Pending · due 9 May 2029
Rules 1.1.0 · as of 14 Sep 2026
Rick Doblin · Said 9 May 2025 · doblin-0229
Quote
“So I think in terms of timeframe, it's probably four or five years before FDA will approve group therapy, maybe longer.”
Doblin on Joe Rogan #2319 estimates FDA approval of group-format psychedelic therapy is four or five years away or more, after individual-format approvals.
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 approves a psychedelic drug product with labeling for group-format dosing
- 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 ›
- 9 May 2029 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 › · “probably four or five years before”
- Probability
- 0.30 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 · “it's probably four or five years before FDA will approve group therapy, maybe longer” · denialA statement that the event will not happen. Its probability on the event side is 1 minus the bin value. Method ›
- 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, denial, 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-0101 · deadline 9 May 2029 · bin B
Registry entry
The FDA approves a psychedelic drug product whose approved labeling or REMS permits dosing sessions in which more than one patient is treated together.
TRUE on the date the FDA approval letter or Drugs@FDA entry (or the sponsor's approval announcement) is dated for a psychedelic drug product (midomafetamine, psilocybin, LSD, ibogaine or another psychedelic or entactogen) whose approved prescribing information or REMS permits administration of the drug in a session with more than one patient present as a treated group. An approval whose labeling requires individual (one-patient) dosing sessions, a complete response letter, a designation or a filing acceptance does not count. FALSE at the deadline when no such approval appears in Drugs@FDA.
Resolution source: Drugs@FDA
Readings: 'Group therapy' reads as a group-format dosing session permitted by the approved labeling or REMS; the forecaster names no drug, so any psychedelic drug product counts.; The forecaster gives a timing estimate ('four or five years ... maybe longer'); the item is scored as a denial of approval within the lower bound (four years).
How to read
Coder A
Resolution
- 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 ›
- 9 May 2029
- 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 psychedelic or entactogen drug product is approved in Drugs@FDA, so no approved labeling or REMS can permit group-format dosing. Drugs@FDA returns no product for midomafetamine, psilocybin, lysergide, ibogaine or mebufotenin as of 2026-09-14. The midomafetamine NDA was resubmitted in August 2026 after the August 2024 complete response letter and has no approval. COMP360 psilocybin holds a national priority voucher and is completing a rolling NDA targeted at Q4 2026, with any decision expected later. A resubmission, a voucher or a filing does not count under the criterion.
- Evidence
How to read
Registry
Timeline
1 claim against 41 events in the field.
Regulatory decisions