026-10-01 · sha256 e825ff049616bd8a8b9171130ce20cda971a1f3301bf968431f46aa855d9cd05 SRC-005 openFDA drugsfda products.active_ingredients.name:"ULIXACALTAMIDE", retrieved 2026-10-01: 404 No matches found. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22ULIXACALTAMIDE%22&limit=100 Retrieved 2026-10-01 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da SRC-006 openFDA drugsfda products.active_ingredients.name:"ULIXACALTAMIDE HYDROCHLORIDE", retrieved 2026-10-01: 404 No matches found. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22ULIXACALTAMIDE%20HYDROCHLORIDE%22&limit=100 Retrieved 2026-10-01 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da SRC-007 openFDA drugsfda openfda.generic_name:"ulixacaltamide", retrieved 2026-10-01: 404 No matches found. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22ulixacaltamide%22&limit=100 Retrieved 2026-10-01 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da --- # 70% forecast: FDA approves zeleciment rostudirsen (z-rostudirsen) for Duchenne muscular dystrophy amenable to exon 51 skipping on or before the disclosed PDUFA goal date of 2027-01-21 URL: https://nextconsensus.com/forecast/ff-037/ Registered forecast 70% registered probability event by 2027-01-21 Unresolved ## FDA approves zeleciment rostudirsen (z-rostudirsen) for Duchenne muscular dystrophy amenable to exon 51 skipping on or before the disclosed PDUFA goal date of 2027-01-21 FF-037 Registered · Unresolved Registered probability 70% Event by 2027-01-21 Resolution window 2026-10-16 → 2027-01-21 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 70% - Calendar cycle 65% - Analyst proxy 70% nextconsensus.com/forecast/ff-037/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on Dyne Therapeutics' Biologics License Application for zeleciment rostudirsen (z-rostudirsen, DYNE-251) for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping, with an approval action date on or before 2027-01-21, the PDUFA target action date disclosed in Dyne Therapeutics' Form 10-Q filed 2026-07-29. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope Duchenne muscular dystrophy amenable to exon 51 skipping The estimate ### The number and the baselines it has to beat 70% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-037 · registered 70% Authority base rate 0 pts 70% Calendar cycle +5 pts 65% Analyst proxy 0 pts 70% Authority base rate 70% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Applications resting on uncontrolled or early-phase trials, or on surrogate endpoints, often under accelerated approval, meet their first goal date less often than those built on completed randomized trials. The calendar's own count does not exist yet. Calendar cycle 65% A clock-only model: the goal date is inside the window and FDA meets most goal dates, but first-cycle approval is less common on uncontrolled, early-phase or surrogate evidence. Analyst proxy 70% A neuromuscular analyst reading the same filings on 2026-10-01 would weigh priority review and a dystrophin increase on the surrogate submitted for accelerated approval, against the sponsor's own warning that FDA may not agree with surrogate endpoints (SRC-001). Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-01-21 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-01-21 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2027-01-21 When the outcome can be read against the rule. Event by 2027-01-21 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger f5b0d0e15845147745cfcc30691b9f9314ab5be9b7aa69a5bd017808ef69fbbf · operator record jc-1792036249642-353eeea8 ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22zeleciment%20rostudirsen%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22ZELECIMENT%20ROSTUDIRSEN%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2027-01-21, and the Drugs@FDA approval letter or label for that application names Duchenne muscular dystrophy amenable to exon 51 skipping in its indication. An approval for a narrower Duchenne muscular dystrophy amenable to exon 51 skipping population than the applicant sought still resolves YES, as does accelerated rather than traditional approval. Resolves NO if no approval action is dated on or before 2027-01-21: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2027-01-21 resolves NO as occurred_after_deadline. Read no earlier than 2027-02-04. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name zeleciment rostudirsen) governs. If neither lists the product, FDA's Purple Book (https://purplebooksearch.fda.gov/, searched by zeleciment rostudirsen) governs for the licensure date, with the approval letter for the indication. The application number was not public at the cutoff, so the rule reads by name; a suffix on the nonproprietary name or a proprietary name does not change the identification. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22zeleciment%20rostudirsen%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22ZELECIMENT%20ROSTUDIRSEN%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/, https://purplebooksearch.fda.gov/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 70% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15. review pathway Priority Review (SRC-001, SRC-002); BLA submitted for potential U.S. Accelerated Approval based on dystrophin as a surrogate endpoint (SRC-001, SRC-004). submission type Original BLA (SRC-001). evidence class Registrational expansion cohort (REC) of the global Phase 1/2 DELIVER trial (randomized vs placebo), surrogate-endpoint basis; confirmatory Phase 3 FORZETTO initiated May 2026 (SRC-004, SRC-001). pivotal n DELIVER REC: 32 participants (24 z-rostudirsen 20 mg/kg Q4W, 8 placebo) (SRC-004). endpoint type Surrogate biomarker: change from baseline in muscle content-adjusted dystrophin at six months (met, p<0.0001; mean absolute expression 5.46% of normal) (SRC-004). approved competitors in class EXONDYS 51 (eteplirsen), a PMO approved for DMD amenable to exon 51 skipping (Sarepta), among four FDA-approved exon-skipping drugs (SRC-001). months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status BLA submission planned for Q2 2026 (SRC-004); FDA acceptance with Priority Review announced July 20, 2026 (SRC-002). odac referral none announced in the archived sources sponsor state change None reported. Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Dyne Form 10-Q for the quarter ended 2026-06-30, filed 2026-07-29. States the FDA accepted the z-rostudirsen BLA (DMD amenable to exon 51 skipping), granted priority review and assigned PDUFA target action date January 21, 2027; BLA based on DELIVER for potential Accelerated Approval; BTD, Fast Track, RPD and Orphan designations; FORZETTO confirmatory trial; approved exon-skipping competitors. https://www.sec.gov/Archives/edgar/data/1818794/000119312526323639/dyn-20260630.htm Retrieved 2026-10-01 · sha256 b88ec820885c1d11755587daa883527c017611297ad35bb6a82eee82a2aefd6a SRC-002 Dyne Form 8-K (Item 8.01), filed 2026-07-20. Announces FDA acceptance of the BLA for zeleciment rostudirsen with Priority Review and a PDUFA target action date of January 21, 2027. https://www.sec.gov/Archives/edgar/data/1818794/000119312526308343/dyn-20260720.htm Retrieved 2026-10-01 · sha256 16260864264917cecb20abf205a38d679672769d01835f91b4efa90261c091c9 SRC-003 Dyne Form 8-K Exhibit 99.1 (Q2 2026 results), filed 2026-07-29. Restates BLA accepted July 2026 with Priority Review and PDUFA date January 21, 2027. https://www.sec.gov/Archives/edgar/data/1818794/000119312526323940/dyn-ex99_1.htm Retrieved 2026-10-01 · sha256 11ca0fdb925d4e752224bc3d465d54cff4773b08ce8717cc116d73360fbb1296 SRC-004 Dyne Form 10-K for fiscal 2025, filed 2026-03-02. DELIVER REC enrollment (32 participants: 24 drug, 8 placebo), primary endpoint met (muscle content-adjusted dystrophin, p<0.0001, 5.46% of normal), plan to submit BLA for Accelerated Approval in Q2 2026 based on dystrophin as a surrogate endpoint. https://www.sec.gov/Archives/edgar/data/1818794/000119312526084178/dyn-20251231.htm Retrieved 2026-10-01 · sha256 87a1d49d01dad74362d08b783fb4da15e16ad81b1d45071448249b422f4763cf SRC-005 Dyne Form 8-K Exhibit 99.1, filed 2026-09-29 (latest Dyne filing before cutoff). Reports z-basivarsen (DM1) data; contains no change to the z-rostudirsen review. https://www.sec.gov/Archives/edgar/data/1818794/000181879426000009/dyn-ex99_1.htm Retrieved 2026-10-01 · sha256 87f950299b9b657eff422b08085ef3269f6b940b69a8f8029b5db8fae82985f9 SRC-006 openFDA drugsfda products.active_ingredients.name:"ZELECIMENT ROSTUDIRSEN", retrieved 2026-10-01: 404 No matches found. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22ZELECIMENT%20ROSTUDIRSEN%22&limit=100 Retrieved 2026-10-01 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da SRC-007 openFDA drugsfda openfda.generic_name:"zeleciment rostudirsen", retrieved 2026-10-01: 404 No matches found. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22zeleciment%20rostudirsen%22&limit=100 Retrieved 2026-10-01 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da --- # 30% forecast: NICE publishes technology appraisal guidance on Elranatamab for treating relapsed and refractory multiple myeloma after 3 or more treatments (managed access review of TA1023) [ID6653] on or before 2027-01-28 URL: https://nextconsensus.com/forecast/ff-038/ Registered forecast 30% registered probability event by 2027-01-28 Unresolved ## NICE publishes technology appraisal guidance on Elranatamab for treating relapsed and refractory multiple myeloma after 3 or more treatments (managed access review of TA1023) [ID6653] on or before 2027-01-28 FF-038 Registered · Unresolved Registered probability 30% Event by 2027-01-28 Resolution window 2026-10-16 → 2027-01-28 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 45% - Analyst proxy 30% nextconsensus.com/forecast/ff-038/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Elranatamab for treating relapsed and refractory multiple myeloma after 3 or more treatments (managed access review of TA1023)' [ID6653], with a publication date on or before 2027-01-28, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11956) on 2026-10-01. Authority National Institute for Health and Care Excellence (NICE), Technology Appraisal Committee (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope Relapsed and refractory multiple myeloma after 3 or more treatments (managed access review) The estimate ### The number and the baselines it has to beat 30% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-038 · registered 30% Authority base rate −20 pts 50% Calendar cycle −15 pts 45% Analyst proxy 0 pts 30% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown at the cutoff is not yet counted; the calendar's census will count it. Expected dates are revised often, most when a committee meeting does not reach a final recommendation or a company asks for time. Calendar cycle 45% A clock-only model: one committee meeting, 49 days before the expected date, is on schedule if that meeting reaches a final recommendation and final draft guidance follows. Analyst proxy 30% An analyst reading the project page on 2026-10-01 would note a managed access review with its only meeting seven weeks before the date and no consultation round in the schedule. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-01-28 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-01-28 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2027-01-28 When the outcome can be read against the rule. Event by 2027-01-28 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger eb859c0c6bf868c64a229e71b88539f59e62388e409b7a9133a68d49981a67be · operator record jc-1792036249960-f93d0442 ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID6653 shows a publication date ('Published: ') on or before 2027-01-28, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6653. Searching for GID-TA11956 finds the same project. This appraisal reviews TA1023; the original publication date of TA1023 does not count. If NICE publishes the review by updating TA1023 in place, the date that page gives for this update is the publication date read. Resolves NO if the guidance is published after 2027-01-28, if the expected date is revised and nothing is published by 2027-01-28, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2027-02-04. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11956, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 30% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15. review pathway STA Standard ("Process: STA Standard"; "Prioritisation programme: Medicines evaluation", SRC-001) submission type Managed access review of TA1023; company "Pfizer (elranatamab)" (SRC-001) evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class Comparator companies on SRC-001: "Johnson & Johnson (bortezomib, ciltacabtagene autoleucel, daratumumab, talquetamab, teclistamab)", "Sanofi (isatuximab)", "Takeda UK (ixazomib)". months since last guideline revision not applicable panel cycle position Committee meeting 1 is on 10 December 2026, 49 days before the expected publication date of 28 January 2027. No draft guidance consultation or second meeting is listed (SRC-001). sponsor request status None recorded (SRC-001). odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change None recorded (SRC-001). Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development "Project information" page for ID6653. Shows the header line "Expected publication date: 28 January 2027", status, process, ID number, the provisional schedule, the enquiry e-mail address, stakeholders (where listed) and the "Timeline" table of key events. https://www.nice.org.uk/guidance/indevelopment/gid-ta11956 Retrieved 2026-10-01 · sha256 9558e68b2ceefb846d5175ec57f6002715ac06cf46797b9ca026d263f9768af6 SRC-002 NICE "Project documents" tab for ID6653: lists documents by stage with publication dates (scope, stakeholder list, draft guidance where issued, committee meeting entries) and the text of notes added to the project documents. https://www.nice.org.uk/guidance/indevelopment/gid-ta11956/documents Retrieved 2026-10-01 · sha256 fe13a88483b400f52acaccfcdd150c9a0e3d4e39c2cd965f45a9821043cc85b3 SRC-003 NICE "Technology appraisal committees" page (reached from the meetings-in-public URL https://www.nice.org.uk/get-involved/meetings-in-public/technology-appraisal-committee, which returned HTTP 308 to it). Under "Next meeting dates" it lists Committee B meetings including "Thursday 12 November 2026" and "Thursday 10 December 2026"; it also lists published TAC minutes. It does not list which appraisals are on each agenda. https://www.nice.org.uk/get-involved/our-committees/nice-committee-meetings/technology-appraisal-committees Retrieved 2026-10-01 · sha256 8e6f62cd7fdf5be519f696bbeb8813e845b461e04dc894f32f2c57c49246c2a8 --- # 40% forecast: NICE publishes technology appraisal guidance on Nerandomilast for treating idiopathic pulmonary fibrosis or progressive pulmonary fibrosis [ID6446] on or before 2027-01-20 URL: https://nextconsensus.com/forecast/ff-039/ Registered forecast 40% registered probability event by 2027-01-20 Unresolved ## NICE publishes technology appraisal guidance on Nerandomilast for treating idiopathic pulmonary fibrosis or progressive pulmonary fibrosis [ID6446] on or before 2027-01-20 FF-039 Registered · Unresolved Registered probability 40% Event by 2027-01-20 Resolution window 2026-10-16 → 2027-01-20 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 55% - Analyst proxy 40% nextconsensus.com/forecast/ff-039/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Nerandomilast for treating idiopathic pulmonary fibrosis or progressive pulmonary fibrosis' [ID6446], with a publication date on or before 2027-01-20, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11552) on 2026-10-01. Authority National Institute for Health and Care Excellence (NICE), Technology Appraisal Committee B (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope Idiopathic or progressive pulmonary fibrosis The estimate ### The number and the baselines it has to beat 40% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-039 · registered 40% Authority base rate −10 pts 50% Calendar cycle −15 pts 55% Analyst proxy 0 pts 40% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown at the cutoff is not yet counted; the calendar's census will count it. Expected dates are revised often, most when a committee meeting does not reach a final recommendation or a company asks for time. Calendar cycle 55% A clock-only model: a second committee meeting on 12 November, 69 days before the expected date, is treated as on schedule: the model assumes final draft guidance and an appeal period fit in that time. Analyst proxy 40% An analyst reading the project page on 2026-10-01 would weigh negative draft guidance against a schedule that leaves room for final draft guidance before the date. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-01-20 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-01-20 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2027-01-20 When the outcome can be read against the rule. Event by 2027-01-20 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger a624a0d9838b59f45db4c61034d461d288285786d4e1aaca59b960eb45dd7bf8 · operator record jc-1792036250266-0952cbd8 ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID6446 shows a publication date ('Published: ') on or before 2027-01-20, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6446. Searching for GID-TA11552 finds the same project. Resolves NO if the guidance is published after 2027-01-20, if the expected date is revised and nothing is published by 2027-01-20, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2027-01-27. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11552, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 40% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15. review pathway STA Standard ("Process: STA Standard", SRC-001) submission type New appraisal; company "Boehringer Ingelheim" (SRC-001) evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class Comparator companies on SRC-001 include Boehringer Ingelheim (nintedanib), and Roche and several generic suppliers (pirfenidone), plus suppliers of immunosuppressants (azathioprine, cyclophosphamide, infliximab, methotrexate, mycophenolate, rituximab). All are listed as "(not participating)". months since last guideline revision not applicable panel cycle position Committee meeting 1 was held on 15 July 2026. The draft guidance consultation ran from 19 August to 10 September 2026. Committee meeting 2 is on 12 November 2026, 69 days before the expected publication date of 20 January 2027 (SRC-001; SRC-004). sponsor request status Rescheduled on the company's advice "to align with latest regulatory expectations" (SRC-003; the timeline note is dated 11 October 2024 on SRC-001). No request is recorded in 2026. odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change None recorded since the appraisal started (SRC-001) Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development "Project information" page for ID6446. Shows the header line "Expected publication date: 20 January 2027", status, process, ID number, the provisional schedule, the enquiry e-mail address, stakeholders (where listed) and the "Timeline" table of key events. https://www.nice.org.uk/guidance/indevelopment/gid-ta11552 Retrieved 2026-10-01 · sha256 bfcfb7b58f7a7db5232616207f79a8d910750564c14e0661e0460f995f54737c SRC-002 NICE "Project documents" tab for ID6446: lists documents by stage with publication dates (scope, stakeholder list, draft guidance where issued, committee meeting entries) and the text of notes added to the project documents. https://www.nice.org.uk/guidance/indevelopment/gid-ta11552/documents Retrieved 2026-10-01 · sha256 03df8f48c1c37f9e016ad64b802a4c5cf97b48db5c11eb14024f613c49a60ecf SRC-003 Undated note page (the project page timeline lists one note, dated 11 October 2024): "Please note that following on from advice received from the company this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin during early December 2025 ... The deadline for submissions is expected in approximately mid-February 2026." https://www.nice.org.uk/guidance/gid-ta11552/documents/html-content-2 Retrieved 2026-10-01 · sha256 629a3f6d74e6424b90dc2ee694b212ec8b89096ca0f65e4966473cde9400e5ec SRC-004 NICE "Draft guidance" consultation page for ID6446: "Closing date for comments: 5pm, 10 September 2026" and "After the consultation has closed the appraisal committee will meet again to consider the responses received and prepare the final draft guidance." https://www.nice.org.uk/guidance/gid-ta11552/documents/html-content-9 Retrieved 2026-10-01 · sha256 973c242d14bc9ea4b1fb47de1db51fc646199a79bb122409005730d0d31e895c SRC-005 Draft guidance (downloadable PDF, published 19 August 2026). Section 1 reads: "1.1 Nerandomilast should not be used to treat idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) in adults." https://www.nice.org.uk/guidance/gid-ta11552/documents/draft-guidance Retrieved 2026-10-01 · sha256 0c8b95dbc1940949ebd3b60807a281cde32bdb88964bd7755357db7634e57568 SRC-006 NICE "Technology appraisal committees" page (reached from the meetings-in-public URL https://www.nice.org.uk/get-involved/meetings-in-public/technology-appraisal-committee, which returned HTTP 308 to it). Under "Next meeting dates" it lists Committee B meetings including "Thursday 15 October 2026", "Thursday 12 November 2026" and "Thursday 10 December 2026"; it also lists published TAC minutes. It does not list which appraisals are on each agenda. https://www.nice.org.uk/get-involved/our-committees/nice-committee-meetings/technology-appraisal-committees Retrieved 2026-10-01 · sha256 8e6f62cd7fdf5be519f696bbeb8813e845b461e04dc894f32f2c57c49246c2a8 SRC-007 Confirmed minutes (Word) of the Technology Appraisal Committee B meeting on 15 July 2026, linked from the TAC page. Includes the agenda item "Appraisal of Nerandomilast for treating idiopathic pulmonary fibrosis or progressive pulmonary fibrosis [ID6446]", records that the chair welcomed "company representatives from Boehringer Ingelheim", and records that "The committee then agreed on the content of the Draft Guidance (DG) or Final Draft Guidance (FDG). The committee decision was reached by consensus." https://a.storyblok.com/f/243782/x/2150b556fa/confirmed-tac-b-minutes-15072026.docx Retrieved 2026-10-01 · sha256 a867da40bde59bce236bc56654becffb9f78413da720d601d4f12e3f3a85cd04 --- # 30% forecast: NICE publishes technology appraisal guidance on Retifanlimab with platinum-based chemotherapy for treating inoperable, locally recurrent or metastatic squamous cell anal canal cancer untreated with systemic chemotherapy [ID6482] on or before 2026-12-16 URL: https://nextconsensus.com/forecast/ff-040/ Registered forecast 30% registered probability event by 2026-12-16 Unresolved ## NICE publishes technology appraisal guidance on Retifanlimab with platinum-based chemotherapy for treating inoperable, locally recurrent or metastatic squamous cell anal canal cancer untreated with systemic chemotherapy [ID6482] on or before 2026-12-16 FF-040 Registered · Unresolved Registered probability 30% Event by 2026-12-16 Resolution window 2026-10-16 → 2026-12-16 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 45% - Analyst proxy 30% nextconsensus.com/forecast/ff-040/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Retifanlimab with platinum-based chemotherapy for treating inoperable, locally recurrent or metastatic squamous cell anal canal cancer untreated with systemic chemotherapy' [ID6482], with a publication date on or before 2026-12-16, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11625) on 2026-10-01. Authority National Institute for Health and Care Excellence (NICE), Technology Appraisal Committee A (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope Untreated inoperable, locally recurrent or metastatic squamous cell anal canal cancer The estimate ### The number and the baselines it has to beat 30% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-040 · registered 30% Authority base rate −20 pts 50% Calendar cycle −15 pts 45% Analyst proxy 0 pts 30% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown at the cutoff is not yet counted; the calendar's census will count it. Expected dates are revised often, most when a committee meeting does not reach a final recommendation or a company asks for time. Calendar cycle 45% A clock-only model: one committee meeting 127 days before the expected date is on schedule if that meeting reached a final recommendation and final draft guidance follows. Analyst proxy 30% An analyst reading the project page on 2026-10-01 would note that 51 days after the meeting neither draft nor final draft guidance had been posted, and that a draft-guidance route would need a second meeting the schedule does not show. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2026-12-16 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2026-12-16 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2026-12-16 When the outcome can be read against the rule. Event by 2026-12-16 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 5b25ed2891c9f0d828b97d9634c7ed70df46c28b34267c94559913ce6e1d65ef · operator record jc-1792036250552-86464494 ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID6482 shows a publication date ('Published: ') on or before 2026-12-16, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6482. Searching for GID-TA11625 finds the same project. Resolves NO if the guidance is published after 2026-12-16, if the expected date is revised and nothing is published by 2026-12-16, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-12-23. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11625, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 30% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15. review pathway STA Standard ("Process: STA Standard", SRC-001) submission type New appraisal; company Incyte Biosciences UK (SRC-005; SRC-004). Topic selected 13 September 2024; referral entries dated 12 December 2024 and 16 April 2025 (SRC-001). evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class The page lists no stakeholders or comparator companies (SRC-001). The final stakeholder list (SRC-005) names only chemotherapy comparator companies: Bristol Myers Squibb Pharmaceuticals (paclitaxel), Genus Pharmaceuticals (paclitaxel), Hospira UK (carboplatin, paclitaxel), Seacross Pharmaceuticals (paclitaxel), Teva UK (paclitaxel). No same-class competitor is named. months since last guideline revision not applicable panel cycle position Only committee meeting on record: 11 August 2026, 127 days before the expected publication date of 16 December 2026 (SRC-001). No draft guidance consultation is listed (SRC-002). Committee A next meets on 15 September, 13 October, 10 November and 8 December 2026 (SRC-003); none of these is linked to this appraisal in the archived sources. sponsor request status No company request, pause or reschedule is recorded in the timeline (SRC-001). odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change None recorded (SRC-001). Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development "Project information" page for ID6482. Shows the header line "Expected publication date: 16 December 2026", status, process, ID number, the provisional schedule, the enquiry e-mail address, stakeholders (where listed) and the "Timeline" table of key events. https://www.nice.org.uk/guidance/indevelopment/gid-ta11625 Retrieved 2026-10-01 · sha256 b85e1379f404a5da0ddd5ecb53f551fc716e2df14a81a48c81ac611a01539f50 SRC-002 NICE "Project documents" tab for ID6482: lists documents by stage with publication dates (scope, stakeholder list, draft guidance where issued, committee meeting entries) and the text of notes added to the project documents. https://www.nice.org.uk/guidance/indevelopment/gid-ta11625/documents Retrieved 2026-10-01 · sha256 24470d2eeb53fa5ab1476cca6ca1f473fe95b9d59fbd5b6aea1d865e4a0ac830 SRC-003 NICE "Technology appraisal committees" page (reached from the meetings-in-public URL https://www.nice.org.uk/get-involved/meetings-in-public/technology-appraisal-committee, which returned HTTP 308 to it). Under "Next meeting dates" it lists Committee A meetings including "Tuesday 15 September 2026", "Tuesday 13 October 2026", "Tuesday 10 November 2026" and "Tuesday 08 December 2026"; it also lists published TAC minutes. It does not list which appraisals are on each agenda. https://www.nice.org.uk/get-involved/our-committees/nice-committee-meetings/technology-appraisal-committees Retrieved 2026-10-01 · sha256 8e6f62cd7fdf5be519f696bbeb8813e845b461e04dc894f32f2c57c49246c2a8 SRC-004 Confirmed minutes (Word) of the Technology Appraisal Committee A meeting on 11 August 2026, linked from the TAC page. Includes the agenda item "Appraisal of Retifanlimab with platinum-based chemotherapy for treating inoperable, locally recurrent or metastatic squamous cell anal canal cancer untreated with systemic chemotherapy [ID6482]", records that the chair welcomed "company representatives from Incyte Biosciences UK", and records that "The committee then agreed on the content of the Draft Guidance (DG) or Final Draft Guidance (FDG). The committee decision was reached by consensus." https://a.storyblok.com/f/243782/x/39fb660b7d/confirmed-tac-a-mintes-11-august-2026.docx Retrieved 2026-10-01 · sha256 5a911525fff000f8022a9eb62e186513b62c16d89b62347945aec5315cf04c26 SRC-005 Final stakeholder list (PDF, "Issue date: January 2026") for ID6482. Names the company "Incyte Biosciences UK (Retifanlimab)" and "Possible comparator companies": Bristol Myers Squibb Pharmaceuticals (paclitaxel), Genus Pharmaceuticals (paclitaxel), Hospira UK (carboplatin, paclitaxel), Seacross Pharmaceuticals (paclitaxel), Teva UK (paclitaxel). https://www.nice.org.uk/guidance/gid-ta11625/documents/final-matrix Retrieved 2026-10-01 · sha256 ef9f0ebd87f2169b3098a7215746381506353a6c22fcb1915d7958d4ef480d70 --- # 30% forecast: NICE publishes technology appraisal guidance on Tarlatamab for treating extensive stage small-cell lung cancer that has progressed after platinum-based chemotherapy [ID6617] on or before 2027-01-13 URL: https://nextconsensus.com/forecast/ff-041/ Registered forecast 30% registered probability event by 2027-01-13 Unresolved ## NICE publishes technology appraisal guidance on Tarlatamab for treating extensive stage small-cell lung cancer that has progressed after platinum-based chemotherapy [ID6617] on or before 2027-01-13 FF-041 Registered · Unresolved Registered probability 30% Event by 2027-01-13 Resolution window 2026-10-16 → 2027-01-13 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 45% - Analyst proxy 30% nextconsensus.com/forecast/ff-041/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Tarlatamab for treating extensive stage small-cell lung cancer that has progressed after platinum-based chemotherapy' [ID6617], with a publication date on or before 2027-01-13, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11812) on 2026-10-01. Authority National Institute for Health and Care Excellence (NICE), Technology Appraisal Committee (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope Extensive-stage small-cell lung cancer after platinum-based chemotherapy The estimate ### The number and the baselines it has to beat 30% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-041 · registered 30% Authority base rate −20 pts 50% Calendar cycle −15 pts 45% Analyst proxy 0 pts 30% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown at the cutoff is not yet counted; the calendar's census will count it. Expected dates are revised often, most when a committee meeting does not reach a final recommendation or a company asks for time. Calendar cycle 45% A clock-only model: a first committee meeting on 10 November, 64 days before the expected date, is on schedule if that meeting reaches a final recommendation. Analyst proxy 30% An analyst reading the project page on 2026-10-01 would note a schedule with no consultation round and expect a first meeting on an oncology medicine to reach draft guidance more often than final draft guidance. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-01-13 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-01-13 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2027-01-13 When the outcome can be read against the rule. Event by 2027-01-13 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 556605b8b10aa17c3a3f2c875283c26d64b96b2ab99b50d9642e35254f0b502e · operator record jc-1792036250883-8069228b ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID6617 shows a publication date ('Published: ') on or before 2027-01-13, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6617. Searching for GID-TA11812 finds the same project. Resolves NO if the guidance is published after 2027-01-13, if the expected date is revised and nothing is published by 2027-01-13, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2027-01-20. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11812, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 30% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15. review pathway STA Standard ("Process: STA Standard", SRC-001) submission type New appraisal; company "Amgen (tarlatamab)" (SRC-004) evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class The page lists no stakeholders (SRC-001). The final stakeholder list names one possible comparator company, Sandoz (oral topotecan) (SRC-004). No same-class competitor is named. months since last guideline revision not applicable panel cycle position Committee meeting 1 is on 10 November 2026, 64 days before the expected publication date of 13 January 2027. No draft guidance consultation or second meeting is listed (SRC-001). sponsor request status None recorded (SRC-001). odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change None recorded (SRC-001). Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development "Project information" page for ID6617. Shows the header line "Expected publication date: 13 January 2027", status, process, ID number, the provisional schedule, the enquiry e-mail address, stakeholders (where listed) and the "Timeline" table of key events. https://www.nice.org.uk/guidance/indevelopment/gid-ta11812 Retrieved 2026-10-01 · sha256 69599e94ad344500243ff3eadb848c6ec4e37ddba432ccf9e74ee2d1f4598df8 SRC-002 NICE "Project documents" tab for ID6617: lists documents by stage with publication dates (scope, stakeholder list, draft guidance where issued, committee meeting entries) and the text of notes added to the project documents. https://www.nice.org.uk/guidance/indevelopment/gid-ta11812/documents Retrieved 2026-10-01 · sha256 55e300b6d8d7abba6ba4132a8249ecabe3aa4a72a825f7007e267361f5ec93e6 SRC-003 NICE "Technology appraisal committees" page (reached from the meetings-in-public URL https://www.nice.org.uk/get-involved/meetings-in-public/technology-appraisal-committee, which returned HTTP 308 to it). Under "Next meeting dates" it lists Committee A meetings including "Tuesday 13 October 2026", "Tuesday 10 November 2026" and "Tuesday 08 December 2026"; it also lists published TAC minutes. It does not list which appraisals are on each agenda. https://www.nice.org.uk/get-involved/our-committees/nice-committee-meetings/technology-appraisal-committees Retrieved 2026-10-01 · sha256 8e6f62cd7fdf5be519f696bbeb8813e845b461e04dc894f32f2c57c49246c2a8 SRC-004 Final stakeholder list (PDF, "Issue date: February 2026") for ID6617. Names the company "Amgen (tarlatamab)" and one "Possible comparator companies" entry: "Sandoz (oral topotecan)". https://www.nice.org.uk/guidance/gid-ta11812/documents/final-matrix Retrieved 2026-10-01 · sha256 fb2e103c406039153bb26fd7c49ea1315ebe44de2c652f81d2ad186e18ec2c34 --- # 40% forecast: NICE publishes technology appraisal guidance on Toripalimab with chemotherapy for untreated recurrent or metastatic nasopharyngeal cancer [ID6406] on or before 2027-01-13 URL: https://nextconsensus.com/forecast/ff-042/ Registered forecast 40% registered probability event by 2027-01-13 Unresolved ## NICE publishes technology appraisal guidance on Toripalimab with chemotherapy for untreated recurrent or metastatic nasopharyngeal cancer [ID6406] on or before 2027-01-13 FF-042 Registered · Unresolved Registered probability 40% Event by 2027-01-13 Resolution window 2026-10-16 → 2027-01-13 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 55% - Analyst proxy 40% nextconsensus.com/forecast/ff-042/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Toripalimab with chemotherapy for untreated recurrent or metastatic nasopharyngeal cancer' [ID6406], with a publication date on or before 2027-01-13, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11341) on 2026-10-01. Authority National Institute for Health and Care Excellence (NICE), Technology Appraisal Committee D (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope Untreated recurrent or metastatic nasopharyngeal cancer The estimate ### The number and the baselines it has to beat 40% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-042 · registered 40% Authority base rate −10 pts 50% Calendar cycle −15 pts 55% Analyst proxy 0 pts 40% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown at the cutoff is not yet counted; the calendar's census will count it. Expected dates are revised often, most when a committee meeting does not reach a final recommendation or a company asks for time. Calendar cycle 55% A clock-only model: a second committee meeting on 4 November, 70 days before the expected date, is treated as on schedule: the model assumes final draft guidance and an appeal period fit in that time. Analyst proxy 40% An analyst reading the project page on 2026-10-01 would weigh negative draft guidance and the company's earlier timeline changes. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-01-13 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-01-13 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2027-01-13 When the outcome can be read against the rule. Event by 2027-01-13 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 4b9f547e41c686454406c0b42587ad96ffae36e5fb558f2f4593b2c7c97f13d9 · operator record jc-1792036251160-f7e7886d ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID6406 shows a publication date ('Published: ') on or before 2027-01-13, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6406. Searching for GID-TA11341 finds the same project. Resolves NO if the guidance is published after 2027-01-13, if the expected date is revised and nothing is published by 2027-01-13, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2027-01-20. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11341, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 40% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15. review pathway STA Standard ("Process: STA Standard", SRC-001) submission type New appraisal; company "Leo Pharma (Toripalimab)" (SRC-001) evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class Comparator companies on SRC-001 are chemotherapy suppliers only (Amarox, Bristol Myers Squibb, Dr Reddys, Genus, Glenmark, Hospira UK, Medac, Sandoz, Seacross, Sun, Synchrony and Teva, for cisplatin, capecitabine, paclitaxel, gemcitabine, fluorouracil and docetaxel), all listed as "confidentiality agreement not signed, not participating". No same-class immunotherapy competitor is named. months since last guideline revision not applicable panel cycle position Committee meeting 1 was held on 5 August 2026. The draft guidance consultation ran from 27 August to 18 September 2026. Committee meeting 2 is on 4 November 2026, 70 days before the expected publication date of 13 January 2027 (SRC-001; SRC-003). sponsor request status The 11 April 2024 entry says that "following on from advice received from the company, further information regarding the timelines for this appraisal will be available in due course". The 29 July 2025 entry says the appraisal "has been scheduled back into the work programme" following advice from the company (SRC-001). No request is recorded in 2026. odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change Scheduled back into the work programme on 29 July 2025, after the 11 April 2024 entry left the timelines to be confirmed (SRC-001). Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development "Project information" page for ID6406. Shows the header line "Expected publication date: 13 January 2027", status, process, ID number, the provisional schedule, the enquiry e-mail address, stakeholders (where listed) and the "Timeline" table of key events. https://www.nice.org.uk/guidance/indevelopment/gid-ta11341 Retrieved 2026-10-01 · sha256 5ed09bf097bc9c2f7f37660323a23156420d075acbe0346b30c8dd7540493143 SRC-002 NICE "Project documents" tab for ID6406: lists documents by stage with publication dates (scope, stakeholder list, draft guidance where issued, committee meeting entries) and the text of notes added to the project documents. https://www.nice.org.uk/guidance/indevelopment/gid-ta11341/documents Retrieved 2026-10-01 · sha256 225db2b5b16d11e34395a2e11821f44816a95c2465bbaed30311b5dcac047acd SRC-003 NICE "Draft guidance: 1" consultation page for ID6406: "Closing date for comments: 5pm, 18 September 2026" and "After the consultation has closed the appraisal committee will meet again to consider the responses received and prepare the final draft guidance." https://www.nice.org.uk/guidance/gid-ta11341/documents/html-content-8 Retrieved 2026-10-01 · sha256 e222e3c3581902f97cca007a680fc06a01004f5bb02a014446750a2ccdfc6ac0 SRC-004 Draft guidance (downloadable PDF, published 27 August 2026). Section 1 reads: "1.1 Toripalimab with gemcitabine and cisplatin should not be used for first-line treatment of nasopharyngeal carcinoma in adults that is:", followed by two bullets (recurrent and not suitable for surgery or radiotherapy; or metastatic). https://www.nice.org.uk/guidance/gid-ta11341/documents/draft-guidance Retrieved 2026-10-01 · sha256 65f93c40e77243283dec388aa21ef886d7665177299b239c124e8681c16bbd6b SRC-005 NICE "Technology appraisal committees" page (reached from the meetings-in-public URL https://www.nice.org.uk/get-involved/meetings-in-public/technology-appraisal-committee, which returned HTTP 308 to it). Under "Next meeting dates" it lists Committee D meetings including "Wednesday 07 October 2026", "Wednesday 04 November 2026" and "Wednesday 02 December 2026"; it also lists published TAC minutes. It does not list which appraisals are on each agenda. https://www.nice.org.uk/get-involved/our-committees/nice-committee-meetings/technology-appraisal-committees Retrieved 2026-10-01 · sha256 8e6f62cd7fdf5be519f696bbeb8813e845b461e04dc894f32f2c57c49246c2a8 SRC-006 Confirmed minutes (Word) of the Technology Appraisal Committee D meeting on 5 August 2026, linked from the TAC page. Includes the agenda item "Appraisal of Toripalimab with chemotherapy for untreated recurrent or metastatic nasopharyngeal cancer [ID6406]", records that the chair welcomed "company representatives from Leo Pharma", and records that "The committee then agreed on the content of the Draft Guidance (DG) or Final Draft Guidance (FDG). The committee decision was reached by consensus." https://a.storyblok.com/f/243782/x/db4f87a2d5/confirmed-tac-d-minutes-5-august-2026.docx Retrieved 2026-10-01 · sha256 1aff5ad95a0a54ee5eb94461416bd678426d0bfc0d27effa25dd3ced81347f95 --- # 30% forecast: NICE publishes technology appraisal guidance on Trastuzumab deruxtecan for treating HER2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma after trastuzumab-based treatment (review of TA879) [ID6680] on or before 2027-01-27 URL: https://nextconsensus.com/forecast/ff-043/ Registered forecast 30% registered probability event by 2027-01-27 Unresolved ## NICE publishes technology appraisal guidance on Trastuzumab deruxtecan for treating HER2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma after trastuzumab-based treatment (review of TA879) [ID6680] on or before 2027-01-27 FF-043 Registered · Unresolved Registered probability 30% Event by 2027-01-27 Resolution window 2026-10-16 → 2027-01-27 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 45% - Analyst proxy 30% nextconsensus.com/forecast/ff-043/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Trastuzumab deruxtecan for treating HER2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma after trastuzumab-based treatment (review of TA879)' [ID6680], with a publication date on or before 2027-01-27, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11963) on 2026-10-01. Authority National Institute for Health and Care Excellence (NICE), Committee not named in the archived sources (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope HER2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma (review of TA879) The estimate ### The number and the baselines it has to beat 30% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-043 · registered 30% Authority base rate −20 pts 50% Calendar cycle −15 pts 45% Analyst proxy 0 pts 30% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown at the cutoff is not yet counted; the calendar's census will count it. Expected dates are revised often, most when a committee meeting does not reach a final recommendation or a company asks for time. Calendar cycle 45% A clock-only model: a first committee meeting on 19 November, 69 days before the expected date, is on schedule if that meeting reaches a final recommendation. Analyst proxy 30% An analyst reading the project page on 2026-10-01 would note that the meeting was moved once without a reason and that the schedule has no consultation round. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-01-27 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-01-27 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2027-01-27 When the outcome can be read against the rule. Event by 2027-01-27 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger d902cf0e98b73d882284e593712357ec3e10e57b41ffc3aa6299748a7b1512c1 · operator record jc-1792036251453-7c39e5bf ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID6680 shows a publication date ('Published: ') on or before 2027-01-27, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6680. Searching for GID-TA11963 finds the same project. This appraisal reviews TA879; the original publication date of TA879 does not count. If NICE publishes the review by updating TA879 in place, the date that page gives for this update is the publication date read. Resolves NO if the guidance is published after 2027-01-27, if the expected date is revised and nothing is published by 2027-01-27, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2027-02-03. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11963, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 30% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15. review pathway STA Standard ("Process: STA Standard"; "Prioritisation programme: Medicines evaluation", SRC-001) submission type Review of existing guidance TA879; company "Daiichi Sankyo (trastuzumab deruxtecan)" (SRC-001) evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class Comparator companies on SRC-001 supply irinotecan, paclitaxel, docetaxel and trifluridine–tipiracil (Amarox, Bristol Myers Squibb, Genus, Hospira, Medac, Pfizer, Seacross, Servier, Sun, Teva), all listed as "confidentiality agreement not signed, not participating". months since last guideline revision not applicable panel cycle position Committee meeting 1 is on 19 November 2026, 69 days before the expected publication date of 27 January 2027. No draft guidance consultation or second meeting is listed (SRC-001). sponsor request status No company request is recorded. The meeting was rescheduled on 20 July 2026, with no reason given (SRC-001). odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change None recorded (SRC-001). Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development "Project information" page for ID6680. Shows the header line "Expected publication date: 27 January 2027", status, process, ID number, the provisional schedule, the enquiry e-mail address, stakeholders (where listed) and the "Timeline" table of key events. https://www.nice.org.uk/guidance/indevelopment/gid-ta11963 Retrieved 2026-10-01 · sha256 2117ee4cd164325f1569381d07566aea2876db983d279591b0705b5db2d4372d SRC-002 NICE "Project documents" tab for ID6680: lists documents by stage with publication dates (scope, stakeholder list, draft guidance where issued, committee meeting entries) and the text of notes added to the project documents. https://www.nice.org.uk/guidance/indevelopment/gid-ta11963/documents Retrieved 2026-10-01 · sha256 989a2a0d2a278d94315cf858ede9cd2c0670ed6106393d42b8eccc886f8d0ec3 SRC-003 NICE "Highly specialised technologies evaluation committee" page. Under "Next meeting dates" it lists "Thursday 22 October 2026", "Thursday 19 November 2026" and "Thursday 17 December 2026". It does not list agenda items. https://www.nice.org.uk/get-involved/our-committees/nice-committee-meetings/highly-specialised-technologies-evaluation-committee Retrieved 2026-10-01 · sha256 34bbf46ef3258a8c0e30dc6dca8a9ec72f63b0bf7bebe267338fc66ec691d7ff SRC-004 NICE "Technology appraisal committees" page (reached from the meetings-in-public URL https://www.nice.org.uk/get-involved/meetings-in-public/technology-appraisal-committee, which returned HTTP 308 to it). Under "Next meeting dates" it lists Committee A–D meetings including Committee A "Tuesday 10 November 2026", Committee B "Thursday 12 November 2026", Committee C "Tuesday 03 November 2026" and Committee D "Wednesday 04 November 2026" (none of the four committees lists 19 November 2026); it also lists published TAC minutes. It does not list which appraisals are on each agenda. https://www.nice.org.uk/get-involved/our-committees/nice-committee-meetings/technology-appraisal-committees Retrieved 2026-10-01 · sha256 8e6f62cd7fdf5be519f696bbeb8813e845b461e04dc894f32f2c57c49246c2a8 --- # 80% forecast: FDA approves oral infigratinib for children with achondroplasia on or before the disclosed PDUFA goal date of 2027-02-04 URL: https://nextconsensus.com/forecast/ff-044/ Registered forecast 80% registered probability event by 2027-02-04 Unresolved ## FDA approves oral infigratinib for children with achondroplasia on or before the disclosed PDUFA goal date of 2027-02-04 FF-044 Registered · Unresolved Registered probability 80% Event by 2027-02-04 Resolution window 2026-10-16 → 2027-02-04 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 85% - Calendar cycle 80% - Analyst proxy 80% nextconsensus.com/forecast/ff-044/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on BridgeBio Pharma's New Drug Application for oral infigratinib for the treatment of children with achondroplasia, with an approval action date on or before 2027-02-04, the PDUFA target action date disclosed in Exhibit 99.1 to BridgeBio's Form 8-K filed 2026-10-13. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope Achondroplasia in children, oral The estimate ### The number and the baselines it has to beat 80% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-044 · registered 80% Authority base rate −5 pts 85% Calendar cycle 0 pts 80% Analyst proxy 0 pts 80% Authority base rate 85% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Original NDAs under Priority Review with a positive phase 3 trial are approved at their first goal date in a large majority of cases. The calendar's own met-goal-date share for disclosed PDUFA dates does not exist yet (docs/foundations/short-horizon-reference-classes.md §4.1). Calendar cycle 80% A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle actions on original NDAs are approvals. With no evidence input it cannot tell a strong application from a weak one. Analyst proxy 80% An analyst reading the same filings on 2026-10-13 would weigh a phase 3 trial that met its primary and key secondary endpoints, Priority Review and Breakthrough Therapy designation against a first approval of an oral FGFR3 inhibitor for long-term use in children, with no statement on an advisory committee. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-02-04 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-02-04 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2027-02-04 When the outcome can be read against the rule. Event by 2027-02-04 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 1538844d949089accb6f028165bb4a479dbb648525433afaeaa75602daa91b16 · operator record jc-1792036449913-beb21bb5 ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast The application number was not public at the cutoff, and the ingredient already has an approval that is not this one: openFDA lists NDA214622 (TRUSELTIQ, infigratinib phosphate, applicant Helsinn Healthcare, both strengths discontinued), whose ORIG-1 was approved 2021-05-28 for an oncology indication (SRC-005). That approval does not count. The adjudicator identifies the qualifying approval by its indication plus its ingredient, never by a name the adjudicator infers: an approval action whose Drugs@FDA approval letter or label names achondroplasia in its indication, for a product whose active ingredient is infigratinib or a salt of it (infigratinib phosphate, for example), under any applicant (BridgeBio Pharma, its subsidiary QED Therapeutics, or another BridgeBio subsidiary) and any proprietary name. Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22INFIGRATINIB%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22infigratinib%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain such an approval: an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2027-02-04, or, if FDA acts on the achondroplasia indication as a supplement to an existing infigratinib application, an efficacy supplement with submission_status AP and a submission_status_date on or before 2027-02-04 whose letter or label adds achondroplasia. An approval for a narrower achondroplasia population than the applicant sought (by age, for example) still resolves YES, as does accelerated rather than traditional approval. Resolves NO if no approval action is dated on or before 2027-02-04: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2027-02-04 resolves NO as occurred_after_deadline. 2027-02-04 is a Thursday. Read no earlier than 2027-02-18. If openFDA has not refreshed by then, or both queries return nothing new, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name infigratinib) governs, under the same identification test. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22infigratinib%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22INFIGRATINIB%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 80% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15, including the one field whose value was unknown then. It is left unknown rather than filled in. review pathway Priority Review (SRC-001). Breakthrough Therapy, Orphan Drug, Fast Track and Rare Pediatric Disease designations (SRC-001). Center CDER is the drafter's understanding (a small-molecule NDA), unverified. submission type NDA for oral infigratinib in achondroplasia (SRC-001, SRC-004); application number not public. The ingredient was approved in 2021 under NDA214622 (TRUSELTIQ, Helsinn Healthcare, discontinued) for another indication (SRC-005). evidence class Placebo-controlled phase 3 trial, PROPEL 3, at 52 weeks; supported by the phase 2 PROPEL 2 trial, on which the Breakthrough Therapy designation rests (SRC-001). pivotal n unknown — not stated in the archived sources endpoint type Clinical growth measure: change from baseline in annualized height velocity at Week 52 (primary) and height Z-score (key secondary) (SRC-001). approved competitors in class BridgeBio states infigratinib would be "the first and only approved oral therapy" for children with achondroplasia (SRC-001); the archived sources do not name the approved non-oral therapy. months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status NDA submitted by 2026-08-10 (SRC-003, SRC-004); FDA acceptance with Priority Review announced 2026-10-06 (SRC-001, SRC-002). odac referral none announced in the archived sources sponsor state change none recorded in the archived sources since NDA submission Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 BridgeBio Form 8-K Exhibit 99.1, filed 2026-10-13: press release dated 2026-10-06. FDA accepted for filing the NDA for oral infigratinib for children with achondroplasia, with Priority Review and a PDUFA target action date of February 4, 2027; PROPEL 3 primary and key secondary endpoints met; Breakthrough Therapy, Orphan Drug, Fast Track and Rare Pediatric Disease designations. https://www.sec.gov/Archives/edgar/data/1743881/000114036126039334/ef20083591_ex99-1.htm Retrieved 2026-10-13 · sha256 abe11708586a7ad9d46577fd0494535f409bf77ee23be9663294d9f8bde201fd SRC-002 BridgeBio Form 8-K (Item 8.01), filed 2026-10-13, date of report 2026-10-06: attaches the press release on FDA acceptance and Priority Review of the oral infigratinib NDA as Exhibit 99.1. https://www.sec.gov/Archives/edgar/data/1743881/000114036126039334/ef20083591_form8k.htm Retrieved 2026-10-13 · sha256 632c2dae627a378654c204a2e3e91f888a3f0446412f9abc17c6869d29efb814 SRC-003 BridgeBio Form 8-K Exhibit 99.1 (Q2 2026 results), filed 2026-08-10. States the oral infigratinib NDA for achondroplasia has been submitted, U.S. launch expected mid-2027, an MAA planned for Q4 2026, and 720.2 million dollars in cash, cash equivalents and marketable securities at 2026-06-30. https://www.sec.gov/Archives/edgar/data/1743881/000174388126000026/bbio-20260630xex991.htm Retrieved 2026-10-13 · sha256 96ceaa9a3ec1b41543806dafe62ca7706dc6744b5fe9ea8c65a4cfcedfb40a72 SRC-004 BridgeBio Form 10-Q for the quarter ended 2026-06-30, filed 2026-08-10. States the NDA for low-dose infigratinib for achondroplasia was submitted to FDA; infigratinib is held through the subsidiary QED Therapeutics; Kyowa Kirin licence for Japan. https://www.sec.gov/Archives/edgar/data/1743881/000174388126000027/bbio-20260630.htm Retrieved 2026-10-13 · sha256 33dd6ac8e3cadc99150a806abaad486506b9db279e36c41521819bdf15d1ddee SRC-005 openFDA drugsfda products.active_ingredients.name:"INFIGRATINIB", retrieved 2026-10-13: one application, NDA214622 (TRUSELTIQ, infigratinib phosphate, applicant Helsinn Healthcare, both strengths Discontinued), ORIG-1 approved 2021-05-28. No application for achondroplasia. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22INFIGRATINIB%22&limit=100 Retrieved 2026-10-13 · sha256 64408fda8ae654c727b3b21ddbca25b0a7db73a5203dfc82955cf4483361eb68 SRC-006 openFDA drugsfda openfda.generic_name:"infigratinib", retrieved 2026-10-13: 404 No matches found. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22infigratinib%22&limit=100 Retrieved 2026-10-13 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da --- # 70% forecast: FDA approves once-weekly oral lenacapavir (YEZTUGO) for HIV-1 pre-exposure prophylaxis on or before the disclosed PDUFA goal date of 2027-02-02 URL: https://nextconsensus.com/forecast/ff-045/ Registered forecast 70% registered probability event by 2027-02-02 Unresolved ## FDA approves once-weekly oral lenacapavir (YEZTUGO) for HIV-1 pre-exposure prophylaxis on or before the disclosed PDUFA goal date of 2027-02-02 FF-045 Registered · Unresolved Registered probability 70% Event by 2027-02-02 Resolution window 2026-10-16 → 2027-02-02 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 85% - Calendar cycle 80% - Analyst proxy 70% nextconsensus.com/forecast/ff-045/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on Gilead Sciences' supplemental New Drug Application for YEZTUGO (lenacapavir) 300-mg tablets as a once-weekly oral regimen for HIV-1 pre-exposure prophylaxis, with an approval action date on or before 2027-02-02, the PDUFA target action date disclosed in Gilead's Form 10-Q filed 2026-08-06. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope HIV-1 pre-exposure prophylaxis, once-weekly oral The estimate ### The number and the baselines it has to beat 70% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-045 · registered 70% Authority base rate −15 pts 85% Calendar cycle −10 pts 80% Analyst proxy 0 pts 70% Authority base rate 85% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Efficacy supplements to approved drugs are approved at their first goal date more often than original applications. The calendar's own count does not exist yet. Calendar cycle 80% A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle supplement actions are approvals. Analyst proxy 70% An HIV analyst reading the same filings on 2026-10-01 would weigh an approved active ingredient already labelled for interim weekly oral use against filings that describe neither the evidence nor the review type for a standalone once-weekly regimen. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-02-02 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-02-02 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2027-02-02 When the outcome can be read against the rule. Event by 2027-02-02 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 8b208db8497b08d9f2b1d79efd1b3eb15e4c5ccd2cd78c455a887da72420f9d9 · operator record jc-1792036539479-aaeb1133 ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast The filings do not give the application number; openFDA lists YEZTUGO 300 mg tablets under NDA220020 (SRC-003), so the approval is identified by content, applicant and date. The label approved with NDA220020 ORIG 1 on 2025-06-18 already permits oral lenacapavir 300 mg once every 7 days on an interim basis while injections are delayed (SRC-005); that does not count. Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22lenacapavir%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22LENACAPAVIR%20SODIUM%22&limit=100, read together, contain a Gilead application with a submission, original or supplement, whose submission_status is AP and whose submission_status_date is after 2026-10-01 and on or before 2027-02-02, and whose Drugs@FDA approval letter or label provides once-weekly oral lenacapavir as a regimen for HIV-1 pre-exposure prophylaxis in its own right, not only as interim dosing while injections are delayed. An approval for a narrower PrEP population than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2027-02-02: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2027-02-02 resolves NO as occurred_after_deadline. Read no earlier than 2027-02-16. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name lenacapavir) governs, under the same content test. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22lenacapavir%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22LENACAPAVIR%20SODIUM%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 70% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15, including the 4 fields whose values were unknown then. Those are left unknown rather than filled in. review pathway unknown — not stated in the archived sources submission type Supplemental NDA (SRC-001, SRC-002). evidence class unknown — not stated in the archived sources pivotal n unknown — not stated in the archived sources endpoint type unknown — not stated in the archived sources approved competitors in class Lenacapavir is already approved for PrEP as YEZTUGO (NDA220018 injection, NDA220020 tablets, approved 2025-06-18) and for treatment as SUNLENCA and in BIXLENVO (SRC-003, SRC-004); other PrEP products (e.g., DESCOVY FOR PREP, TRUVADA FOR PREP) are Gilead trademarks listed in SRC-001. months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status FDA acceptance of the sNDA is stated in the Q2 2026 results filed 2026-08-04 and the 10-Q filed 2026-08-06; neither states the submission date (SRC-001, SRC-002). odac referral none announced in the archived sources sponsor state change None reported. Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Gilead Form 10-Q for the quarter ended 2026-06-30, filed 2026-08-06 (latest filing stating the date). States FDA accepted a supplemental NDA submission for Yeztugo 300-mg tablet as a potential once-weekly oral formulation for HIV PrEP with PDUFA target action date February 2, 2027. https://www.sec.gov/Archives/edgar/data/882095/000088209526000031/gild-20260630.htm Retrieved 2026-10-01 · sha256 d5966689c4b6acc58b939e92e2dc798c9148549b34baf98187eb8c9c8d4a43f0 SRC-002 Gilead Form 8-K Exhibit 99.1 (Q2 2026 results), filed 2026-08-04. Same statement: supplemental NDA for Yeztugo (lenacapavir) 300-mg tablets as a potential once-weekly oral formulation for PrEP accepted, PDUFA target action date February 2, 2027. https://www.sec.gov/Archives/edgar/data/882095/000088209526000028/exhibit991earningspressrel.htm Retrieved 2026-10-01 · sha256 875fc8007ddd619b0a0da442a811ed4c5a5a9252d19ff8412517807728cede10 SRC-003 openFDA drugsfda application_number:"NDA220020", retrieved 2026-10-01 (meta last_updated 2026-09-29): YEZTUGO tablet, lenacapavir sodium eq 300 mg base; ORIG-1 approved 2025-06-18; no supplements. https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA220020%22 Retrieved 2026-10-01 · sha256 0a3a30b3f1b5dbe3610044be68acf6287a1620b63c13283c49181f22f4bc2541 SRC-004 openFDA drugsfda products.active_ingredients.name:"LENACAPAVIR", retrieved 2026-10-01: six Gilead lenacapavir applications (YEZTUGO, SUNLENCA, BIXLENVO). https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22LENACAPAVIR%22&limit=100 Retrieved 2026-10-01 · sha256 a9d88723d46aab585e53ec5f35141ac5dd6481a0af2c1797ab24ad27bae57290 SRC-005 Drugs@FDA prescribing information for YEZTUGO approved with NDA 220020 ORIG 1 (2025-06-18). Its dosing table for anticipated delayed injections gives oral lenacapavir 300 mg once every 7 days for interim use only. This is why the rule requires an approval after the cutoff for a standalone weekly regimen. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/220020s000lbl.pdf Retrieved 2026-10-01 · sha256 e41e9284827ea5f028d41d0b70c4b6b013900a8ad2858dc9e21e5157d471e394 --- # 85% forecast: FDA approves the leniolisib (JOENJA) pediatric supplement for APDS in children weighing 13 kg to 27 kg on or before the disclosed PDUFA goal date of 2027-01-30 URL: https://nextconsensus.com/forecast/ff-046/ Registered forecast 85% registered probability event by 2027-01-30 Unresolved ## FDA approves the leniolisib (JOENJA) pediatric supplement for APDS in children weighing 13 kg to 27 kg on or before the disclosed PDUFA goal date of 2027-01-30 FF-046 Registered · Unresolved Registered probability 85% Event by 2027-01-30 Resolution window 2026-10-16 → 2027-01-30 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 85% - Calendar cycle 80% - Analyst proxy 85% nextconsensus.com/forecast/ff-046/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on a supplement to NDA 217759 (leniolisib, JOENJA; applicant Pharming) whose approved labeling provides dosing for patients with activated phosphoinositide 3-kinase delta syndrome (APDS) weighing 13 kg to less than 27 kg, with an approval action date on or before 2027-01-30, the PDUFA target action date disclosed in Pharming's Form 6-K furnished 2026-09-25. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope APDS in children 4 years and older weighing 13 kg to less than 27 kg The estimate ### The number and the baselines it has to beat 85% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-046 · registered 85% Authority base rate 0 pts 85% Calendar cycle +5 pts 80% Analyst proxy 0 pts 85% Authority base rate 85% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Efficacy supplements to approved drugs are approved at their first goal date more often than original applications. The calendar's own count does not exist yet. Calendar cycle 80% A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle supplement actions are approvals. Analyst proxy 85% An analyst reading the same filings on 2026-10-01 would weigh priority review and FDA's approval of the previous pediatric supplement on 2026-09-11 against an open-label single-arm basis and a chief executive's sudden departure. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-01-30 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-01-30 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2027-01-30 When the outcome can be read against the rule. Event by 2027-01-30 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 7d58d3ccc4f675de696cdbed410ac76e0198710c03c6c10f60f7f3691c5f4822 · operator record jc-1792036524728-eb86fb81 ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the openFDA Drugs@FDA record for application NDA217759 (https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA217759%22) contains a submission with submission_type SUPPL, submission_status AP and a submission_status_date on or before 2027-01-30, and the Drugs@FDA approval letter or label for that supplement provides dosing for patients with APDS weighing 13 kg to less than 27 kg. The supplement is identified by that content, not by its number or class code. At the cutoff the latest approved supplement was SUPPL 6, approved 2026-09-11, which added dosing for children aged 4 to 11 weighing 27 kg or more and is not this supplement (SRC-003). An approval covering part of the 13 kg to 27 kg range, or a narrower age range, still resolves YES. Resolves NO if no approval action is dated on or before 2027-01-30: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2027-01-30 resolves NO as occurred_after_deadline. 2027-01-30 is a Saturday; an approval action dated that day still counts. Read no earlier than 2027-02-13; if openFDA has not refreshed, the Drugs@FDA web record for NDA217759 (https://www.accessdata.fda.gov/scripts/cder/daf/) governs. Resolves unresolvable only if neither source can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA217759%22, https://www.accessdata.fda.gov/scripts/cder/daf/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 85% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15, including the one field whose value was unknown then. It is left unknown rather than filled in. review pathway Priority Review (SRC-001). Center CDER is the drafter's understanding (NDA listed in openFDA drugsfda), unverified. submission type Supplemental NDA (efficacy; new pediatric population/lower doses) (SRC-001, SRC-002). evidence class Open-label, multinational, single-arm Phase III study in children aged 4–11 years plus clinical pharmacology assessments supporting lower-weight dosing (SRC-001). pivotal n unknown — not stated in the archived sources endpoint type Pharmacodynamic/clinical markers over 12 weeks: reduced lymphadenopathy and increased naive B cells (SRC-001). approved competitors in class None stated: Joenja is described as "the first and only targeted treatment" of APDS (SRC-001). months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status sNDA submitted July 30, 2026 (SRC-002); acceptance and Priority Review announced September 25, 2026 (SRC-001). A prior sNDA (40 mg and 50 mg doses, ages 4–11 weighing ≥27 kg) was approved September 11, 2026 (SRC-002, SRC-003). odac referral none announced in the archived sources sponsor state change CEO Fabrice Chouraqui stepped down with immediate effect on September 29, 2026; interim co-CEOs appointed (SRC-004). Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Pharming Form 6-K with press release dated 2026-09-25. Announces FDA acceptance and Priority Review of the sNDA for lower doses of Joenja for children aged 4 years and older weighing between 13 kg and 27 kg with APDS; PDUFA target action date January 30, 2027; supporting single-arm Phase III data. https://www.sec.gov/Archives/edgar/data/1828316/000182831626000041/pharmingannouncesusfdaacce.htm Retrieved 2026-10-01 · sha256 e6986192cdd37573490fe51206ccedb3db01e6b8621e279dc43b793c781a856b SRC-002 Pharming Form 6-K with press release dated 2026-09-11. Announces FDA approval of the sNDA for 40 mg and 50 mg doses for children 4–11 years weighing at least 27 kg, and that on July 30 Pharming submitted a separate sNDA for lower doses for patients aged 4 to 11 weighing 13 kg to less than 27 kg. https://www.sec.gov/Archives/edgar/data/1828316/000182831626000037/fdaapprovespharmingsjoenja.htm Retrieved 2026-10-01 · sha256 20cd82713279acc0a141da4321616995a2f29d6a5407a47f00b1e97107b54664 SRC-003 openFDA drugsfda application_number:"NDA217759", retrieved 2026-10-01 (meta last_updated 2026-09-29): ORIG-1 (2023-03-24), SUPPL-5 labeling (2025-05-28), SUPPL-6 efficacy approved 2026-09-11. https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA217759%22 Retrieved 2026-10-01 · sha256 5debf1c67b168cc924cc9116064b3679025ccbbe4b1c9c0e65d0eb4a41610c60 SRC-004 Pharming Form 6-K with press release dated 2026-09-29 (latest before cutoff). Announces CEO Fabrice Chouraqui stepping down with immediate effect and appointment of interim co-CEOs. https://www.sec.gov/Archives/edgar/data/1828316/000182831626000043/pharmingannouncesceotransi.htm Retrieved 2026-10-01 · sha256 8dc9a1cc16a4a1ffb0d4dde6d279ae01fef60fd3014df2dd053c04113100e8b3 --- # 78% forecast: FDA approves fast-acting meloxicam (MR-107A-02) for moderate-to-severe acute pain on or before the disclosed PDUFA goal date of 2026-12-27 URL: https://nextconsensus.com/forecast/ff-047/ Registered forecast 78% registered probability event by 2026-12-27 Unresolved ## FDA approves fast-acting meloxicam (MR-107A-02) for moderate-to-severe acute pain on or before the disclosed PDUFA goal date of 2026-12-27 FF-047 Registered · Unresolved Registered probability 78% Event by 2026-12-27 Resolution window 2026-10-16 → 2026-12-27 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 85% - Calendar cycle 80% - Analyst proxy 75% nextconsensus.com/forecast/ff-047/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on Viatris' New Drug Application for MR-107A-02, a fast-acting formulation of meloxicam, for the treatment of moderate-to-severe acute pain, with an approval action date on or before 2026-12-27, the PDUFA goal date disclosed in Exhibit 99.1 to Viatris' Form 8-K filed 2026-08-06. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope Moderate-to-severe acute pain The estimate ### The number and the baselines it has to beat 78% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-047 · registered 78% Authority base rate −7 pts 85% Calendar cycle −2 pts 80% Analyst proxy +3 pts 75% Authority base rate 85% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Applications built on positive randomized controlled trials are approved at their first goal date in a large majority of cases. The calendar's own met-goal-date share for disclosed PDUFA dates does not exist yet. Calendar cycle 80% A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle actions on applications like this are approvals. With no evidence input it cannot tell a strong application from a weak one. Analyst proxy 75% An analyst reading the same filings on 2026-10-01 would weigh two positive phase 3 trials for a new formulation of an approved molecule against a large applicant reporting manufacturing disruptions elsewhere in its business, and would call approval by the goal date likely. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2026-12-27 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2026-12-27 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2026-12-27 When the outcome can be read against the rule. Event by 2026-12-27 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 9c51088291ab311f3c636cb2e206928cd7cdccc0514f8d1f59f36c91a80149f7 · operator record jc-1792036513857-9a533f43 ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Meloxicam is already marketed under several applications, so this one is identified by applicant and indication, not by ingredient alone. At the cutoff openFDA listed no meloxicam NDA held by Viatris or Mylan (SRC-003, SRC-005). Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22MELOXICAM%22&limit=100 contain an NDA held by Viatris, Mylan or another Viatris subsidiary whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-12-27, and the Drugs@FDA approval letter or label for that application indicates the product for acute pain. An approval for a narrower acute-pain population or a narrower setting than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2026-12-27: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-12-27 resolves NO as occurred_after_deadline. 2026-12-27 is a Sunday; an approval action dated that day still counts. Read no earlier than 2027-01-10. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name meloxicam) governs, under the same applicant and indication test. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22MELOXICAM%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 78% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15, including the 2 fields whose values were unknown then. Those are left unknown rather than filled in. review pathway unknown — not stated in the archived sources. Center CDER is the drafter's understanding, unverified. submission type New Drug Application (SRC-001); Viatris describes fast-absorbing meloxicam among its "505(b)(2) products" (SRC-002). evidence class Two pivotal randomized, double-blind, placebo- (double-dummy) and active-controlled Phase 3 trials (post-herniorrhaphy and post-bunionectomy), all primary and key secondary endpoints met per Viatris (SRC-002). pivotal n unknown — not stated in the archived sources endpoint type Acute post-surgical pain efficacy endpoints (specific primary endpoint not stated in the archived sources) (SRC-002). approved competitors in class Multiple meloxicam NDAs are approved (e.g., MOBIC, VIVLODEX, QMIIZ ODT, ANJESO, XIFYRM, QAMZOVA, ZYNRELEF KIT, SYMBRAVO per openFDA, SRC-004); none held by Viatris/Mylan. months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status FDA accepted the NDA for review (announced May 2026) (SRC-001); submission date not stated in the archived sources. odac referral none announced in the archived sources sponsor state change None reported for the program. Viatris reported expected product supply disruptions affecting 2H 2026 revenues (company-level; not tied to MR-107A-02 in the source) (SRC-001). Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Viatris Form 8-K Exhibit 99.1 (Q2 2026 results), filed 2026-08-06. States that in May the FDA accepted for review the NDA for MR-107A-02 (fast-acting meloxicam) for moderate-to-severe acute pain with a PDUFA goal date of December 27, 2026; mentions expected product supply disruptions. https://www.sec.gov/Archives/edgar/data/1792044/000179204426000037/exhibit991-2q26earningsrel.htm Retrieved 2026-10-01 · sha256 b1a637e248f6efc8a3c674603cbd5b4fa501c0d551c7cb490685b582449738b0 SRC-002 Viatris Form 10-K for fiscal 2025, filed 2026-02-26. Describes positive topline results from two pivotal Phase 3 studies of MR-107A-02 (herniorrhaphy, bunionectomy) and lists fast-absorbing meloxicam among Viatris 505(b)(2) products. https://www.sec.gov/Archives/edgar/data/1792044/000179204426000013/vtrs-20251231.htm Retrieved 2026-10-01 · sha256 93452ba56d17910104f3582dd7de728324fe611874b836e25d0ad67b3e991c40 SRC-003 openFDA drugsfda products.active_ingredients.name:"MELOXICAM" AND sponsor_name:"VIATRIS", retrieved 2026-10-01: 404 No matches found. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22MELOXICAM%22+AND+sponsor_name:%22VIATRIS%22&limit=100 Retrieved 2026-10-01 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da SRC-004 openFDA drugsfda products.active_ingredients.name:"MELOXICAM" AND application_number:NDA*, retrieved 2026-10-01 (meta last_updated 2026-09-29): nine meloxicam NDAs, none held by Viatris or Mylan. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22MELOXICAM%22+AND+application_number:NDA*&limit=100 Retrieved 2026-10-01 · sha256 3b719a289b7cde82da8e105d23ed0ded16964fcfaa9e673746f9be2d0902386c SRC-005 openFDA drugsfda products.active_ingredients.name:"MELOXICAM" AND sponsor_name:"MYLAN", retrieved 2026-10-01: one result, ANDA077934 (generic). https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22MELOXICAM%22+AND+sponsor_name:%22MYLAN%22&limit=100 Retrieved 2026-10-01 · sha256 5202f0bb11b3b0be247a195de0f131baea6dea4f74e10aacc03f12be907a5582 --- # 35% forecast: NICE publishes technology appraisal guidance on Intrathecal onasemnogene abeparvovec for treating spinal muscular atrophy in people 2 years and over [ID6556] on or before 2026-11-25 URL: https://nextconsensus.com/forecast/ff-048/ Registered forecast 35% registered probability event by 2026-11-25 Unresolved ## NICE publishes technology appraisal guidance on Intrathecal onasemnogene abeparvovec for treating spinal muscular atrophy in people 2 years and over [ID6556] on or before 2026-11-25 FF-048 Registered · Unresolved Registered probability 35% Event by 2026-11-25 Resolution window 2026-10-16 → 2026-11-25 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 55% - Analyst proxy 35% nextconsensus.com/forecast/ff-048/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Intrathecal onasemnogene abeparvovec for treating spinal muscular atrophy in people 2 years and over' [ID6556], with a publication date on or before 2026-11-25, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11733) on 2026-10-01. Authority National Institute for Health and Care Excellence (NICE), Technology Appraisal Committee C (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope Spinal muscular atrophy in people 2 years and over (intrathecal) The estimate ### The number and the baselines it has to beat 35% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-048 · registered 35% Authority base rate −15 pts 50% Calendar cycle −20 pts 55% Analyst proxy 0 pts 35% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown at the cutoff is not yet counted; the calendar's census will count it. Expected dates are revised often, most when a committee meeting does not reach a final recommendation or a company asks for time. Calendar cycle 55% A clock-only model: a second committee meeting on 6 October, 50 days before the expected date, is treated as on schedule: the model assumes final draft guidance and an appeal period fit in that time. Analyst proxy 35% An analyst reading the project page on 2026-10-01 would see negative draft guidance that gives an evidence reason, that there is not enough evidence to determine benefit in this population, and would weigh whether the company can answer it at the second meeting. