Void · Condition unmet
Rules 1.1.0 · as of 14 Sep 2026
Rick Doblin · Said 12 Dec 2022 · doblin-0181
Quote
“I would say they'll be two years behind. And then if you have FDA approval, most countries of the world will give reciprocity. If you have FDA and EMA approval, pretty much you get the whole world. Except for Russia, China, and Japan.”
Doblin on The Third Wave episode 173, after the host suggests 2026 for Europe, says European (EMA) approval will be about two years behind the US and that FDA plus EMA approval brings near-global reciprocity.
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 ›
- EU 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 12 Dec 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 · “I would say they'll be”
- 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
- affiliated, conditional, 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-0004 · deadline none · bin B
Registry entry
The European Medicines Agency's CHMP gives a positive opinion, or the European Commission grants a marketing authorisation, for midomafetamine (MDMA-assisted therapy) for post-traumatic stress disorder.
TRUE on the earlier of the date of a CHMP positive opinion recommending marketing authorisation, or the date of the European Commission marketing authorisation decision, for a midomafetamine (MDMA) product for post-traumatic stress disorder, under any sponsor name. A negative opinion, a withdrawal of the application, a PRIME designation, a national compassionate-use scheme or a single-country authorisation is not EU approval. A label narrower than PTSD counts if it names a PTSD population and the reading is logged. Resolution source: the EMA medicines database (EPAR pages), with the European Commission Union Register as the secondary source for the Commission decision date. FALSE at the deadline when neither a CHMP positive opinion nor a Commission authorisation for midomafetamine for PTSD is recorded there.
Resolution source: EMA medicines database (EPAR); European Commission Union Register as a secondary source
Readings: 'approval by the European Medicines Agency' reads as the EU centralised route: a CHMP positive opinion or the Commission decision that follows it, whichever comes first.; Approval under any sponsor name (MAPS Europe, MAPS PBC, Lykos Therapeutics or a successor) counts; the entry is on the asset.
How to read
Coder C
Resolution
- State
- VoidAn item that cannot be scored: the coders disagreed (AMBIGUOUS), the condition was unmet, or the source never published (UNRESOLVABLE). Counted, never scored. Method ›
- 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 ›
- 12 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 occurred as of 2026-09-13. The September 2026 CHMP list of initial marketing authorisation applications under evaluation (published 2026-09-09) contains no midomafetamine, MDMA or PTSD entry, and the Commission's Union Register of authorised products contains no midomafetamine product (esketamine/Spravato appears, as a control). No EPAR, CHMP opinion or Commission decision exists. The sponsor line (MAPS PBC, Lykos, now Resilient Pharmaceuticals) has publicly pursued only the FDA route, with an NDA resubmission in August 2026. The EMA full-text search page returned HTTP 401 to the fetch, so the monthly under-evaluation list and the Union Register were used as the database checks.
- Evidence
- Medicines for human use under evaluation (monthly CHMP list, latest September 2026) · 9 Sep 2026
- Applications for new human medicines under evaluation by the CHMP, September 2026 (spreadsheet) · 9 Sep 2026
- Union Register of medicinal products for human use: authorised products (active list)
- MAPS Responds to Report of Progress for MDMA-assisted therapy for PTSD with FDA · 10 Aug 2026
How to read
Registry
Receding horizon
Doblin promised EU approval of midomafetamine (MDMA-assisted therapy) for PTSD 3 times; it has not happened.
Cluster E-0004
Timeline
1 claim against 60 events in the field.
Regulatory decisions