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 - 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 2026-10-06 Share image
NextConsensus registered this probability on 2026-09-26. It is one of 14 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 rungA 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 classThe 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
The alternatives it was registered against, each with the reasoning that produced it.
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.
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.
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
- 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 adjudicator can read the outcome. - Event by
- 2026-10-30
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar
9c6197a7bfbb4b11603222825b467a6fa2ee4e9aba0ce2f6bfaedde7d7b30a28 · operator record jc-1790461077734-ded9d6e3
Around this record
- This kind of deadline
- Check it, follow it
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.
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 covariatesThe 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.
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SRC-001Inovio 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.