Will the FDA approve Palvella Therapeutics's rapamycin (QTORIN) for treatment of microcystic lymphatic malformations by March 14, 2027?
deadline 2027-03-14
confidence medium
tier 4 evidence
80%Asturna estimate
Resolution criterion
Yes if the FDA approves rapamycin for the indication stated above (Drugs@FDA entry, FDA announcement or Palvella Therapeutics press release) no later than March 14, 2027. 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 29, 2026: according to the Palvella Therapeutics filing of October 28, 2026, the FDA has set a PDUFA target action date of February 28, 2027. Source: https://www.sec.gov/Archives/edgar/data/1583648/000119312526435113/pvla-ex99_1.htm
What pushes it up
- FDA has set a PDUFA target action date of Feb 28 2027, indicating active review and typical adherence to target dates [tier 1]
- The application received priority review, which historically speeds evaluation and is associated with higher approval odds [tier 1]
What pushes it down
- Historical data show that a minority of reviews miss their PDUFA dates, creating risk of a post‑deadline decision [general knowledge]
What would move this number most
Whether the FDA will meet the Feb 28 2027 PDUFA target date
How this number is built
| Deadline | 2027-03-14 |
| Base rate | 87% |
| Best evidence | tier 4 · 0 article(s) used |
| Independent runs | 80 · 80 (spread 0 pts) |
| Confidence | medium |
| Evidence cap | not triggered |
| Last revised | 2026-10-29 20:05 |
| Model | openai/gpt-oss-120b (Groq) |