Will the CHMP issue an opinion on apitegromab in spinal muscular atrophy before 30 June 2027?
deadline 2027-06-30
confidence medium
tier 4 evidence
62%Asturna estimate
Resolution criterion
Yes if the CHMP adopts an opinion, positive or negative, published in its meeting highlights, by 30 June 2027. A withdrawal of the application or the absence of an opinion count as no.
Verified starting state
The CHMP opinion is held up pending the FDA's classification of the Catalent Indiana fill-finish site, inspected in April 2026, or the addition of a second fill site to the MAA. Scholar Rock was targeting an opinion later in 2026. The blockage is industrial rather than scientific, on a timeline dependent on a third-party regulator. (20 July 2026)
What pushes it up
- The regulatory bottleneck is industrial (fill-finish site classification or adding a secondary site) rather than clinical efficacy or safety, keeping the review path straightforward once manufacturing compliance is satisfied [tier 1 starting state].
- Scholar Rock was already targeting an opinion in late 2026, meaning much of the evaluation had matured prior to the hold-up, leaving ample procedural runway before June 2027 if the existing review resumed [tier 1 starting state].
What pushes it down
- Resolving FDA inspection classifications for third-party facilities or validating an alternate fill-finish site often encounters recurring administrative or inspection delays outside the sponsor's control [tier 1 starting state].
- Reports indicate Scholar Rock resubmitted the MAA in October 2026; if this constituted a formal procedural restart, the standard 210-day timetable plus clock-stops risks slipping past 30 June 2027, although this resubmission report currently lacks tier 1 or 2 corroboration [tier 4].
What would move this number most
Whether the October 2026 submission is a full procedural restart with a fresh 210-day clock or the resolution of a clock-stop under the ongoing MAA.
How this number is built
| Deadline | 2027-06-30 |
| Base rate | 65% |
| Best evidence | tier 4 · 2 article(s) used |
| Independent runs | 62 · 62 (spread 0 pts) |
| Confidence | medium |
| Evidence cap | not triggered |
| Last revised | 2026-10-11 09:07 |
| Model | gemini-3.8-flash |
Sources consulted
Probability history
2026-10-11 09:07 62% 22 article(s) on file · gemini-3.8-flash
- What pushes it up. The regulatory bottleneck is industrial (fill-finish site classification or adding a secondary site) rather than clinical efficacy or safety, keeping the review path straightforward once manufacturing compliance is satisfied [tier 1 starting state].
- What pushes it up. Scholar Rock was already targeting an opinion in late 2026, meaning much of the evaluation had matured prior to the hold-up, leaving ample procedural runway before June 2027 if the existing review resumed [tier 1 starting state].
- What pushes it down. Resolving FDA inspection classifications for third-party facilities or validating an alternate fill-finish site often encounters recurring administrative or inspection delays outside the sponsor's control [tier 1 starting state].
- What pushes it down. Reports indicate Scholar Rock resubmitted the MAA in October 2026; if this constituted a formal procedural restart, the standard 210-day timetable plus clock-stops risks slipping past 30 June 2027, although this resubmission report currently lacks tier 1 or 2 corroboration [tier 4].
- What would move this number most. Whether the October 2026 submission is a full procedural restart with a fresh 210-day clock or the resolution of a clock-stop under the ongoing MAA.
2026-09-20 09:02 87% 11 article(s) on file · gemini-3-flash-preview
Reasons not recorded for this revision (detailed history has only been kept since recently).