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2026-11-25 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2026-11-25 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2026-11-25 When the outcome can be read against the rule. Event by 2026-11-25 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 1c0eae273bc6b82f713fbd6719cd297f5258c7a10c8f6559bd0aa7eef528c792 · operator record jc-1792036498691-cb762f38 ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID6556 shows a publication date ('Published: ') on or before 2026-11-25, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6556. Searching for GID-TA11733 finds the same project. Resolves NO if the guidance is published after 2026-11-25, if the expected date is revised and nothing is published by 2026-11-25, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-12-02. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11733, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 35% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15. review pathway STA by Technology Appraisal Committee C (SRC-001, SRC-003) submission type New appraisal; company Novartis Pharmaceuticals UK (SRC-001) evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class Comparator companies: Biogen (nusinersen) - participating; Roche (risdiplam) - participating; Novartis Pharmaceuticals UK (onasemnogene abeparvovec [intravenous infusion]) - not participating (SRC-001) months since last guideline revision not applicable panel cycle position Committee meeting 1: 07 July 2026; draft guidance 29 July - 19 August 2026; committee meeting 2 scheduled 06 October 2026, 50 days before the expected publication date of 25 November 2026 (SRC-001, SRC-003, SRC-005). sponsor request status No company request for more time or pause is recorded in the archived sources. odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change None recorded in the archived sources. Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development page (Project information tab) for GID-TA11733. Shows 'Expected publication date: 25 November 2026', status 'In progress', 'Process: STA Standard', provisional schedule (committee meeting 2: 06 October 2026; expected publication 25 November 2026), comparator companies and the timeline (committee meeting 1 on 07 July 2026; draft guidance 29 July - 19 August 2026). https://www.nice.org.uk/guidance/indevelopment/gid-ta11733 Retrieved 2026-10-01 · sha256 fbd7fcac68660dd731045fc4ce7625456cc3b421fbe6d786229442a58a60861e SRC-002 NICE Project documents tab for GID-TA11733. Latest documents: draft guidance and committee papers 'Published: 29 July 2026'; register of interests 'Published: 14 September 2026'. https://www.nice.org.uk/guidance/indevelopment/gid-ta11733/documents Retrieved 2026-10-01 · sha256 12e2cfb3f77734e7e03667380e4235799167d722b17e9bebd88cd8149e1f1cd7 SRC-003 Draft guidance consultation PDF (issue date July 2026). Recommendation 1.1 (should not be used), key dates (closing date for comments 19th August 2026; second evaluation committee meeting 6th October 2026) and 'This topic was considered by committee C.' https://www.nice.org.uk/guidance/gid-ta11733/documents/draft-guidance Retrieved 2026-10-01 · sha256 95d8f31a0562253b1db442a569b3d9857a73dba65db0848d07b39f65e323b3b6 SRC-004 Confirmed minutes of NICE Technology Appraisal Committee C, Tuesday 7 July 2026 (Word). Records the appraisal of intrathecal onasemnogene abeparvovec [ID6556] with company Novartis Pharmaceuticals and a discussion of the evidence. https://a.storyblok.com/f/243782/x/c556eb085c/confirmed-tac-c-minutes-7-july-2026.docx Retrieved 2026-10-01 · sha256 dd87a4a844e5f386e67eead247587529c728c986769befb166589293449538b0 SRC-005 NICE Technology appraisal committees page. Lists next meeting dates including Committee C 'Tuesday 06 October 2026', 'Tuesday 03 November 2026' and 'Tuesday 01 December 2026'. https://www.nice.org.uk/get-involved/our-committees/nice-committee-meetings/technology-appraisal-committees Retrieved 2026-10-01 · sha256 8e6f62cd7fdf5be519f696bbeb8813e845b461e04dc894f32f2c57c49246c2a8 --- # 35% forecast: NICE publishes technology appraisal guidance on Pembrolizumab with enfortumab vedotin for neoadjuvant and adjuvant treatment of muscle-invasive bladder cancer [ID6607] on or before 2027-02-10 URL: https://nextconsensus.com/forecast/ff-049/ Registered forecast 35% registered probability event by 2027-02-10 Unresolved ## NICE publishes technology appraisal guidance on Pembrolizumab with enfortumab vedotin for neoadjuvant and adjuvant treatment of muscle-invasive bladder cancer [ID6607] on or before 2027-02-10 FF-049 Registered · Unresolved Registered probability 35% Event by 2027-02-10 Resolution window 2026-10-16 → 2027-02-10 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 50% - Analyst proxy 35% nextconsensus.com/forecast/ff-049/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Pembrolizumab with enfortumab vedotin for neoadjuvant and adjuvant treatment of muscle-invasive bladder cancer' [ID6607], with a publication date on or before 2027-02-10, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11694) on 2026-10-13. Authority National Institute for Health and Care Excellence (NICE), Technology Appraisal Committee (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope Muscle-invasive bladder cancer, neoadjuvant and adjuvant The estimate ### The number and the baselines it has to beat 35% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-049 · registered 35% Authority base rate −15 pts 50% Calendar cycle −15 pts 50% Analyst proxy 0 pts 35% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown at the cutoff is not yet counted; the calendar's census will count it. Expected dates are revised often, most when a committee meeting does not reach a final recommendation or a company asks for time. Calendar cycle 50% A clock-only model: a committee meeting on 7 October, 126 days before the expected date, leaves time for final draft guidance and an appeal period if that meeting reached a final recommendation. Analyst proxy 35% An analyst reading the project page on 2026-10-13 would note a combined appraisal of a high-cost combination in a curative-intent setting, with one meeting scheduled and nothing yet published from it, and would expect draft guidance more often than final draft guidance. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-02-10 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-02-10 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2027-02-10 When the outcome can be read against the rule. Event by 2027-02-10 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 9fa7009db5ca9c68eeaeadef57686242b38043921756c0c9b8b3d7693485cf2b · operator record jc-1792036450236-7dd1d527 ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID6607 shows a publication date ('Published: ') on or before 2027-02-10, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6607. Searching for GID-TA11694 finds the same project. The project page records that ID6301 was combined into this appraisal, which continues under ID6607 with the title "Enfortumab vedotin with pembrolizumab for neoadjuvant and adjuvant treatment of muscle-invasive bladder cancer"; guidance published from project ID6607 under either title counts. Resolves NO if the guidance is published after 2027-02-10, if the expected date is revised and nothing is published by 2027-02-10, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2027-02-17. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11694, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 35% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15. review pathway STA Standard ("Process: STA Standard", SRC-001) submission type New appraisal, combined with ID6301 on 16 January 2026 (SRC-001; SRC-002); company "MSD (pembrolizumab)" (SRC-001) evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class Comparator companies on SRC-001: Astellas Pharma (enfortumab vedotin), AstraZeneca (durvalumab), Hospira UK (cisplatin, gemcitabine); Amarox, Sandoz (cisplatin), Bristol Myers Squibb (nivolumab), Sun Pharma and Synchrony (gemcitabine) are listed as "CAU not returned, not participating". months since last guideline revision not applicable panel cycle position Committee meeting on 7 October 2026, 126 days before the expected publication date of 10 February 2027. No draft guidance, consultation or second meeting is listed at the cutoff (SRC-001; SRC-002). The enquiry address is TACommD, and committee D met on 7 October 2026 (SRC-003). sponsor request status Timelines revised on information from the company, with the appraisal starting in March 2026 (note of 7 November 2025, SRC-001). No request is recorded since. odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change Combined with ID6301 "following discussions with the company" (SRC-001; SRC-002). Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development "Project information" page. Shows the header line with the expected publication date, status, process, ID number, the provisional schedule, stakeholders (where listed) and the "Timeline" table of key events. https://www.nice.org.uk/guidance/indevelopment/gid-ta11694 Retrieved 2026-10-13 · sha256 6045283733758b489050f167f6c2931a868d624a602669afe8b34f5f1f15943d SRC-002 NICE "Project documents" tab: lists documents by stage with publication dates (scope, stakeholder list, draft guidance where issued, committee meeting entries) and the text of notes added to the project documents. https://www.nice.org.uk/guidance/indevelopment/gid-ta11694/documents Retrieved 2026-10-13 · sha256 43cba5e676a43587db28513e2a2cad23a7952c0b850b15a9afdc1286329ef473 SRC-003 NICE "Technology appraisal committees" page. Under "Next meeting dates" it lists each committee's meeting dates; it does not list which appraisals are on each agenda. https://www.nice.org.uk/get-involved/our-committees/nice-committee-meetings/technology-appraisal-committees Retrieved 2026-10-13 · sha256 b0a65e8a58be22b7148ac6aa68c60e3fddfddb04170396b160cf23b857db0d46 SRC-004 Final stakeholder list (PDF) for the appraisal: names the company and the possible comparator companies. https://www.nice.org.uk/guidance/gid-ta11694/documents/final-matrix Retrieved 2026-10-13 · sha256 a7e119771cd280be2144b320b0c22577b226a8bc7b7a46c312f71b4102508fbb --- # 35% forecast: NICE publishes technology appraisal guidance on Resmetirom for treating non-alcoholic steatohepatitis and liver fibrosis [ID6529] on or before 2026-12-09 URL: https://nextconsensus.com/forecast/ff-050/ Registered forecast 35% registered probability event by 2026-12-09 Unresolved ## NICE publishes technology appraisal guidance on Resmetirom for treating non-alcoholic steatohepatitis and liver fibrosis [ID6529] on or before 2026-12-09 FF-050 Registered · Unresolved Registered probability 35% Event by 2026-12-09 Resolution window 2026-10-16 → 2026-12-09 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 55% - Analyst proxy 35% nextconsensus.com/forecast/ff-050/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Resmetirom for treating non-alcoholic steatohepatitis and liver fibrosis' [ID6529], with a publication date on or before 2026-12-09, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11414) on 2026-10-01. Authority National Institute for Health and Care Excellence (NICE), Technology Appraisal Committee B (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope Non-alcoholic steatohepatitis with liver fibrosis The estimate ### The number and the baselines it has to beat 35% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-050 · registered 35% Authority base rate −15 pts 50% Calendar cycle −20 pts 55% Analyst proxy 0 pts 35% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown at the cutoff is not yet counted; the calendar's census will count it. Expected dates are revised often, most when a committee meeting does not reach a final recommendation or a company asks for time. Calendar cycle 55% A clock-only model: a second committee meeting on 15 October, 55 days before the expected date, is treated as on schedule: the model assumes final draft guidance and an appeal period fit in that time. Analyst proxy 35% An analyst reading the project page on 2026-10-01 would weigh negative draft guidance, an earlier delay for technical engagement and 107 days between consultation close and the second meeting. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2026-12-09 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2026-12-09 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2026-12-09 When the outcome can be read against the rule. Event by 2026-12-09 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 35103f3939b15ede34d42a73e3351cf55b355784a43a5c462c6d8ae4a99022b1 · operator record jc-1792036505360-d4071c3d ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID6529 shows a publication date ('Published: ') on or before 2026-12-09, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6529. Searching for GID-TA11414 finds the same project. Resolves NO if the guidance is published after 2026-12-09, if the expected date is revised and nothing is published by 2026-12-09, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2026-12-16. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11414, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 35% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15. review pathway STA by Technology Appraisal Committee B, with a technical engagement step (SRC-001, SRC-003, SRC-005) submission type New appraisal; company Madrigal Pharmaceuticals (SRC-001) evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class Comparator companies: Novo Nordisk Ltd (semaglutide); vitamin E (Alliance Pharmaceuticals, Kora Healthcare) and pioglitazone (Brown & Burk UK, Mylan, Neon Healthcare, Sandoz) manufacturers - not participating (SRC-001) months since last guideline revision not applicable panel cycle position Committee meeting 1: 14 May 2026; draft guidance 09 June - 30 June 2026; committee meeting 2 scheduled 15 October 2026 (107 days after consultation closed), 55 days before the expected publication date of 09 December 2026 (SRC-001, SRC-007). sponsor request status No company request for more time or pause is recorded. NICE delayed the committee meeting for technical engagement (29 December 2025 timeline entry) (SRC-001). odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change Process note: the topic was to be progressed as an MTA alongside semaglutide [ID6458] (SRC-004); the page now shows STA Standard and the draft guidance covers resmetirom alone (SRC-001, SRC-003). Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development page (Project information tab) for GID-TA11414. Shows 'Expected publication date: 09 December 2026', status 'In progress', 'Process: STA Standard', 'ID number: 11905', provisional schedule (committee meeting 15 October 2026; expected publication 09 December 2026), comparator companies and the timeline (technical engagement delay note; committee meeting 1 on 14 May 2026; draft guidance 09 June - 30 June 2026). https://www.nice.org.uk/guidance/indevelopment/gid-ta11414 Retrieved 2026-10-01 · sha256 1def49a1b857e1ad2845fe96d1f86f243a62f718405a7ea1363e9928b3baa46c SRC-002 NICE Project documents tab for GID-TA11414. Latest documents: draft guidance, committee papers and slides 'Published: 09 June 2026'; register of interests 'Published: 01 June 2026'; notes including the technical engagement note. https://www.nice.org.uk/guidance/indevelopment/gid-ta11414/documents Retrieved 2026-10-01 · sha256 84e619f8056f9ef4de1da6d8a9ba2aa822a7ab7ce5d15092f1a0848f6fb81667 SRC-003 Draft guidance consultation PDF (issue date June 2026), titled for metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis (without cirrhosis). Recommendation 1.1 (should not be used), key dates (closing date for comments 30 June 2026; second evaluation committee meeting TBC) and 'This topic was considered by committee B.' https://www.nice.org.uk/guidance/gid-ta11414/documents/draft-guidance Retrieved 2026-10-01 · sha256 3a4604d22e37e6a62b4451c79be5b8423d5bce26e20ffb1f4f2e2e9bab5770d1 SRC-004 NICE note page (Project documents) for GID-TA11414 (undated): states the topic would be progressed as a Multiple Technology Appraisal alongside semaglutide [ID6458], with the invitation to participate in the week commencing 07 July 2025. https://www.nice.org.uk/guidance/gid-ta11414/documents/html-content Retrieved 2026-10-01 · sha256 6b82f564f3d3b2a4aa055076986a628d36a6529bfd1cf45918f1544f34d0a13d SRC-005 NICE note page (Project documents) for GID-TA11414 (undated): 'Technical engagement will be undertaken for this appraisal. The Committee meeting date will be adjusted to allow this.' https://www.nice.org.uk/guidance/gid-ta11414/documents/html-content-5 Retrieved 2026-10-01 · sha256 f8f014aff96fcad89a72a4fe049ea4683058653bddd9608cc8bfd74f532c847a SRC-007 NICE Technology appraisal committees page. Lists next meeting dates including Committee B 'Thursday 15 October 2026', 'Thursday 12 November 2026' and 'Thursday 10 December 2026'. https://www.nice.org.uk/get-involved/our-committees/nice-committee-meetings/technology-appraisal-committees Retrieved 2026-10-01 · sha256 8e6f62cd7fdf5be519f696bbeb8813e845b461e04dc894f32f2c57c49246c2a8 --- # 25% forecast: NICE publishes technology appraisal guidance on Semaglutide for treating moderate to advanced liver fibrosis (without cirrhosis) caused by metabolic dysfunction-associated steatohepatitis [ID6458] on or before 2027-01-07 URL: https://nextconsensus.com/forecast/ff-051/ Registered forecast 25% registered probability event by 2027-01-07 Unresolved ## NICE publishes technology appraisal guidance on Semaglutide for treating moderate to advanced liver fibrosis (without cirrhosis) caused by metabolic dysfunction-associated steatohepatitis [ID6458] on or before 2027-01-07 FF-051 Registered · Unresolved Registered probability 25% Event by 2027-01-07 Resolution window 2026-10-16 → 2027-01-07 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 45% - Analyst proxy 25% nextconsensus.com/forecast/ff-051/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Semaglutide for treating moderate to advanced liver fibrosis (without cirrhosis) caused by metabolic dysfunction-associated steatohepatitis' [ID6458], with a publication date on or before 2027-01-07, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11477) on 2026-10-01. Authority National Institute for Health and Care Excellence (NICE), Technology Appraisal Committee (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope Moderate to advanced liver fibrosis caused by MASH (without cirrhosis) The estimate ### The number and the baselines it has to beat 25% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-051 · registered 25% Authority base rate −25 pts 50% Calendar cycle −20 pts 45% Analyst proxy 0 pts 25% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown at the cutoff is not yet counted; the calendar's census will count it. Expected dates are revised often, most when a committee meeting does not reach a final recommendation or a company asks for time. Calendar cycle 45% A clock-only model: a first committee meeting on 15 October, 84 days before the expected date, is on schedule if that meeting reaches a final recommendation. Analyst proxy 25% An analyst reading the project page on 2026-10-01 would weigh a schedule with no consultation round against a delay at the company's request earlier in the year. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-01-07 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-01-07 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2027-01-07 When the outcome can be read against the rule. Event by 2027-01-07 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 6822a458b0f44f7f702e13a50c348c5445175cbee3beec3c29da4872387276ec · operator record jc-1792036520056-8de8f349 ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID6458 shows a publication date ('Published: ') on or before 2027-01-07, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6458. Searching for GID-TA11477 finds the same project. Resolves NO if the guidance is published after 2027-01-07, if the expected date is revised and nothing is published by 2027-01-07, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2027-01-14. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11477, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 25% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15. review pathway STA Standard ("Process: STA Standard", SRC-001); earlier planned as an MTA (SRC-003) and then converted to an STA (SRC-005) submission type New appraisal; company "Novo Nordisk Ltd" (SRC-001) evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class Comparator companies on SRC-001: Madrigal Pharmaceuticals (resmetirom), listed as participating; Alliance Pharmaceuticals (vitamin E), Brown & Burk UK (pioglitazone), Kora Healthcare (vitamin E), Mylan (pioglitazone), Neon Healthcare (pioglitazone) and Sandoz (pioglitazone), all listed as not participating. months since last guideline revision not applicable panel cycle position Provisional schedule (SRC-001): committee meeting 1 on 15 October 2026, 84 days before the expected publication date of 7 January 2027. No draft guidance consultation and no second meeting are listed. Committee B also meets on 12 November and 10 December 2026 (SRC-006). sponsor request status The timeline records a delay at the company's request on 16 April 2026 and a restart on 20 May 2026 that set the first committee meeting for 15 October 2026 (SRC-001). odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change Process changed from a planned MTA with resmetirom [ID6529] to an STA of semaglutide alone (SRC-003; SRC-005). The scope-consultation response records that the company proposed an STA and that "The routing has been updated to a single technology appraisal for semaglutide" (SRC-007). Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development "Project information" page for ID6458. Shows the header line "Expected publication date: 07 January 2027", status, process, ID number, the provisional schedule, the enquiry e-mail address, stakeholders (where listed) and the "Timeline" table of key events. https://www.nice.org.uk/guidance/indevelopment/gid-ta11477 Retrieved 2026-10-01 · sha256 7de1145a121fe61eae4b3432eb02ce315b0927b46c3ef982b1e871b319f5ed8a SRC-002 NICE "Project documents" tab for ID6458: lists documents by stage with publication dates (scope, stakeholder list, draft guidance where issued, committee meeting entries) and the text of notes added to the project documents. https://www.nice.org.uk/guidance/indevelopment/gid-ta11477/documents Retrieved 2026-10-01 · sha256 c03c3457122e30e2be1387d87bc4502193746c97d2e5c15d661cba742fdd017f SRC-003 Undated note page in the project documents: "This topic will now be progressed as a Multiple Technology Appraisal (MTA) alongside the following topic; Resmetirom for treating metabolic dysfunction-associated steatohepatitis with liver fibrosis [ID6529]" and "The Invitation to Participate (ITP) will now be issued week commencing 07 July 2025 ...". The timeline on the project page lists notes dated 11 April 2025, 15 May 2025 and 09 July 2025 without saying which note is which. https://www.nice.org.uk/guidance/gid-ta11477/documents/html-content-3 Retrieved 2026-10-01 · sha256 052f88a8f1824dbb0220360b74a504141fa5288fbc9b9ef3303c82666d905b45 SRC-004 Undated note page: about NICE consulting on the draft scope for the partial update of guideline NG49 (MASLD terminology), consultation closing 01 June 2025. https://www.nice.org.uk/guidance/gid-ta11477/documents/html-content-5 Retrieved 2026-10-01 · sha256 1e9f49f3214557b14d79be9f03255de6baa2023e40afdbe36eee1c2ad91fc08a SRC-005 Undated note page: "This evaluation will now go ahead as a Single Technology Appraisal (STA). This evaluation will only cover semaglutide for treating metabolic dysfunction-associated steatohepatitis with liver fibrosis." and "The evaluation will begin in early November 2025." https://www.nice.org.uk/guidance/gid-ta11477/documents/html-content-6 Retrieved 2026-10-01 · sha256 edf6526123796ae81a37d066df10299035b3963d4dfc8e43846f49c1dcc284fc SRC-006 NICE "Technology appraisal committees" page (reached from the meetings-in-public URL https://www.nice.org.uk/get-involved/meetings-in-public/technology-appraisal-committee, which returned HTTP 308 to it). Under "Next meeting dates" it lists Committee B meetings including "Thursday 15 October 2026", "Thursday 12 November 2026" and "Thursday 10 December 2026"; it also lists published TAC minutes. It does not list which appraisals are on each agenda. https://www.nice.org.uk/get-involved/our-committees/nice-committee-meetings/technology-appraisal-committees Retrieved 2026-10-01 · sha256 8e6f62cd7fdf5be519f696bbeb8813e845b461e04dc894f32f2c57c49246c2a8 SRC-007 PDF linked from the Project documents tab (SRC-002), in its invitation-to-participate section, as the downloadable draft consultation document (published 4 November 2025). Its content is NICE's "Response to stakeholder organisation comments on the draft remit and draft scope" ("Issue date: November 2025"), not draft guidance. It records the company's comment "Therefore, Novo Nordisk proposes that semaglutide is evaluated as a single technology appraisal" and NICE's action "The routing has been updated to a single technology appraisal for semaglutide". https://www.nice.org.uk/guidance/gid-ta11477/documents/consultation-document Retrieved 2026-10-01 · sha256 ba4f3685235b867a767b9d2afb2e7e843ad2401928e23a20f7dd49589e9b39d9 --- # 45% forecast: NICE publishes technology appraisal guidance on Tislelizumab with chemotherapy for untreated advanced oesophageal squamous cell cancer [ID5113] on or before 2027-02-10 URL: https://nextconsensus.com/forecast/ff-052/ Registered forecast 45% registered probability event by 2027-02-10 Unresolved ## NICE publishes technology appraisal guidance on Tislelizumab with chemotherapy for untreated advanced oesophageal squamous cell cancer [ID5113] on or before 2027-02-10 FF-052 Registered · Unresolved Registered probability 45% Event by 2027-02-10 Resolution window 2026-10-16 → 2027-02-10 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 55% - Analyst proxy 45% nextconsensus.com/forecast/ff-052/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-15. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Tislelizumab with chemotherapy for untreated advanced oesophageal squamous cell cancer' [ID5113], with a publication date on or before 2027-02-10, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11025) on 2026-10-13. Authority National Institute for Health and Care Excellence (NICE), Technology Appraisal Committee (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope Untreated advanced oesophageal squamous cell cancer The estimate ### The number and the baselines it has to beat 45% probability, method v0.1.0 · frozen at the 2026-10-15 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-052 · registered 45% Authority base rate −5 pts 50% Calendar cycle −10 pts 55% Analyst proxy 0 pts 45% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown at the cutoff is not yet counted; the calendar's census will count it. Expected dates are revised often, most when a committee meeting does not reach a final recommendation or a company asks for time. Calendar cycle 55% A clock-only model: a first committee meeting on 13 October, 120 days before the expected date, is on schedule if that meeting reaches a final recommendation; a streamlined process makes that more likely than in a standard one. Analyst proxy 45% An analyst reading the project page on 2026-10-13 would weigh a streamlined process and named immunotherapy comparators against an appraisal that was suspended once for want of a company submission. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-02-10 Evidence cutoff 2026-10-15 Registered 2026-10-15 Window opens 2026-10-16 Deadline 2027-02-10 Evidence cutoff 2026-10-15 Nothing after this date informed the estimate. Registered 2026-10-15 Frozen and hashed. Resolution window 2026-10-16 → 2027-02-10 When the outcome can be read against the rule. Event by 2027-02-10 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 77542815d601a1066bbbf805e0899f618d82b7d818aaf8d056f7bfa32fd5f5b7 · operator record jc-1792036450563-b5143e11 ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID5113 shows a publication date ('Published: ') on or before 2027-02-10, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID5113. Searching for GID-TA11025 finds the same project. Resolves NO if the guidance is published after 2027-02-10, if the expected date is revised and nothing is published by 2027-02-10, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2027-02-17. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11025, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 45% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-15. review pathway STA Streamlined ("Process: STA Streamlined", SRC-001) submission type New appraisal, referred by the Department of Health and Social Care; company "BeOne Medicines (tislelizumab)" (SRC-004) evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class Possible comparator companies on SRC-004 include Bristol-Myers Squibb (nivolumab) and MSD (pembrolizumab), and suppliers of platinum-based and fluoropyrimidine chemotherapy. months since last guideline revision not applicable panel cycle position Committee meeting 1 on 13 October 2026, the cutoff date, 120 days before the expected publication date of 10 February 2027. No draft guidance consultation or second meeting is listed (SRC-001; SRC-002). sponsor request status Suspended on 16 April 2025 after the company said it would not provide an evidence submission; scheduled back into the work programme on 19 December 2025 "following discussions with the company" (SRC-001). odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change The company named on the 2026 stakeholder list is BeOne Medicines (SRC-004). Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development "Project information" page. Shows the header line with the expected publication date, status, process, ID number, the provisional schedule, stakeholders (where listed) and the "Timeline" table of key events. https://www.nice.org.uk/guidance/indevelopment/gid-ta11025 Retrieved 2026-10-13 · sha256 0f6fc69272e9af1de834c99ebacd587bdc3fcdb63fa3a63cd63bb3dcdb7447f9 SRC-002 NICE "Project documents" tab: lists documents by stage with publication dates (scope, stakeholder list, draft guidance where issued, committee meeting entries) and the text of notes added to the project documents. https://www.nice.org.uk/guidance/indevelopment/gid-ta11025/documents Retrieved 2026-10-13 · sha256 498a132ba6e3718cf2a363e02b32ad505d4cab5202231a545cc061afa10cf8fe SRC-003 NICE "Technology appraisal committees" page. Under "Next meeting dates" it lists each committee's meeting dates; it does not list which appraisals are on each agenda. https://www.nice.org.uk/get-involved/our-committees/nice-committee-meetings/technology-appraisal-committees Retrieved 2026-10-13 · sha256 b0a65e8a58be22b7148ac6aa68c60e3fddfddb04170396b160cf23b857db0d46 SRC-004 Final stakeholder list (PDF) for the appraisal: names the company and the possible comparator companies. https://www.nice.org.uk/guidance/gid-ta11025/documents/final-matrix Retrieved 2026-10-13 · sha256 e8ebfff743bd81fd96e54433d07cdb8b96c1b0a0fef114664025d567010c7447 --- # 70% forecast: FDA approves oral tinlarebant for Stargardt disease type 1 on or before the disclosed PDUFA goal date of 2027-02-12 URL: https://nextconsensus.com/forecast/ff-053/ Registered forecast 70% registered probability event by 2027-02-12 Unresolved ## FDA approves oral tinlarebant for Stargardt disease type 1 on or before the disclosed PDUFA goal date of 2027-02-12 FF-053 Registered · Unresolved Registered probability 70% Event by 2027-02-12 Resolution window 2026-10-22 → 2027-02-12 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 80% - Calendar cycle 80% - Analyst proxy 70% nextconsensus.com/forecast/ff-053/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-21. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on Belite Bio's New Drug Application for oral tinlarebant for the treatment of Stargardt disease type 1 (STGD1), with an approval action date on or before 2027-02-12, the PDUFA target action date disclosed in Exhibit 99.1 to Belite Bio's Form 6-K filed 2026-08-13. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope Stargardt disease type 1 The estimate ### The number and the baselines it has to beat 70% probability, method v0.1.0 · frozen at the 2026-10-21 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-053 · registered 70% Authority base rate −10 pts 80% Calendar cycle −10 pts 80% Analyst proxy 0 pts 70% Authority base rate 80% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Original NDAs under Priority Review with a positive phase 3 trial are approved at their first goal date in a large majority of cases; first NDAs from small sponsors carry more complete-response risk on manufacturing and inspection. The calendar's own met-goal-date share for disclosed PDUFA dates does not exist yet (docs/foundations/short-horizon-reference-classes.md §4.1). Calendar cycle 80% A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle actions on original NDAs are approvals. With no evidence input it cannot tell a strong application from a weak one. Analyst proxy 70% An analyst reading the same filings on 2026-10-20 would weigh a phase 3 trial that met its primary endpoint, Priority Review and Breakthrough Therapy designation, and a disease with no approved treatment, against one modest-sized trial on a structural endpoint with no visual-acuity result reported, drug-related ocular adverse events reported as mild (SRC-006), and a first NDA from a small sponsor. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-21 Registered 2026-10-21 Window opens 2026-10-22 Deadline 2027-02-12 Evidence cutoff 2026-10-21 Registered 2026-10-21 Window opens 2026-10-22 Deadline 2027-02-12 Evidence cutoff 2026-10-21 Nothing after this date informed the estimate. Registered 2026-10-21 Frozen and hashed. Resolution window 2026-10-22 → 2027-02-12 When the outcome can be read against the rule. Event by 2027-02-12 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 46b8f22573354dbaf2a5b1906a9032fa8d1670a760ef413cc6f6671b0b62f077 · operator record jc-1792548712659-9d77113a ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast The application number was not public at the cutoff, and openFDA held no record for the ingredient (SRC-004, SRC-005). The adjudicator identifies the qualifying approval by its indication plus its ingredient, never by a name the adjudicator infers: an approval action whose Drugs@FDA approval letter or label names Stargardt disease (STGD1, or Stargardt disease caused by ABCA4 mutations) in its indication, for a product whose active ingredient is tinlarebant (LBS-008) or a salt of it, under any applicant (Belite Bio, Inc or a Belite Bio subsidiary) and any proprietary name. Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22TINLAREBANT%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22tinlarebant%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain such an approval: an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2027-02-12. An approval for a narrower STGD1 population than the applicant sought (by age, for example) still resolves YES, as does accelerated rather than traditional approval. Resolves NO if no approval action is dated on or before 2027-02-12: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2027-02-12 resolves NO as occurred_after_deadline. 2027-02-12 is a Friday. Read no earlier than 2027-02-26. If openFDA has not refreshed by then, or both queries return nothing, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name tinlarebant) governs, under the same identification test. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22tinlarebant%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22TINLAREBANT%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 70% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-21. review pathway Priority Review (SRC-001, SRC-002). Breakthrough Therapy, Fast Track, Rare Pediatric Disease and Orphan Drug designations in the U.S. (SRC-001). Center CDER is the drafter's understanding (a small-molecule NDA), unverified. submission type Original NDA for oral tinlarebant in STGD1 (SRC-001); application number not public, and openFDA holds no record for the ingredient (SRC-004, SRC-005). evidence class One completed placebo-controlled phase 3 trial, DRAGON: 24 months, 104 subjects aged 12 to 20, randomized 2:1, double-masked, which met its primary endpoint (SRC-001, SRC-003). A phase 2/3 trial (DRAGON II) is ongoing (SRC-001). pivotal n 104 (SRC-001) endpoint type Structural imaging endpoint: growth rate of atrophic retinal lesions, reduced 35.7% against placebo (SRC-006; SRC-002 describes it as slowing lesion growth); quantitative autofluorescence reported as a secondary endpoint (SRC-001). The archived sources report no visual-acuity result. approved competitors in class None: Belite Bio states tinlarebant would be the first approved treatment for STGD1 (SRC-001, SRC-002). months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status NDA accepted with Priority Review, announced by 2026-08-12 (SRC-001); Japanese NDA under Sakigake submitted 2026-09-08 (SRC-002). odac referral none announced in the archived sources sponsor state change Uplisted to the Nasdaq Global Select Market 2026-10-19 (SRC-003); no change to the application recorded in the archived sources. Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-21 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Belite Bio Form 6-K Exhibit 99.1, filed 2026-08-13: Q2 2026 results press release dated 2026-08-12. FDA accepted the NDA for tinlarebant in Stargardt disease type 1 with Priority Review and a PDUFA target action date of February 12, 2027; phase 3 DRAGON (24 months, 104 subjects aged 12 to 20, randomized 2:1) met its primary endpoint; Breakthrough Therapy, Fast Track, Rare Pediatric Disease and Orphan Drug designations; 279.9 million dollars cash and 500.1 million dollars in treasuries at 2026-06-30. https://www.sec.gov/Archives/edgar/data/1889109/000110465926095218/tm2623018d1_ex99-1.htm Retrieved 2026-10-20 · sha256 54a0352b19de870895a76294ea68c3a782a6578a597a3d7214ea090d0e56ba1a SRC-002 Belite Bio Form 6-K Exhibit 99.1, filed 2026-09-08: NDA for tinlarebant in STGD1 submitted to Japan's MHLW under the Sakigake designation; restates the U.S. Priority Review and the PDUFA target action date of February 12, 2027, and describes the data as slowing the growth rate of retinal lesions against placebo. https://www.sec.gov/Archives/edgar/data/1889109/000110465926105608/tm2624806d1_ex99-1.htm Retrieved 2026-10-20 · sha256 345ae97452b4c83e9e5418c595caa0d38f089cc85fc3d51753358ae1d7af57b0 SRC-003 Belite Bio Form 6-K Exhibit 99.1, filed 2026-10-19: uplisting to the Nasdaq Global Select Market; restates that DRAGON met its primary endpoint and that DRAGON II and PHOENIX are ongoing. No change to the U.S. application. https://www.sec.gov/Archives/edgar/data/1889109/000110465926116685/tm2627719d1_ex99-1.htm Retrieved 2026-10-20 · sha256 3aba19b5b396f78ae376efc7d8ddf6cba67cd9293b93d8d584be30c86c67e3eb SRC-004 openFDA drugsfda products.active_ingredients.name:"TINLAREBANT", retrieved 2026-10-20: 404 No matches found. No application for the ingredient. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22TINLAREBANT%22&limit=100 Retrieved 2026-10-20 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da SRC-005 openFDA drugsfda openfda.generic_name:"tinlarebant", retrieved 2026-10-20: 404 No matches found. