Void · Condition unmet
Rules 1.1.0 · as of 14 Sep 2026
Rick Doblin · Said 10 May 2019 · doblin-0249
Quote
“The main difference is that cannabis is a take-home medicine for people to use on their own. And MDMA is only to assist psychotherapy—it's always used under direct supervision of trained therapists.”
Doblin contrasts cannabis with MDMA: MDMA is always used under direct supervision of trained therapists, never self-administered at home. This denies an approval with no in-clinic supervision.
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 labeling or REMS requires supervised in-clinic administration of midomafetamine, with no take-home dispensing
- 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 10 May 2021
- 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 · “it's always used under direct supervision of trained therapists”
- 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, 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-0078 · deadline none · bin A
Registry entry
The FDA approves midomafetamine (MDMA-assisted therapy) for post-traumatic stress disorder with labeling or a REMS that requires the drug to be administered under direct supervision in a certified healthcare setting and not dispensed to patients for use outside that setting.
TRUE on the date of an FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD, under any sponsor name, whose approved labeling or REMS document requires that each dose is administered in a certified healthcare setting under the supervision of a healthcare provider, and does not permit dispensing the drug to the patient for use outside that setting. FALSE on the date of an approval whose labeling or REMS permits a pharmacy to dispense the product to the patient for use outside a healthcare setting, or permits unsupervised use. The event is unresolved while no approval exists. Resolution source: Drugs@FDA (approved labeling) read with REMS@FDA.
Resolution source: Drugs@FDA (approved labeling) with REMS@FDA
Readings: 'Only be able to administer MDMA under direct supervision in clinic settings', 'not as a take-home drug but only for use in controlled therapeutic settings' and 'it will be approved only under direct supervision of therapists' name the same restriction.; 'Not like a normal drug that's approved' is the contrast with retail dispensing.; A REMS that certifies healthcare settings and requires monitoring during the session counts as 'direct supervision'; whether the supervising person is a licensed therapist or another healthcare provider does not change the reading.; The claim presupposes FDA approval of midomafetamine for PTSD; if no approval occurs in the window the condition is unmet and the item is void rather than scored.; E-0067 (retail-pharmacy dispensing for a psilocybin, LSD or MDMA product, class reading) is the mirror image on a wider asset; this entry is on midomafetamine alone, so that a psilocybin decision does not resolve it. The relation is logged for the registry.; Distinct from mdma-rems-sponsor-trained-therapists (who may administer) and mdma-approval-carries-rems (any REMS).
How to read
Coder A
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 ›
- 10 May 2021
- 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 14 Sep 2026
- Resolver note
- No FDA approval of midomafetamine for PTSD exists, so no approved labeling or REMS can be read. FDA issued a complete response letter on 2024-08-09 for NDA 215455 (Lykos). Resilient Pharmaceuticals (ex-Lykos) resubmitted the NDA on about 2026-08-09, announced 2026-08-10, without a new phase 3; the application is under review with no action date reported. Drugs@FDA lists no approved midomafetamine product at the access date. A resubmission and an open review are not an approval, so the criterion stays unmet as of 2026-09-14. This says nothing about later dates.
- Evidence
- 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
- FDA Briefing Document, NDA 215455, midomafetamine capsules, Psychopharmacologic Drugs Advisory Committee · 4 Jun 2024
- Drugs@FDA: FDA-Approved Drugs (search for midomafetamine / MDMA) · 14 Sep 2026
How to read
Registry
Receding horizon
Doblin promised FDA labeling or REMS requires supervised in-clinic administration of midomafetamine, with no take-home dispensing 4 times; it has not happened.
Cluster E-0078
Timeline
1 claim against 60 events in the field.
Regulatory decisions