True · Brier 0.09
Rules 1.1.0 · as of 14 Sep 2026
Rick Doblin · Said 14 Sep 2023 · doblin-0197
Quote
“Thanks to the combined efforts of dozens of therapists, hundreds of participants who volunteered in MAPS-sponsored trials, and many thousands of generous donors, MDMA-assisted therapy for PTSD is on track to be considered for approval by the FDA in 2024.”
MAPS press release on Nature Medicine publication of the second Phase 3 trial (MAPP2). Doblin states the FDA approval decision is on track for 2024, with the NDA expected later in 2023.
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 (approval or complete response letter) on the 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 ›
- 31 Dec 2024 AnchorThe fixed table that turns the person's own words ('by 2026', 'Q2', 'within two years') into a deadline. The coder never invents a date. Method › · “in 2024”
- Probability
- 0.70 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 › B · “is on track to be considered for approval by the FDA in 2024”
- 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-0090 · deadline 31 Dec 2024 · bin B
Registry entry
The FDA issues its action (approval or complete response letter) on a new drug application for midomafetamine (MDMA-assisted therapy) for post-traumatic stress disorder.
TRUE on the date of the FDA's first action letter (an approval letter or a complete response letter) on a new drug application for midomafetamine (MDMA-assisted therapy) for post-traumatic stress disorder, under any sponsor name, as dated in Drugs@FDA or announced by the sponsor. NDA submission, filing acceptance, a PDUFA date assignment, an advisory committee meeting or a refuse-to-file letter is not an action on the application. FALSE at the deadline when no such action letter is dated. Resolution source: Drugs@FDA, with the sponsor's press release as a secondary source.
Resolution source: Drugs@FDA; sponsor press release as a secondary source
Readings: 'On track to be considered for approval by the FDA in 2024' = the FDA issues its action (approval or complete response letter) on the NDA in 2024; submission and filing acceptance alone are not 'considered for approval'.; The event resolves on either action; it does not score whether the action was an approval (that is E-0001).
How to read
Coder A
Resolution
- State
- True
- 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 ›
- 31 Dec 2024
- 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 ›
- occurred on 8 Aug 2024 · checked through 14 Sep 2026
- Resolver note
- The FDA's first action on the midomafetamine NDA for PTSD was a complete response letter. FDA's own released letter for NDA 215455 (Lykos Therapeutics, midomafetamine capsules) carries letter date 2024-08-08, recorded as letter_date 08/08/2024 in the openFDA CRL dataset; the sponsor announced it on 2024-08-09. The letter says FDA cannot approve the application and asks for a further phase 3 trial. Date taken as the letter date, 2024-08-08. A later resubmission by Resilient Pharmaceuticals (reported August 2026) does not change the first action.
- Evidence
- Complete Response Letter, NDA 215455, midomafetamine capsules, Lykos Therapeutics (letter date 08/08/2024) · 8 Aug 2024
- openFDA transparency CRL dataset, record for NDA 215455 (letter_date 08/08/2024, company Lykos Therapeutics, status Unapproved) · 7 Sep 2026
- Lykos Therapeutics Announces Complete Response Letter for Midomafetamine Capsules for PTSD · 9 Aug 2024
Adversarial recheck
upheld (date): Case for 2024-08-09: the criterion dates the action 'as dated in Drugs@FDA or announced by the sponsor', and Drugs@FDA carries no action letter for an unapproved NDA, which would leave the sponsor's announcement of 2024-08-09 as the only admissible date. The argument fails because the event is the FDA's first action letter, and that letter carries its own date. FDA's released letter for NDA 215455 is signed electronically 08/08/2024 02:39:42 PM, and the openFDA transparency CRL dataset records letter_date 08/08/2024 for Lykos Therapeutics, status Unapproved. The sponsor's 2024-08-09 release reports receipt, one day later. No earlier action exists: the NDA was accepted for filing with priority review, so no refuse-to-file letter intervenes, and the June 2024 advisory committee is excluded by the criterion.
How to read
Registry
Timeline
1 claim against 60 events in the field.
Regulatory decisions