Will the FDA approve the paediatric extension of cefiderocol before 30 April 2027?
deadline 2027-04-30
confidence medium
tier 4 evidence
48%PolySignal estimate
⚠ Evidence cap applied: the model proposed 65%, brought back to 48% for lack of sources solid enough to justify the departure from the base rate.
Resolution criterion
Yes if the FDA approves the paediatric sNDA by 30 April 2027 (Drugs@FDA or a Shionogi release). A complete response letter, a postponed PDUFA date, or no decision by that date all count as no. An approval covering only one of the two indications (hospital-acquired pneumonia or complicated urinary tract infections) counts as no for this question; flag for manual review.
Verified starting state
sNDA accepted, PDUFA date 23 February 2027, for hospital-acquired pneumonia and complicated urinary tract infections in children from 26 weeks gestational age, based on three studies totalling 154 children. The paediatric extrapolation rests on a small sample. (17 July 2026)
What pushes it up
- PDUFA date of 23 Feb 2027 set for the sNDA, well before the 30 Apr 2027 deadline (hand‑verified tier 1)
- Recent FDA activity shows many pediatric and accelerated approvals, indicating a favorable regulatory climate (tier 1)
What pushes it down
- The paediatric data set is small (154 children), which could raise safety concerns and trigger a CRL (hand‑verified tier 1)
- Historical first‑cycle approval rate for comparable NDAs is only 40% (base‑rate)
What would move this number most
Whether the FDA issues a complete response letter or postpones the PDUFA date, which would prevent approval by 30 Apr 2027
How this number is built
| Deadline | 2027-04-30 |
| Base rate | 40% |
| Best evidence | tier 4 · 0 article(s) used |
| Independent runs | 48 · 48 (spread 0 pts) |
| Confidence | medium |
| Evidence cap | applied: 65% brought back to 48% |
| Last revised | 2026-09-21 22:26 |
| Model | openai/gpt-oss-120b (Groq) |
Probability history
2026-09-21 22:26 48% 5 article(s) on file · openai/gpt-oss-120b (Groq)
Reasons not recorded for this revision (detailed history has only been kept since recently).
2026-09-19 13:46 80% 5 article(s) on file · gemini-3.5-flash
Reasons not recorded for this revision (detailed history has only been kept since recently).