False · Brier 0.49
Rules 1.1.0 · as of 14 Sep 2026
Christian Angermayer · Said Jun 2023 · angermayer-0007
Quote
“on the cusp of MDMA being ideally medicalized next year”
MDMA-assisted therapy (MAPS/Lykos) would be approved in 2024.
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 ›
- 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 › · “next year”
- 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 · “on the cusp of MDMA being ideally medicalized next year”
- 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 ›
- phase3_to_approval_psychiatry · 0.56 · halvedWhen the item window is shorter than the base-rate class's median time to decision, the base rate is halved. The halved value is an upper bound that favours the person. Method › to 0.28 (window shorter than the median 36 months)
- Tags
- 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 31 Dec 2024 · bin B
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
- State
- False
- 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 ›
- 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
- BrierThe squared gap between a probability and the outcome, (p - o)^2. 0 is perfect, 0.25 is the constant coin flip, 1 is confidently wrong. Lower is better. Method ›
- 0.49 = (0.70 − 0)²
- Base-rate Brier
- 0.08
- RestatementsAll of one person's items on one registry event. A cluster is one observation in every metric, so a claim repeated six times still gets one vote. Method ›
- angermayer-0010
How to read
Registry
Receding horizon
Angermayer promised FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD 5 times; it has not happened.
Cluster E-0001
Timeline
1 claim against 60 events in the field.
Regulatory decisions