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22tinlarebant%22&limit=100 Retrieved 2026-10-20 · sha256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da SRC-006 Healio, 2026-01-02, reporting Belite Bio's DRAGON topline release: lesion growth rate reduced 35.7% against placebo (primary endpoint met); four treatment-related drug discontinuations; the most common drug-related ocular adverse event was xanthopsia, with delayed dark adaptation and night vision impairment, mild and mostly resolved during the trial. It reports no visual-acuity result. https://www.healio.com/news/ophthalmology/20260102/tinlarebant-reduces-lesion-growth-rate-in-stargardt-disease Retrieved 2026-10-20 · sha256 9b04499262d3cb3279dbb9f266988d0990d316f5640db43862bc95404d2e8d56 --- # 35% forecast: NICE publishes technology appraisal guidance on Linvoseltamab for treating relapsed or refractory multiple myeloma after 3 or more treatments [ID6609] on or before 2027-02-17 URL: https://nextconsensus.com/forecast/ff-054/ Registered forecast 35% registered probability event by 2027-02-17 Unresolved ## NICE publishes technology appraisal guidance on Linvoseltamab for treating relapsed or refractory multiple myeloma after 3 or more treatments [ID6609] on or before 2027-02-17 FF-054 Registered · Unresolved Registered probability 35% Event by 2027-02-17 Resolution window 2026-10-22 → 2027-02-17 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 50% - Analyst proxy 35% nextconsensus.com/forecast/ff-054/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-21. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Linvoseltamab for treating relapsed or refractory multiple myeloma after 3 or more treatments' [ID6609], with a publication date on or before 2027-02-17, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11052) on 2026-10-20. Authority National Institute for Health and Care Excellence (NICE), Technology Appraisal Committee (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope Relapsed or refractory multiple myeloma after 3 or more treatments The estimate ### The number and the baselines it has to beat 35% probability, method v0.1.0 · frozen at the 2026-10-21 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-054 · registered 35% Authority base rate −15 pts 50% Calendar cycle −15 pts 50% Analyst proxy 0 pts 35% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown at the cutoff is not yet counted; the calendar's census will count it. Expected dates are revised often, most when a committee meeting does not reach a final recommendation or a company asks for time. Calendar cycle 50% A clock-only model: a single committee meeting on 1 December 2026, 78 days before the expected date, is on schedule if that meeting reaches a final recommendation. Analyst proxy 35% An analyst reading the project page on 2026-10-20 would note a first meeting on a high-cost later-line myeloma medicine, appraised against several active comparators including another BCMA×CD3 bispecific, and would expect draft guidance more often than final draft guidance from that meeting. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-21 Registered 2026-10-21 Window opens 2026-10-22 Deadline 2027-02-17 Evidence cutoff 2026-10-21 Registered 2026-10-21 Window opens 2026-10-22 Deadline 2027-02-17 Evidence cutoff 2026-10-21 Nothing after this date informed the estimate. Registered 2026-10-21 Frozen and hashed. Resolution window 2026-10-22 → 2027-02-17 When the outcome can be read against the rule. Event by 2027-02-17 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 955bbe9e2e4d7a1f28f9a9d278895a3d923a092668490aff384daaaacc285cbe · operator record jc-1792548712971-c4f5f6ca ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID6609 shows a publication date ('Published: ') on or before 2027-02-17, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6609. Resolves NO if the guidance is published after 2027-02-17, if the expected date is revised and nothing is published by 2027-02-17, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2027-02-24. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11052, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 35% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-21. review pathway STA Standard ("Process: STA Standard", SRC-001) submission type New appraisal; company "Regeneron Pharmaceuticals, Inc. (Linvoseltamab)" (SRC-001, SRC-004) evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class Comparator companies participating under confidentiality agreements include Pfizer (elranatamab), Janssen-Cilag (teclistamab, talquetamab, ciltacabtagene autoleucel, daratumumab, bortezomib) and Gilead Sciences (anitocabtagene autoleucel) (SRC-001). Elranatamab and teclistamab are in linvoseltamab's class (BCMA×CD3 bispecific antibodies). months since last guideline revision not applicable panel cycle position One committee meeting, on 1 December 2026, 78 days before the expected publication date of 17 February 2027 (SRC-001). SRC-003 lists committee C meeting that day, and the project's enquiry address is TACommC (SRC-001). No draft guidance or second meeting is listed (SRC-001, SRC-002). sponsor request status None recorded (SRC-001). odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change None recorded (SRC-001). Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-21 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development page for ID6609, linvoseltamab for relapsed or refractory multiple myeloma after 3 or more treatments, retrieved at the cutoff. https://www.nice.org.uk/guidance/indevelopment/gid-ta11052 Retrieved 2026-10-20 · sha256 81ec477128e6a82dda3f00ff635dfd1a08dd8a6715415a3cbf28e79510f8899d SRC-002 NICE project documents page for ID6609, retrieved at the cutoff. https://www.nice.org.uk/guidance/indevelopment/gid-ta11052/documents Retrieved 2026-10-20 · sha256 e6980df67500a691db5402bed1602ac50989cf421df515ee691459461a7f2872 SRC-003 NICE technology appraisal committee meetings page, retrieved at the cutoff. https://www.nice.org.uk/get-involved/our-committees/nice-committee-meetings/technology-appraisal-committees Retrieved 2026-10-20 · sha256 4fbdcb56218ee67eb522728828d28d44f61b109c3700434ab59d21f246ffd699 SRC-004 Final stakeholder list (PDF) for the appraisal: names the company and the possible comparator companies. https://www.nice.org.uk/guidance/gid-ta11052/documents/final-matrix Retrieved 2026-10-20 · sha256 a8e3fcf824e1dd337c9bbc9f123d46edc8be732274b0e0978198b896bbe7201f --- # 30% forecast: NICE publishes technology appraisal guidance on Setmelanotide for treating acquired hypothalamic obesity in people 4 years and over [ID6542] on or before 2027-02-10 URL: https://nextconsensus.com/forecast/ff-055/ Registered forecast 30% registered probability event by 2027-02-10 Unresolved ## NICE publishes technology appraisal guidance on Setmelanotide for treating acquired hypothalamic obesity in people 4 years and over [ID6542] on or before 2027-02-10 FF-055 Registered · Unresolved Registered probability 30% Event by 2027-02-10 Resolution window 2026-10-27 → 2027-02-10 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 50% - Calendar cycle 50% - Analyst proxy 30% nextconsensus.com/forecast/ff-055/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-26. It is one of 24 registered NICE scheduled-date forecasts . The proposition ### What was claimed NICE publishes final technology appraisal guidance for the appraisal 'Setmelanotide for treating acquired hypothalamic obesity in people 4 years and over' [ID6542], with a publication date on or before 2027-02-10, the expected publication date shown on its in-development page (https://www.nice.org.uk/guidance/indevelopment/gid-ta11525) as of the 2026-10-26 cutoff. Authority National Institute for Health and Care Excellence (NICE), Technology Appraisal Committee (England) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 7: Payer/coverage action — NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates NICE guidance by scheduled date Scope Acquired hypothalamic obesity in people 4 years and over The estimate ### The number and the baselines it has to beat 30% probability, method v0.1.0 · frozen at the 2026-10-26 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-055 · registered 30% Authority base rate −20 pts 50% Calendar cycle −20 pts 50% Analyst proxy 0 pts 30% Authority base rate 50% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. The share of NICE technology appraisals published on or before the expected date shown at the cutoff is not yet counted; the calendar's census will count it. Expected dates are revised often, most when a committee meeting does not reach a final recommendation or a company asks for time. Calendar cycle 50% A clock-only model: a first committee meeting on 13 October, 120 days before the expected date, is on schedule if that meeting reaches a final recommendation. Analyst proxy 30% An analyst reading the project page under the 2026-10-26 cutoff would note a first meeting on a high-cost medicine for a rare form of obesity, with weight-management comparators, and would expect draft guidance more often than final draft guidance. Estimated by reconstructing that read, not by surveying analysts. Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-26 Registered 2026-10-26 Window opens 2026-10-27 Deadline 2027-02-10 Evidence cutoff 2026-10-26 Registered 2026-10-26 Window opens 2026-10-27 Deadline 2027-02-10 Evidence cutoff 2026-10-26 Nothing after this date informed the estimate. Registered 2026-10-26 Frozen and hashed. Resolution window 2026-10-27 → 2027-02-10 When the outcome can be read against the rule. Event by 2027-02-10 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger ccc2005d756e61bfa21549038147bbf5764e2c7dde8df9c2fd9b8ebcd49bdfe7 · operator record jc-1793054466914-b3eda7a3 ### Around this record This kind of deadline - Every registered NICE date, by month - What a NICE scheduled date commits NICE to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on NICE for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the NICE technology appraisal guidance page published from project ID6542 shows a publication date ('Published: ') on or before 2027-02-10, whatever the guidance recommends. The adjudicator finds the page from the in-development page above, which links to or redirects to the published guidance, or by searching nice.org.uk for ID6542. Searching for GID-TA11525 finds the same project. Resolves NO if the guidance is published after 2027-02-10, if the expected date is revised and nothing is published by 2027-02-10, if the appraisal is paused or suspended past that date, or if it is terminated. A terminated appraisal stays in the denominator and resolves NO, as registry/CALENDAR.md's rule for this class says. A suspension, however NICE words it, resolves NO. Resolves cancelled_external only if NICE removes the appraisal from its work programme without publishing anything. A removal that NICE describes as temporary, or after which the appraisal resumes, is a suspension. The frozen date is the one archived at the cutoff; a later revision does not move it. Read no earlier than 2027-02-17. The recommendation itself is a different question and is not scored here. Resolves VOID, with the reason recorded, only if NICE stops publishing technology appraisal guidance pages with publication dates, so that no publication date for this appraisal can be read from nice.org.uk or its successor; while a publication date can be read, the rule stands. Source the rule names: https://www.nice.org.uk/guidance/indevelopment/gid-ta11525, https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (NICE guidance by scheduled date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 30% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-26. review pathway STA Standard ("Process: STA Standard", SRC-001) submission type New appraisal; company "Rhythm Pharmaceuticals (setmelanotide)" (SRC-004) evidence class not applicable — the proposition is a publication date, not an evidence judgement pivotal n not applicable endpoint type not applicable — the proposition is a publication date approved competitors in class Possible comparator companies on SRC-004 include Eli Lilly (tirzepatide), Novo Nordisk (semaglutide, liraglutide), and suppliers of liraglutide and orlistat. No same-class competitor is named. months since last guideline revision not applicable panel cycle position Committee meeting on 13 October 2026, the cutoff date, 120 days before the expected publication date of 10 February 2027. No draft guidance consultation or second meeting is listed (SRC-001; SRC-002). sponsor request status None recorded (SRC-001). odac referral not applicable — NICE committee, not an FDA advisory committee sponsor state change None recorded (SRC-001). Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-26 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 NICE in-development "Project information" page. Shows the header line with the expected publication date, status, process, ID number, the provisional schedule, stakeholders (where listed) and the "Timeline" table of key events. https://www.nice.org.uk/guidance/indevelopment/gid-ta11525 Retrieved 2026-10-13 · sha256 7fd5bcc7bfc271d5de0d0bb3619e99c629dda17f35bc30a90deb00e4661e78b3 SRC-002 NICE "Project documents" tab: lists documents by stage with publication dates (scope, stakeholder list, draft guidance where issued, committee meeting entries) and the text of notes added to the project documents. https://www.nice.org.uk/guidance/indevelopment/gid-ta11525/documents Retrieved 2026-10-13 · sha256 5c59f60122fea31b3b069f07cf363bbb6cf1df0762c32dc1eeb0b5822f9088c2 SRC-003 NICE "Technology appraisal committees" page. Under "Next meeting dates" it lists each committee's meeting dates; it does not list which appraisals are on each agenda. https://www.nice.org.uk/get-involved/our-committees/nice-committee-meetings/technology-appraisal-committees Retrieved 2026-10-13 · sha256 b0a65e8a58be22b7148ac6aa68c60e3fddfddb04170396b160cf23b857db0d46 SRC-004 Final stakeholder list (PDF) for the appraisal: names the company and the possible comparator companies. https://www.nice.org.uk/guidance/gid-ta11525/documents/final-matrix Retrieved 2026-10-13 · sha256 63d94d6ba650ee371f7e3caed5c60888d5c364039e6a1f7407720405e4b51f2c --- # 88% forecast: FDA approves the ZORYVE (roflumilast) cream 0.05% supplement for atopic dermatitis in infants aged 3 to 24 months on or before the disclosed PDUFA goal date of 2027-02-23 URL: https://nextconsensus.com/forecast/ff-056/ Registered forecast 88% registered probability event by 2027-02-23 Unresolved ## FDA approves the ZORYVE (roflumilast) cream 0.05% supplement for atopic dermatitis in infants aged 3 to 24 months on or before the disclosed PDUFA goal date of 2027-02-23 FF-056 Registered · Unresolved Registered probability 88% Event by 2027-02-23 Resolution window 2026-10-27 → 2027-02-23 Target rung - 5 Guideline - 6 Regulatory - 7 Coverage Baselines it has to beat - Authority base rate 85% - Calendar cycle 80% - Analyst proxy 85% nextconsensus.com/forecast/ff-056/ registry snapshot 2026-10-26 Share image NextConsensus registered this probability on 2026-10-26. It is one of 28 registered FDA goal-date forecasts . The proposition ### What was claimed The FDA takes an approval action on a supplement to NDA 215985 (roflumilast, ZORYVE cream; applicant Arcutis Biotherapeutics) whose approved labeling extends ZORYVE cream 0.05% to the treatment of mild to moderate atopic dermatitis in infants younger than 2 years, with an approval action date on or before 2027-02-23, the PDUFA target action date disclosed in Arcutis’s Form 10-Q filed 2026-08-05. Authority US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US) Target rung A step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. Forecast class The group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates FDA action by goal date Scope Mild to moderate atopic dermatitis in infants 3 to 24 months The estimate ### The number and the baselines it has to beat 88% probability, method v0.1.0 · frozen at the 2026-10-26 cutoff The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate. Probability scale 0% 25% 50% 75% 100% FF-056 · registered 88% Authority base rate +3 pts 85% Calendar cycle +8 pts 80% Analyst proxy +3 pts 85% Authority base rate 85% ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Efficacy supplements that extend an approved product to a younger pediatric age group are approved at their first goal date more often than original applications. The calendar’s own met-goal-date share for disclosed PDUFA dates does not exist yet (docs/foundations/short-horizon-reference-classes.md §4.1). Calendar cycle 80% A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle supplement actions are approvals. With no evidence input it cannot tell a strong application from a weak one. Analyst proxy 85% An analyst reading the same filings on 2026-10-21 would weigh the same strength already approved for children 2 to 5, a sponsor with seven approvals in four years on this product family, and low systemic exposure from a topical cream, against a small open-label four-week infant study as the only new efficacy and safety evidence. Estimated by reconstructing that read, not by surveying analysts. Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. The clock ### Dates that constrain the record resolution window Today Evidence cutoff 2026-10-26 Registered 2026-10-26 Window opens 2026-10-27 Deadline 2027-02-23 Evidence cutoff 2026-10-26 Registered 2026-10-26 Window opens 2026-10-27 Deadline 2027-02-23 Evidence cutoff 2026-10-26 Nothing after this date informed the estimate. Registered 2026-10-26 Frozen and hashed. Resolution window 2026-10-27 → 2027-02-23 When the outcome can be read against the rule. Event by 2027-02-23 The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar ledger 0da7134ee5a59e2e0876cd4738ad186afcae68e6496ab24c8363a8d5c09a7fd1 · operator record jc-1793055163874-36604cbd ### Around this record This kind of deadline - Every registered FDA goal date, by month - What a PDUFA goal date commits FDA to Check it, follow it - Verify this record - RSS feed of every registration and adjudication Single-claim evaluation ### Waiting on the FDA for an asset of your own? Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page. $9,500, ten business days One claim, one decision-maker, one date: the dated evidence baseline, the qualifiers that changed, and where the evidence has stalled. Your question, registered Who decides, the decision, and your date, as a public forecast like this one. Then the portfolio The same record can cover every decision your portfolio is waiting on, on a cadence you set. Start with one claim What the evaluation includes Resolution ### The rule that settles the forecast Resolves YES if the openFDA Drugs@FDA record for application NDA215985 (https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA215985%22) contains a submission with submission_type SUPPL, submission_status AP and a submission_status_date on or before 2027-02-23, and the Drugs@FDA approval letter or label for that supplement extends the ZORYVE cream 0.05% atopic dermatitis indication to patients younger than 2 years. The supplement is identified by that content, not by its number or class code. At the cutoff the latest approved supplement was SUPPL 15, approved 2026-06-29 (SRC-004), which is not this one: the 0.05% cream was then labeled for children 2 to 5 years old, and Arcutis described the infant supplement as under review after that date (SRC-001, SRC-002). An approval whose lower age bound is above 3 months but below 2 years still resolves YES. Resolves NO if no approval action is dated on or before 2027-02-23: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2027-02-23 resolves NO as occurred_after_deadline. 2027-02-23 is a Tuesday. Read no earlier than 2027-03-09; if openFDA has not refreshed, the Drugs@FDA web record for NDA215985 (https://www.accessdata.fda.gov/scripts/cder/daf/) governs. Resolves unresolvable only if neither source can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands. Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA215985%22, https://www.accessdata.fda.gov/scripts/cder/daf/ Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far. #### What this record will show once it resolves Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. The finding As the rule above reads it: occurred on time, did not occur, or left unscored. The readers and their sources Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. The number against its baselines 88% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them. Reasoning ### What the number rests on The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers. Frozen covariates The facts about the evidence and the authority's process that were frozen with the forecast at its cutoff ### The state of the record at the cutoff Recorded as they stood on 2026-10-26, including the one field whose value was unknown then. It is left unknown rather than filled in. review pathway Standard review, inferred: the sNDA was submitted in the second quarter of 2026 (SRC-003 states the plan) and accepted in June 2026 with a goal date of 2027-02-23 (SRC-001, SRC-002); the archived sources do not name a designation. Center CDER (NDA listed in openFDA drugsfda, SRC-004). submission type Supplemental NDA (efficacy; new pediatric age group) to NDA 215985, ZORYVE cream 0.05% (SRC-001, SRC-002, SRC-004). evidence class One open-label, multicenter phase 2 study, INTEGUMENT-INFANT, once daily for four weeks, plus the earlier maximal-use pharmacokinetic trial ARQ-151-105 in the same age group (SRC-003). pivotal n 101 (SRC-003) endpoint type Safety and tolerability (primary, per SRC-003’s description of the study as evaluating safety and tolerability); efficacy reported as EASI-75 at week 4 (58%) (SRC-003). approved competitors in class unknown — the archived sources do not name the treatments approved for atopic dermatitis in infants younger than 2 years months since last guideline revision not applicable — no guideline is the subject of this proposition panel cycle position not applicable — the act is an FDA approval action sponsor request status sNDA accepted for review in June 2026 with a PDUFA target action date of 2027-02-23 (SRC-001, SRC-002). The latest approval on the application, SUPPL 15 on 2026-06-29, extended ZORYVE cream 0.3% in plaque psoriasis to children down to age 2 (SRC-002, SRC-004). odac referral none announced in the archived sources sponsor state change none recorded in the archived sources since the sNDA was accepted; Arcutis raised its 2026 net product sales guidance (SRC-002). Sources ### Everything the estimate was built from Each was retrieved on or before the 2026-10-26 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible. SRC-001 Arcutis Form 10-Q for the quarter ended 2026-06-30, filed 2026-08-05: Arcutis submitted an sNDA based on INTEGUMENT-INFANT to extend ZORYVE cream 0.05% to infants with atopic dermatitis down to 3 months, assigned a PDUFA target action date of February 23, 2027; its launch table lists the 0.05% cream for U.S. infants 3 months to 2 years as sNDA accepted for review in June. ZORYVE cream 0.05% was approved and launched for children 2 to 5 years old in October 2025. https://www.sec.gov/Archives/edgar/data/1787306/000178730626000051/arqt-20260630.htm Retrieved 2026-10-21 · sha256 61f919f06a4dba0c584307fdc9d7888ebb548dcbec32fc26243f41a6c557e7c0 SRC-002 Arcutis Form 8-K Exhibit 99.1, filed 2026-08-05: Q2 2026 results release. FDA accepted the sNDA for ZORYVE cream 0.05% to include infants aged 3 to 24 months with mild to moderate atopic dermatitis, target action date February 23, 2027; FDA approved ZORYVE cream 0.3% for plaque psoriasis down to age 2 in June 2026, described as the seventh FDA approval in four years; 2026 net product sales guidance raised. https://www.sec.gov/Archives/edgar/data/1787306/000178730626000049/pressreleaseex991q22026.htm Retrieved 2026-10-21 · sha256 af857bfd3e7e419d834362f5cf9b387ac80f8ffd4bf19914223dfeec3a6d55bd SRC-003 Arcutis Form 10-K for 2025, filed 2026-02-25: INTEGUMENT-INFANT was a phase 2, open-label, multicenter study of ZORYVE cream 0.05% once daily for four weeks in 101 infants aged 3 months to under 24 months with mild to moderate atopic dermatitis, building on the maximal-use pharmacokinetic trial ARQ-151-105; well tolerated, all reported events mild to moderate, 58% reached EASI-75 at week 4; the sNDA was planned for the second quarter of 2026. https://www.sec.gov/Archives/edgar/data/1787306/000178730626000018/arqt-20251231.htm Retrieved 2026-10-21 · sha256 18499fc6c1db5b71d2240554f208cbd823d651bfb73f3e94b977610f3a9af722 SRC-004 openFDA drugsfda application_number:"NDA215985", retrieved 2026-10-21 (meta last_updated 2026-10-20): ZORYVE cream 0.3%, 0.15% and 0.05%, applicant Arcutis; ORIG-1 approved 2022-07-29 and efficacy supplements SUPPL 2 (2023-10-05), 7 (2024-07-09), 12 (2025-10-04) and 15 (2026-06-29) approved. No approval after 2026-06-29. https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA215985%22 Retrieved 2026-10-21 · sha256 5b431dd49b2cb9d8b38e5dc09d3fbdb81ef1effba27bb132d7d2e9a2e80b42f0 --- # Evidence Ledgers URL: https://nextconsensus.com/ledger/ ## The record for one asset, dated and chained A team with a submission date, a coverage review, or a transaction closing gets the record about its asset as it stands: every act the deciding institutions have recorded, each dated to the day its source carries, tied to an archived copy by its digest, and chained so an edit anywhere shows. These published ledgers show what an evaluation delivers for an asset. Nothing on a ledger is estimated; the registered record an asset may also have lives on its own page and is linked, not restated. Start with one claim Read the full ledger ### Sunvozertinib, first line, EGFR exon 20 insertion NSCLC 2026-05-27 → 2026-08-17 · 8 rows · record hash chain d668f1a1d4d1… First-line use of sunvozertinib in EGFR exon 20 insertion mutation-positive NSCLC: the trial readout, its publication, regulatory filings and designations, and the guideline position, each as the institution or its recorder stated it. Date Institution What was recorded Source Digest 2026-05-27 China NMPA, Center for Drug Evaluation — as recorded by the sponsor Dizal release: the CDE “has accepted and granted priority review to the New Drug Application (NDA) for ZEGFROVY® (sunvozertinib)” in EGFR exon 20 insertion mutation-positive NSCLC, headlined as first-line treatment and “based on the results of WU-KONG28 study”. SRC-004 retrieved 2026-07-31 sha256 6dc5663822dd9950c749c765045abe4c3ce4d8f6f632251106d222c577549214 chain 4608f395d1668ed46c9541b81e4f8f629f99b3190477c4906c0782d686c7d650 2026-05-29 Dizal (sponsor) Dizal announces WU-KONG28 phase 3 results. The release headlines that sunvozertinib “outperforms platinum-doublet chemotherapy” in first-line EGFR exon 20 insertion mutation-positive NSCLC, “presented as a Late-Breaking Abstract Oral Presentation (#LBA8500)” at ASCO 2026 “and simultaneously published in The New England Journal of Medicine”. SRC-001 retrieved 2026-07-31 sha256 8d36a5ba14efa04cbdbbc0ea3ceda931828048f5dfdeed0c9621ed5fdd394489 chain 49a03be772ed184d1a6834b43f5414a86dbe30a91ef277ee72c2d60e3e8ab323 2026-05-29 The New England Journal of Medicine — PubMed record Primary publication indexed: “First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations”, N Engl J Med, PMID 42212913, doi 10.1056/NEJMoa2604461. Archived as the PubMed record because the publisher served a bot-challenge page rather than the article. SRC-002 retrieved 2026-07-31 sha256 a8b05e1e6f2c03013cad238c9404d0f10d28437e26d60251c01d55052a61a6fe chain 0ee99e5f59acb815f375816bb7c28bfd0149b16afcfeb06434a7a185dcdcc94c All 8 rows, the chain scheme, and the steps to recompute it Observation only: dated, sourced, and hash-chained. Phase 0, 2026-09-06. A ledger is a snapshot. When a guideline body, a regulator, or a payer next acts on the asset a ledger covers, the action is dated and sourced on the evidence change feed . --- # Evidence ledger: Sunvozertinib, first line, EGFR exon 20 insertion NSCLC URL: https://nextconsensus.com/ledger/sunvozertinib-first-line/ Evidence ledger ## Sunvozertinib, first line, EGFR exon 20 insertion NSCLC A launch team inside an HTA window or a BD team mid-transaction on this asset gets the record as it stands: every action the deciding institutions have put on the record about first-line use, each dated to the day its source carries, tied to an archived copy by its digest, and chained so an edit anywhere shows. Observation only: dated, sourced, and hash-chained. Phase 0, 2026-09-06. Asset Sunvozertinib (ZEGFROVY) Scope First-line use of sunvozertinib in EGFR exon 20 insertion mutation-positive NSCLC: the trial readout, its publication, regulatory filings and designations, and the guideline position, each as the institution or its recorder stated it. Runs 2026-05-27 → 2026-08-17 Rows 8, over 6 archived sources and 1 registration Chain head The digest of the last row, computed over every row before it, so an edit anywhere in the ledger changes it. How to check it chain d668f1a1d4d15be44653f597be0cee53baea3bc129e5b544363446c58732c8b8 ### What each institution put on the record, by date In the source's own words where the wording matters. Where a fact is known only through a sponsor's release, the row says so: a release is primary for what the sponsor stated, not for what the institution did. Date Institution What was recorded Source Digest 2026-05-27 China NMPA, Center for Drug Evaluation — as recorded by the sponsor Dizal release: the CDE “has accepted and granted priority review to the New Drug Application (NDA) for ZEGFROVY® (sunvozertinib)” in EGFR exon 20 insertion mutation-positive NSCLC, headlined as first-line treatment and “based on the results of WU-KONG28 study”. SRC-004 retrieved 2026-07-31 sha256 6dc5663822dd9950c749c765045abe4c3ce4d8f6f632251106d222c577549214 chain 4608f395d1668ed46c9541b81e4f8f629f99b3190477c4906c0782d686c7d650 2026-05-29 Dizal (sponsor) Dizal announces WU-KONG28 phase 3 results. The release headlines that sunvozertinib “outperforms platinum-doublet chemotherapy” in first-line EGFR exon 20 insertion mutation-positive NSCLC, “presented as a Late-Breaking Abstract Oral Presentation (#LBA8500)” at ASCO 2026 “and simultaneously published in The New England Journal of Medicine”. SRC-001 retrieved 2026-07-31 sha256 8d36a5ba14efa04cbdbbc0ea3ceda931828048f5dfdeed0c9621ed5fdd394489 chain 49a03be772ed184d1a6834b43f5414a86dbe30a91ef277ee72c2d60e3e8ab323 2026-05-29 The New England Journal of Medicine — PubMed record Primary publication indexed: “First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations”, N Engl J Med, PMID 42212913, doi 10.1056/NEJMoa2604461. Archived as the PubMed record because the publisher served a bot-challenge page rather than the article. SRC-002 retrieved 2026-07-31 sha256 a8b05e1e6f2c03013cad238c9404d0f10d28437e26d60251c01d55052a61a6fe chain 0ee99e5f59acb815f375816bb7c28bfd0149b16afcfeb06434a7a185dcdcc94c 2026-06-08 The ASCO Post — secondary reporting Independent report of the same readout: “As reported at the 2026 ASCO Annual Meeting and in The New England Journal of Medicine by Zhou et al, the phase III WU-KONG28 trial has shown that first-line sunvozertinib improved progression-free survival vs chemotherapy” in EGFR exon 20 insertion mutation-positive NSCLC. SRC-005 retrieved 2026-07-31 sha256 81a89a602bfbc251e80c5cf06192df596808daa1d552db12ff7475987b5dda2b chain 043dde0cf0f852abb4c2ee6a85aa8695aeec86270b79627cb8d8891c29752870 2026-07-01 Cancer Discovery — PubMed record Commentary indexed: “Rare EGFRm NSCLC: More First-Line Options Emerge”, Cancer Discov 16(7), PMID 42224429, doi 10.1158/2159-8290.CD-NW2026-0061. SRC-006 retrieved 2026-07-31 sha256 d8898e1c83e58d791ef7466d371ccf1728f120b1c0aa46a61c0bac75571f0098 chain 625f5199471119018daab6feca3de4fc54e3cbc332de24587b521d7533fe1b1f 2026-07-14 AstraZeneca; US FDA and China CDE as recorded in the release AstraZeneca announces an exclusive global license for sunvozertinib from Dizal. The release records that “a Supplemental New Drug Application for approval in the 1st-line setting has been submitted to the US Food and Drug Administration (FDA) and China’s Center for Drug Evaluation (CDE)” and that both “have also both granted Breakthrough Therapy Designation to Zegfrovy in this setting”. SRC-003 retrieved 2026-07-31 sha256 56e8ee9aceb9ca38a075dc5b969135c71e2b48cc9f82487f39a0c49d35697f0f chain 31b7e528a67e8078c76e773e41c3952303d606472c154fadfb66c6d7a7dadef3 2026-07-14 NCCN NSCLC Guidelines Panel — as recorded by the sponsor The same release records the guideline position at that date: sunvozertinib “is included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC as a Category 2A recommended subsequent therapy option”. Subsequent therapy, not first line; the guideline itself requires registration and is not archived here. SRC-003 retrieved 2026-07-31 sha256 56e8ee9aceb9ca38a075dc5b969135c71e2b48cc9f82487f39a0c49d35697f0f chain 4f5bc6fb1ee0debd181752438f2c543ec4f246a1c6e9fe374c1733345c38b2fa 2026-08-17 NextConsensus public registry Registration Registration FF-001 recorded against this asset: a frozen proposition on NCCN first-line listing, availability cutoff 2026-07-31, resolution window to 2027-07-31, two named adjudicator roles. The hash on this row is the ledger hash minted over the frozen commitment; the registered record itself is on its own page and is not restated here. FF-001 recorded 2026-08-17 ledger ad43205978351a4affaeb1d6b2cbe00dd6aa0bdf3ac78fd24f9d7259ca3f34fd chain d668f1a1d4d15be44653f597be0cee53baea3bc129e5b544363446c58732c8b8 ### How the chain is built, and what it checks Scheme nc-ledger-v1 : each row's chain value is the SHA-256 of the previous chain value, the row's date, and its source digest, concatenated with nothing between them; the first row's previous value is the empty string. Recompute any step: node -e "const {createHash}=require('node:crypto');const [p,d,s]=process.argv.slice(1);console.log(createHash('sha256').update(p+d+s).digest('hex'))" "" "" "" Digests are over archived copies, so a publisher editing a page after the fact makes the substitution visible. Recomputing the chain checks the ledger's integrity, not whether a source is true, and it is separate from the specification-hash tool . - Safety and adverse-event signals never enter the corpus: efficacy and coverage evidence only. - The observation layer is deterministic and open source: the same archived bytes give the same digest, and the record is checkable rather than a black box. That is tamper-evidence over an observation, not a claim that any reading of it is correct. Guideline listing (NCCN, ESMO): offered on judgment, with no calibration figure until 15 in the class have resolved. Chain head chain d668f1a1d4d1… · registered record: FF-001 . The ledger is a snapshot. When a guideline body, a regulator, or a payer next acts on this asset, the action is dated and sourced on the evidence change feed . --- # Who It's For URL: https://nextconsensus.com/use-cases/ ## Market access, HEOR, and BD teams working to a date someone else set A P&T meeting, an HTA submission, a label negotiation, a transaction closing. NextConsensus rebuilds the evidence record behind your claims and registers the probability that the regulator, guideline body, or payer you're waiting on acts by your date. Start with one claim Programs ### Questions for your next review #### Market access and regulatory - Which guideline recommendations changed before our next coverage review? - Could new trial results lead payers to tighten step-therapy requirements? Update your payer evidence package and advisory-board briefings before the review. Check the payer's procedures for reconsideration or appeal if the policy has already been published. Playbook: taking a claim into a coverage or P&T review #### HEOR and medical affairs - Which product claims are vulnerable to guideline downgrades? - Where does the real-world evidence say something different from the pivotal trial? Prioritize real-world evidence and subgroup analyses for documented gaps in support before the next guideline review. Playbook: when the guideline or label behind your claim moves #### Business development and transactions - Which guideline, label, or coverage assumptions in the deal model remain uncertain? - Are the claims that justify peak sales projections supported by current evidence? Price the transaction on a dated, checkable record of the asset's claims, and on the probability that the regulator, guideline body, or payer you are waiting on acts before close. #### Royalty, credit, and valuation diligence - Which approval, label, or guideline assumptions in the valuation or royalty model are most exposed to a change? - How would a delayed or narrowed approval move the milestone or royalty schedule? Stress-test the milestone, royalty, or credit model against a dated record of the claims it rests on, and against the probability that the regulator or guideline body acts by the date the model assumes. ### Plan backward from the review date Adapt these steps to your review calendar and the evidence behind your claim. A year out Evidence gaps - Direct RWE studies to documented evidence gaps - Brief KOLs before guideline drafting opens Six months out Dossier and committee prep - Answer the contested claims in the P&T dossier - Brief regional teams on differences between current recommendations and coverage policies Three months out Rapid response - Submit payer evidence packages with dated sources - Draft field responses for the contested claims only Decision day Published decision - Check the published wording and its effective date - Confirm whether a consultation, reconsideration, appeal, or later review is available ### If the decision comes earlier or later An earlier action pulls your calendar forward. A later one leaves time to resequence dependent work or close a specific evidence gap. Each team's playbook writes out both branches in the planning guides . --- # Start with one claim URL: https://nextconsensus.com/contact/ ## Start with one claim Name the claim you are taking into a review, or the guideline, label, or coverage decision you are waiting on, and the date you need to know by. We reply within one business day to confirm whether we can take on the evaluation or ask a follow-up question. Your submission has been recorded. Reference ticket: . Expect a reply within one business day. Forecasts are offered on judgment. As of the 2026-10-26 registry snapshot, 56 are registered in public and 0 have resolved; a class gets a calibration figure once it holds resolved forecasts on 15 different decisions. - 1 Your question - 2 Context (optional) ### What to include - Which decision you are waiting on: a guideline, a label, or a coverage policy - The authority and the public action - The date, and the document that will settle it - The evidence you already know has moved ### What happens next We reply within one business day. Send your question and work email; the additional details on step two are optional. Forecasts are offered on judgment. As of the 2026-10-26 registry snapshot, 56 are registered in public and 0 have resolved; a class gets a calibration figure once it holds resolved forecasts on 15 different decisions. ### Other inquiries Partner inquiries Security inquiries --- # Programs URL: https://nextconsensus.com/programs/ For market access, HEOR, regulatory, and BD teams ## The dated record behind your claim, and a probability registered before your review Each program is scoped to a decision with a date: a P&T meeting, an HTA submission, a label negotiation, or a deal closing. You can start with one claim at a fixed price and extend the same record to the rest of your portfolio. Start with one claim See the examples ### What a program is scoped around - The claim, drug, or therapeutic class your team needs to review. - The decision it feeds: an evidence strategy, a market access plan, a claim review. - The date that decision is due, and the period the reconstruction has to cover. ### Claim Intelligence A dated, sourced record of how the claims about your drugs, competitor indications, or a whole therapeutic class are worded and supported across FDA and EMA labels, NCCN and other guidelines, coverage policies, and trial literature, and where those sources disagree. #### Start with one claim before your deadline Name one contested claim, coverage restriction, or guideline criterion, who decides it, and the review it goes into. For that claim, that decision-maker, and that date, a single-claim evaluation is a fixed $9,500 and delivers within ten business days: the dated evidence baseline, a comparison showing which qualifiers changed, a reading of where the evidence has stalled, and your question registered as a forecast before your deadline. You pay for the question and the work behind it. The probability itself is public, so your team can share it by link. #### For legal and compliance teams: Asset Transition Ledger If your legal or regulatory compliance review cannot accept probability estimates, an Asset Transition Ledger is available at a fixed $25,000 (fifteen business days). It provides the complete dated evidence baseline, authority divergence redline, and claim change history with zero forward-looking probabilities. #### Standing Authority Coverage across the portfolio The same record can cover every asset and decision your portfolio is waiting on, refreshed on a cadence you set, with a registered probability for each decision that has a date. Standing Authority Coverage ($75,000/year) maintains an updated ledger across key pipeline assets, with a fresh briefing memo each time a major authority publishes, and at each scheduled review cycle. #### For diligence, valuation, and dispute work For royalty, credit, or valuation teams pricing an asset on a milestone, label, or guideline assumption, a single-claim evaluation stress-tests that assumption against a dated record of the claims it rests on and the probability that the regulator or guideline body acts by the date the model assumes. - Claim history. When the claim first appeared, each change to its wording and evidence, whether it was contested, and how long it held. Every step carries the revision date and its source document. - Cohort analysis. Which claims are shared, contested, or unique to one drug in the class. - Claims you name. A dated record of every public change to each, including the finding that a claim has not moved. Rebuilt from dated public revisions. Adverse-event, REMS, boxed-warning, and recall-safety evidence stays outside the record by design ( evidence boundary ). ### A source-linked history for the next review An evaluation brings label versions, guideline editions, and coverage policy PDFs into one dated, source-linked history. Your team can use that history again at the next review. See a real one: an evidence ledger from the public record, with a source and a digest on every row ### Every evaluation arrives as four documents Executive Briefing Memo Three to five pages for your CMO, head of market access, or deal team: the contested claims, how each authority's published wording has changed, and the decision dates ahead. Claim Vulnerability Matrix A redline of your asset's claims across FDA label text, NCCN guideline versions, and major payer coverage policies, marking where the wording diverges. Evidence Gap Roadmap The endpoints and real-world evidence that the authority's published record asks for and your dossier does not yet answer, set against your submission calendar. Verifiable Audit Ledger Every source revision, evidence cutoff, and forecast probability, dated, in one ledger your compliance and regulatory teams can hand to a reviewer. Inside every evaluation, or on its own ### A registered forecast on the change you are waiting for A probability that a defined action is taken by your date: a guideline body changing a recommendation, a regulator changing a label, a payer changing coverage. 