Forecast Ledgerinterventional psychiatry and psychedelic medicineQuoted, dated predictions scored against public outcomes under one written method. Every score links to the words, the rule and the evidence.

Pending · due 31 Dec 2026

Rules 1.1.0 · as of 14 Sep 2026

Owen Scott Muir · Said 1 Jan 2026 · owen-2032

Quote

“COMP360 and KetaFree (IV Ketamine) will be approved for MDD by FDA.”
· Ten 2026 Predictions on Which to Hang Your Hat. · substack post

Item 10 of the 2026 predictions list: FDA approval in 2026 of Compass Pathways' COMP360 (psilocybin) and NRx's KetaFree (IV ketamine) for major depressive disorder.

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 › · “2026 predictions list ('Ten 2026 Predictions on Which to Hang Your Hat.', published 1 January 2026)”
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 be approved for MDD by FDA”
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
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
The event, criterion and deadline were written at intake, before the 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 › was looked up. Coder B coded the statement independently.

Coder A

Resolution

State
PendingAn item whose deadline has not passed. 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 ›
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
BrierThe squared gap between a probability and the outcome, (p - o)^2. 0 is perfect, 0.25 is the constant coin flip, 1 is confidently wrong. Lower is better. Method ›
Not scored
How to read
State at window close; the outcome comes from the registry, the score from the rule.

Registry

Timeline

1 claim against 24 events in the field.

saiddueevent
1 Jan 2026 · Czech Republic: Czech medical psilocybin framework takes effect: psychiatrists may administer ps5 Jan 2026 · GH Research (GH001): FDA lifts the clinical hold on GH001, clearing a global phase 3 program in TRD t12 Jan 2026 · Neurolief (Proliv Rx): FDA grants PMA approval to Neurolief's Proliv Rx, the first at-home brain neurom23 Jan 2026 · FDA / Janssen: FDA approves Spravato REMS modification S-027, reverting the October 2025 vendor3 Mar 2026 · AtaiBeckley (BPL-003): AtaiBeckley reports a successful End-of-Phase 2 meeting with FDA for BPL-003 in ATAIBECKLEY (BPL-003): ATAIBECKLEY REPORTS A SUCCESSFUL END-OF-PHASE 2 MEETING WITH FDA FOR BPL-003 IN 13 Apr 2026 · FDA / Janssen: FDA approves Spravato REMS modification S-028 adding Spanish translations of REM18 Apr 2026 · President Trump: EO 14401 orders FDA priority vouchers for breakthrough psychedelics, an ibogaine23 Apr 2026 · DOJ / DEA (Acting AG Blanche): Final order moves FDA-approved marijuana products and state-licensed medical mar24 Apr 2026 · FDA: FDA awards Commissioner's National Priority Vouchers to Compass (COMP360 psilocy24 Apr 2026 · FDA / Compass Pathways: FDA grants Compass a rolling NDA submission and review for COMP360 psilocybin in24 Apr 2026 · FDA / Compass Pathways, Usona Institute, Transcend Therapeutics: FDA awards Commissioner's National Priority Vouchers to Compass (COMP360), Usona24 Apr 2026 · FDA Commissioner Marty Makary: Makary says he expects an FDA approval decision on at least one priority psyched30 Apr 2026 · Axsome Therapeutics (Auvelity / AXS-05): FDA approves Auvelity for agitation associated with Alzheimer's disease, the fir23 Jun 2026 · Louisiana Legislature: SB 43 becomes Act 956 without the governor's signature after unanimous votes, cr24 Jun 2026 · FDA / Janssen: FDA approves Spravato REMS modification S-029 with updated REMS website workflow26 Jun 2026 · Oregon Health Authority: OHA proposes fee increases for the psilocybin services program ahead of the Sept29 Jun 2026 · DEA: Expedited administrative hearing opens on broader rescheduling of marijuana, inc13 Jul 2026 · FDA (psychedelic drugs guidance): FDA finalizes 'Psychedelic Drugs: Considerations for Clinical Investigations', s14 Jul 2026 · FDA: FDA finalizes the guidance 'Psychedelic Drugs: Considerations for Clinical Inves14 Jul 2026 · FDA: FDA announces a September 14, 2026 public hearing on future therapeutic use of p10 Aug 2026 · Resilient Pharmaceuticals (ex-Lykos, midomafetamine): Resilient resubmits the MDMA-assisted therapy NDA for PTSD without a new phase 310 Aug 2026 · Resilient Pharmaceuticals (formerly Lykos): Company resubmits its NDA for MDMA-assisted therapy for PTSD (proposed brand Rys25 Aug 2026 · DEA: DEA sends its final telemedicine special registration rule to OIRA for review; t8 Sep 2026 · Definium Therapeutics (DT120): FDA grants Breakthrough Therapy Designation to DT120 (lysergide) ODT in MDD follFDA APPROVAL OF C…FDA approval of COMP360 (psilocybin) for major depressive disorder · stated 1 Jan 2026FDA approval of COMP360 (psilocybin) for major depressive disorder · restated 1 Jan 2026 · p 90%90%TODAY2026

Regulatory decisions

← Earlier · