Pending · due 7 Jan 2028
Rules 1.1.0 · as of 14 Sep 2026
Rick Doblin · Said 7 Jan 2026 · doblin-0239
Quote
“MDMA will eventually become a medicine”
Same article. Doblin, quoted from a video interview, asserts MDMA will eventually be approved as a medicine, with no date.
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 approval of midomafetamine (MDMA-assisted therapy) 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 7 Jan 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 · “MDMA will eventually become a medicine”
- 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 ›
- post_crl_eventual_approval · 0.64
- 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-0001 · deadline none · bin A
Registry entry
The FDA approves midomafetamine (MDMA-assisted therapy) for post-traumatic stress disorder.
TRUE on the date the FDA approval letter or Drugs@FDA entry (or the sponsor's approval announcement) for midomafetamine (MDMA-assisted therapy) for post-traumatic stress disorder is dated, on any review cycle and under any sponsor name. A complete response letter, a positive advisory vote, a filing acceptance, a breakthrough designation or an expanded-access program is not an approval. A label narrower than PTSD (for example a PTSD subgroup or severity band) counts if the claim's indication reasonably includes it and the reading is logged at intake; a label that requires a REMS or a psychological-intervention component counts. Resolution source: Drugs@FDA, with the sponsor's press release as a secondary source. FALSE at the deadline when no such approval appears in Drugs@FDA.
Resolution source: Drugs@FDA; sponsor press release as a secondary source
Readings: Approval under any sponsor name (Lykos Therapeutics, MAPS PBC or a successor) counts; the entry is on the asset.; Eventual approval on any review cycle counts; the first-cycle proposal for the Lykos NDA under review in June 2024 (owen-1072, owen-1090, owen-1137, doblin-0031) is merged into this event.; 'As it stands' (owen-1072) and 'at this stage' (owen-1090) refer to the NDA review cycle pending on the statement date; in the merged event a complete response letter is not an approval and does not by itself resolve the event.; MDMA-assisted therapy, MDMA-AT and midomafetamine name the same asset.; 'MDMA' and 'get over the line' = FDA approval of the midomafetamine (MDMA-assisted therapy) NDA for PTSD that the post discusses; approval of MDMA for any other indication does not count.; A label with a REMS or a mandated psychological-intervention component counts as 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 ›
- 7 Jan 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 13 Sep 2026
- Resolver note
- Not approved as of 2026-09-13. The Drugs@FDA data (openFDA mirror) return no application for midomafetamine, while the same query returns NDA 211243 for esketamine as a control; FDA's 2026 novel drug approvals list (current to 2026-09-11) has no MDMA, midomafetamine or Rysanso entry. History: the Lykos NDA 215455 received a complete response letter in August 2024, which is not an approval under the criterion. Resilient Pharmaceuticals (successor to MAPS PBC and Lykos) resubmitted the NDA in early August 2026 (MAPS statement 2026-08-10; Psychedelic Alpha 2026-08-12); that review is pending and no approval letter, Drugs@FDA entry or sponsor approval announcement exists.
- Evidence
- openFDA Drugs@FDA API query for midomafetamine (response: NOT_FOUND, 'No matches found!')
- Novel Drug Approvals for 2026 · 11 Sep 2026
- MAPS Responds to Report of Progress for MDMA-assisted therapy for PTSD with FDA · 10 Aug 2026
- Two Years After Rejection, Resilient Quietly Refiles MDMA for PTSD Application · 12 Aug 2026
How to read
Registry
Receding horizon
Doblin promised FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD 26 times; it has not happened.
Cluster E-0001
Timeline
1 claim against 22 events in the field.
Regulatory decisions