Void · Condition unmet
Rules 1.1.0 · as of 14 Sep 2026
Rick Doblin · Said Apr 2019 · doblin-0088
Quote
“If approved, the only therapists who will be able to directly administer it to patients are going to be therapists that have been through our training program, and they will only be able to administer MDMA under direct supervision in clinic settings.”
Post-approval access model: only MAPS-trained therapists, supervised clinic settings.
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 restricts midomafetamine (MDMA-assisted therapy) to sponsor-trained therapists
- 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 1 Apr 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 · “the only therapists who will be able to directly administer it to patients are going to be therapists that have been...”
- 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-0077 · deadline none · bin A
Registry entry
The FDA approves midomafetamine (MDMA-assisted therapy) for post-traumatic stress disorder with labeling or a REMS under which only therapists who have completed the sponsor's (MAPS) training program may administer the treatment.
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 the therapists or healthcare providers who administer the drug or conduct dosing sessions complete a training or certification program provided or certified by the sponsor (MAPS, MAPS PBC or a successor), with no other route to eligibility. FALSE on the date of an approval whose labeling and REMS permit administration by providers without sponsor-provided training, name the sponsor's program as one acceptable route among others, or set no provider training requirement. 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: 'The only therapists who will be able to directly administer it ... are going to be therapists that have been through our training program' (doblin-0088) and 'MAPS will be the only FDA-approved entity to train therapists' (doblin-0094) name the same restriction; so does doblin-0140.; 'Directly administer it to patients' = the therapists or providers who conduct the MDMA dosing sessions; prescribers who do not sit in the session are not the set the words name.; 'Our training program' = the MAPS / MAPS PBC MDMA Therapy Training Program under any later corporate name.; A REMS whose certification program is run by the sponsor, or by a training body it designates, counts; a REMS that accepts training from any accredited provider does not. A REMS that names the sponsor's program as one acceptable route among others resolves FALSE: the words say 'the only therapists'.; Distinct from mdma-approval-carries-rems (any REMS) and from mdma-rems-supervised-clinic-administration (setting restriction).
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 ›
- 1 Apr 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 ›
- unresolvable · checked through 14 Sep 2026
- Resolver note
- The criterion cannot be applied yet: it holds the event unresolved while no approval exists. The FDA has not approved midomafetamine for PTSD under any sponsor name, so there is no approved labeling and no REMS document to read for a sponsor-trained-therapist requirement. Drugs@FDA holds no midomafetamine application record and REMS@FDA holds no midomafetamine entry. The only FDA action on NDA 215455 is the 2024 complete response letter, which asks for a new Phase 3 trial. Re-check after any future approval.
- Evidence
How to read
Registry
Receding horizon
Doblin promised FDA labeling or REMS restricts midomafetamine (MDMA-assisted therapy) to sponsor-trained therapists 4 times; it has not happened.
Cluster E-0077
Timeline
1 claim against 60 events in the field.
Regulatory decisions