56 forecasts registered in public, 0 resolved; the next deadline is Oct 26, 2026 . Read them all , or read how a forecast is scored . ### Three questions buyers ask first How is the number formed? We assess four inputs at the evidence cutoff: the public evidence behind the claim; the status of the submission or review and the authority's schedule; comparable past decisions; and evidence or procedural constraints against the proposed action. The reasoning is published beside the probability. What happens when a forecast is wrong? It stays published, beside the reasoning that produced it, and counts in its class's score. How does a program run? A fixed-scope statement of work names the claims, the period covered, and each deliverable with its date. The evidence record arrives as a dated, sourced document with a digest on every archived copy. One named contact, and a reply within one business day. ### How a program starts Four steps. The signature is the last one. - First conversation Send the drug, class, or area and the decision it feeds. Public sources and high-level context are enough, and a mutual NDA can come first if you want one. - Confirm the scope Within one business day, at no charge, we confirm whether the public sources support an evaluation. If they do not, we explain why. - Fixed-scope statement of work It fixes the drugs, the look-back period, the claims covered, the deliverables and their dates, and the price. - Contracting and delivery Any confidentiality, data-processing, retention, and delivery terms are settled in writing before work starts. On pricing. Beyond one claim, four things set the figure: how many drugs or claims, how many decision-makers, how far back the record goes, and whether it is kept current or delivered once. The figure is in the statement of work. Start with one claim Read the method Validation status, by type of forecast Forecasts are offered on judgment. As of the 2026-10-26 registry snapshot, 56 are registered in public and 0 have resolved; a class gets a calibration figure once it holds resolved forecasts on 15 different decisions. --- # Guideline, Approval, and Coverage Planning Guides URL: https://nextconsensus.com/guides/ ## Prepare for the next guideline, label, or coverage decision A P&T meeting, a coverage reconsideration, an HTA submission, or a label negotiation has a date set by someone else. The guideline, label, and coverage policy behind the claim you are bringing can move before it. Choose the institutional question or preparation task below. Each guide explains what to check, who needs it, and what an earlier or later date changes. Start with the coverage review See the examples ### What to check before your date #### FDA approval, NCCN guidelines, and payer coverage: three separate decisions How oncology market access teams distinguish label approval, guideline inclusion, and payer coverage, and prepare when their dates diverge. #### CMS and NICE timelines: decision dates and implementation windows Distinguish CMS national coverage review milestones from NICE technology appraisal funding windows when planning evidence and implementation work. #### What is a PDUFA date? Plan for approval, a CRL, or an extension A PDUFA date is FDA's target for acting on a drug or biologic application. What approval, a CRL, an extension or a missed date means for a launch or deal plan. #### NICE scheduled dates: plan for publication, a delay, or a suspension What an expected NICE publication date commits NICE to, which outcomes a UK launch or access plan must cover, and where NICE's own record confirms the action. #### When the guideline or label behind your claim moves before your date How a written claim loses the guideline, label, or coverage policy under it, with a dated worked example and the seven-question check to run before your date. #### When a guideline, label, or coverage change is delayed Distinguish missing evidence, procedural delay, a different action, and an outcome after the deadline when an institutional change does not arrive. #### GLP-1 coverage changes: start with the indication and the plan A guide for market access and payer teams comparing GLP-1 coverage by indication, population, benefit, and effective date, with historical evidence examples. ### What to bring to the review #### Evidence preparation before a P&T or HTA deadline What market access, HEOR, and medical affairs teams can prepare twelve, six, or three months before a committee or submission deadline. #### Taking a claim into a coverage or P&T review The restriction's PICO against today's record, the usual shapes of the gap between restriction and evidence, and the three-item packet that gets a decision rather than a deferral. #### Label expansion readiness: planning for a new indication A preparation guide for regulatory, launch, and market access teams assessing a possible label expansion and an earlier or later decision date. ### How the decisions are ordered #### The 12-rung ladder How guideline, label, and coverage decisions are ordered, and which of them a forecast is registered against. --- # Taking a claim into a coverage or P&T review URL: https://nextconsensus.com/guides/coverage-review/ ## Taking a claim into a coverage or P&T review For a step-therapy rule, a prior-authorization criterion, a coverage determination, or a formulary tier, the request shows, with dates, what changed in the record after the position was set, what still holds, and what you are asking the payer to decide. It has to be ready before the payer's meeting date. ### The restriction's PICO, against today's record Compare the restriction's population, comparator, and outcomes with the current evidence. Address each part in your payer evidence package: Population Is the population the restriction excludes now inside the population the evidence supports? Comparator Is the comparison the restriction assumed still the one the evidence uses? Outcome Has a surrogate the restriction leaned on been joined, or replaced, by a functional outcome? Limits What uncertainty is still there, stated plainly, so the reviewer does not have to find it for you? The answers make one document: what changed since the restriction was written, what still holds, where a caveat belongs, and exactly what you are asking the policy owner or the committee to decide. ### What a dated record adds to the request A summary for one review A summary of current evidence describes what is available for this review. Publication dates show which findings came after the restriction was set. A history of changes since the restriction A dated history places the restriction beside later trial results, label changes, and guideline revisions. It shows which evidence changed and can be reused at the next review. ### Where the gap usually opens Check these three possible grounds for reconsideration, including the dates and the payer's review criteria. - A step-therapy rule the guideline has moved past. The sequence the rule enforces is no longer the one the current recommendation gives; the guideline revision postdates the rule. - An NCD or LCD narrower than the label. The determination covers a subpopulation the label, or a later trial, has since widened; the excluded patients are now inside the evidence. - A tier that predates the readout. The formulary placement was set before the outcomes trial or the guideline upgrade that would argue for a different one. The record can also have moved against you: a guideline downgrade, changed efficacy evidence, or a restriction on a comparator changes what the reviewer will ask. Bring the change and its date rather than let the reviewer find it first. If nothing has moved, say so, with the sources checked and the date they were checked. ### Three parts of the evidence package Organize the evidence package into three parts so the policy owner or P&T committee can review the evidence and the requested change separately: - What changed in the record The trial readouts, guideline revisions, and label changes that landed after the current position was set, each with its date and source. - What still holds Your claim's population, comparator, endpoint, and caveats as the evidence now supports them, including where it does not yet. - What you are asking for The placement, criterion, or restriction change you want, stated so the committee can vote on it rather than send it back for clarification. ### Include sources with the evidence package Include the relevant wording, publication dates, source references, and hashes of archived copies. These let the reviewer trace your interpretation to the original documents. Confirm the payer's submission cutoff and review schedule; a request for missing evidence may delay consideration. A registered forecast about the guideline or label behind your claim belongs in the preparation, never in the submission. The committee decides on the evidence, not on a probability. The forecast tells you which claims to prepare first and by when; the packet carries the dated record and nothing else. ### Bring this claim Name who decides, the decision, and the date you need to know by. A forecast is registered against a guideline, label, or coverage decision with a date and an author; the 12-rung ladder sets out how those decisions are ordered. Start with one claim See a worked example --- # Guideline or label changes before your date URL: https://nextconsensus.com/guides/guideline-windows/ ## When the guideline or label behind your claim moves before your date A claim supported when your team wrote it may need revision before the next review. Trial results, guidelines, labels, and coverage policies can change in the meantime. Check the claim against the evidence available on a specific date, and state that date in your evidence package. ### Where it happens Teams working to a date usually meet the gap at the date: - The guideline you cite in the dossier changed after you cited it. The HTA submission quotes a recommendation as it stood in the spring. The guideline panel revised the wording in the fall, and the reviewer reads the current version. - The comparator's label moved and your positioning did not. A competitor's label gains or loses a population, and every head-to-head claim built on the old label is now measured against a different product. - The payer's restriction outlived the evidence that justified it. A step-therapy criterion was written against the record of three years ago. The trials that would reopen it have published; nobody has put them beside the criterion with dates. - A deal model values an asset on a position that is already contested. The deal model treats a guideline recommendation as settled. The public record shows that independent sources disagree about the qualifier. That disagreement leaves an assumption in the deal model unresolved. - A subgroup claim was carried past the trial that supported it. Benefit was shown in the full cohort; a subgroup analysis did not reach significance. The claim was written for the subgroup anyway, and the next readout is the one you will be asked about. ### The claim that was fine in March A market access team prepares a payer deck in March. The deck includes a claim: "Therapy X reduces hospitalization-related outcomes in high-risk patients with Condition Y." At the time, the evidence supports it: the pivotal trial showed benefit in the high-risk subgroup, the label includes the indication, and the guideline recommends use. By August, three things have changed. A new trial readout shows no benefit in moderate-risk patients, the guideline narrows its recommendation to patients with prior hospitalization, and the label narrows its indication. The claim is still in the deck. The deck is still in circulation. Whether the claim is defensible depends on when you ask. In March, yes. In August, not as written. The record that answers both dates holds what the claim asserted, what the evidence supported at the time, what changed since, and whether the claim still stands as written. It also answers the questions a present-tense summary cannot: was the claim supportable when the deck was approved, did it lose a caveat or drop a subgroup between versions, and is it being used in a higher-stakes setting than it was written for. ### The timelines a claim sits on The changes that reach a claim arrive on five separate timelines. The worked example above had the same wording in March and August; what moved was the evidence and the authority under it. Illustrative review date Evidence Wording Authority Use Review At each review, check changes to evidence, wording, guidelines, labels, and coverage since the previous review. Evidence time When did the studies, safety data, endpoint analyses, or real-world evidence appear? A trial published after the claim was written can strengthen or weaken it. Wording time When did the claim's language change? "May reduce hospitalization-related outcomes" became "reduces hospitalization": the revised wording makes a stronger claim and changes the outcome it names. Check whether the evidence supports both changes. Authority time When did a guideline, label, payer policy, or regulator adopt, weaken, or retire the claim? A guideline change can undermine a claim even when no new evidence has appeared. Use time When did the claim move into a higher-stakes setting? An internal scientific note tolerates uncertainty that a payer-facing deck cannot. Review time When was the claim last checked, within what review window, and what would warrant another look? ### Why reviewing more often does not fix it Most teams re-read the record on a schedule set by someone else: the quarter before a P&T cycle, the run-up to an HTA submission, the weeks before a launch. Between those points, trial results publish, labels change, and coverage policies shift, and the re-read happens under the deadline it was meant to prepare for. Shortening the cycle reduces how much accumulates between checks. It does not say which claims are about to need attention, so the extra reviews land evenly across a portfolio where the exposure is not even, and most of that work confirms claims that were never in question. The events that invalidate a claim are decisions by named institutions, taken on published calendars, in response to evidence already on the public record: a guideline narrowing a recommendation, a label restricting a population, a payer tightening coverage. Each has an institution, an action, and a date, and the check below is run against that date rather than against the calendar. ### The check to run before your date Whatever form the review takes, it comes down to seven questions: - Does the stated population still match the evidence population? - Is the comparator still the one current practice uses? - Do the endpoints still carry the weight the claim gives them? - Are the caveats from the original publication still attached? - Has the claim broadened beyond what the source record supports? - Have label changes or guideline updates narrowed the supported scope? - Does the claim still hold under the most recent guideline language? ### Bring this claim Name who decides, the decision, and the date you need to know by. A forecast is registered against that decision before the outcome is known, with its evidence cutoff and resolution rule published beside it; the 12-rung ladder sets out how guideline, label, and coverage decisions are ordered. Start with one claim See a worked example --- # The 12-Rung Evidence-to-Action Ladder URL: https://nextconsensus.com/guides/evidence-to-action-ladder/ ## The 12-rung ladder Evidence accumulates on the lower rungs, a guideline body, regulator, or payer acts on one of the middle three, and the market responds on the rest. Forecasts are registered against the middle three, because those are the steps with a date and an author. Read the method Read the first record ### The twelve rungs The 12-rung ladder Rung 5 / 12 · Guideline action Select a rung EVIDENCE (1–4) AUTHORITY (5–7) CONSEQUENCE (8–12) resolvable Rung 5: Guideline action Formal recommendation change by a recognized guideline body: grade shift, new/retracted endorsement, population expansion/restriction. Role: Primary forecast target: public, dated, adjudicable Rung 1 Evidence 18+ months before authority review · Illustrative ### Evidence emergence New trial results, replications, subgroup analyses, novel mechanisms, or new indications enter the public record. What a team can do at this rung - Set new readouts and subgroup analyses beside the claims they touch - Compare effect size and endpoint definitions with the competitors' trials - Note the first qualifier changes in the new publications Why it stalls here The single-study effect fails to replicate, or a safety signal appears in longer follow-up. Rung 2 Evidence 12–18 months before authority review · Illustrative ### Replication & strengthening Independent confirmation, effect consistency across populations, endpoint coherence, and methodological rigor. What a team can do at this rung - Read the meta-analyses and confirmatory trials for whether the effect holds - Judge whether the evidence now matches what this committee has previously required - Design registry or observational studies for the endpoints still contested Why it stalls here Endpoints differ between studies, or the meta-analyses disagree, and no consensus forms. Rung 3 Evidence 9–12 months before authority review · Illustrative ### Expert recognition & KOL convergence Field-level interpretation shifts: review articles, conference narratives, advisory-board consensus, editorial positions. What a team can do at this rung - Brief the clinical experts before the guideline drafting panel convenes - Put medical affairs effort on the contested qualifiers before the committee fixes its scope - Watch consensus statements and reviews for the wording the authority will later use Why it stalls here Experts disagree on clinical relevance or on how the subgroup is defined, and the field does not converge. Rung 4 Evidence 6–9 months before authority review · Illustrative ### Real-world confirmation RWE accumulation, registry data, claims analyses, practice-pattern shifts, and post-market surveillance. What a team can do at this rung - Assemble the real-world and claims analyses on persistence and adherence - Draft the P&T dossier responses and the health-economics case - Note where routine practice has already diverged from the label Why it stalls here Trial efficacy does not show up as effectiveness in routine-care cohorts. Rung 5 Authority 3–6 months before public release, in the drafting and comment window · Illustrative ### Guideline action Formal recommendation change by a recognized guideline body: grade shift, new/retracted endorsement, population expansion/restriction. What a team can do at this rung - Submit public comment while the guideline's review window is open - Prepare regional access leads for a change in recommendation grade, such as Category 1 to 2A - Re-read formulary exposure against the draft recommendation Why it stalls here The committee defers, waiting for long-term outcomes or a class review. Rung 6 Authority 3–6 months before action deadline, in the window before an advisory committee · Illustrative ### Regulatory action Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc. What a team can do at this rung - Prepare advisory committee briefing material on the contested indications and safety wording - Weigh the chance of a label restriction, a REMS requirement, or a boxed warning - Align FDA and EMA filings where their wording is starting to differ Why it stalls here The review raises an unresolved safety question or asks for post-marketing commitments. Rung 7 Authority 0–3 months before the coverage decision · Illustrative ### Payer/coverage action NCD, LCD, formulary change, step-therapy revision, or access expansion/restriction by CMS, MACs, or major commercial payers. What a team can do at this rung - File the formulary package with the dated evidence record attached - Negotiate tier placement and step-therapy criteria before the final LCD or NCD posts - Prepare the field reimbursement team's response material Why it stalls here The payer restricts coverage to a subpopulation or adds prior authorization despite guideline support. Rungs 8–12: what follows the decision Adoption, coverage in practice, revenue, repricing. These are the consequences a team plans against; no forecast is registered on them, and no recorded decision has reached them. - Rung 8 · Institutional policy adoption. Hospital pathways, P&T formulary placements, protocols, and EHR order sets updated to match the decision. - Rung 9 · Clinical adoption. Prescribing moves to match the new position, at different speeds in specialist, primary-care, academic, and community settings. - Rung 10 · Commercial strategy adjustment. Promotional claims, field messaging, patient support, and contracting are redone against the new wording. - Rung 11 · Market repricing. The asset's valuation and deal terms move once the decision is public; a diligence read done before it priced the asset on the old position. - Rung 12 · Patient-access / outcome consequences. Time to treatment, patient eligibility, and the cost to a health system: these change last, and they are the reason the earlier rungs matter. ### When the expected act does not come A guideline update, label expansion, or coverage revision that does not arrive by the expected date is usually recorded as a non-event. Read against the ladder, it is a stall at a particular rung, and the rung says what is missing: Rungs 1–2 · The evidence #### Replication fails or endpoints disagree The pivotal effect does not replicate in independent cohorts, or the meta-analyses conflict. Rung 3 · The field #### Experts disagree Key opinion leaders and specialty societies contest the endpoint's relevance or the population's definition, and the committee waits. Rung 4 · Routine care #### Practice diverges from the trial The trial effect does not appear in registry cohorts, or discontinuation and adherence problems show up in practice. Rungs 5–7 · The procedure #### The institution defers The committee defers the review, the comment period is extended, or the authority asks for post-marketing commitments. ### What a proposition on rung 5 looks like The first registered record is a rung-5 proposition: NCCN lists sunvozertinib as a first-line option in EGFR exon 20 insertion NSCLC , by 2027-07-31, with its evidence cutoff, its baselines, and the rule that settles it. Sunvozertinib (ZEGFROVY) First line, EGFR exon 20 insertion NSCLC, 2026-05-27 → 2026-08-17 Evidence builds 1 → 7 Rung 7 Authority Payer/coverage action No payer action on record (downstream target). Rung 6 Authority Regulatory action 2026-05-27 China's CDE accepts the first-line NDA and grants priority review 2026-07-14 Supplemental NDA submitted to FDA; Breakthrough Therapy Designation granted Rung 5 Authority ★ forecast target Guideline action 2026-07-14 NCCN lists the agent as a Category 2A subsequent-therapy option; not first line 2026-08-17 FF-001 registered: 75% that NCCN lists it first line by 2027-07-31 · pending Rung 4 Evidence ↳ feeds Rung 5 Real-world confirmation No real-world evidence published on record. Rung 3 Evidence ↳ feeds Rung 5 Expert recognition & KOL convergence 2026-06-08 The ASCO Post reports the readout independently 2026-07-01 Cancer Discovery commentary: more first-line options in rare EGFR-mutant NSCLC Rung 2 Evidence ↳ feeds Rung 5 Replication & strengthening Nothing recorded at this rung. Rung 1 Evidence ↳ feeds Rung 5 Evidence emergence 2026-05-29 WU-KONG28 phase 3 reads out: first-line use beats platinum doublet on progression-free survival 2026-05-29 Primary publication in the New England Journal of Medicine Every row is on the evidence ledger with its source and digest. Observation only: dated, sourced, and hash-chained. Phase 0, 2026-09-06. --- # FDA approval, NCCN guidelines, and payer coverage: three separate decisions URL: https://nextconsensus.com/guides/approval-guideline-coverage/ ## FDA approval, NCCN guidelines, and payer coverage: three separate decisions A trial result, an approved indication, a guideline listing, and a payable claim answer different questions. Keep the population and line of therapy fixed when comparing them. A change in one document is a reason to check the others; it does not establish that they changed too. For oncology market access, medical affairs, payer pharmacy, and provider reimbursement teams. ### Follow the same indication through each institution Evidence emergence and strengthening sit upstream, on rungs 1–4. A guideline action is rung 5, a regulatory action rung 6, and a coverage action rung 7. These labels identify the decisions; they do not require institutions to act in that order. For an oncology therapy, record the exact NCCN version and listing, the FDA indication and action date, and the named payer's policy and effective date. A listing for previously treated disease does not establish a first-line position. A recommendation also does not establish coverage for a particular member. - Population, biomarker, and line of therapy match across the documents. - Recommendation wording and category are recorded with their version date. - The coverage policy identifies the plan, indication, restrictions, and effective date. - An announcement date is kept separate from an implementation date. ### Prepare for either institution to move first If the guideline changes first, market access can identify which payer policies refer to that recommendation and prepare a review question. The reviewer must still check the applicable policy. If the label changes first, teams can compare the new indication with the existing guideline and coverage criteria. When both remain pending, prepare separate scenarios. Specify which evidence or public document would change each scenario. A forecast of which institution acts first is a different proposition from a forecast that either acts by a deadline. ### Read one worked institutional sequence The linked oncology dossier brings together an observed evidence history and registered questions about guideline inclusion, label expansion, and their order. Estimates remain attached to their frozen records. Coverage and clinical adoption are not inferred from those records. - First-line oncology: the evidence and institutional timing dossier ### Who needs to prepare if the date moves? What each team changes if the decision comes earlier or later than planned. #### Manufacturer market access If the decision is earlier Bring the relevant indication and evidence comparison into an upcoming payer review. If the decision is later Keep the existing policy assumption explicit and schedule the next evidence check. #### Medical affairs and payer reviewers If the decision is earlier Review version-specific scientific materials and the population affected. If the decision is later Avoid replacing current wording with a proposed recommendation. #### Provider reimbursement and pharmacy If the decision is earlier Check plan requirements and prepare documentation before implementation. If the decision is later Keep authorizations tied to the policy actually in force. ### Bring the action and your deadline Which decision matters to your team, and by what date? Include the population and the plan it would inform. Start with one claim --- # Label expansion readiness: planning for a new indication URL: https://nextconsensus.com/guides/label-expansion-readiness/ ## Label expansion readiness: planning for a new indication A possible new indication changes the questions a team needs answered before launch. It does not change the approved label. Anchor readiness work to the precise population, treatment setting, and regulatory action being considered. For regulatory strategy, launch operations, market access, and competitive intelligence teams. ### Separate the indication question from the review clock Upstream trial evidence on rungs 1–4 can support a question about regulatory action on rung 6. Record the application or supplement, the proposed indication, and the source for each procedural milestone. A submission, an acceptance, a review target, and an approval are distinct facts. Use the agency's published record for an action already taken. Attribute sponsor statements about a submission to the sponsor. Where an agency date is unavailable, say that it is unavailable; an estimated date should not acquire the appearance of an official schedule. - Which population or treatment line would be added? - Which document establishes the current approved indication? - Is the milestone a submission, acceptance, target date, or completed action? - Which dependencies remain with guideline panels, payers, and local implementation teams? ### Work backward from the date your team needs For a decision potentially months away, identify work that can be prepared while the outcome remains uncertain: evidence comparisons, an indication-specific dossier outline, internal review ownership, and payer questions. Scientific and commercial materials need the reviews appropriate to their intended use. Keep a second plan for a later decision. Identify which work remains useful, which assumptions need revision, and which commitments depend on the actual approved wording. A narrower population or a different treatment line may require a different plan even when an approval occurs. ### Make the question scorable Define the named regulator, indication, action, deadline, and document that settles the outcome. A probability of an action by March and a probability of the same action by July answer different planning questions. Neither date should be presented as an agency commitment. - First-line oncology: the evidence and institutional timing dossier ### Who needs to prepare if the date moves? What each team changes if the decision comes earlier or later than planned. #### Regulatory and launch operations If the decision is earlier Bring document review and operational dependencies forward. If the decision is later Reassess sequencing and preserve resources needed for the eventual wording. #### Market access and HEOR If the decision is earlier Prioritize the evidence package for the proposed population. If the decision is later Use available time to address a defined evidence gap, where feasible. #### Competing manufacturers If the decision is earlier Review whether the relevant comparator and access assumptions change. If the decision is later Retain the existing scenario with a dated reason for revisiting it. ### Bring the action and your deadline Which decision matters to your team, and by what date? Include the population and the plan it would inform. Start with one claim --- # Evidence preparation before a P&T or HTA deadline URL: https://nextconsensus.com/guides/evidence-preparation/ ## Evidence preparation before a P&T or HTA deadline Start with the date evidence must be submitted, which can precede the committee meeting. The useful question is what can still be completed and reviewed before that cutoff. More notice and a later institutional decision create different kinds of room to work. For HEOR, evidence strategy, medical affairs, and market access submission teams. ### Twelve to six months: define the missing evidence Illustrative planning horizon: identify the population, comparator, endpoint, and uncertainty the reviewer is likely to examine. Decide whether an existing dataset can answer the question or whether new evidence work is needed. Study initiation may be feasible; completion is not assured within this horizon. Assign an owner and a feasible delivery date to each gap. Record which guideline, regulatory, or payer assumption could change the planned analysis. This makes a later update a specific revision rather than a complete reconstruction. ### Six to three months: assemble and review the dossier Illustrative planning horizon: compare current authority wording with the evidence available at the dossier cutoff. Update the evidence tables, document remaining uncertainty, and route the package through internal review. Verify the receiving body's format and actual submission timetable. Keep scientific evidence changes separate from procedural changes. A new readout can alter the argument without moving the meeting date; a rescheduled meeting can move the date without adding evidence. ### Three months to the deadline: control the final changes Illustrative planning horizon: prioritize analyses and updates that can be completed and checked. Prepare a concise account of what changed after the earlier draft, the source for each change, and its bearing on the requested decision. Confirm whether the reviewer accepts supplementary evidence after submission. Once the cutoff passes, the available route depends on the institution: a later submission, consultation response, reconsideration, or appeal may apply. Do not assume that every policy stays closed until an annual cycle. - Submission cutoff and meeting date - Named decision owner and requested action - Current restriction or recommendation, dated - Evidence added since that wording was adopted - Remaining limitations and any evidence still unavailable - Taking a claim into a coverage or P&T review - CMS and NICE decision and implementation windows ### Who needs to prepare if the date moves? What each team changes if the decision comes earlier or later than planned. #### HEOR and evidence strategy If the decision is earlier More opportunity to specify and commission targeted analysis. If the decision is later Check whether added time can answer a remaining question before extending the plan. #### Medical affairs If the decision is earlier Review the changed scientific claim and prepare sourced responses. If the decision is later Refresh materials only when the evidence or authority wording changes. #### Submission owner If the decision is earlier Bring internal review forward to protect the filing cutoff. If the decision is later Confirm the revised cutoff instead of assuming the meeting delay extends it. ### Bring the action and your deadline Which decision matters to your team, and by what date? Include the population and the plan it would inform. Start with one claim --- # When a guideline, label, or coverage change is delayed URL: https://nextconsensus.com/guides/delayed-transitions/ ## When a guideline, label, or coverage change is delayed An expected change that has not arrived leaves a planning question: what is still missing, and which commitments depend on it? Preserve the original deadline and evidence cutoff while investigating the delay. Moving the goalposts would erase the question the forecast was meant to answer. For market access, regulatory strategy, evidence planning, and business development teams. ### Locate the unresolved step Check whether the limiting step is upstream evidence on rungs 1–4 or an institutional process on rungs 5–7. Missing replication, an unresolved population question, a deferred committee review, and an institution choosing a different action imply different follow-up work. Use a public document to support the explanation. If the reason for inaction is not public, mark it unknown. Silence alone cannot establish that an institution rejected the evidence or postponed its review. - What was the last documented action, and when? - Has the institution stated why the process has not advanced? - Did a different population, recommendation, or restriction move instead? - Which new document would justify changing the planning assumption? ### Keep late outcomes distinct from on-time outcomes An action after a forecast deadline does not satisfy a by-deadline proposition, even if the eventual action matches. Read the frozen resolution rule: the outcome deadline and the date on which an adjudicator checks the record may differ. A pending record, a resolved non-event, an ambiguous result, and an expired record are separate statuses. The published status should follow adjudication, not a page's clock. An updated planning view can coexist with the original frozen estimate. ### Use the delay in the operating plan Identify what remains useful under the existing label, guideline, or policy. Revisit commitments whose value depends on a specific date. A later decision may allow additional analysis, but it may also move access or implementation beyond the team's planning period. For a transaction, separate an observed institutional milestone from a forecast assumption. Record the source and the unresolved dependency rather than treating anticipated action as completed evidence. ### Who needs to prepare if the date moves? What each team changes if the decision comes earlier or later than planned. #### Market access and launch operations If the decision is earlier Complete the work needed for the nearer decision window. If the decision is later Resequence dependent work and retain the existing policy scenario. #### HEOR If the decision is earlier Prioritize evidence that can be ready by the cutoff. If the decision is later Evaluate whether the extra time can resolve a specific evidence gap. #### Business development If the decision is earlier Review which assumptions depend on a completed milestone. If the decision is later Keep unresolved institutional action visible in the transaction assessment. ### Bring the action and your deadline Which decision matters to your team, and by what date? Include the population and the plan it would inform. Start with one claim --- # GLP-1 coverage changes: start with the indication and the plan URL: