Pending · due 9 May 2027
Rules 1.1.0 · as of 14 Sep 2026
Rick Doblin · Said 9 May 2025 · doblin-0228
Quote
“If the FDA says, we want another phase three study, that could delay approval for another three and a half years or so.”
Doblin on Joe Rogan #2319 gives the alternative scenario: a required new Phase 3 study would delay MDMA approval by about three and a half years.
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 agrees the midomafetamine NDA can proceed without an additional Phase 3 trial
- 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 9 May 2027
- Probability
- 0.50 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 › C · “could delay approval for another three and a half years or so” · 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, 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-0099 · deadline none · bin C
Registry entry
The FDA informs the sponsor of midomafetamine (MDMA-assisted therapy) for PTSD that the application can be resubmitted or reviewed without an additional Phase 3 trial.
TRUE on the date the sponsor of the midomafetamine (MDMA-assisted therapy) NDA for PTSD publicly announces, or the FDA publishes, that the FDA has agreed the application can be resubmitted or reviewed without an additional Phase 3 trial (a Phase 4 or other post-approval requirement does not defeat the condition). FALSE when the FDA requires an additional Phase 3 trial before resubmission or approval, per the sponsor's announcement or the FDA's published correspondence, and FALSE at the deadline when no such agreement has been announced.
Resolution source: Sponsor press release; FDA published correspondence (Drugs@FDA)
Readings: 'They might require what's called a phase four study' names the alternative; the condition is met by any FDA path that does not require a new Phase 3 trial.; 'Approved in six months or so without an additional Phase 3 study' and 'if the FDA says, we want another phase three study' are the two sides of one event; the requirement of a new Phase 3 trial is the FALSE side, not a separate event.; The corporate name of the sponsor may change; the event is written on the midomafetamine NDA, not on the company.
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 ›
- 9 May 2027
- 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
- Close call, resolved no. Resilient Pharmaceuticals, the renamed sponsor of the midomafetamine NDA, is reported to have resubmitted the NDA in early August 2026 without a new Phase 3 study, using external data and a new Phase 1 study. But the sponsor has published nothing: reporting notes Resilient has not publicly discussed the resubmission. MAPS, which states it has no active role in Resilient's development programme, said the NDA is being submitted without a new Phase 3 study. The FDA has published no correspondence in Drugs@FDA, and no acceptance or filing decision is public. So no sponsor announcement and no FDA publication of an FDA agreement exists as of 2026-09-14. A sponsor choosing its filing route is not the FDA agreeing to it.
- Evidence
How to read
Registry
Timeline
1 claim against 41 events in the field.
Regulatory decisions