False · Brier 0.25

The FDA's written action on, or review of, the midomafetamine (MDMA-assisted therapy) application for post-traumatic stress disorder cites an unsuccessful double-blind in the Phase 3 trials as a basis for not accepting the efficacy results.

TRUE on the date of an FDA written action (complete response letter, refuse-to-file letter or other written FDA communication the sponsor discloses), an FDA review document posted on Drugs@FDA, or an FDA advisory committee briefing document that names failure or loss of the double-blind (functional unblinding, or expectancy bias from unblinding) in the Phase 3 trials of midomafetamine (MDMA-assisted therapy) for PTSD, under any sponsor name, as a reason the efficacy results are not adequate for approval. A document that only asks a question about blinding, without treating it as a deficiency, does not count. Resolution source: Drugs@FDA (action letters and review documents) with the FDA advisory committee materials page. FALSE when the FDA approves the application with no such finding, or when no such document exists at the deadline.

Resolution source: Drugs@FDA (action letters, review documents); FDA advisory committee materials

Readings: 'Our final results will not be challenged on the basis of an unsuccessful double-blind' = the FDA does not cite unblinding as a deficiency of the Phase 3 efficacy results; the forecaster denies the proposition.; Any sponsor name (MAPS, MAPS PBC or a successor) counts; the entry is on the asset.; Distinct from E-0027 (safety data cited in a non-approval) and from E-0001 (approval): this event is about the stated basis of the FDA's assessment, not the approval decision.

overturned (date): The state is safe: the complete response letter for NDA 215455 does name functional unblinding as a deficiency, saying participants with prior midomafetamine use are 'more likely to recognize the effects of midomafetamine (i.e., leading to functional unblinding)', and that 'These limitations impact the interpretability of MAPP1 and MAPP2 and ... preclude the ability to establish substantial evidence of effectiveness.' The date is wrong. The criterion fixes TRUE on the date of the FDA written action, not the date the sponsor disclosed it. FDA's released letter carries one date only: the electronic signature reads 08/08/2024 02:39:42 PM, and openFDA records letter_date 08/08/2024. The sponsor release of 2024-08-09 is secondary. The same registry dates the same letter 2024-08-08 at E-0090. The earlier 2024-06-04 briefing document does not qualify: it poses questions and calls the two studies positive.