https://nextconsensus.com/guides/glp1-coverage-by-indication/ ## GLP-1 coverage changes: start with the indication and the plan A therapy-class headline cannot establish an individual plan's coverage. Separate the indication, eligible population, benefit, and policy date before comparing a coverage change. Evidence about a class also does not establish that every product has the same approved use. For metabolic market access, payer pharmacy, employer benefits, and provider authorization teams. ### Build a policy comparison with explicit boundaries For each policy, record the named payer or program, the product and indication, eligibility criteria, prior-authorization requirements, announcement date, and effective date. Keep proposed changes apart from rules already in force. CMS's provider information for the Medicare GLP-1 Bridge illustrates why these distinctions matter: it sets out a program-specific route and directs some patients with other indications to their Part D plan for a coverage determination. Consult that source for current eligibility; this guide does not determine a patient's eligibility. - Indication and population - Product and presentation covered - Plan, benefit, or demonstration program - Eligibility and authorization requirements - Announcement, effective date, and policy source - CMS: Medicare GLP-1 Bridge information for providers ### Keep historical evidence examples in their own lane The linked GLP-1 material reconstructs how claims and population qualifiers changed in a historical record. It is useful for seeing how evidence boundaries move. It is not a current payer-policy directory or a registered coverage forecast. A new coverage forecast would need a named payer, a defined action, a deadline, and an independent resolution source. No probability should be inferred from a historical evidence example. - Population boundaries: a historical example baseline - GLP-1 historical evidence reconstruction ### Prepare around the policy's effective date Manufacturers can identify the evidence question behind a restriction and prepare a dated response. Payer and benefits teams can assess implementation dependencies and plan communications. Provider teams need the actual policy and documentation requirements before updating authorization workflows. A later effective date may provide more preparation time; it does not establish continuing coverage after the current policy expires. Keep the published policy period visible and confirm the next document before relying on it. ### Who needs to prepare if the date moves? What each team changes if the decision comes earlier or later than planned. #### Manufacturer market access If the decision is earlier Prioritize the indication-specific evidence package. If the decision is later Check whether a reconsideration request can address the restriction before implementation. #### Payer and employer benefits If the decision is earlier Bring administrative review and member communications forward. If the decision is later Confirm the benefit calendar and document which policy remains in force. #### Provider authorization teams If the decision is earlier Review the documentation required under the new policy. If the decision is later Use current requirements and avoid treating an announcement as an effective rule. ### Bring the action and your deadline Which decision matters to your team, and by what date? Include the population and the plan it would inform. Start with one claim --- # CMS and NICE timelines: decision dates and implementation windows URL: https://nextconsensus.com/guides/authority-decision-windows/ ## CMS and NICE timelines: decision dates and implementation windows An authority's process supplies several dates, not one. Evidence submission, consultation, a published decision, and implementation each create a different preparation window. Start with the named process and its current official timetable. For US and UK market access, regional HEOR, and health-system implementation teams. ### US: the national coverage determination process Under its published process, CMS issues a proposed national coverage determination within six months after posting the tracking sheet, or nine months when the analysis includes an external technology assessment or a MEDCAC meeting. Public comment and the final determination are further steps. The proposed-decision date is not the implementation date. Use the tracking sheet to establish the process stage and dates for the particular review. These NCD windows do not describe a commercial payer's formulary process, a local coverage determination, or an individual coverage request. - CMS: National Coverage Determination Process & Timeline ### England: NICE appraisal and NHS availability NICE states that when a technology appraisal recommends a treatment as an option, the NHS must make it available within three months of publication unless otherwise specified. Read the recommendation's actual funding requirement and population; a draft recommendation is not the final instruction. The funding window follows the appraisal. A regional team still needs to distinguish committee review, publication, the applicable funding period, and local implementation work. A regulatory authorization and a NICE recommendation answer different institutional questions. - NICE: What is technology appraisal guidance? ### Compare jurisdictions without importing their clocks Keep a separate row for each authority and action. A date in the US is not a deadline for a UK institution; evidence shared between submissions does not make the procedures interchangeable. For other jurisdictions, establish the local source, process stage, deadline, and implementation rule before constructing a comparison. This guide covers US NCD and English NICE appraisal planning; it does not imply that NextConsensus has registered forecasts in other markets. - Jurisdiction and responsible institution - Action and population being assessed - Submission or consultation cutoff - Decision publication and effective date - Exceptions stated in the official process - Evidence still missing and the team responsible for it ### Who needs to prepare if the date moves? What each team changes if the decision comes earlier or later than planned. #### Regional market access If the decision is earlier Align the evidence package with the actual local submission window. If the decision is later Confirm whether the evidence cutoff moves with the decision date. #### HEOR If the decision is earlier Prioritize analyses accepted by the relevant assessment process. If the decision is later Reassess comparators and data currency before reusing an earlier dossier. #### Health-system implementation If the decision is earlier Check staffing, pharmacy, and administrative dependencies. If the decision is later Use the published funding or effective date to revise the implementation plan. ### Bring the action and your deadline Which decision matters to your team, and by what date? Include the population and the plan it would inform. Start with one claim --- # What is a PDUFA date? Plan for approval, a CRL, or an extension URL: https://nextconsensus.com/guides/pdufa-goal-dates/ ## What is a PDUFA date? Plan for approval, a CRL, or an extension A PDUFA date, or goal date, is FDA's target date for acting on a drug or biologic application under the Prescription Drug User Fee Act. A complete response letter (CRL) is also an action. Launch sequences, licensing milestones, and first payer meetings are often dated from the goal date a sponsor disclosed. Plan for each outcome the date can bring, and read the public documents that already bear on which one it will be. For launch, business development, and market access teams planning around an FDA action date. ### How is a PDUFA date set, and who discloses it? FDA does not publish the goal date of an application under review. The date in a plan comes from the sponsor or its partner: a press release, a 10-Q, or an 8-K. Each registered goal-date record below names the filing its date was taken from; for FF-007 that is the licensor's quarterly report, not the applicant's. Under the PDUFA goals for fiscal years 2023 to 2027, FDA aims to review and act on 90 percent of applications within the goal period: ten months for a standard review and six for a priority review. The clock starts at the 60-day filing date for a new molecular entity or an original biologic, and at receipt for other original applications and for efficacy supplements. The goal is to act, and a CRL meets it as fully as an approval does. - The filing the date came from, and the day it was filed - Original application, efficacy supplement, or resubmission after a CRL - Standard or priority review, and any designation the sponsor states - Review center: CDER or CBER, which decides where the approval is recorded - Advisory committee: held, scheduled, or stated as not planned - FDA: PDUFA reauthorization performance goals and procedures, fiscal years 2023 through 2027 ### What happens if FDA approves by the PDUFA date? The approved indication can be narrower than the one sought, by population, line of therapy, or setting of use. Tie promotional review, the payer dossier, and field planning to the approved label rather than the proposed one. ### What does a complete response letter mean? A CRL means the application is not approved in its present form. A resubmission is classed by what it contains, and FDA's goal is to act on a Class 1 resubmission within two months and a Class 2 within six. FF-008 is a Class 2 resubmission after a CRL that found the evidence of effectiveness insufficient. ### Can a PDUFA date be extended? A major amendment submitted during review, such as a new clinical study report or a major reanalysis, may extend the goal date by three months, and the goals allow one extension per review cycle. FF-008 and FF-013 each had their goal date extended this way before registration; both records froze the extended date. ### What happens if FDA misses a PDUFA date? FDA can let a goal date pass and act later, and the sponsor can withdraw the application before it. Where a plan or a contract is written as approval by a date, a later approval is a different outcome from an on-time one, and the registered records score it as having occurred after the deadline. ### Read what is already public about the date Read the sponsor's 10-Q, 10-K, and 8-K filings as well as its press releases. Each item below comes from a sponsor's filing that a registered record found before its evidence cutoff and cites. - A review issue raised at filing: accelerated-approval eligibility (FF-010), or a statement that overall survival must be significant in the setting when the primary survival analysis was not (FF-011) - An advisory committee that voted against effectiveness for one proposed benefit and did not vote on the other (FF-008) - A history before this review: a CRL (FF-008) or a refusal to file (FF-013) - Manufacturing and inspections: a new drug substance supplier with vendors not yet inspected (FF-013), or an inspection observation on trial conduct (FF-008) - The sponsor itself: a bankruptcy filing during review, and a pending asset sale whose milestone payments depend on the outcome and timing of the supplement (FF-009) ### The registered goal dates Each row is a registered estimate that FDA approves by the goal date the sponsor disclosed, frozen before the date. Beside it is the record's calendar-cycle baseline, a model that knows only the clock. A baseline is a competing estimate frozen at the same cutoff, not an observed result. The record page carries the proposition, the sources, and the rule an adjudicator will read. FDA action by goal date: 28 registered · 28 unresolved · 0 resolved. Registry snapshot 2026-10-26. FF-007 FDA · CDER Calendar cycle baseline 80% Bepirovirsen · hepatitis B approval 84 % Goal date Oct 26, 2026 Unresolved FF-010 FDA · CBER Calendar cycle baseline 65% INO-3107 · papillomatosis approval 45 % Goal date Oct 30, 2026 Unresolved FF-012 FDA · CDER Calendar cycle baseline 80% Mitapivat · sickle cell supplement approval 72 % Goal date Nov 1, 2026 Unresolved FF-005 FDA · CDER Calendar cycle baseline 80% Aficamten · MAPLE-HCM supplement approval 82 % Goal date Nov 14, 2026 Unresolved FF-009 FDA · CDER Calendar cycle baseline 80% IGALMI · at-home supplement approval 35 % Goal date Nov 14, 2026 Unresolved FF-011 FDA · CDER Calendar cycle baseline 65% Ivonescimab · post-TKI NSCLC approval 15 % Goal date Nov 14, 2026 Unresolved FF-008 FDA · CBER Calendar cycle baseline 60% Deramiocel · Duchenne approval 35 % Goal date Nov 22, 2026 Unresolved FF-013 FDA · CDER Calendar cycle baseline 75% Molgramostim · aPAP approval 75 % Goal date Nov 22, 2026 Unresolved FF-027 FDA · CDER Calendar cycle baseline 80% Venglustat · type 3 Gaucher disease approval 75 % Goal date Nov 25, 2026 Unresolved FF-006 FDA · CDER Calendar cycle baseline 80% BBP-418 · muscular dystrophy approval 85 % Goal date Nov 27, 2026 Unresolved FF-025 FDA · CDER Calendar cycle baseline 65% Neladalkib · ALK-positive NSCLC approval 85 % Goal date Nov 27, 2026 Unresolved FF-024 FDA · CDER Calendar cycle baseline 80% D-PLEX100 · colorectal surgical site infection approval 55 % Goal date Nov 28, 2026 Unresolved FF-023 FDA · CDER Calendar cycle baseline 80% Bezuclastinib · GIST approval 85 % Goal date Nov 30, 2026 Unresolved FF-026 FDA · CDER Calendar cycle baseline 65% Povetacicept · IgA nephropathy approval 85 % Goal date Nov 30, 2026 Unresolved FF-032 FDA · CDER Calendar cycle baseline 80% Imsidolimab · generalized pustular psoriasis approval 70 % Goal date Dec 12, 2026 Unresolved FF-034 FDA · CDER Calendar cycle baseline 60% Relacorilant · Cushing's syndrome approval 45 % Goal date Dec 17, 2026 Unresolved FF-033 FDA · CDER Calendar cycle baseline 80% Lorundrostat · hypertension approval 82 % Goal date Dec 22, 2026 Unresolved FF-030 FDA · CBER Calendar cycle baseline 65% Anito-cel · multiple myeloma approval 75 % Goal date Dec 23, 2026 Unresolved FF-035 FDA · CDER Calendar cycle baseline 80% Relutrigine · SCN2A/SCN8A epilepsy approval 80 % Goal date Dec 27, 2026 Unresolved FF-047 FDA · CDER Calendar cycle baseline 80% Fast-acting meloxicam · acute pain approval 78 % Goal date Dec 27, 2026 Unresolved FF-031 FDA · CDER Calendar cycle baseline 80% Bezuclastinib · nonadvanced systemic mastocytosis approval 80 % Goal date Dec 30, 2026 Unresolved FF-037 FDA · CDER Calendar cycle baseline 65% Z-rostudirsen · Duchenne exon 51 approval 70 % Goal date Jan 21, 2027 Unresolved FF-036 FDA · CDER Calendar cycle baseline 80% Ulixacaltamide · essential tremor approval 80 % Goal date Jan 29, 2027 Unresolved FF-046 FDA · CDER Calendar cycle baseline 80% Leniolisib · APDS children 13–27 kg supplement approval 85 % Goal date Jan 30, 2027 Unresolved FF-045 FDA · CDER Calendar cycle baseline 80% Lenacapavir · once-weekly oral PrEP approval 70 % Goal date Feb 2, 2027 Unresolved FF-044 FDA · CDER Calendar cycle baseline 80% Infigratinib · achondroplasia approval 80 % Goal date Feb 4, 2027 Unresolved FF-053 FDA · CDER Calendar cycle baseline 80% Tinlarebant · Stargardt disease approval 70 % Goal date Feb 12, 2027 Unresolved FF-056 FDA · CDER Calendar cycle baseline 80% Roflumilast cream · infant atopic dermatitis supplement approval 88 % Goal date Feb 23, 2027 Unresolved Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved. - PDUFA calendar: these goal dates by month, with each applicant ### Confirm the action in FDA's record A sponsor's announcement is its statement; the approval letter and the label are FDA's record. Drugs@FDA lists approvals of drugs and of the biologics CDER reviews. The Purple Book lists licensed biologics, including the cell and gene therapies CBER reviews. Each registered record names the database it will be read from and a read date after the goal date, because the public databases can trail the letter. For a supplement, identify the approval by what the new label says: the trial, population, or setting your plan assumed. The supplement number is not public until FDA acts, and a database's category for a supplement can mislead; FF-009's record explains one that did. - FDA: Drugs@FDA - FDA: Purple Book database of licensed biological products ### Who needs to prepare if the date moves? What each team changes if the decision comes earlier or later than planned. #### Launch and supply If the decision is earlier Confirm which steps can start on an approval letter that arrives before the goal date, and which wait for the approved label. If the decision is later Hold label-dependent commitments and re-date the plan to the extension or resubmission clock the sponsor discloses. #### Business development and licensing If the decision is earlier Check whether milestones and option windows run from the approval date or from the goal date. If the decision is later Read what an extension or a CRL does to milestones and termination rights; approval by a date and approval at all are different conditions. #### Market access and HEOR If the decision is earlier Bring the payer dossier and the first P&T submission forward; both depend on the approved label. If the decision is later Re-date P&T submissions to the new action date, and keep payer discussions to what may be shared before approval. ### Bring the action and your deadline Which decision matters to your team, and by what date? Include the population and the plan it would inform. Start with one claim --- # NICE scheduled dates: plan for publication, a delay, or a suspension URL: https://nextconsensus.com/guides/nice-scheduled-dates/ ## NICE scheduled dates: plan for publication, a delay, or a suspension A UK launch plan, an access milestone, and a first payer conversation are often dated from the expected publication date NICE shows on an appraisal's in-development page. That date is NICE's published expectation for when the final guidance appears, not a commitment, and it can move. Plan for each outcome the date can bring, and read the public documents that already bear on which one it will be. For UK and European launch, market access, HEOR, and business development teams planning around a NICE publication date. ### Read the scheduled date for what it is The expected date comes from NICE's own in-development page for the appraisal (nice.org.uk/guidance/indevelopment/gid-ta#####), and each registered record below names the page and what it showed at its evidence cutoff. The date is an expectation, not a commitment: it moves for procedural reasons, and the frozen record keeps the date it was registered with. What the records score is publication of the appraisal's final guidance by that date, whatever the guidance recommends. The recommendation itself is a different question and is not scored. A managed access review publishes new guidance from the review, and the original technology appraisal's publication date never counts; if NICE publishes the review by updating the earlier appraisal in place, the update entry that names the review is the publication date read. - The in-development page and the project ID (ID####, GID-TA#####) - A new technology appraisal or a managed access review - The expected date exactly as the page showed it at the cutoff - The population and treatment line the guidance will cover - The committee that appraises it, from the record - NICE: What is technology appraisal guidance? ### Plan for each outcome the date can bring Publication on or before the date. The final guidance page shows a publication date ('Published: '). Whatever the guidance recommends, publication by the date is the scored outcome; a narrower or different recommendation is a separate question for the access plan. A revised date with nothing published. NICE can revise the expected date, and the record still resolves against the date frozen at registration. Nothing published by the frozen date resolves NO, and the archived date is not moved by a later revision. A pause or a suspension. However NICE words it, an appraisal paused or suspended past the date resolves NO. A termination stays in the denominator and resolves NO as well. Removed without publishing. If NICE removes the appraisal from its work programme without publishing anything, the record is resolved as cancelled by an outside event rather than scored as a miss. ### Read what is already public about the date The in-development page is the public source: it shows the expected date, the appraisal's status, and the project ID. The records below were registered from what that page showed at each cutoff, and each frozen rule names the page. One record is a managed access review of an earlier appraisal (FF-018): the review's publication is the event the forecast scores, never the original appraisal's date. - The expected date on the in-development page, and whether it has moved since the cutoff - Whether the appraisal is a managed access review of an earlier appraisal - The project ID and the GID number the page shows - Where the frozen rule's answer comes from, and the earliest date it can be checked ### The registered scheduled dates Each row is a registered estimate that NICE publishes the appraisal's final guidance by the expected date shown on its in-development page at the cutoff, frozen before that date. Beside it is the record's calendar-cycle baseline, a model that knows only the clock. A baseline is a competing estimate frozen at the same cutoff, not an observed result. The record page carries the proposition, the sources, and the rule an adjudicator will read. NICE guidance by scheduled date: 24 registered · 24 unresolved · 0 resolved. Registry snapshot 2026-10-26. FF-016 NICE Calendar cycle baseline 55% Epcoritamab combination · guidance publication 45 % Scheduled date Oct 28, 2026 Unresolved FF-017 NICE Calendar cycle baseline 60% Inavolisib combination · guidance publication 50 % Scheduled date Nov 3, 2026 Unresolved FF-019 NICE Calendar cycle baseline 55% Nivolumab + ipilimumab · guidance publication 45 % Scheduled date Nov 11, 2026 Unresolved FF-022 NICE Calendar cycle baseline 60% Zuranolone · guidance publication 50 % Scheduled date Nov 12, 2026 Unresolved FF-014 NICE · STA Calendar cycle baseline 60% Beremagene geperpavec · guidance publication 35 % Scheduled date Nov 18, 2026 Unresolved FF-015 NICE · STA Calendar cycle baseline 60% Efgartigimod · CIDP guidance publication 45 % Scheduled date Nov 18, 2026 Unresolved FF-018 NICE Calendar cycle baseline 60% Larotrectinib · guidance publication 55 % Scheduled date Nov 18, 2026 Unresolved FF-020 NICE Calendar cycle baseline 25% Orforglipron · guidance publication 5 % Scheduled date Nov 18, 2026 Unresolved FF-021 NICE Calendar cycle baseline 60% Pembrolizumab combination · guidance publication 50 % Scheduled date Nov 18, 2026 Unresolved FF-028 NICE Calendar cycle baseline 55% Obicetrapib · hypercholesterolaemia guidance publication 40 % Scheduled date Nov 25, 2026 Unresolved FF-029 NICE Calendar cycle baseline 55% Polihexanide · acanthamoeba keratitis guidance publication 35 % Scheduled date Nov 25, 2026 Unresolved FF-048 NICE Calendar cycle baseline 55% Onasemnogene abeparvovec (intrathecal) · SMA guidance publication 35 % Scheduled date Nov 25, 2026 Unresolved FF-050 NICE Calendar cycle baseline 55% Resmetirom · MASH guidance publication 35 % Scheduled date Dec 9, 2026 Unresolved FF-040 NICE Calendar cycle baseline 45% Retifanlimab · anal cancer guidance publication 30 % Scheduled date Dec 16, 2026 Unresolved FF-051 NICE Calendar cycle baseline 45% Semaglutide · MASH guidance publication 25 % Scheduled date Jan 7, 2027 Unresolved FF-041 NICE Calendar cycle baseline 45% Tarlatamab · small-cell lung cancer guidance publication 30 % Scheduled date Jan 13, 2027 Unresolved FF-042 NICE Calendar cycle baseline 55% Toripalimab · nasopharyngeal cancer guidance publication 40 % Scheduled date Jan 13, 2027 Unresolved FF-039 NICE Calendar cycle baseline 55% Nerandomilast · pulmonary fibrosis guidance publication 40 % Scheduled date Jan 20, 2027 Unresolved FF-043 NICE Calendar cycle baseline 45% Trastuzumab deruxtecan · gastric cancer guidance publication 30 % Scheduled date Jan 27, 2027 Unresolved FF-038 NICE Calendar cycle baseline 45% Elranatamab · myeloma guidance publication 30 % Scheduled date Jan 28, 2027 Unresolved FF-049 NICE Calendar cycle baseline 50% Pembrolizumab · muscle-invasive bladder cancer guidance publication 35 % Scheduled date Feb 10, 2027 Unresolved FF-052 NICE Calendar cycle baseline 55% Tislelizumab · oesophageal cancer guidance publication 45 % Scheduled date Feb 10, 2027 Unresolved FF-055 NICE Calendar cycle baseline 50% Setmelanotide · hypothalamic obesity guidance publication 30 % Scheduled date Feb 10, 2027 Unresolved FF-054 NICE Calendar cycle baseline 50% Linvoseltamab · myeloma guidance publication 35 % Scheduled date Feb 17, 2027 Unresolved Technology appraisal (NICE): offered on judgment, with no calibration figure until 15 in the class have resolved. - NICE appraisal calendar: these dates by month, with NICE's title and project ID ### Confirm the action in NICE's record The in-development page links to or redirects to the published guidance, or a search of nice.org.uk for the project ID finds it. The publication date is the 'Published: ' line on the final guidance page. For a managed access review published as an update to the earlier appraisal, the update entry naming the review is the publication date read. The public pages can trail the event: each record's rule names a date it may be read from, a week or more after the scheduled date. The recommendation is read from the final guidance, but it is a different question from publication and is not what the forecast scores. - NICE: Guidance in development ### Who needs to prepare if the date moves? What each team changes if the decision comes earlier or later than planned. #### Launch and supply If the decision is earlier Prepare the steps that start on publication of the final guidance: the funding-window clock, recommendation-dependent materials, and the field plan tied to the approved wording. If the decision is later If the date moves or the appraisal is suspended, hold recommendation-dependent commitments and re-date the plan to NICE's revised expectation. #### Business development and licensing If the decision is earlier Check whether milestones and option windows run from publication of the final guidance or from the recommendation's wording. If the decision is later Read what a suspension or a termination does to milestones and access assumptions; publication by a date and a recommendation at all are different conditions. #### Market access and HEOR If the decision is earlier Bring the evidence package and the funding-window preparation forward; the funding window after publication is on the decision-windows guide. If the decision is later Re-date implementation to the revised publication, and keep the recommendation's population requirement separate from the publication date. ### Bring the action and your deadline Which decision matters to your team, and by what date? Include the population and the plan it would inform. Start with one claim --- # Semaglutide: from high-risk comorbidity settings to general obesity weight management URL: https://nextconsensus.com/baselines/semaglutide/ Public Example Baseline ## Semaglutide: from high-risk comorbidity settings to general obesity weight management Review of a metabolic claim that began in a high-risk comorbidity setting and is now being extended to general adult obesity weight management. Start with one claim Back to reconstructions Illustrative POSITION Indication scope CONTEXT Metabolic UPDATED Illustrative: public sources only, no customer data How far the indication moved Population the trials studied Type 2 diabetes with cardiovascular or renal risk → Population the claim now reaches General adult obesity weight management Where each claim stands One row per claim. The claim the record has moved furthest past is first. The claim Population it is used for Where it stands Why Record at cutoff What would move it Semaglutide reduces major adverse cardiovascular events in adults with established cardiovascular disease and overweight or obesity. High-risk cardiovascular population (SELECT-like) Claim still holds Supported by a dedicated cardiovascular outcomes trial in the public record. Still holds New trial readouts or label changes that narrow or broaden the indicated population. Semaglutide is appropriate for general adult weight management without comorbidity-based restriction. General adult obesity weight management Record moved past the claim Long-term outcomes evidence in lower-risk populations is less mature; payer and guideline positions vary by jurisdiction. Moved past the claim Local coverage determination, guideline update, or new population-specific outcome data. Furthest moved first: Moved past the claim → Moving → Still holds → Withdrawn Limits Public sources only. A particular plan's coverage rules are out of scope for a public example. Where a claim stands is read off the dated record. Nothing here is a forecast of what a payer or regulator will do about it. The grid says what the public record supports today and what would have to publish before the claim could be carried to the wider population. Compare GLP-1 coverage by indication, plan, and effective date . This example is a historical reconstruction, not a current policy directory or a registered coverage forecast. --- # GLP-1 receptor agonist (public encyclopedia provenance reconstruction) URL: https://nextconsensus.com/baselines/provenance/glp1/ Method demonstration ## GLP-1 receptor agonist (public encyclopedia provenance reconstruction) Reconstructed from 22 public encyclopedia revisions showing article evolution Illustrative POSITION Provenance reconstruction CONTEXT Metabolic UPDATED Public encyclopedia revision history, read automatically. Phase 1 Source 22 revisions 3 claim families 14 variants 9 events What this demonstration is for This is a test of the reconstruction, not a reading of an asset: whether one claim can be held as the same claim through years of public edits, whether related statements group into stable families, whether the places the record was disputed or weakened show up, and whether a second analyst working independently lands on the same families. Every statement keeps the revision it came from, so any of it can be checked. The source is a public encyclopedia's revision history. Its dated revisions let readers check the reconstruction against individual edits. This is a test corpus for the method; registered forecasts use their own source evidence. Illustrative. Nothing here is a recommendation for clinical or institutional action, and none of it is a registered forecast. Download the artifact as JSON . Reproducibility Independent assertion extraction and claim-family grouping by two analysts, with disagreements resolved by documented criteria. 3/3 Family overlap 11/14 Variant overlap 1 Documented disagreement Passed Two-analyst check Documented disagreement Disagreement: Bridge process split a drug-list assertion into two families because word overlap fell below the 0.5 threshold; human analyst treated it as one semantic family. Resolution: Added section-anchored joining: merge assertions in the same section when overlap > 0.3. The full artifact: assessments, claim families, events, review decisions, reliance, citations Where the record stands against the claim Record moving The evidence under the claim moved across the reviewed revisions. The claim as written may no longer describe what the sources support. - Movement in the record: moderate, read across 3 claim groups and 3 assessed sources. - How much rests on the claim: strong, from 1 endorsement and 2 operational uses found in the sources. - Signs of support and restriction in the sources: strong. Assessments Family Direction Variants Disputes Last change Basis fam-sentence-1 disputed 3 1 2012-08-22 analyst asserted fam-sentence-2 mixed 7 0 2012-09-27 analyst asserted fam-sentence-3 mixed 4 0 2012-09-27 analyst asserted Claim Families One of their advantages is that they have a lower risk of ca... 3 variants · 2 relationships var-fam-sentence-1-1 One of their advantages is that they have a lower risk of causing hypoglycemia Seen: 2009-01-13 · Basis: normalized var-fam-sentence-1-2 One of their advantages (over insulin?) is that they have a lower risk of causing hypoglycemia Seen: 2010-07-27 · Basis: normalized var-fam-sentence-1-3 One of their advantages over older insulin secretagogues, such as sulfonylureas or meglitinides, is that they have a lower risk of causing hypoglycemia Seen: 2012-08-22 · Basis: normalized Relationships qualifies var-fam-sentence-1-1 → var-fam-sentence-1-2 qualifies var-fam-sentence-1-2 → var-fam-sentence-1-3 Licenced : exenatide (2005) Under investigation : liragluti... 7 variants · 6 relationships var-fam-sentence-2-1 Licenced : exenatide (2005) Under investigation : liraglutide, albiglutide, taspoglutide Seen: 2009-01-13 · Basis: normalized var-fam-sentence-2-2 Licenced : exenatide Under investigation : liraglutide, albiglutide Seen: 2009-01-13 · Basis: normalized var-fam-sentence-2-3 Licenced : exenatide (2005) Under investigation : albiglutide, taspoglutide Seen: 2010-01-26 · Basis: normalized var-fam-sentence-2-4 Licenced : exenatide (2005), liraglutide (2010) Under investigation : albiglutide, taspoglutide Seen: 2010-01-27 · Basis: normalized var-fam-sentence-2-5 Licenced : exenatide (2005), liraglutide (2010) Under investigation : albiglutide, taspoglutide, AVE0010 Seen: 2010-07-27 · Basis: normalized var-fam-sentence-2-6 Licensed GLP-1 agonists: exenatide (licensed 2005), liraglutide (licensed 2010) Under investigation: albiglutide, taspoglutide, AVE0010 Seen: 2012-08-17 · Basis: normalized var-fam-sentence-2-7 Licensed GLP-1 agonists: * exenatide (Byetta), licensed in 2005 * liraglutide (Victoza), licensed 2010 Under investigation: albiglutide, taspoglutide, AVE0010 Seen: 2012-09-27 · Basis: normalized Relationships narrows var-fam-sentence-2-1 → var-fam-sentence-2-2 qualifies var-fam-sentence-2-2 → var-fam-sentence-2-3 qualifies var-fam-sentence-2-3 → var-fam-sentence-2-4 qualifies var-fam-sentence-2-4 → var-fam-sentence-2-5 qualifies var-fam-sentence-2-5 → var-fam-sentence-2-6 qualifies var-fam-sentence-2-6 → var-fam-sentence-2-7 Glucagon-like peptide-1 agonists (GLP-1 agonists) are new cl... 4 variants · 3 relationships var-fam-sentence-3-1 Glucagon-like peptide-1 agonists (GLP-1 agonists) are new classes of drugs for the treatment of type 2 diabetes Seen: 2012-08-17 · Basis: normalized var-fam-sentence-3-2 Glucagon-like peptide-1 analogs are a new class of drug for treatment of type 2 diabetes Seen: 2012-08-17 · Basis: normalized var-fam-sentence-3-3 Glucagon-like peptide-1 agonists (GLP-1 agonists) are a new class of drug for the treatment of type 2 diabetes Seen: 2012-08-17 · Basis: normalized var-fam-sentence-3-4 Glucagon-like peptide-1 agonists (GLP-1 agonists) are a class of drugs for the treatment of type 2 diabetes Seen: 2012-09-27 · Basis: normalized Relationships narrows var-fam-sentence-3-1 → var-fam-sentence-3-2 qualifies var-fam-sentence-3-2 → var-fam-sentence-3-3 qualifies var-fam-sentence-3-3 → var-fam-sentence-3-4 Events 2012-01-30 Revert detected Reverted edits by [[Special:Contributions/59.95.72.254|59.95.72.254]] ([[User talk:59.95.72.254|talk]]) to last revision 2023-11-12 Page moved: GLP-1 receptor agonist → Draft:Move/Glucagon-like peptide-1 receptor agonist from=GLP-1 receptor agonist to=Draft:Move/Glucagon-like peptide-1 receptor agonist comment=[[WP:PMRC#4|Round-robin histo 2012-08-17 Talk page correlation time_delta_hours=0 talk_comment=Facts707 moved page [[Talk:Glucagon-like peptide-1 analog]] to [[Talk:Glucagon-like pept 2012-08-17 Talk page correlation time_delta_hours=0 talk_comment=Facts707 moved page [[Talk:Glucagon-like peptide-1 analog]] to [[Talk:Glucagon-like pept 2012-08-17 Talk page correlation time_delta_hours=0 talk_comment=Facts707 moved page [[Talk:Glucagon-like peptide-1 analog]] to [[Talk:Glucagon-like pept 2012-08-17 Talk page correlation time_delta_hours=129.3 talk_comment=Facts707 moved page [[Talk:Glucagon-like peptide-1 analog]] to [[Talk:Glucagon-like 2005-04-28 FDA approves exenatide for type 2 diabetes FDA approves exenatide (Byetta), the first GLP-1 receptor agonist, for type 2 diabetes treatment. 2010-01-25 FDA approves liraglutide for type 2 diabetes FDA approves liraglutide (Victoza), expanding the GLP-1 receptor agonist class for type 2 diabetes. 2024-01-01 ADA Standards of Care endorse GLP-1 receptor agonists American Diabetes Association Standards of Care recommend GLP-1 receptor agonists for type 2 diabetes, particularly in p Review Decisions reject Confident Family: fam-sentence-1 · Trigger: Revert detected Reverted edits by [[Special:Contributions/59.95.72.254|59.95.72.254]] ([[User talk:59.95.72.254|talk]]) to last revision by PhiLiP ([[WP:HG|HG]]) 2012-01-30 · By: unspecified · Basis: analyst asserted adopt Confident Family: fam-sentence-3 · Trigger: FDA approves exenatide for type 2 diabetes · Impact: support-enhanced FDA approval provides direct institutional operationalization of the class-level T2D claim. 2005-04-28 · By: automated reviewer · Basis: analyst asserted amend Confident Family: fam-sentence-2 · Trigger: FDA approves liraglutide for type 2 diabetes · Impact: support-enhanced Add liraglutide to the list of licensed GLP-1 agonists without changing the family scope. 2010-01-25 · By: automated reviewer · Basis: analyst asserted retain-with-caveats Uncertain Family: fam-sentence-3 · Trigger: ADA Standards of Care endorse GLP-1 receptor agonists · Impact: support-enhanced Endorsement supports the class claim but is inferred from guideline language, not an operational record; retain with ASCVD qualification. 2024-01-01 · By: automated reviewer · Basis: analyst asserted Institutional Reliance FDA operational-use high Exenatide (Byetta) approval for type 2 diabetes, NDA 021773 on var-fam-sentence-3-3 FDA approval converts the evidence claim "GLP-1 agonists are a class of drugs for type 2 diabetes" into an operational regulatory commitment for exenatide. 2005-04-28 · Basis: institution confirmed FDA operational-use high Liraglutide (Victoza) approval for type 2 diabetes, NDA 022341 on var-fam-sentence-2-6 FDA approval extends the operational commitment to another GLP-1 agonist, supporting the family that exenatide and liraglutide are licensed options. 