Will the CHMP issue a positive opinion on narsoplimab following re-examination before 31 December 2026?
deadline 2026-12-31
confidence medium
tier 4 evidence
6%Asturna 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 re-examination following the June 2026 negative opinion, which keeps the approval pathway active for a final CHMP vote before the end of 2026 [tier 1].
What pushes it down
- The primary grounds for the June 2026 refusal—lack of a placebo control arm and insufficient paediatric data—cannot be resolved by re-analysing existing trial data [tier 1].
- CHMP re-examinations rarely overturn initial negative votes unless new scientific evidence or re-evaluations significantly alter the benefit-risk balance, which is improbable given structural study design limitations [tier 1].
What would move this number most
Whether CHMP scientific re-examiners accept alternative real-world evidence or historical control data to satisfy the requirement for control comparisons without a prospective placebo arm.
How this number is built
| Deadline | 2026-12-31 |
| Base rate | 10% |
| Best evidence | tier 4 · 1 article(s) used |
| Independent runs | 5 · 7 (spread 2 pts) |
| Confidence | medium |
| Evidence cap | not triggered |
| Last revised | 2026-10-12 09:03 |
| Model | gemini-3.5-flash |
Sources consulted
Probability history
2026-10-12 09:03 6% 3 article(s) on file · gemini-3.5-flash
- What pushes it up. Omeros requested a re-examination following the June 2026 negative opinion, which keeps the approval pathway active for a final CHMP vote before the end of 2026 [tier 1].
- What pushes it down. The primary grounds for the June 2026 refusal—lack of a placebo control arm and insufficient paediatric data—cannot be resolved by re-analysing existing trial data [tier 1].
- What pushes it down. CHMP re-examinations rarely overturn initial negative votes unless new scientific evidence or re-evaluations significantly alter the benefit-risk balance, which is improbable given structural study design limitations [tier 1].
- What would move this number most. Whether CHMP scientific re-examiners accept alternative real-world evidence or historical control data to satisfy the requirement for control comparisons without a prospective placebo arm.
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).