Will the FDA approve Inovio Pharmaceuticals's INO-3107 for Recurrent Respiratory Papillomatosis by November 13, 2026?
deadline 2026-11-13
confidence medium
tier 4 evidence
81%Asturna estimate
Resolution criterion
Yes if the FDA approves INO-3107 for the indication stated above (Drugs@FDA entry, FDA announcement or Inovio Pharmaceuticals press release) no later than November 13, 2026. A complete response letter, an extension of the PDUFA date or the absence of a decision by then counts as no. An accelerated or conditional approval counts as an approval; a later label update does not change the outcome.
Verified starting state
As of October 12, 2026: according to the Inovio Pharmaceuticals filing of August 12, 2026, the FDA has set a PDUFA target action date of October 30, 2026. Source: https://www.sec.gov/Archives/edgar/data/1055726/000105572626000024/ino-63026x8kex991.htm
What pushes it up
- The FDA established a PDUFA target action date of October 30, 2026, safely within the November 13, 2026 resolution deadline [tier 1]
- First-cycle approval rates for FDA novel drug submissions historically stand at approximately 87% [tier 1]
What pushes it down
- The deadline is only 14 days after the PDUFA action date, meaning any standard three-month review extension triggered by major amendments would push the decision past November 13, 2026 [tier 1]
- The FDA may issue a Complete Response Letter due to efficacy, safety, or manufacturing/electroporation delivery device compliance issues [tier 1]
What would move this number most
Whether the FDA issues a timely approval by October 30, 2026, or implements a standard 3-month PDUFA extension / issues a Complete Response Letter.
How this number is built
| Deadline | 2026-11-13 |
| Base rate | 87% |
| Best evidence | tier 4 · 0 article(s) used |
| Independent runs | 80 · 82 (spread 2 pts) |
| Confidence | medium |
| Evidence cap | not triggered |
| Last revised | 2026-10-14 09:05 |
| Model | gemini-flash-latest |
Probability history
2026-10-14 09:05 81% 22 article(s) on file · gemini-flash-latest
- What pushes it up. The FDA established a PDUFA target action date of October 30, 2026, safely within the November 13, 2026 resolution deadline [tier 1]
- What pushes it up. First-cycle approval rates for FDA novel drug submissions historically stand at approximately 87% [tier 1]
- What pushes it down. The deadline is only 14 days after the PDUFA action date, meaning any standard three-month review extension triggered by major amendments would push the decision past November 13, 2026 [tier 1]
- What pushes it down. The FDA may issue a Complete Response Letter due to efficacy, safety, or manufacturing/electroporation delivery device compliance issues [tier 1]
- What would move this number most. Whether the FDA issues a timely approval by October 30, 2026, or implements a standard 3-month PDUFA extension / issues a Complete Response Letter.
2026-10-12 16:31 84% 8 article(s) on file · openai/gpt-oss-120b (Groq)
- What pushes it up. FDA set a PDUFA target action date of Oct 30, 2026, indicating the review is on schedule [tier 1]
- What pushes it down. No tier 1‑2 confirmation of approval; only speculative tier‑4 articles; FDA could issue a complete response letter or denial [tier 4]
- What would move this number most. The outcome of the FDA’s Oct 30, 2026 decision (approval vs complete response letter)