2010-01-25 · Basis: institution confirmed American Diabetes Association endorsement medium Standards of Care in Diabetes — Glycemic Goals and Telehealth on var-fam-sentence-3-3 ADA Standards of Care endorse GLP-1 receptor agonists for type 2 diabetes, particularly when atherosclerotic cardiovascular disease is present. This is an endorsement inferred from guideline language, not an operational record of a specific institution acting on it. 2024-01-01 · Basis: inferred Source Citations www.fda.gov http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/uc 2010-01-27 www.medscape.com Glucagon-like Peptide-1 Analogs Other Than Exenatide 2010-07-27 www.fda.gov FDA Approves New Treatment for Type 2 Diabetes 2010-07-27 www.medscape.com http://www.medscape.com/viewarticle/578304 2010-07-27 www.fda.gov http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/uc 2010-07-27 www.medscape.com http://www.medscape.com/viewarticle/578304 2010-07-27 www.fda.gov http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/uc 2010-07-27 www.medscape.com Glucagon-like Peptide-1 Analogs Other Than Exenatide 2010-07-27 www.fda.gov FDA Approves New Treatment for Type 2 Diabetes 2010-07-27 Unknown Unnamed citation 2012-08-22 Cross-example impact propagation Changes in related examples can add context to this claim history. These links show where a source event in one domain creates a question for a related claim. ← Incoming support-enhanced high From: Liraglutide (public encyclopedia provenance reconstruction) · family fam-sentence-7 FDA approval of liraglutide for chronic weight management strengthens the cross-specimen claim that GLP-1-class drugs, including liraglutide, have an obesity/weight-management indication. Triggered by event: FDA approves liraglutide for chronic weight management → Outgoing support-enhanced medium To: Liraglutide (public encyclopedia provenance reconstruction) · family fam-sentence-3 The GLP-1 class ADA endorsement supports the liraglutide T2D mechanism claim because liraglutide is a member of the endorsed class. Triggered by event: ADA Standards of Care endorse GLP-1 receptor agonists Classification Evidentiary - Public encyclopedia version identifiers - Edit timestamps - Editor usernames - Edit comments - Citation URLs - Page move records - Template changes Derived - Sentence-level diffs (before/after) - Citation added/removed events - Section reorganization events - Edit magnitude (minor/moderate/major) - Content change type - Key terms extraction - Direction signal (strengthening/weakening/neutral) Inferred - Claim family membership - Claim variant relationships - Confidence assignment - Impact direction - Decision rationale reconstruction - Reliance commitment interpretation --- # Liraglutide (public encyclopedia provenance reconstruction) URL: https://nextconsensus.com/baselines/provenance/liraglutide/ Method demonstration ## Liraglutide (public encyclopedia provenance reconstruction) Reconstructed from 20 public encyclopedia revisions showing article evolution Illustrative POSITION Provenance reconstruction CONTEXT Metabolic UPDATED Public encyclopedia revision history, read automatically. Phase 1 Source 20 revisions 22 claim families 36 variants 3 events What this demonstration is for This is a test of the reconstruction, not a reading of an asset: whether one claim can be held as the same claim through years of public edits, whether related statements group into stable families, whether the places the record was disputed or weakened show up, and whether a second analyst working independently lands on the same families. Every statement keeps the revision it came from, so any of it can be checked. The source is a public encyclopedia's revision history. Its dated revisions let readers check the reconstruction against individual edits. This is a test corpus for the method; registered forecasts use their own source evidence. Illustrative. Nothing here is a recommendation for clinical or institutional action, and none of it is a registered forecast. Download the artifact as JSON . Reproducibility Single-analyst automated reconstruction. Two-analyst reproducibility validation has not yet been performed on this specimen. — Family overlap — Variant overlap — Documented disagreement Not yet run Two-analyst check A second analyst has not yet reconstructed this example baseline independently, so there is no overlap to report. The cells fill when that comparison runs. The full artifact: assessments, claim families, events, review decisions, reliance, citations Where the record stands against the claim Record moving The evidence under the claim moved across the reviewed revisions. The claim as written may no longer describe what the sources support. - Movement in the record: moderate, read across 22 claim groups and 22 assessed sources. - How much rests on the claim: strong, from 1 endorsement and 2 operational uses found in the sources. - Signs of support and restriction in the sources: strong. - The second-analyst check has not finished (1 analyst so far), so read this as a demonstration of the format rather than a finished record. Assessments Family Direction Variants Disputes Last change Basis fam-sentence-1 stable 2 0 2008-02-17 analyst asserted fam-sentence-2 stable 1 0 2008-02-17 analyst asserted fam-sentence-3 stable 3 0 2008-02-17 analyst asserted fam-sentence-4 stable 1 0 2008-02-17 analyst asserted fam-sentence-5 stable 1 0 2008-02-17 analyst asserted fam-sentence-6 stable 1 0 2008-02-17 analyst asserted fam-sentence-7 stable 1 0 2008-02-17 analyst asserted fam-sentence-8 stable 2 0 2008-02-17 analyst asserted fam-sentence-9 stable 1 0 2008-02-17 analyst asserted fam-sentence-10 stable 1 0 2008-02-17 analyst asserted fam-sentence-11 stable 3 0 2008-02-17 analyst asserted fam-sentence-12 stable 3 0 2008-02-17 analyst asserted fam-sentence-13 stable 1 0 2008-02-17 analyst asserted fam-sentence-14 stable 3 0 2008-02-17 analyst asserted fam-sentence-15 stable 1 0 2008-02-17 analyst asserted fam-sentence-16 stable 4 0 2008-02-17 analyst asserted fam-sentence-17 stable 1 0 2008-02-17 analyst asserted fam-sentence-18 stable 1 0 2008-02-17 analyst asserted fam-sentence-19 stable 1 0 2008-02-17 analyst asserted fam-sentence-20 stable 1 0 2008-02-17 analyst asserted fam-sentence-21 stable 1 0 2008-02-17 analyst asserted fam-sentence-22 stable 2 0 2008-02-17 analyst asserted Claim Families Following subcutaneous administration, the protracted action... 2 variants · 1 relationship var-fam-sentence-1-1 Following subcutaneous administration, the protracted action profile is based on three mechanisms: binding to albumin and enzymatic stability towards the DPP-IV enzyme both of which result in a long plasma half-life, and self-association which results in a slow absorption Seen: 2008-02-17 · Basis: normalized var-fam-sentence-1-2 Following subcutaneous administration, the protracted action profile is based on three mechanisms: binding to albumin and enzymatic stability towards the Dipeptidyl peptidase-4 enzyme both of which result in a long plasma half-life, and self-association which results in a slow absorption Seen: 2008-02-17 · Basis: normalized Relationships qualifies var-fam-sentence-1-1 → var-fam-sentence-1-2 Liraglutide action is mediated via a specific interaction wi... 1 variant · 0 relationships var-fam-sentence-2-1 Liraglutide action is mediated via a specific interaction with GLP-1 receptors, leading to an increase in cAMP Seen: 2008-02-17 · Basis: normalized Liraglutide stimulates insulin secretion and improves beta-c... 3 variants · 2 relationships var-fam-sentence-3-1 Liraglutide stimulates insulin secretion and improves beta-cell function in a glucose-dependent manner Seen: 2008-02-17 · Basis: normalized var-fam-sentence-3-2 Simultaneously, liraglutide lowers inappropriately high glucagon secretion, also in a glucose dependent manner Seen: 2008-02-17 · Basis: normalized var-fam-sentence-3-3 Liraglutide stimulates insulin secretion and improves beta-cell function in a glucose dependent manner Seen: 2008-02-17 · Basis: normalized Relationships qualifies var-fam-sentence-3-1 → var-fam-sentence-3-2 qualifies var-fam-sentence-3-2 → var-fam-sentence-3-3 Thus, when blood glucose is high, insulin secretion is stimu... 1 variant · 0 relationships var-fam-sentence-4-1 Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited Seen: 2008-02-17 · Basis: normalized Liraglutide does not impair glucagon response during hypogly... 1 variant · 0 relationships var-fam-sentence-5-1 Liraglutide does not impair glucagon response during hypoglycaemia Seen: 2008-02-17 · Basis: normalized Furthermore, the mechanism of blood glucose lowering involve... 1 variant · 0 relationships var-fam-sentence-6-1 Furthermore, the mechanism of blood glucose lowering involves a minor decrease in gastric emptying Seen: 2008-02-17 · Basis: normalized Liraglutide reduces body weight and body fat mass, by a mech... 1 variant · 0 relationships var-fam-sentence-7-1 Liraglutide reduces body weight and body fat mass, by a mechanism of reduced hunger and lowered energy intake Seen: 2008-02-17 · Basis: normalized Liraglutide has been shown to delay the progression of diabe... 2 variants · 1 relationship var-fam-sentence-8-1 Liraglutide has been shown to delay the progression of diabetes in animal models of pre-diabetes Seen: 2008-02-17 · Basis: normalized var-fam-sentence-8-2 Liraglutide has been shown to delay the progression of diabetes in animal models of prediabetes Seen: 2008-02-17 · Basis: normalized Relationships qualifies var-fam-sentence-8-1 → var-fam-sentence-8-2 Liraglutide has been shown in vitro to be a potent agent for... 1 variant · 0 relationships var-fam-sentence-9-1 Liraglutide has been shown in vitro to be a potent agent for specific stimulation of beta-cell proliferation and prevention of both cytokine and free fatty acid induced apoptosis Seen: 2008-02-17 · Basis: normalized In vivo, liraglutide increases insulin biosynthesis, and bet... 1 variant · 0 relationships var-fam-sentence-10-1 In vivo, liraglutide increases insulin biosynthesis, and beta-cell mass in diabetic animal models Seen: 2008-02-17 · Basis: normalized References: [http://www.glucagon.com/liraglutide.htm] 3 variants · 2 relationships var-fam-sentence-11-1 References: [http://www.glucagon.com/liraglutide.htm] Seen: 2008-02-17 · Basis: normalized var-fam-sentence-11-2 Drucker Lab [http://www.glucagon.com/liraglutide.htm] Seen: 2008-02-17 · Basis: normalized var-fam-sentence-11-3 Drucker Lab [http://www.glucagon.com/liraglutide.htm] Novo Nordisk R&D Pipeline [http://www.novonordisk.net/press/rd_pipeline/rd_pipeline.asp?showid=5] Seen: 2008-02-17 · Basis: normalized Relationships qualifies var-fam-sentence-11-1 → var-fam-sentence-11-2 qualifies var-fam-sentence-11-2 → var-fam-sentence-11-3 In a phase 2 trial enrolling 165 patients with type 2 diabet... 3 variants · 2 relationships var-fam-sentence-12-1 In a phase 2 trial enrolling 165 patients with type 2 diabetes, 14 weeks of liraglutide monotherapy reduced the estimated mean HbA1c values by 1.74% vs placebo from an average baseline of 8.5% and FPG by 3.4 mmol/l without hypoglycemic episodes Seen: 2008-02-17 · Basis: normalized var-fam-sentence-12-2 In a phase 2 trial enrolling 165 patients with type 2 diabetes, 14 weeks of liraglutide monotherapy reduced the estimated mean HbA1c values by 1.74% vs placebo from an average baseline of 8.5% and fasting plasma glucose by 3.4 mmol/l without hypoglycemic episodes Seen: 2008-02-17 · Basis: normalized var-fam-sentence-12-3 In a phase 2 trial enrolling 165 patients with type 2 diabetes, 14 weeks of liraglutide monotherapy reduced the estimated mean HbA1c values by 1.74% vs placebo from an average baseline of 8.5% and fasting blood glucose by 3.4 mmol/l without hypoglycemic episodes Seen: 2008-02-17 · Basis: normalized Relationships qualifies var-fam-sentence-12-1 → var-fam-sentence-12-2 qualifies var-fam-sentence-12-2 → var-fam-sentence-12-3 A dose-dependent decrease in body weight was observed, with ... 1 variant · 0 relationships var-fam-sentence-13-1 A dose-dependent decrease in body weight was observed, with a mean weight loss of 3.0 kg in the 1.9-mg liraglutide group Seen: 2008-02-17 · Basis: normalized Significant improvements in indices of beta cell function an... 3 variants · 2 relationships var-fam-sentence-14-1 Significant improvements in indices of beta cell function and blood pressure were also found along with a decrease in fasting glucagon with lira 1.9 mg Seen: 2008-02-17 · Basis: normalized var-fam-sentence-14-2 Significant improvements in indices of beta cell function and systolic blood pressure decrease of 2–3 mmHg were also found along with a decrease in fasting glucagon with lira 1.9 mg Seen: 2008-02-17 · Basis: normalized var-fam-sentence-14-3 Furthermore, a significant improvement in systolic blood pressure and a reduction of body weight of between 3 and 4 kg were seen in patients treated with liraglutide when compared to patients treated with glimepiride Seen: 2008-02-17 · Basis: normalized Relationships qualifies var-fam-sentence-14-1 → var-fam-sentence-14-2 qualifies var-fam-sentence-14-2 → var-fam-sentence-14-3 The LEAD programme evaluated the efficacy and safety of lira... 1 variant · 0 relationships var-fam-sentence-15-1 The LEAD programme evaluated the efficacy and safety of liraglutide in patients with type 2 diabetes either as monotherapy (LEAD 3) or in combination with metformin (LEAD 2), glimepiride (LEAD 1), metformin and rosiglitazone (LEAD 4) or metformin and glimepiride (LEAD 5) Seen: 2008-02-17 · Basis: normalized Liraglutide treatment resulted in around 40-50% of patients ... 4 variants · 3 relationships var-fam-sentence-16-1 Liraglutide treatment resulted in around 40-50% of patients reaching the American Diabetes Association goal of HbA1c < 7% at study completion Seen: 2008-02-17 · Basis: normalized var-fam-sentence-16-2 However, among the patients that were previously treated with only a single oral antidiabetic drug, liraglutide treatment resulted in around 50-60% of patients reaching this goal Seen: 2008-02-17 · Basis: normalized var-fam-sentence-16-3 Liraglutide treatment resulted in around 40-50% of patients reaching the American Diabetes Association goal of HbA1c Novo Nordisk R&D Pipeline [http://www.novonordisk.net/press/rd_pipeline/rd_pipeline.asp?showid=5] Seen: 2008-02-17 · Basis: normalized var-fam-sentence-16-4 Liraglutide treatment resulted in around 40-50% of patients reaching the American Diabetes Association goal of HbA1c Dr D Seen: 2008-02-17 · Basis: normalized Relationships qualifies var-fam-sentence-16-1 → var-fam-sentence-16-2 qualifies var-fam-sentence-16-2 → var-fam-sentence-16-3 qualifies var-fam-sentence-16-3 → var-fam-sentence-16-4 These success rates were the result of an HbA1c reduction of... 1 variant · 0 relationships var-fam-sentence-17-1 These success rates were the result of an HbA1c reduction of approximately 1 to 1.5 percentage points Seen: 2008-02-17 · Basis: normalized HbA1c was sustained for up to 12 months of liraglutide thera... 1 variant · 0 relationships var-fam-sentence-18-1 HbA1c was sustained for up to 12 months of liraglutide therapy Seen: 2008-02-17 · Basis: normalized The HbA1c reduction achieved in the liraglutide group was mo... 1 variant · 0 relationships var-fam-sentence-19-1 The HbA1c reduction achieved in the liraglutide group was more than 0.2 percentage points better than in the insulin glargine group, a difference which is statistically significant Seen: 2008-02-17 · Basis: normalized In LEAD 2, liraglutide-treated patients achieved blood gluco... 1 variant · 0 relationships var-fam-sentence-20-1 In LEAD 2, liraglutide-treated patients achieved blood glucose control with low levels of hypoglycaemia similar to placebo, contrasting with the glimepiride-treated group where hypoglycaemia occurred in a larger number of patients Seen: 2008-02-17 · Basis: normalized The most frequently reported adverse event during liraglutid... 1 variant · 0 relationships var-fam-sentence-21-1 The most frequently reported adverse event during liraglutide treatment was nausea at an absolute level of between 5% and 20% Seen: 2008-02-17 · Basis: normalized The GLP-1 receptor is the target for native GLP-1, an endoge... 2 variants · 1 relationship var-fam-sentence-22-1 The GLP-1 receptor is the target for native GLP-1, an endogenous incretin hormone that potentiates glucose-dependent insulin secretion from thepancreatic beta cells Seen: 2008-02-17 · Basis: normalized var-fam-sentence-22-2 The GLP-1 receptor is the target for native GLP-1, an endogenous incretin hormone that potentiates glucose-dependent insulin secretion from the pancreatic beta cells Seen: 2008-02-17 · Basis: normalized Relationships qualifies var-fam-sentence-22-1 → var-fam-sentence-22-2 Events 2010-01-25 FDA approves liraglutide for type 2 diabetes FDA approves liraglutide (Victoza) for improving glycemic control in adults with type 2 diabetes. 2014-12-23 FDA approves liraglutide for chronic weight management FDA approves liraglutide (Saxenda) for chronic weight management in adults with obesity or overweight with at least one 2024-01-01 ADA Standards of Care endorse liraglutide class American Diabetes Association Standards of Care recommend liraglutide and other GLP-1 receptor agonists for type 2 diabe Review Decisions adopt Confident Family: fam-sentence-3 · Trigger: FDA approves liraglutide for type 2 diabetes · Impact: support-enhanced FDA approval provides direct operationalization for the T2D mechanism claim. 2010-01-25 · By: automated reviewer · Basis: analyst asserted amend Confident Family: fam-sentence-7 · Trigger: FDA approves liraglutide for chronic weight management · Impact: support-enhanced FDA obesity approval narrows the weight-loss claim from observational to approved indication without changing the family scope. 2014-12-23 · By: automated reviewer · Basis: analyst asserted retain-with-caveats Uncertain Family: fam-sentence-3 · Trigger: ADA Standards of Care endorse liraglutide class · Impact: support-enhanced ADA endorsement supports the claim but is inferred from guideline language; retain with ASCVD qualification. 2024-01-01 · By: automated reviewer · Basis: analyst asserted Institutional Reliance Wikipedia reference medium http://care.diabetesjournals.org/cgi/content/full/25/8/1398 on unspecified variant citation_added in revision 192131328 2008-02-17 · Basis: inferred Wikipedia reference medium http://www.medscape.com/viewarticle/551640 on unspecified variant citation_added in revision 192131328 2008-02-17 · Basis: inferred Wikipedia reference medium http://www.medpagetoday.com/MeetingCoverage/AACE/tb/5480 on unspecified variant citation_added in revision 192131328 2008-02-17 · Basis: inferred Wikipedia reference medium http://www.glucagon.com/liraglutide.htm on unspecified variant citation_removed in revision 192131328 2008-02-17 · Basis: inferred Wikipedia reference medium http://care.diabetesjournals.org/cgi/content/full/30/6/1608 on unspecified variant citation_added in revision 192133935 2008-02-17 · Basis: inferred Wikipedia reference medium http://www.novonordisk.net/press/sea/sea.asp?sNewsTypeGUID=&lMonth=0&lYear=2007&sLanguageCode=en-GB&sSearchText=liraglutide&sShowNewsItemGUID=0611b01a-e3c2-4ea4-9986-c28247e5021c&sShowLanguageCode=en-GB on unspecified variant citation_added in revision 192138024 2008-02-17 · Basis: inferred Wikipedia reference medium http://www.novonordisk.net/press/sea/sea.asp?sNewsTypeGUID=&lMonth=0&lYear=2007&sLanguageCode=en-GB&sSearchText=liraglutide&sShowNewsItemGUID=200a7488-b399-4a27-b379-9250effdfe30&sShowLanguageCode=en-GB on unspecified variant citation_added in revision 192138024 2008-02-17 · Basis: inferred FDA operational-use high Liraglutide (Victoza) approval for type 2 diabetes, NDA 022341 on var-fam-sentence-3-1 FDA approval operationalizes the claim that liraglutide stimulates insulin secretion and improves glycemic control in type 2 diabetes. 2010-01-25 · Basis: institution confirmed FDA operational-use high Liraglutide (Saxenda) approval for chronic weight management, NDA 206321 on var-fam-sentence-7-1 FDA approval for chronic weight management operationalizes the claim that liraglutide reduces body weight and fat mass. 2014-12-23 · Basis: institution confirmed American Diabetes Association endorsement medium Standards of Care in Diabetes — Glycemic Goals on var-fam-sentence-3-1 ADA Standards of Care endorse liraglutide and other GLP-1 receptor agonists for type 2 diabetes, particularly when ASCVD is present. 2024-01-01 · Basis: inferred Source Citations No source citations captured. Cross-example impact propagation Changes in related examples can add context to this claim history. These links show where a source event in one domain creates a question for a related claim. → Outgoing scope-broadened high To: GLP-1 receptor agonist (public encyclopedia provenance reconstruction) · family fam-sentence-2 FDA approval of liraglutide for chronic weight management broadens the GLP-1 class claim about licensed indications, adding obesity/weight-management to the class narrative. Triggered by event: FDA approves liraglutide for chronic weight management ← Incoming support-enhanced medium From: GLP-1 receptor agonist (public encyclopedia provenance reconstruction) · family fam-sentence-3 The GLP-1 class ADA endorsement inferred in the GLP-1 specimen also supports liraglutide's T2D claim, demonstrating how class-level institutional reliance propagates to member drugs. Triggered by event: ADA Standards of Care endorse liraglutide class Classification Evidentiary - Public encyclopedia version identifiers - Edit timestamps - Editor usernames - Edit comments - Citation URLs - Page move records - Template changes Derived - Sentence-level diffs (before/after) - Citation added/removed events - Section reorganization events - Edit magnitude (minor/moderate/major) - Content change type - Key terms extraction - Direction signal (strengthening/weakening/neutral) Inferred - Claim family membership - Claim variant relationships - Confidence assignment - Impact direction - Decision rationale reconstruction - Reliance commitment interpretation --- # Examples URL: https://nextconsensus.com/examples/ ## A registered forecast and the dated evidence it was built from See a registered forecast, its source evidence, subsequent updates, and historical reconstructions. A single-claim evaluation delivers the same pair for your asset: a dated evidence baseline and a probability registered before your date. Start with one claim Read the registered record A registered forecast ### The probability, published before the outcome For some claims we publish the probability that a regulator, guideline body, or payer changes its position by a set date. This is one, as the registry holds it. FF-001 Registered 2026-08-17 Unresolved NCCN lists sunvozertinib as a first-line option in EGFR exon 20 insertion NSCLC Registered probability 75% baselines to beat precedent 62% · calendar alone 40% · analyst proxy 80% Resolves by 2027-07-31 National Comprehensive Cancer Network (NCCN) ledger ad432059…3f34fd Read the record Compare all 56 registered forecasts ### The terms set at registration Each forecast names who decides, the action, the deadline, the evidence cutoff, and the public document used to resolve the outcome. These are the terms of the record above. Proposition A version of the NCCN Clinical Practice Guidelines in Oncology for Non-Small Cell Lung Cancer carrying a version date on or before 2027-07-31 lists sunvozertinib (ZEGFROVY) as a first-line / initial systemic therapy option, at any NCCN category, for EGFR exon 20 insertion mutation-positive metastatic non-squamous NSCLC. Who decides National Comprehensive Cancer Network (NCCN) · Rung 5: Guideline action Deadline 2027-07-31 · an action dated from 2026-08-01 counts Evidence cutoff 2026-07-31 · nothing dated after this counts toward the estimate Resolution source NCCN NSCLC guideline — initial systemic therapy algorithm and tables for EGFR exon 20 insertion mutation-positive disease, latest version dated on or before 2027-07-31 Built from 6 public sources archived at the cutoff, each with its retrieval date and digest. The sources, the rule, and the reasoning The evidence baseline ### A claim history, dated and sourced Each entry carries the source’s publication date and an archived copy. The forecast above was estimated from this record. - Sunvozertinib, first line, EGFR exon 20 insertion NSCLC 2026-05-27 → 2026-08-17 · 8 rows · record hash chain d668f1a1d4d1… First-line use of sunvozertinib in EGFR exon 20 insertion mutation-positive NSCLC: the trial readout, its publication, regulatory filings and designations, and the guideline position, each as the institution or its recorder stated it. Observation only: dated, sourced, and hash-chained. Phase 0, 2026-09-06. The change feed ### What changed in the evidence When a guideline body, a regulator, or a payer next acts on an asset we keep a record for, the action goes on the evidence change feed, dated and sourced. The evidence change feed Reconstructions ### The same method, run over the historical record Claim histories rebuilt from public revision history for cases that have already played out. - Semaglutide: from high-risk comorbidity settings to general obesity weight management Metabolic · Type 2 Diabetes / Obesity The indication has widened from the high-risk diabetic and cardiovascular populations the pivotal trials studied to general weight management. The evidence that carried the first claim does not carry the second in the same way, and a payer or guideline body deciding on the wider population will ask about the gap. ### Oncology decision timing Read a subject dossier connecting the observed evidence, registered guideline and label questions, and the consequences of earlier or later action for each team. First-line oncology decision dossier --- # Reconstructions URL: https://nextconsensus.com/case-library/ ## Historical reconstructions of what the record showed Each rebuild shows what the public record held between the first movement in the evidence and the formal decision. Cut off at its evidence date, each case shows what was knowable before the decision, not what it looks like after the fact. Start with one claim See the examples What the record showed at the cutoff Metabolic Record moved past the claim ### Semaglutide: from high-risk comorbidity settings to general obesity weight management GLP-1 receptor agonist · Type 2 Diabetes / Obesity · Indication scope The indication has widened from the high-risk diabetic and cardiovascular populations the pivotal trials studied to general weight management. The evidence that carried the first claim does not carry the second in the same way, and a payer or guideline body deciding on the wider population will ask about the gap. Source timeline - 2017-12 Initial FDA approval for type 2 diabetes - 2021-06 FDA approval for chronic weight management in adults with obesity or overweight with at least one weight-related comorbidity - 2023-11 SELECT trial cardiovascular outcomes published - 2024-03 FDA adds reduction of major adverse cardiovascular events in adults with cardiovascular disease and overweight or obesity to the label - 2025-04 CMS declines to finalize Part D coverage of anti-obesity medications for weight management Reconstructed, not yet published - Nonsteroidal MRA in diabetic kidney disease: a guideline recommendation strengthened Cardiorenal · CKD associated with Type 2 Diabetes - Anti-CD3 antibody in type 1 diabetes: the record before the regulator acted Metabolic · Type 1 Diabetes - Amyloid-directed therapy in early Alzheimer's: the coverage restriction and the evidence since Neurodegenerative · Early Alzheimer's Disease - Anti-amyloid antibody in Alzheimer's: the efficacy question as the public record states it Neurodegenerative · Alzheimer's Disease Public limits - These are historical reconstructions from public sources, labeled separately from the registered forecasts. - Later outcomes cannot enter the evidence state at the declared cutoff. ### Oncology decision timing Read a subject dossier connecting the observed evidence, registered guideline and label questions, and the consequences of earlier or later action for each team. First-line oncology decision dossier --- # Evidence Change Feed URL: https://nextconsensus.com/evidence-change/ ## What changed in the evidence This feed records what a guideline body, a regulator, or a payer has done about an asset we keep a record for, each action dated, sourced, and placed on rungs 5–7 of the 12-rung ladder. Every entry is written after the action; nothing here is a forecast. Today that is a single asset, sunvozertinib, the subject of FF-001 . Start with one claim RSS feed ### Dated, sourced evidence changes Newest first, each with its source, its date, and its rung . 2026-07-14 Rung 6: Regulatory action #### Supplemental NDA submitted to FDA; Breakthrough Therapy Designation granted AstraZeneca announces an exclusive global license for sunvozertinib from Dizal. The release records that “a Supplemental New Drug Application for approval in the 1st-line setting has been submitted to the US Food and Drug Administration (FDA) and China’s Center for Drug Evaluation (CDE)” and that both “have also both granted Breakthrough Therapy Designation to Zegfrovy in this setting”. The first-line indication now has a regulatory clock running. FF-001 is registered against the NCCN listing, a separate step. AstraZeneca; US FDA and China CDE as recorded in the release 2026-05-27 Rung 6: Regulatory action #### China's CDE accepts the first-line NDA and grants priority review Dizal release: the CDE “has accepted and granted priority review to the New Drug Application (NDA) for ZEGFROVY® (sunvozertinib)” in EGFR exon 20 insertion mutation-positive NSCLC, headlined as first-line treatment and “based on the results of WU-KONG28 study”. Recorded from the sponsor's release; a release is primary for what the sponsor stated, not for what the regulator did. The same row is on the evidence ledger with its archived copy. China NMPA, Center for Drug Evaluation — as recorded by the sponsor --- # Sunvozertinib First-Line NSCLC: FDA, NCCN, and Decision Timing URL: https://nextconsensus.com/baselines/sunvozertinib-first-line/ Oncology decision dossier ## Sunvozertinib in first-line EGFR exon 20 NSCLC: evidence, FDA, and NCCN timing The treatment setting is the boundary. Evidence for first-line use, an FDA indication, and an NCCN listing are separate records. This dossier connects the published evidence history to the registered questions and the work their timing could affect. For oncology market access, regulatory strategy, medical affairs, and payer reviewers. Phase 1 of the record: registered before outcomes, registry snapshot 2026-10-26 , outcomes pending. ### What the observed record establishes On July 2, 2025, FDA granted accelerated approval to sunvozertinib for adults with the specified EGFR exon 20 insertion mutation-positive, locally advanced or metastatic NSCLC whose disease had progressed on or after platinum chemotherapy. That later-line approval does not establish a first-line indication. FDA: the July 2025 approval and its population . The dated evidence ledger records the first-line trial report and institutional documents available to the assessment. Each entry identifies its source and date. The forecast records retain their own evidence cutoffs; later information does not rewrite them. This page describes those records at their published cutoffs. For current approved use, consult the agency's current labeling. For guideline wording, consult the applicable NCCN version. Neither a frozen estimate nor its pending status establishes today's clinical recommendation or coverage. ### Four registered questions about the same asset These are related propositions with overlapping outcomes, not four independent therapy examples. Each record publishes its estimate, cutoff, baselines, and resolution rule. Calibration and useful lead time are not yet demonstrated. #### FF-001: Guideline inclusion Whether the NCCN first-line position changes by the registered deadline. Cutoff 2026-07-31 · deadline 2027-07-31 · unresolved #### FF-002: FDA action by July Whether FDA approves the specified first-line indication by July 31, 2027. Cutoff 2026-09-22 · deadline 2027-07-31 · unresolved #### FF-003: FDA action by March Whether the same action occurs by March 31, 2027. An April–July action would miss this deadline while potentially satisfying the July record. Cutoff 2026-09-22 · deadline 2027-07-31 · unresolved #### FF-004: Which institution acts first Whether FDA action precedes NCCN listing, with both occurring within the frozen window. This is a separate ordering question. Cutoff 2026-09-22 · deadline 2027-07-31 · unresolved The deadline is the last qualifying action date. The adjudication window can extend beyond it so an outcome can be checked. Read each frozen rule before comparing dates. ### What March versus July would change Illustrative planning scenarios built on the registered record's deadlines. An earlier decision compresses preparation; a later decision can justify resequencing work. Earlier notice of the same decision gives a team more time without changing the institutional date. #### Manufacturer regulatory and launch teams By March Prepare the review of indication-specific materials and operational dependencies for the nearer window. After March, by July Revisit dependent commitments and keep the current indication separate from the proposed expansion. #### Market access and HEOR By March Prioritize the evidence comparison and payer questions that can be ready for upcoming review dates. After March, by July Check whether additional time can address a population or comparator question before the dossier cutoff. #### Payer and provider teams By March Assess the actual label, guideline, and applicable coverage policy before implementation. After March, by July Keep existing policies explicit and identify the document that would prompt another review. An institutional forecast describes an authority's action; treatment suitability and coverage remain decisions for the treating clinician and the payer. ### If NCCN and FDA move in a different order Guideline inclusion on rung 5 and regulatory action on rung 6 are distinct from payer action on rung 7. If NCCN moves first, review which policies reference that wording. If FDA moves first, compare the new indication with the guideline and policy already in force. Neither path establishes an automatic coverage change. If one action does not occur by the deadline, retain that result. A later action does not retroactively satisfy an earlier deadline. The guide to delayed changes explains how to distinguish a procedural delay, a different action, and an unresolved reason. - FDA approval, guideline inclusion, and coverage - Preparation for a possible label expansion - Evidence preparation before a committee deadline - Verify a record ### Which institutional date matters to your team? Name the authority, the action, the population, and your deadline. Include what your team would prepare differently if the action occurred months earlier or later. Start with one claim --- # Research URL: https://nextconsensus.com/research/ ## Authority transitions leave tracks in the public record That is the premise, and the research program tests it: estimates for named regulatory, guideline, and coverage decisions, registered before the outcome is known and then checked against what happened. The method is public so the answer does not depend on trusting us. The registry stands whichever way the answer comes out; About separates what is contributed now from what is under test. Start with one claim Read the method ### Registered questions, outcomes still pending Registry snapshot: 2026-10-26 . Several records concern the same asset, with overlapping outcomes. Registered 56 Resolved yes or no 0 Unresolved 56 Expired 0 Every registered forecast, by class NCCN guideline reclassification 2 registered; 0 resolved, 2 unresolved, 0 expired. FDA label revision 2 registered; 0 resolved, 2 unresolved, 0 expired. FDA action by goal date 28 registered; 0 resolved, 28 unresolved, 0 expired. NICE guidance by scheduled date 24 registered; 0 resolved, 24 unresolved, 0 expired. - Unresolved 56 - Resolved 0 - Not scored 0 - Expired 0 One cell for each registered forecast; open one to read its record. A cell fills in when its forecast resolves, whichever way it came out. A forecast that could not be scored stays in its class count as a hatched cell. Registration fixes what was estimated and when. Each forecast is scored once its deadline passes and the outcome is adjudicated, against the three baselines registered beside it. Verify a record · Read the research questions ### The questions the program asks Can defined public medical transitions be forecast prospectively? in progress Do the numbers mean what they say? Does a 70% forecast happen about 70 times in 100? planned Does NextConsensus outperform base-rate, heuristic, expert, and LLM baselines? planned Which evidence and institutional features improve forecasts? planned Does an action by one authority make an action by another more likely, including across markets? planned Which authorities move first, and which follow? planned How far ahead can a forecast be issued before its false alarms cost more than the lead time is worth? planned Which target rungs are forecastable, and which are not? planned How many resolved forecasts does one kind of decision need before its record means anything? planned ### The transition model Evidence, expert recognition, and the decision itself move at different speeds. A decision at rungs 5–7 of the 12-rung ladder is one of three public actions: a guideline body changing a recommendation, a regulator changing a label, a payer changing coverage. The model estimates the probability of one of those happening by a stated deadline, from what was observable at registration. Evidence clock Evidence emerges Evidence strengthens Real-world confirmation Recognition clock Expert convergence Committee agenda Draft position Authority clock Procedure opens Public action Resolution recorded Illustrative sequence Current stage Evidence emerges Registry state Not registered An observable upstream event enters the time-bounded evidence record. ### How the program runs Public research tests whether the method forecasts. Program work tests whether a forecast is useful in a decision. Neither result stands in for the other. Retrospective backtesting Reconstruct forecasts from historical evidence. Hold out future information. Score against outcomes. Control for temporal leakage. Prospective registration Register forecasts before outcomes are known. Freeze the evidence state. Publish registration timestamps. Adjudicate outcomes independently. Calibration analysis Compute Brier scores, reliability curves, and baseline comparisons per cohort, event class, and method version. Boundary determination Identify which target rungs can be forecast. Report verdicts: detection, nowcasting, forecasting, or unsupported. ### Ranking which claims to review first Between reconstruction and forecasting sits a step that ranks which claims to look at first, by how much their evidence has moved. It exists as a review workflow; the validation below decides whether it becomes a program. Claim prioritization The direction and strength of movement on rungs 1–4 (support attaching, qualifiers falling away, spread across sources, or regulator language arriving early), ordered into a review queue with the record and its limits. What would settle it Whether the queue ranks claims that later moved on rungs 5–7 higher than those that did not, measured on held-out history with the cutoff enforced. An earlier proof cycle that appeared to show this was invalid; the corrected rebuild found no lift in general revision activity, so the test now runs on specific claims and specific patterns. ### Method demonstrations Two reconstructions built to test the method, not an asset: whether one claim can be held across years of public edits, and whether a second analyst working independently arrives at the same claim families. Both use a public encyclopedia's revision history, the largest openly versioned medical text available. #### GLP-1 receptor agonist claim history: diabetes to obesity indication Provenance reconstruction of a metabolic claim from a public encyclopedia revision history, validated by two independent analysts. Two-analyst check passed, overlap 3/3 #### Liraglutide claim history: single-drug provenance reconstruction Provenance reconstruction of a single-drug metabolic article, showing how a dated source trail can be preserved beyond the GLP-1 class example. Two-analyst check pending ### What the program publishes - Registered forecast specifications with defined resolution rules - Retrospective backtests that control for temporal leakage - Prospective forecast cohorts resolved against pre-registered rules - Calibration analyses by event class and authority - Baseline comparison results - Open-source tooling via Refract Refract on GitHub Method basis ### Reading The works this program leans on. They frame the problem — evidence records age, guidelines lag, and citations make claims look more settled than they are. - How quickly do systematic reviews go out of date? A survival analysis Shojania et al., Annals of Internal Medicine , 2007 Shows that review currency varies by topic and can decay before normal review schedules catch it. - Validity of the Agency for Healthcare Research and Quality clinical practice guidelines: how quickly do guidelines become outdated? Shekelle et al., JAMA , 2001 Shows that guideline validity changes over time and should be reassessed against new evidence. - The answer is 17 years, what is the question: understanding time lags in translational research Morris, Wooding, and Grant, Journal of the Royal Society of Medicine , 2011 Background on the gap between evidence production and institutional uptake; useful as a caution, not as a fixed timing claim. - Living systematic review: 1. Introduction—the why, what, when, and how Elliott et al., Journal of Clinical Epidemiology , 2017 Frames evidence synthesis as an updating problem, not a one-time search problem. - How citation distortions create unfounded authority: analysis of a citation network Greenberg, BMJ , 2009 Shows how citation patterns can make a claim appear more settled than the source record supports. - Reporting and Interpretation of Randomized Controlled Trials With Statistically Nonsignificant Results for Primary Outcomes Boutron, Dutton, Ravaud, and Altman, JAMA , 2010 Documents how reporting can overstate or distract from primary results, which is one way claim wording can outrun evidence. - A Decade of Reversal: An Analysis of 146 Contradicted Medical Practices Prasad et al., Mayo Clinic Proceedings , 2013 Shows why settled-looking practices and claims need structured review when stronger contrary evidence appears. - GRADE: an emerging consensus on rating quality of evidence and strength of recommendations Guyatt et al., BMJ , 2008 Separates evidence quality from the strength of recommendations and makes uncertainty explicit. - GRADE Evidence to Decision frameworks: a systematic and transparent approach to making well informed healthcare choices Alonso-Coello et al., BMJ , 2016 Shows why evidence assessment and final decisions should be structured separately. - The PRISMA 2020 statement: an updated guideline for reporting systematic reviews Page et al., BMJ , 2021 Supports transparent reporting of search, selection, appraisal, synthesis, and update methods. - AMCP Format for Formulary Submissions Academy of Managed Care Pharmacy, AMCP guidance , 2024 Shows how healthcare decision makers expect clinical and economic evidence to be organized for formulary, coverage, policy, and reimbursement review. - Good practices for real-world data studies of treatment and/or comparative effectiveness Berger et al., Pharmacoepidemiology and Drug Safety , 2017 Frames real-world evidence around reproducibility, registration, stakeholder involvement, and decision-maker confidence. - The FAIR Guiding Principles for scientific data management and stewardship Wilkinson et al., Scientific Data , 2016 Supports the need for durable, inspectable, reusable evidence and provenance records. - Guidelines for Human-AI Interaction Amershi et al., CHI , 2019 Supports interface patterns that keep uncertainty, user control, correction, and human authority visible in AI-assisted systems. --- # How It Works URL: https://nextconsensus.com/how-it-works/ ## From observable evidence to a registered forecast We compile public evidence revisions, distinguish substantive changes from routine edits, and identify claims for review. That history supports your evidence packages and briefings. We also register forecasts for defined guideline, label, and coverage actions. Whether claim history improves those forecasts is under test; current forecasts use the decision's own review record ( how the number is formed ). Start with one claim Read the method ### Turn a broad question into a verifiable forecast Before any evidence is read, the question you bring is rewritten into four parts: a named authority, a defined action, a target population, and a deadline. In that form, the institution either takes the action by the date or it does not. 1 · Authority Who decides NCCN NSCLC Guidelines Panel 2 · Action Specified action A first-line listing, at any NCCN category 3 · Population Patient population EGFR exon 20 insertion mutation-positive metastatic non-squamous NSCLC 4 · Deadline Date it must happen by 2027-07-31 That is the first record: NCCN lists sunvozertinib as a first-line option in EGFR exon 20 insertion NSCLC , which resolves by reading the guideline's own tables. What is still under test is on the research page . ### Extract, classify, prioritize, register Classification distinguishes new evidence and changed recommendations from routine document edits. Where sources disagree, the record shows that disagreement before summarizing the claim. 