False · Brier 0.49
Rules 1.1.0 · as of 14 Sep 2026
Rick Doblin · Said 2 Dec 2019 · doblin-0098
Quote
“We have excellent advisers and lawyers assisting MAPS in these negotiations, and there is a very good chance that FDA will eventually come to appreciate and approve our proposals. I’m optimistic because our proposals are strongly data-driven and make clinical sense.”
Negotiations with FDA on therapist MDMA-experience protocol, Expanded Access, and co-therapist credential requirements.
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 accepts MAPS' three MDMA program proposals
- 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 2 Dec 2021
- 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 · “there is a very good chance that FDA will eventually come to appreciate and approve our proposals”
- 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
- retrospective, affiliated
- 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-0082 · deadline none · bin B
Registry entry
The FDA accepts all three of MAPS' proposals for the MDMA-assisted therapy for PTSD program: the therapist MDMA-experience protocol, the Expanded Access program and the co-therapist credential requirements.
TRUE on the date MAPS, MAPS Public Benefit Corporation or its successor first states publicly that the FDA has agreed to all three proposals named in the claim: the protocol under which therapists receive MDMA themselves, the Expanded Access program for MDMA-assisted therapy for PTSD, and the co-therapist credential requirements. All three must be reported as accepted; acceptance of one or two does not resolve TRUE. A submitted proposal, a scheduled or held FDA meeting, a pending request or an FDA comment short of agreement is not acceptance. Resolution source: MAPS announcements (press releases and the MAPS Bulletin). FALSE at the deadline when MAPS has not reported all three as accepted.
Resolution source: MAPS (MAPS Public Benefit Corporation) press releases and MAPS Bulletin announcements
Readings: 'Our three proposals' = the therapist MDMA-experience protocol, the Expanded Access program and the co-therapist credential requirements, the three items named in the statement; 'A and B' would split, but the claim is one package the FDA accepts or does not.; 'Accepts' = the FDA agrees to the proposals as reported by the sponsor, not a published rule or guidance.
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 ›
- 2 Dec 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
- Two of the three proposals are reported accepted, the third is not. MAPS announced FDA agreement to the Expanded Access programme on 2020-01-17 (FDA notice 2019-12-20), and on 2021-05-12 announced that FDA granted its appeal and authorized the study giving MDMA to healthy volunteer therapists. On co-therapist credentials MAPS reports the opposite of acceptance: the Expanded Access release states FDA is requiring at least one therapist of each pair to hold a medical or clinical doctorate. No MAPS press release or Bulletin reports all three as accepted. Checked 2026-09-14; this says nothing about later dates.
- Evidence
- FDA Agrees to Expanded Access Program for MDMA-Assisted Therapy for PTSD · 17 Jan 2020
- MAPS Wins Appeal and Authorization to Study MDMA in Healthy Volunteer Therapists · 12 May 2021
- From the Desk of Rick Doblin, Ph.D. - Winter 2021 (MAPS Bulletin) · 1 Jan 2021
- Research News - Spring 2020 (MAPS Bulletin) · 1 Apr 2020
How to read
Registry
Timeline
1 claim against 60 events in the field.
Regulatory decisions