Will the CHMP issue a positive opinion on narsoplimab following re-examination before 31 December 2026?
deadline 2026-12-31
confidence high
tier 1 evidence
6%PolySignal estimate
Resolution criterion
Yes if the CHMP adopts a positive opinion at the end of the re-examination procedure and publishes it in its meeting highlights or on the EPAR page by 31 December 2026. A confirmation of the refusal or the absence of an opinion count as no.
Verified starting state
Negative CHMP opinion on 25 June 2026 for transplant-associated thrombotic microangiopathy. Omeros requested a re-examination, listed as ongoing in the July 2026 meeting highlights. The grounds for refusal (no placebo arm, insufficient paediatric data) cannot be corrected by new analyses.
What pushes it up
- Omeros requested a formal re-examination, providing an opportunity to argue high unmet medical need or seek conditional approval before an EMA scientific advisory group [Hand-verified starting state, tier 1].
What pushes it down
- The initial grounds for refusal—lack of a placebo control arm and insufficient paediatric data—stem from core study design and cannot be solved through re-analysis of existing data [Hand-verified starting state, tier 1].
- EMA re-examination procedures do not permit the introduction of new clinical trial data, making structural trial deficiencies virtually impossible to overcome within the 60-day review period [Hand-verified starting state, tier 1].
- The September 2026 CHMP meeting highlights do not announce any reversal for narsoplimab, leaving very little time before year-end for a positive outcome [0, tier 1].
What would move this number most
Whether CHMP would consider exceptional circumstances or conditional approval based purely on scientific advisory re-argument of existing uncontrolled data.
How this number is built
| Deadline | 2026-12-31 |
| Base rate | 12% |
| Best evidence | tier 1 · 1 article(s) used |
| Independent runs | 5 · 6 (spread 1 pts) |
| Confidence | high |
| Evidence cap | not triggered |
| Last revised | 2026-09-28 09:02 |
| Model | gemini-3.8-flash |
Sources consulted
Probability history
2026-09-28 09:02 6% 55 article(s) on file · gemini-3.8-flash
- What pushes it up. Omeros requested a formal re-examination, providing an opportunity to argue high unmet medical need or seek conditional approval before an EMA scientific advisory group [Hand-verified starting state, tier 1].
- What pushes it down. The initial grounds for refusal—lack of a placebo control arm and insufficient paediatric data—stem from core study design and cannot be solved through re-analysis of existing data [Hand-verified starting state, tier 1].
- What pushes it down. EMA re-examination procedures do not permit the introduction of new clinical trial data, making structural trial deficiencies virtually impossible to overcome within the 60-day review period [Hand-verified starting state, tier 1].
- What pushes it down. The September 2026 CHMP meeting highlights do not announce any reversal for narsoplimab, leaving very little time before year-end for a positive outcome [0, tier 1].
- What would move this number most. Whether CHMP would consider exceptional circumstances or conditional approval based purely on scientific advisory re-argument of existing uncontrolled data.
2026-09-24 09:00 7% 46 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 07:37 5% 27 article(s) on file · gemini-3-flash-preview
Reasons not recorded for this revision (detailed history has only been kept since recently).