1 #### Extract We rebuild the claim's history across label revisions, guideline editions, and published trials. We date each wording change and citation and link it to its source. 2 #### Classify We distinguish new trial results supporting a claim, changes to published recommendations, and routine edits such as citation cleanup. We record which qualifier changed and what evidence supports the change. 3 #### Prioritize We rank claims for commercial review using documented changes: a qualifier removed, an evidence gap identified, or a new restriction in a coverage policy. 4 #### Register The probability that the named authority (such as NCCN, FDA, or CMS) takes a defined action by the deadline is registered before the outcome is known. --- # Method URL: https://nextconsensus.com/method/ ## A public standard for reviewable forecasts Each forecast specifies who decides, the action, the deadline, and the evidence cutoff before the outcome is known. The registered terms remain available for review after the decision. FF-001 is the first record. Whether a claim's public history improves these forecasts is a separate research question . Read the first record Start with one claim ### What a forecast is made of "Will payers cover our drug?" cannot be scored. A forecast is that question rewritten until a named regulator, guideline body, or payer either takes a defined action by a date or does not. A named decision-maker and a defined action Specific enough that an independent reader can tell whether it happened: NCCN lists the agent first-line; FDA approves the supplemental application; CMS issues the determination. A deadline and an evidence cutoff The date by which the action must happen, and the evidence cutoff: the last date a source can carry and still be used. Both are written into the record at registration, so the forecast reflects only what was public by the cutoff. A resolution rule and its source Which document settles it and how to read it, written before the window opens. Listing confined to a later line of therapy does not count; a withdrawn agent resolves NO rather than being voided. The baselines it has to beat A base rate from comparable cases, a model that knows only the authority's calendar, and a reconstruction of what an analyst reading the same record would say — each frozen at the same cutoff. These same four terms apply to any probability your team plans against, ours included. A probability answers a specific question: the same claim can carry a different probability when the body or the deadline differs. A number published without its terms cannot be checked after the outcome. ### How a claim keeps its identity across revisions A claim is rarely deleted. It is reworded, moved to another section, qualified, broadened, narrowed, given a new citation, and sometimes put back after being taken out. The claim keeps one identity across all of those steps. A sentence that says "reduces" where it used to say "may reduce" is the same claim with a qualifier gone. A sentence that now names a different population is a different claim, and the history says so rather than carrying the old identity forward. Keeping the claim linked across revisions lets us distinguish changes in evidence from rewording and citation cleanup. We label evidence as strengthened only when new evidence supports that finding. The illustration below shows a qualifier added, removed, and restored by different authors while the claim retains the same identity. Illustrative "Aducanumab demonstrates amyloid reduction but clinical benefit remains contested contested contested ." rev 03 rev 04 rev 05 + added − removed + re-added Revision trail ### Keeping hindsight out NextConsensus freezes every source at the evidence cutoff date; the probability, proposition, baselines, and sources are locked at registration and never retroactively modified. If new trial readouts or policy revisions occur later, they go into a new, distinct forecast; the earlier one stands on its original record, and both are in the registry, each with its hash . ### How an outcome is read We read the evidence and make the estimate. Whether the specified action occurred is read separately, from the first day the registered rule allows, by applying that rule to the sources it names. Two readings are taken. One is mechanical only where the registered evaluator can produce one — an openFDA query by application or product, a captured NICE page, a CBER list entry it can name; otherwise both are separate readings by a language model given only those sources, not its own knowledge of events. Neither reading weighs evidence or touches the probability. If the two readings agree, and the model is confident, that is the outcome, and the record names the machine readers that produced it — except that a "did not occur" reading waits until the source's own data runs far enough past the deadline that its silence means something. If the readings disagree, or the model is unsure, the record resolves as ambiguous and is never scored. A record whose sources cannot be read for 30 days after that first day resolves as unresolvable. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus. What happens at a deadline - Step 1 The deadline passes The record stays as registered. - Step 2 The window closes Nothing is adjudicated before it does. - Step 3 The rule is applied The rule written at registration, to the source it names. - Step 4 What is recorded Scored - Occurred on time - Did not occur - Occurred after the deadline - Occurred in part; the rule was not met Not scored - Ambiguous, handled by the rule - Could not be resolved - Cancelled by an outside event Posted with its status. It stays in the class count. No finding Posted with no finding. It stays in the class count. - Step 5 It is posted In the same layout whether it occurred or not, with the count for its class beside it. - Step 6 The class count updates Registered, resolved, unresolved, and expired. ### How a record is scored Each resolved forecast is scored against its outcome using a proper scoring rule, declared in advance, beside the baselines it was registered against. Results are published per reference class with the denominator, the unresolved and expired records, the method version, and the date range needed to read them. A lead-time figure is always published with the precision and false alarms it cost. A forecast that does not resolve is classified by reason rather than scored as a miss. ### How results will be reported Written down on 2026-09-26, when the registry held 22 registered forecasts and none had resolved, so the way results are shown was not chosen after seeing one. Every deadline is posted Every forecast that reaches its deadline is posted, whether it occurred or not, in the same layout. What a posting shows A posted resolution shows who adjudicated it, the sources they read where the adjudication lists them, the finding, and the registered probability beside the baselines it was registered against, all scored by one rule: squared error. The count beside it Each posted resolution carries the count for its class: registered, resolved, unresolved, and expired. One forecast is one instance, not a rate. Classes are never pooled NCCN guideline reclassification, FDA label revision, FDA action by goal date, and NICE guidance by scheduled date are counted apart. No class figure before 15 admissible No figure across a class, such as the share that occurred or an average score, appears until the class has 15 admissible resolved forecasts. Forecasts that turn on the same decision count once. Unresolved forecasts stay in the count A forecast that cannot be resolved is posted with its status, and stays in the class count: ambiguous, could not be resolved, or cancelled by an outside event. The same readers The same two reader roles are assigned to every forecast registered so far. Departures of 15 points are shown apart Within each class, the forecasts whose registered probability sits 15 points or more from their base-rate baseline are counted and scored as one group, and the rest of the class as another, by the same rules. Which group a forecast is in is fixed by those two numbers at registration, before any outcome. Neither group shows a figure until it has 15 admissible resolved forecasts of its own. “Departures of 15 points are shown apart” was added on 2026-10-06, when the registry held 22 registered forecasts and none had resolved. Where a chart groups forecasts by registered probability, it uses five bins of equal width, each 20 points wide, fixed here before any outcome: 0–20%, 20–40%, 40–60%, 60–80%, 80–100%. Bins chosen after the results are a way to tune a picture. ### When we decline to forecast When the public evidence cannot support an estimate, we decline to forecast. We publish the reason and date beside the scoring record so readers can see which questions were declined. Thin record The public documents are too thin to support an estimate. More than one reading The documents support two readings, and the rule cannot choose between them. Sources in conflict Credible public sources disagree, and the record preserves the disagreement. Outside the boundary The question needs something the declared record does not contain. The works this standard leans on are listed once on the research page , with the contribution of each. Validation standard Updated July 2026 · Public examples only; private packages include full source references --- # Verify a record URL: https://nextconsensus.com/verification/ ## Verify a record Check the proposition, evidence cutoff, probability, and resolution rule recorded before the outcome was known. Each registration carries a ledger hash. The tool below recomputes a separate specification hash from the published terms. You can compare that hash with a copy you saved earlier to check for changes. Read the first record Start with one claim ### Registered questions, outcomes still pending Registry snapshot: 2026-10-26 . Several records concern the same asset, with overlapping outcomes. Registered 56 Resolved yes or no 0 Unresolved 56 Expired 0 Registration fixes what was estimated and when. Each forecast is scored once its deadline passes and the outcome is adjudicated, against the three baselines registered beside it. Verify a record · Read the research questions Reporting format set in advance ### Where the results will go The reporting format was published before any forecast resolved. The bins are the ones set out on the method page . Registered probability, in five bins fixed before any outcome NCCN guideline reclassification 2 registered Measure 0–20% 20–40% 40–60% 60–80% 80–100% Registered 0 0 1 1 0 Resolved 0 0 0 0 0 15 or more points from the base rate: 0 registered, 0 resolved. The rest: 2 registered, 0 resolved. Why they are counted apart FDA label revision 2 registered Measure 0–20% 20–40% 40–60% 60–80% 80–100% Registered 0 0 1 0 1 Resolved 0 0 0 0 0 15 or more points from the base rate: 0 registered, 0 resolved. The rest: 2 registered, 0 resolved. Why they are counted apart FDA action by goal date 28 registered Measure 0–20% 20–40% 40–60% 60–80% 80–100% Registered 1 2 3 9 13 Resolved 0 0 0 0 0 15 or more points from the base rate: 9 registered, 0 resolved. The rest: 19 registered, 0 resolved. Why they are counted apart NICE guidance by scheduled date 24 registered Measure 0–20% 20–40% 40–60% 60–80% 80–100% Registered 1 12 11 0 0 Resolved 0 0 0 0 0 15 or more points from the base rate: 13 registered, 0 resolved. The rest: 11 registered, 0 resolved. Why they are counted apart It was drawn empty on purpose and fills in as forecasts resolve, whether or not the result flatters us. For a class, the share that occurred in each bin is added once the class has 15 admissible resolved forecasts, and not before. No line is drawn for how it should look. ### Every registration and its hash Record Hash Method version v0.1.0 Current scheme nc-v1 FF-001 · NCCN lists sunvozertinib as a first-line option in EGFR exon 20 insertion NSCLC Registered 2026-08-17, resolves by 2027-07-31, resolution pending ledger ad43205978351a4affaeb1d6b2cbe00dd6aa0bdf3ac78fd24f9d7259ca3f34fd FF-002 · FDA approves a first-line indication for sunvozertinib in EGFR exon 20 insertion NSCLC Registered 2026-09-22, resolves by 2027-07-31, resolution pending ledger 56015937eab42488ee1a6706401594c56146be557f1536688ff27c3835e0b2c5 FF-003 · FDA approves first-line sunvozertinib in EGFR exon 20 insertion NSCLC on or before 2027-03-31 Registered 2026-09-22, resolves by 2027-07-31, resolution pending ledger c1f038e701df6f687ad521494d0f0e5fec7c39b3f565f3e38732de1317ea768a FF-004 · FDA first-line approval of sunvozertinib precedes the NCCN first-line listing Registered 2026-09-22, resolves by 2027-07-31, resolution pending ledger 114dae9f9853bf368b35569c63d28c9aa3f183dbd10bebe9c4f5654b63d86f84 FF-005 · FDA approves the aficamten MAPLE-HCM supplement to NDA 219083 on or before the disclosed PDUFA goal date of 2026-11-14 Registered 2026-09-26, resolves by 2026-11-14, resolution pending ledger a5cceddb217f50728de0be9b274908b92398542751b2c1e5f5aac2647294e93c FF-006 · FDA approves BBP-418 for limb-girdle muscular dystrophy type 2I/R9 on or before the disclosed PDUFA goal date of 2026-11-27 Registered 2026-09-26, resolves by 2026-11-27, resolution pending ledger 56a534eeec5d40e039a81e7783a01a2d1661afbbb6bb11f9b30d64fd36dbdf25 FF-007 · FDA approves bepirovirsen for chronic hepatitis B on or before the disclosed PDUFA goal date of 2026-10-26 Registered 2026-09-26, resolves by 2026-10-26, resolution pending ledger 7a94b79fadc84e089049a64c530c032a32cfc876c966e1f24e37683f016a66e8 FF-008 · FDA approves deramiocel for Duchenne muscular dystrophy on or before the disclosed PDUFA goal date of 2026-11-22 Registered 2026-09-26, resolves by 2026-11-22, resolution pending ledger 53dcbd72a686d5c74158eebc1b0aca044cd2fa9b317017ce1645fe902cdcb6ec FF-009 · FDA approves the IGALMI at-home use supplement to NDA 215390 on or before the disclosed PDUFA goal date of 2026-11-14 Registered 2026-09-26, resolves by 2026-11-14, resolution pending ledger 132037f290c965911776fecf29f898a2e433a4794ebee5b18eb54c6e3c04a89d FF-010 · FDA approves INO-3107 for recurrent respiratory papillomatosis on or before the disclosed PDUFA goal date of 2026-10-30 Registered 2026-09-26, resolves by 2026-10-30, resolution pending ledger 9c6197a7bfbb4b11603222825b467a6fa2ee4e9aba0ce2f6bfaedde7d7b30a28 FF-011 · FDA approves ivonescimab for EGFR-mutated non-small cell lung cancer after EGFR TKI therapy on or before the disclosed PDUFA goal date of 2026-11-14 Registered 2026-09-26, resolves by 2026-11-14, resolution pending ledger 8a2d166c0ea14aa76d0a28312995a97f845fb8289237dadc0a520404c5c5de3c FF-012 · FDA approves the mitapivat sickle cell disease supplement to NDA 216196 on or before the disclosed PDUFA goal date of 2026-11-01 Registered 2026-09-26, resolves by 2026-11-01, resolution pending ledger d9729672f768800f59c0828a962a9f8b7911e1225296817037a10b5de6b5049d FF-013 · FDA approves molgramostim (MOLBREEVI) for autoimmune pulmonary alveolar proteinosis on or before the disclosed PDUFA goal date of 2026-11-22 Registered 2026-09-26, resolves by 2026-11-22, resolution pending ledger 0b638dd5666d29fd6769192cbf9068ceb940dba70bb0e7bfe01b84028d705d81 FF-014 · NICE publishes technology appraisal guidance on Beremagene geperpavec for treating skin wounds associated with dystrophic epidermolysis bullosa [ID3959] on or before 2026-11-18 Registered 2026-09-26, resolves by 2026-11-18, resolution pending ledger 669bf39db23b33d8c6a6d624bcf63ac8d7517ed44c4226e27f6a7f975fd9f9a8 FF-015 · NICE publishes technology appraisal guidance on Efgartigimod for treating chronic inflammatory demyelinating polyneuropathy [ID6409] on or before 2026-11-18 Registered 2026-09-26, resolves by 2026-11-18, resolution pending ledger e715bfe2a8099aa2162258d2a6d0d934776705ce86bdf980ef67ca4d9312c55c FF-016 · NICE publishes technology appraisal guidance on Epcoritamab with rituximab and lenalidomide for treating relapsed or refractory follicular lymphoma after 1 or more systemic treatments [ID6586] on or before 2026-10-28 Registered 2026-09-26, resolves by 2026-10-28, resolution pending ledger f3dc7e9a0fd079f1f2cdf78b395ae1c89f8f451aca00d735ed257eedc8f2dee0 FF-017 · NICE publishes technology appraisal guidance on Inavolisib with palbociclib and fulvestrant for treating recurrent hormone receptor-positive HER2-negative PIK3CA-positive advanced breast cancer after adjuvant endocrine treatment [ID6425] on or before 2026-11-03 Registered 2026-09-26, resolves by 2026-11-03, resolution pending ledger cdce96623d2c92f80738e1efa131809f0a4c32da26098ac171e673d16acdb1bf FF-018 · NICE publishes technology appraisal guidance on Larotrectinib for treating NTRK fusion-positive advanced solid tumours (MA review of TA630) [ID6292] on or before 2026-11-18 Registered 2026-09-26, resolves by 2026-11-18, resolution pending ledger 735f8ef595baeaab7844eb785692fe6d897f514e5ab3ec702c5fbe5eede0a5d9 FF-019 · NICE publishes technology appraisal guidance on Nivolumab with ipilimumab for untreated advanced hepatocellular carcinoma [ID6239] on or before 2026-11-11 Registered 2026-09-26, resolves by 2026-11-11, resolution pending ledger 110ca8dcc7a2c2ab6b417d5a355b88cdffff103181b3503873d10c7a1b251019 FF-020 · NICE publishes technology appraisal guidance on Orforglipron for managing overweight and obesity [ID6516] on or before 2026-11-18 Registered 2026-09-26, resolves by 2026-11-18, resolution pending ledger 4fe0cbed9b8443dea2133c8f88dd3c452aac74eeec41fe93439f55fabfe997fd FF-021 · NICE publishes technology appraisal guidance on Pembrolizumab with chemotherapy with or without bevacizumab for treating platinum-resistant recurrent ovarian cancer after 1 or 2 treatments [ID6363] on or before 2026-11-18 Registered 2026-09-26, resolves by 2026-11-18, resolution pending ledger 80d14b258192d4b4d16dabc0f47be5dc510901f559ce701020f11b39224e5e22 FF-022 · NICE publishes technology appraisal guidance on Zuranolone for treating postnatal depression [ID6431] on or before 2026-11-12 Registered 2026-09-26, resolves by 2026-11-12, resolution pending ledger f8ceb2e7f05c5212e38731e78252d5bace74d5a31bc67309afabc65c3ba0d2e4 FF-023 · FDA approves bezuclastinib with sunitinib for gastrointestinal stromal tumor after imatinib on or before the disclosed PDUFA goal date of 2026-11-30 Registered 2026-10-06, resolves by 2026-11-30, resolution pending ledger 7fa4097d054e825b3e0895600217f1b711f8a49430c6b2980b9d0233e9cd659a FF-024 · FDA approves D-PLEX100 (extended-release doxycycline) for prevention of surgical site infections in colorectal surgery on or before the disclosed PDUFA goal date of 2026-11-28 Registered 2026-10-06, resolves by 2026-11-28, resolution pending ledger 78267586fe018127a09ef07cd55d477d78dbace1df7d6bdad0b43c4e4704ac9e FF-025 · FDA approves neladalkib for ALK-positive non-small cell lung cancer after a prior ALK inhibitor on or before the disclosed PDUFA goal date of 2026-11-27 Registered 2026-10-06, resolves by 2026-11-27, resolution pending ledger a912641a8f1dfb783320fb6599a0e4d8f2aa1d9250f29ebb3abe316ffc6a68b0 FF-026 · FDA approves povetacicept for IgA nephropathy on or before the disclosed PDUFA goal date of 2026-11-30 Registered 2026-10-06, resolves by 2026-11-30, resolution pending ledger 3579c949d3f51f469db7d882ce86439cd190f53841739638ddb56b1413b12a61 FF-027 · FDA approves venglustat for type 3 Gaucher disease on or before the disclosed PDUFA goal date of 2026-11-25 Registered 2026-10-06, resolves by 2026-11-25, resolution pending ledger e47801540786a6fe2ed9a4a168e3e7923e30b1e5efe6a34cee6a64d3108081f8 FF-028 · NICE publishes technology appraisal guidance on Obicetrapib and obicetrapib–ezetimibe for treating primary hypercholesterolaemia or mixed dyslipidaemia [ID6519] on or before 2026-11-25 Registered 2026-10-06, resolves by 2026-11-25, resolution pending ledger 1e21419a5ead2a82d8f93717b1141df0883f93890b2fe56fa3a8b3ed2b5a1912 FF-029 · NICE publishes technology appraisal guidance on Polihexanide 0.8 mg/ml eye drops for treating acanthamoeba keratitis in people 12 years and over [ID6497] on or before 2026-11-25 Registered 2026-10-06, resolves by 2026-11-25, resolution pending ledger 6743177dc95da81113b18db16a14f1716ec4a7783c26571d1e8e3498debb1daa FF-030 · FDA approves anitocabtagene autoleucel (anito-cel) for relapsed or refractory multiple myeloma after 3 or more lines on or before the disclosed PDUFA goal date of 2026-12-23 Registered 2026-10-15, resolves by 2026-12-23, resolution pending ledger 9f476a053fbff5ae6708d1471fa3d3dedd96b3a9a3e75f53b0d346ae088a458b FF-031 · FDA approves bezuclastinib for nonadvanced systemic mastocytosis on or before the disclosed PDUFA goal date of 2026-12-30 Registered 2026-10-15, resolves by 2026-12-30, resolution pending ledger ee048aedc9382c734fe3af3f5a44247c1270bba9983104a3991026af98262a61 FF-032 · FDA approves imsidolimab for generalized pustular psoriasis on or before the disclosed PDUFA goal date of 2026-12-12 Registered 2026-10-15, resolves by 2026-12-12, resolution pending ledger 41c59f846806fdd51750606007d7d5861960bd532e5b23f07b3ba897880a15b7 FF-033 · FDA approves lorundrostat for hypertension on or before the disclosed PDUFA goal date of 2026-12-22 Registered 2026-10-15, resolves by 2026-12-22, resolution pending ledger 44b1dd75f68f58f6cbca5c7e8c96d7e47592152e153061faf20a6a112851d076 FF-034 · FDA approves relacorilant for Cushing's syndrome (resubmission) on or before the disclosed PDUFA goal date of 2026-12-17 Registered 2026-10-15, resolves by 2026-12-17, resolution pending ledger fc3ac1610959707a4812d77bb108b55de1f4cd352bd231e60d6d3408aec5ddf8 FF-035 · FDA approves relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies on or before the disclosed PDUFA goal date of 2026-12-27 Registered 2026-10-15, resolves by 2026-12-27, resolution pending ledger 55d89291184e24857575879dca8c42900a4c1e7c2030d141349a63f201dde604 FF-036 · FDA approves ulixacaltamide for essential tremor on or before the disclosed PDUFA goal date of 2027-01-29 Registered 2026-10-15, resolves by 2027-01-29, resolution pending ledger 6cd7820ace1c35bc8346892f8b767d059fcb0e7d819a5fdef261a11e9b8aa51b FF-037 · FDA approves zeleciment rostudirsen (z-rostudirsen) for Duchenne muscular dystrophy amenable to exon 51 skipping on or before the disclosed PDUFA goal date of 2027-01-21 Registered 2026-10-15, resolves by 2027-01-21, resolution pending ledger f5b0d0e15845147745cfcc30691b9f9314ab5be9b7aa69a5bd017808ef69fbbf FF-038 · NICE publishes technology appraisal guidance on Elranatamab for treating relapsed and refractory multiple myeloma after 3 or more treatments (managed access review of TA1023) [ID6653] on or before 2027-01-28 Registered 2026-10-15, resolves by 2027-01-28, resolution pending ledger eb859c0c6bf868c64a229e71b88539f59e62388e409b7a9133a68d49981a67be FF-039 · NICE publishes technology appraisal guidance on Nerandomilast for treating idiopathic pulmonary fibrosis or progressive pulmonary fibrosis [ID6446] on or before 2027-01-20 Registered 2026-10-15, resolves by 2027-01-20, resolution pending ledger a624a0d9838b59f45db4c61034d461d288285786d4e1aaca59b960eb45dd7bf8 FF-040 · NICE publishes technology appraisal guidance on Retifanlimab with platinum-based chemotherapy for treating inoperable, locally recurrent or metastatic squamous cell anal canal cancer untreated with systemic chemotherapy [ID6482] on or before 2026-12-16 Registered 2026-10-15, resolves by 2026-12-16, resolution pending ledger 5b25ed2891c9f0d828b97d9634c7ed70df46c28b34267c94559913ce6e1d65ef FF-041 · NICE publishes technology appraisal guidance on Tarlatamab for treating extensive stage small-cell lung cancer that has progressed after platinum-based chemotherapy [ID6617] on or before 2027-01-13 Registered 2026-10-15, resolves by 2027-01-13, resolution pending ledger 556605b8b10aa17c3a3f2c875283c26d64b96b2ab99b50d9642e35254f0b502e FF-042 · NICE publishes technology appraisal guidance on Toripalimab with chemotherapy for untreated recurrent or metastatic nasopharyngeal cancer [ID6406] on or before 2027-01-13 Registered 2026-10-15, resolves by 2027-01-13, resolution pending ledger 4b9f547e41c686454406c0b42587ad96ffae36e5fb558f2f4593b2c7c97f13d9 FF-043 · NICE publishes technology appraisal guidance on Trastuzumab deruxtecan for treating HER2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma after trastuzumab-based treatment (review of TA879) [ID6680] on or before 2027-01-27 Registered 2026-10-15, resolves by 2027-01-27, resolution pending ledger d902cf0e98b73d882284e593712357ec3e10e57b41ffc3aa6299748a7b1512c1 FF-044 · FDA approves oral infigratinib for children with achondroplasia on or before the disclosed PDUFA goal date of 2027-02-04 Registered 2026-10-15, resolves by 2027-02-04, resolution pending ledger 1538844d949089accb6f028165bb4a479dbb648525433afaeaa75602daa91b16 FF-045 · FDA approves once-weekly oral lenacapavir (YEZTUGO) for HIV-1 pre-exposure prophylaxis on or before the disclosed PDUFA goal date of 2027-02-02 Registered 2026-10-15, resolves by 2027-02-02, resolution pending ledger 8b208db8497b08d9f2b1d79efd1b3eb15e4c5ccd2cd78c455a887da72420f9d9 FF-046 · FDA approves the leniolisib (JOENJA) pediatric supplement for APDS in children weighing 13 kg to 27 kg on or before the disclosed PDUFA goal date of 2027-01-30 Registered 2026-10-15, resolves by 2027-01-30, resolution pending ledger 7d58d3ccc4f675de696cdbed410ac76e0198710c03c6c10f60f7f3691c5f4822 FF-047 · FDA approves fast-acting meloxicam (MR-107A-02) for moderate-to-severe acute pain on or before the disclosed PDUFA goal date of 2026-12-27 Registered 2026-10-15, resolves by 2026-12-27, resolution pending ledger 9c51088291ab311f3c636cb2e206928cd7cdccc0514f8d1f59f36c91a80149f7 FF-048 · NICE publishes technology appraisal guidance on Intrathecal onasemnogene abeparvovec for treating spinal muscular atrophy in people 2 years and over [ID6556] on or before 2026-11-25 Registered 2026-10-15, resolves by 2026-11-25, resolution pending ledger 1c0eae273bc6b82f713fbd6719cd297f5258c7a10c8f6559bd0aa7eef528c792 FF-049 · NICE publishes technology appraisal guidance on Pembrolizumab with enfortumab vedotin for neoadjuvant and adjuvant treatment of muscle-invasive bladder cancer [ID6607] on or before 2027-02-10 Registered 2026-10-15, resolves by 2027-02-10, resolution pending ledger 9fa7009db5ca9c68eeaeadef57686242b38043921756c0c9b8b3d7693485cf2b FF-050 · NICE publishes technology appraisal guidance on Resmetirom for treating non-alcoholic steatohepatitis and liver fibrosis [ID6529] on or before 2026-12-09 Registered 2026-10-15, resolves by 2026-12-09, resolution pending ledger 35103f3939b15ede34d42a73e3351cf55b355784a43a5c462c6d8ae4a99022b1 FF-051 · NICE publishes technology appraisal guidance on Semaglutide for treating moderate to advanced liver fibrosis (without cirrhosis) caused by metabolic dysfunction-associated steatohepatitis [ID6458] on or before 2027-01-07 Registered 2026-10-15, resolves by 2027-01-07, resolution pending ledger 6822a458b0f44f7f702e13a50c348c5445175cbee3beec3c29da4872387276ec FF-052 · NICE publishes technology appraisal guidance on Tislelizumab with chemotherapy for untreated advanced oesophageal squamous cell cancer [ID5113] on or before 2027-02-10 Registered 2026-10-15, resolves by 2027-02-10, resolution pending ledger 77542815d601a1066bbbf805e0899f618d82b7d818aaf8d056f7bfa32fd5f5b7 FF-053 · FDA approves oral tinlarebant for Stargardt disease type 1 on or before the disclosed PDUFA goal date of 2027-02-12 Registered 2026-10-21, resolves by 2027-02-12, resolution pending ledger 46b8f22573354dbaf2a5b1906a9032fa8d1670a760ef413cc6f6671b0b62f077 FF-054 · NICE publishes technology appraisal guidance on Linvoseltamab for treating relapsed or refractory multiple myeloma after 3 or more treatments [ID6609] on or before 2027-02-17 Registered 2026-10-21, resolves by 2027-02-17, resolution pending ledger 955bbe9e2e4d7a1f28f9a9d278895a3d923a092668490aff384daaaacc285cbe FF-055 · NICE publishes technology appraisal guidance on Setmelanotide for treating acquired hypothalamic obesity in people 4 years and over [ID6542] on or before 2027-02-10 Registered 2026-10-26, resolves by 2027-02-10, resolution pending ledger ccc2005d756e61bfa21549038147bbf5764e2c7dde8df9c2fd9b8ebcd49bdfe7 FF-056 · FDA approves the ZORYVE (roflumilast) cream 0.05% supplement for atopic dermatitis in infants aged 3 to 24 months on or before the disclosed PDUFA goal date of 2027-02-23 Registered 2026-10-26, resolves by 2027-02-23, resolution pending ledger 0da7134ee5a59e2e0876cd4738ad186afcae68e6496ab24c8363a8d5c09a7fd1 56 registered, 0 resolved. Each row carries the ledger hash minted when its commitment was frozen. The specification hash above is computed over the published terms and is a different digest. Correction, 6 October 2026: FF-001 and FF-005 to FF-022 were registered on their stated dates in a development copy of the ledger, not the production ledger. On 7 October (UTC) they were copied into the production ledger with their original identifiers, hashes, and registration times, and each is marked there as an import. The registry's public commit history shows when each was registered. The record on its own, without the estimate: an evidence ledger shows the dated, sourced, hash-chained record the registered forecast's sources were archived from. ### Recompute the specification hash For compliance officers, diligence teams, and data auditors: every published forecast specification can be independently recomputed against its canonical fields using standard SHA-256 digests. The specification hash below covers the fixed-order fields (proposition, authority, rung, deadline, cutoff, threshold, resolution rule, and method version). Below are FF-001's published terms; edit any field and watch the digest change. This is not the ledger hash; the ledger hash is minted over commitment fields that this page does not publish, so it identifies the record without being reproducible here. scheme=nc-v1 method=v0.1.0 proposition=A version of the NCCN Clinical Practice Guidelines in Oncology for Non-Small Cell Lung Cancer carrying a version date on or before 2027-07-31 lists sunvozertinib (ZEGFROVY) as a first-line / initial systemic therapy option, at any NCCN category, for EGFR exon 20 insertion mutation-positive metastatic non-squamous NSCLC. authority=National Comprehensive Cancer Network (NCCN) rung=5 — Rung 5: Guideline action deadline=2027-07-31 evidence_cutoff=2026-07-31 threshold=75% resolution=Resolves YES if any NCCN NSCLC guideline version dated on or before 2027-07-31 names sunvozertinib (or ZEGFROVY) anywhere in the initial-systemic-therapy recommendation set for EGFR exon 20 insertion mutation-positive metastatic non-squamous NSCLC, at any category (1, 2A, 2B, or 3) and whether or not it is marked preferred. The adjudicator reads the NSCLC algorithm page for initial systemic therapy in EGFR exon 20 insertion mutation-positive disease and the corresponding systemic therapy tables, in the latest version dated on or before 2027-07-31. Resolves NO if no such version names it there. Listing confined to subsequent-line or post-progression therapy does NOT count. Access requires free NCCN registration; no clinical judgement about the drug is needed to apply this rule. Computed Short Hash (nc-v1) nc-381c658d5bbe Full SHA-256 Digest 381c658d5bbe4846787c53aef71284a1efa90d080e67fe1b0d8c1ab5bb65bcd9 ### Auditing outside this page For technical diligence and compliance review: recompute the specification digest directly in your own environment using Node.js or any standard crypto library. Any environment that can run SHA-256 on the serialized fields will reproduce the nc-v1 specification hash of the worked example above. node -e "const {createHash}=require('node:crypto');const t=process.argv[1];console.log(createHash('sha256').update(t).digest('hex'))" "scheme=nc-v1 method=v0.1.0 proposition=A version of the NCCN Clinical Practice Guidelines in Oncology for Non-Small Cell Lung Cancer carrying a version date on or before 2027-07-31 lists sunvozertinib (ZEGFROVY) as a first-line / initial systemic therapy option, at any NCCN category, for EGFR exon 20 insertion mutation-positive metastatic non-squamous NSCLC. authority=National Comprehensive Cancer Network (NCCN) rung=5 — Rung 5: Guideline action deadline=2027-07-31 evidence_cutoff=2026-07-31 threshold=75% resolution=Resolves YES if any NCCN NSCLC guideline version dated on or before 2027-07-31 names sunvozertinib (or ZEGFROVY) anywhere in the initial-systemic-therapy recommendation set for EGFR exon 20 insertion mutation-positive metastatic non-squamous NSCLC, at any category (1, 2A, 2B, or 3) and whether or not it is marked preferred. The adjudicator reads the NSCLC algorithm page for initial systemic therapy in EGFR exon 20 insertion mutation-positive disease and the corresponding systemic therapy tables, in the latest version dated on or before 2027-07-31. Resolves NO if no such version names it there. Listing confined to subsequent-line or post-progression therapy does NOT count. Access requires free NCCN registration; no clinical judgement about the drug is needed to apply this rule." Validation standard Updated July 2026 · Public examples only; private packages include full source references --- # About URL: https://nextconsensus.com/about/ ## About NextConsensus NextConsensus forecasts institutional action, not medical truth: for the claims behind your asset, the probability that a named regulator, guideline body, or payer changes its position by a date. What we contribute now Registered forecasts for upcoming guideline, label, and coverage decisions, each scored after its deadline (the method page has the standard). Alongside them, dated reconstructions of how the claims behind an asset were worded, supported, and contested across regulators and payers, for commercial and HEOR teams before committee meetings. Both are available today; the programs page carries the validation status of each forecast class. Under test Whether earlier movement in the published record, such as new results supporting a claim or qualifiers being removed, improves forecasts of downstream decisions. None of the forecasts registered so far depends on that improvement: each is built from the decision's own formal review record. The registry holds 56 registered forecasts, 0 resolved; each is adjudicated in public after its deadline, whatever the result, and a class gets a calibration figure once it holds resolved forecasts on 15 different decisions. If that earlier movement adds nothing, the registry and the dated reconstructions stand on their own. What we model For each key claim behind an asset: what clinical evidence demonstrates, what each regulator, guideline body, and payer has formally committed to, and where those positions diverge, dated as each one changes. A forecast gives the probability of a specified action by one of those decision-makers before a deadline. ### Kanav Jain Founder. Built products at Epic, Doximity, Transcarent, and CancerCompass. Those products were used by clinicians, patients, and healthcare organizations to manage care access, communication, and navigation. From 2022 to 2024 he co-founded and led Andwise, a financial education and advisor platform for physicians, then built governance infrastructure for algorithmic healthcare systems. kanav.net LinkedIn Working with us: partners, contributors, future hires ### Evidence can change before the next review New trial results, guideline revisions, and coverage updates may arrive between scheduled reviews. Teams preparing a submission or launch need to check what changed since their evidence package was assembled. We compare public revisions and return a dated history, with sources for each change. ### Where to start Find planning questions for your team, or read about the research still under test. Who it's for Research ### How Refract fits Refract is the open-source machinery that rebuilds versioned public records. NextConsensus builds on Refract to read claim histories, write propositions, and test forecasts in public. NextConsensus Reads claim histories, writes propositions, and tests forecasts in public runs on Refract open source Rebuilds versioned public records, dates and hashes every revision, and keeps later evidence out --- # Security & Compliance URL: https://nextconsensus.com/security/ ## Everything we use is public. What you tell us stays private. Forecasts and evidence records are built only from public sources, so anyone can check every one and nothing your organization holds is needed or can surface in a public record. Who is asking, the decision, the date, and any internal view you share stay private, and we sign a mutual NDA before the first call if you want one. Program-specific security requirements are agreed in writing before work begins. 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Program terms are set in each program's agreement. Start with one claim Security and compliance ### Privacy notice Effective October 8, 2026. This notice covers nextconsensus.com. It is the operative document, not a summary of one. #### Who is responsible NextConsensus, Inc., a Delaware corporation, is the controller for the personal data described here. Reach us at legal@nextconsensus.com. #### What this site collects Three things, and nothing else. - The contact form. Your work email and the claim or authority decision you are asking about, with the date you need to know by. Everything else on the form is optional: the authority or payer, the date your team needs and the time left before it, the therapeutic area, the kind of help you want, the decision it would inform, the people who would use it, and evidence you already know has moved. 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