False · Brier 0.01
Rules 1.1.0 · as of 14 Sep 2026
Owen Scott Muir · Said 10 Aug 2024 · owen-1192
Quote
“It costs a lot of money to run phase 3 trials, as I’ve previously covered. So, an appeal makes sense…no matter how doomed to failure.”
After the FDA's complete response letter asking Lykos for an additional Phase 3 trial of midomafetamine (MDMA-AT), Lykos said it would request a meeting to seek reconsideration. The author cites CDER appeal statistics (16% granted, 2003-2014) and expects the Lykos appeal to fail.
Intake
- EventA proposition written from a template on the asset, with a resolution criterion and a named public source, before the outcome is looked up. The same event resolves every person's items on it. Method ›
- FDA grants the Lykos appeal of the 2024 midomafetamine complete response letter
- AreaOne of five topic classes: regulatory decisions, clinical trial outcomes, company and market outcomes, payer and policy, practice adoption. Every event has one area. Method ›
- Regulatory decisions
- DeadlineThe date by which the event must happen for the item to be true. It comes only from the person's words through the anchor table. Method ›
- None stated · undated panelItems with no deadline in the person's words, scored on a uniform 24-month window from the statement date. Part of the headline panel since rules 1.1.0; also shown on its own. Method ›, 24-month window to 10 Aug 2026
- Probability
- 0.10 LexiconThe fixed five-bin table that turns a phrase into a probability. The strongest phrase in the claim sentence decides; coders never read tone. Method › · binOne of five lexicon steps: A 'will' 0.90, B 'probably' 0.70, C 'may' 0.50, D 'unlikely' 0.30, E 'never' 0.10. A stated number goes to the nearest bin for calibration only. Method › A · “no matter how doomed to failure” · denialA statement that the event will not happen. Its probability on the event side is 1 minus the bin value. Method ›
- Base rateThe probability a published external study gives an event of that class and stage, fixed at intake. Halved when the item window is shorter than the class median time to decision. Never learned from the ledger's own items. Method ›
- None in the table
- Tags
- denial, retrospective
- Coder BCohen's kappa: agreement between two coders beyond chance, from -1 to 1. Reported for admit, event, deadline, bin and asserts from the second-coder match test. Method ›
- admittedA statement that passed intake: sincere, the person's own claim, forward-looking, inside the five areas, and not excluded by a reason code. Only admitted statements become items. Method › · event E-0030 · deadline none · bin A
Registry entry
The FDA grants Lykos Therapeutics' request for reconsideration or formal dispute resolution appeal of the August 2024 complete response letter for midomafetamine for PTSD.
TRUE on the date of the FDA's written decision (or, if that letter is not public, the sponsor's public announcement of it) that grants the request for reconsideration or the formal dispute resolution appeal of the August 2024 complete response letter: the FDA withdraws its request for an additional Phase 3 trial or approves the NDA on the data already submitted. A meeting granted or held, a resubmission accepted for review, or an approval that follows a new Phase 3 trial does not count. If no reconsideration request or appeal is decided in the sponsor's favour by the end of the window, the event is FALSE.
Resolution source: Lykos Therapeutics press releases; FDA CDER formal dispute resolution decision letters
Readings: 'An appeal' is read as the request for reconsideration that Lykos said it would make after the complete response letter (per the post), or a formal dispute resolution appeal; either route counts.; 'Doomed to failure' is read as: the FDA does not grant the appeal. The event is written positively (the appeal is granted) and the forecaster denies it.; court_outcome is the closest template: an agency ruling on an administrative appeal. The event resolves on the decision on the appeal, not on a later approval after new trials.
How to read
Coder A
Resolution
- State
- False
- Effective deadlineAn item enters the score only when its deadline has passed and the outcome is true or false. A claim already known true still waits for its deadline. Method ›
- 10 Aug 2026
- Outcome1 if the registry event happened on or before the item's deadline, 0 if it did not. Written by a resolver who never sees p. Method ›
- not occurred · checked through 13 Sep 2026
- Resolver note
- Lykos said on 2024-08-09 it would seek a meeting to ask FDA to reconsider the CRL. After that Type A meeting Lykos reported (2024-10-21) a 'path forward' that still included an additional Phase 3 trial plus a third-party review of prior data, so FDA did not withdraw its request. No formal dispute resolution decision or reconsideration grant has been published by FDA, Lykos or its successor Resilient Pharmaceuticals through 2026-09-13. Resilient's August 2026 resubmission without a new Phase 3 relies on third-party VA data, a 32-subject cardiac safety study and an audit; reporting shows no FDA statement waiving the Phase 3 request, no acceptance-for-review notice and no goal date, and a resubmission accepted for review would not count in any case. The Lykos and Resilient websites could not be read (redirect loop and empty page).
- Evidence
- Lykos Therapeutics Announces Complete Response Letter for Midomafetamine Capsules for PTSD · 9 Aug 2024
- Lykos Announces 'Productive' Meeting With FDA Regarding Rejected MDMA Drug · 21 Oct 2024
- Lykos Plots FDA Appeal: Reeling from CRL and Journal Article Retractions, MDMA Developer Hopes to Change Your Mind · 13 Aug 2024
- Two Years After Rejection, Resilient Quietly Refiles MDMA for PTSD Application · 9 Aug 2026
- MAPS Responds to Report of Progress for MDMA-assisted therapy for PTSD with FDA · 10 Aug 2026
- MAPS-Funded MDMA Therapy for PTSD Is Back at the FDA, Without a New Phase 3 Trial · 11 Aug 2026
- MDMA and the FDA, Take Two · 24 Aug 2026
How to read
Registry
Timeline
1 claim against 57 events in the field.
Regulatory decisions