Will the FDA approve relutrigine in SCN2A/SCN8A developmental and epileptic encephalopathies before 15 January 2027?
deadline 2027-01-15
confidence medium
tier 4 evidence
65%Asturna estimate
⚠ Evidence cap applied: the model proposed 58%, brought back to 65% for lack of sources solid enough to justify the departure from the base rate.
Resolution criterion
Yes if the FDA approves the NDA by 15 January 2027 (Drugs@FDA or a Praxis release). A complete response letter, a postponement of the PDUFA date, or the absence of a decision by that date count as no. An approval restricted to only SCN2A or only SCN8A (not both) counts as no for this question; flag for manual review if the label's exact scope is unclear.
Verified starting state
PDUFA date pushed to 27 December 2026 after the FDA classified additional sensitivity analyses as a "major amendment". No new clinical study was requested, and no safety or manufacturing issue was reported. The request for sensitivity analyses suggests a debate over the robustness of the primary endpoint. (29 June 2026)
What pushes it up
- The FDA did not request new clinical trials, and no safety or manufacturing issues were reported during the review [tier 1]
- The revised PDUFA date of 27 December 2026 falls before the 15 January 2027 deadline [tier 1]
What pushes it down
- The major amendment stemmed from additional sensitivity analyses, signaling regulatory scrutiny or debate regarding the robustness of primary efficacy endpoints [tier 1]
- The resolution criteria specify that approval restricted to only SCN2A or only SCN8A counts as no, creating label-breadth risk [tier 1]
- With the PDUFA date set for 27 December 2026, any further administrative delay, complete response letter, or review extension would cause the deadline of 15 January 2027 to be missed [tier 1]
What would move this number most
Whether the FDA accepts the sensitivity analyses supporting dual SCN2A/SCN8A efficacy without requiring a narrow label or issuing a complete response letter.
How this number is built
| Deadline | 2027-01-15 |
| Base rate | 73% |
| Best evidence | tier 4 · 3 article(s) used |
| Independent runs | 65 · 65 (spread 0 pts) |
| Confidence | medium |
| Evidence cap | applied: 58% brought back to 65% |
| Last revised | 2026-10-11 09:06 |
| Model | gemini-3.8-flash |
Sources consulted
Probability history
2026-10-11 09:06 65% 6 article(s) on file · gemini-3.8-flash
- What pushes it up. The FDA did not request new clinical trials, and no safety or manufacturing issues were reported during the review [tier 1]
- What pushes it up. The revised PDUFA date of 27 December 2026 falls before the 15 January 2027 deadline [tier 1]
- What pushes it down. The major amendment stemmed from additional sensitivity analyses, signaling regulatory scrutiny or debate regarding the robustness of primary efficacy endpoints [tier 1]
- What pushes it down. The resolution criteria specify that approval restricted to only SCN2A or only SCN8A counts as no, creating label-breadth risk [tier 1]
- What pushes it down. With the PDUFA date set for 27 December 2026, any further administrative delay, complete response letter, or review extension would cause the deadline of 15 January 2027 to be missed [tier 1]
- What would move this number most. Whether the FDA accepts the sensitivity analyses supporting dual SCN2A/SCN8A efficacy without requiring a narrow label or issuing a complete response letter.
2026-09-25 09:04 62% 49 article(s) on file · gemini-3-flash-preview
- What pushes it up. The current PDUFA date of 27 December 2026 falls before the 15 January 2027 deadline [Starting State, tier 1].
- What pushes it up. The FDA has explicitly stated that no new clinical studies are requested and no safety or manufacturing issues have been reported [Starting State, tier 1].
- What pushes it up. Manufacturing and quality issues, which account for over 90% of Complete Response Letters according to some analyst data, are reportedly not an issue here [19, tier 3; Starting State, tier 1].
- What pushes it down. The FDA's request for additional sensitivity analyses suggests significant debate over the robustness of the primary endpoint [Starting State, tier 1].
- What pushes it down. The resolution criterion requires approval for both SCN2A and SCN8A; a partial approval for only one would result in a 'No' [Resolution Criterion].
- What pushes it down. The classification of the sensitivity analyses as a 'major amendment' indicates that the initial data submission was insufficient for a standard review cycle [Starting State, tier 1].
- What would move this number most. The primary uncertainty is whether the additional sensitivity analyses will sufficiently resolve the FDA's concerns regarding the primary endpoint's robustness for both genetic indications simultaneously.
2026-09-21 22:21 67% 44 article(s) on file · gemini-3.7-flash
Reasons not recorded for this revision (detailed history has only been kept since recently).
2026-09-19 07:39 68% 36 article(s) on file · gemini-3.6-flash
Reasons not recorded for this revision (detailed history has only been kept since recently).