Pending · due 31 Dec 2026
Rules 1.1.0 · as of 14 Sep 2026
Christian Angermayer · Said 24 Oct 2025 · angermayer-0139
Quote
“my guess is that psilocybin sort of the compound of compass will be approved. They already finished phase three. They released phase three results uh at least parts of it uh is going to be approved end of next year. So hopefully then early 2027 the latest really patients in the US and then Europe hopefully follow soon can go to their doctor.”
AlphaNooner, Oct 2025. Angermayer guesses Compass psilocybin will be approved by end of 2026, with US patients treated by early 2027 at the latest and Europe following.
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 approval of COMP360 (psilocybin) for major depressive disorder
- 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 ›
- 31 Dec 2026 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 › · “end of next year”
- 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 · “my guess is that psilocybin ... will be approved ... is going to be approved end of next year”
- 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
- 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-0047 · deadline 31 Dec 2026 · bin A
Registry entry
The FDA approves COMP360 (psilocybin) for a major depressive disorder indication.
TRUE on the date of the FDA approval letter (Drugs@FDA entry; Compass Pathways' approval announcement as a secondary source) for COMP360 (psilocybin) with an indication in major depressive disorder, including treatment-resistant depression or another MDD subpopulation. A complete response letter, a positive advisory committee vote, filing acceptance, priority review or breakthrough therapy designation is not approval. An approval for an indication outside the depressive disorders (for example PTSD alone) does not count. FALSE at the deadline when no such approval is dated in Drugs@FDA by then. Resolution source: Drugs@FDA.
Resolution source: Drugs@FDA; Compass Pathways press release as a secondary source
Readings: TRD counts as MDD: a label narrower than the claim's indication counts when the claim's indication reasonably includes it (template rule, reading logged).; 'COMP360 and KetaFree ... will be approved for MDD by FDA' is 'A and B' and is split; KetaFree is coded at owen-2032-b.; Related proposal new:fda-psilocybin-approval (angermayer-0008-b) is on any psilocybin product; this event is on COMP360 for MDD specifically.
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 ›
- 31 Dec 2026
- 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
- Drugs@FDA, queried through the openFDA drugsfda dataset (data last updated 2026-09-11), lists no application for psilocybin or for Compass Pathways. Compass's Q2 2026 results release (2026-08-05) and its 2026-09-09 release state that the rolling NDA for COMP360 in treatment-resistant depression is still being submitted, with final submission expected in Q4 2026 and commercial launch expected in H1 2027 'subject to FDA approval'. Rolling review, the Commissioner's National Priority Voucher and Breakthrough Therapy designation are not approval. No approval letter exists as of 2026-09-13.
- Evidence
- Compass Pathways Announces Second Quarter and First Half 2026 Financial Results and Business Highlights (Form 8-K exhibit) · 5 Aug 2026
- Compass Pathways' New 52-Week Topline Open-Label Data from Phase 3 COMP005 Trial Demonstrates Additional Benefit from Another COMP360 Dose in Part C Extending Durability Out to 1 Year · 9 Sep 2026
- openFDA Drugs@FDA dataset query for psilocybin (no matches) · 11 Sep 2026
- Drugs@FDA: FDA-Approved Drugs
How to read
Registry
Receding horizon
Angermayer promised FDA approval of COMP360 (psilocybin) for major depressive disorder 6 times; it has not happened.
Cluster E-0047
Timeline
1 claim against 29 events in the field.
Regulatory decisions