Void · Condition unmet
Rules 1.1.0 · as of 14 Sep 2026
Rick Doblin · Said 5 Apr 2017 · doblin-0055
Quote
“Advances in psychedelic research over the last several decades have reached the point that the U.S. Food and Drug Administration (FDA) is formally reviewing protocols for Phase 3 drug development clinical trials that will evaluate psychedelic-assisted psychotherapy for a variety of conditions. These upcoming studies will lead to prescription access, should they demonstrate both safety and efficacy.”
Psychedelic Science 2017 special issue. Conditional call that upcoming Phase 3 studies lead to prescription access.
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 ›
- First FDA approval of a psychedelic medicine (class)
- 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 5 Apr 2019
- 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 · “will lead to prescription access”
- 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
- conditional, affiliated, 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-0024 · deadline none · bin A
Registry entry
The FDA approves at least one psychedelic medicine (class reading) for any indication.
TRUE on the date of the first FDA approval letter or Drugs@FDA entry (the sponsor's approval announcement is the secondary source) for a drug in the psychedelic class: MDMA (midomafetamine), psilocybin, ibogaine, or another compound that its sponsor or the FDA describes as a psychedelic or an entactogen; esketamine and ketamine are excluded. Any indication counts. A complete response letter, a positive advisory vote, a filing acceptance or a breakthrough therapy designation is not an approval. FALSE when no such approval appears in Drugs@FDA by the deadline.
Resolution source: Drugs@FDA; sponsor press release as a secondary source
Readings: Same class reading as the main event.; Novel psychedelics reaching clinical care = FDA approval of a psychedelic for a psychiatric indication.
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 ›
- 5 Apr 2019
- 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
- No FDA approval letter or Drugs@FDA entry exists for any psychedelic-class drug as of 2026-09-13 (esketamine and ketamine excluded). openFDA Drugs@FDA returns no match for psilocybin, psilocin, midomafetamine/MDMA, lysergide, ibogaine, mebufotenin or DMT, and FDA Novel Drug Approvals 2026 lists 39 approvals through 2026-09-11, none in the class. Closest programs: COMP360 (psilocybin) NDA in rolling submission, all modules due Q4 2026, launch expected H1 2027 subject to approval (Compass, 2026-08-05); midomafetamine NDA resubmitted August 2026 by Resilient Pharmaceuticals (formerly Lykos), decision pending (MAPS, 2026-08-10); DT120/MM120 (lysergide) has two positive Phase 3 readouts (June and August 2026) and no NDA; BPL-003 is at Phase 2b. CRLs, priority vouchers, rolling review and breakthrough designations are not approvals. Not occurred as of 2026-09-13.
- Evidence
- Novel Drug Approvals for 2026 (39 approvals through 2026-09-11; no psychedelic-class drug)
- openFDA Drugs@FDA query: psilocybin (no matches)
- openFDA Drugs@FDA query: midomafetamine (no matches)
- Compass Pathways Announces Second Quarter and First Half 2026 Financial Results and Business Highlights (Form 8-K exhibit) · 5 Aug 2026
- MAPS Responds to Report of Progress for MDMA-assisted therapy for PTSD with FDA · 10 Aug 2026
- Definium Therapeutics Announces Positive Topline Results from Phase 3 Voyage Study of DT120 ODT in Generalized Anxiety Disorder · 12 Aug 2026
How to read
State at window close; the outcome comes from the registry, the score from the rule.
Registry
Timeline
1 claim against 60 events in the field.
saiddueevent
Regulatory decisions