Registered forecasts

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 sourcehttps://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.

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 sourcehttps://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.

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 sourcehttps://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.

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 sourcehttps://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.

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 sourcehttps://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.

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 sourcehttps://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.

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 sourcehttps://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.

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 sourcehttps://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.

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 sourcehttps://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.

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 sourcehttps://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.

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 sourcehttps://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.

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 sourcehttps://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.

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 sourcehttps://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.

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 sourcehttps://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.

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 sourceopenFDA 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.

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 sourceopenFDA 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.

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 sourceNCCN 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.

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 sourceFDA 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.

Resolves YES if the NICE technology appraisal guidance page published from project ID6586 shows a publication date ('Published: <date>') 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 sourcehttps://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.

Resolves YES if the NICE technology appraisal guidance page published from project ID6425 shows a publication date ('Published: <date>') 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 sourcehttps://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.

Resolves YES if the NICE technology appraisal guidance page published from project ID6239 shows a publication date ('Published: <date>') 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 sourcehttps://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.

Resolves YES if the NICE technology appraisal guidance page published from project ID6431 shows a publication date ('Published: <date>') 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 sourcehttps://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.

Resolves YES if the NICE technology appraisal guidance page published from project ID3959 shows a publication date ('Published: <date>') 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 sourcehttps://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.

Resolves YES if the NICE technology appraisal guidance page published from project ID6409 shows a publication date ('Published: <date>') 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 sourcehttps://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.

Resolves YES if the NICE technology appraisal guidance page published from project ID6292 shows a publication date ('Published: <date>') 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 sourcehttps://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.

Resolves YES if the NICE technology appraisal guidance page published from project ID6516 shows a publication date ('Published: <date>') 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 sourcehttps://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.

Resolves YES if the NICE technology appraisal guidance page published from project ID6363 shows a publication date ('Published: <date>') 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 sourcehttps://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.

Resolves YES if the NICE technology appraisal guidance page published from project ID6519 shows a publication date ('Published: <date>') 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 sourcehttps://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.

Resolves YES if the NICE technology appraisal guidance page published from project ID6497 shows a publication date ('Published: <date>') 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 sourcehttps://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.