Pending · due 10 Aug 2028
Rules 1.1.0 · as of 14 Sep 2026
Rick Doblin · Said 10 Aug 2026 · doblin-0244
Quote
“I'm grateful that everyone who contributed to those trials — the donors, researchers, independent raters, and most importantly the participants — will see a new evaluation by the FDA.”
MAPS response to the Psychedelic Alpha report that Resilient Pharmaceuticals resubmitted the MDMA-assisted therapy NDA without a new Phase 3 study. Doblin expects a fresh FDA evaluation of the data.
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 action on the resubmitted midomafetamine NDA for PTSD
- 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 2028
- Probability
- 0.90 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 · “will see a new evaluation by the FDA”
- 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
- affiliated, 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-0122 · deadline none · bin A
Registry entry
The FDA acts on the resubmitted new drug application for midomafetamine (MDMA-assisted therapy) for post-traumatic stress disorder, by taking it under review or by issuing an action letter on it.
TRUE on the earlier of (1) the date the sponsor (Resilient Pharmaceuticals, formerly Lykos Therapeutics, or a successor) announces that the FDA has accepted a resubmission of the midomafetamine (MDMA-assisted therapy) NDA for PTSD for review, with or without a stated goal date, or the FDA publishes that acceptance, and (2) the date of an FDA action letter (approval or complete response) on that resubmission, as dated in Drugs@FDA or the sponsor's announcement. A report that the sponsor resubmitted, a meeting, or FDA correspondence that refuses to file the resubmission does not count. FALSE at the deadline when neither has occurred.
Resolution source: Sponsor press release; Drugs@FDA
Readings: 'A new evaluation by the FDA' reads as the FDA taking the resubmitted application under review; acceptance for review or an action letter, whichever comes first, resolves it.; The resubmission itself is reported in the context (Psychedelic Alpha), not asserted by the FDA; the event is the FDA's step, not the sponsor's.; A complete response letter counts as an FDA action here, although the drug_approval template counts it as no approval; the event is the action, not the approval.
How to read
Coder A
Resolution
- 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 2028
- 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 14 Sep 2026
- Resolver note
- Resilient Pharmaceuticals resubmitted the midomafetamine NDA for PTSD on or about 2026-08-09, reported by Psychedelic Alpha on 2026-08-12 from anonymous sources; MAPS confirmed the resubmission on 2026-08-10 and said it will start a new evaluation. Neither report states that the FDA accepted or filed the resubmission, and neither gives a review goal date. The sponsor itself has published nothing. Drugs@FDA shows no approved midomafetamine product and no action letter. The criterion excludes a report that the sponsor resubmitted, so nothing has resolved as of 2026-09-14. This says nothing about later dates: an FDA filing decision on a class 2 resubmission would normally follow within about 30 days.
- Evidence
How to read
Registry
Timeline
1 claim against 4 events in the field.
Regulatory decisions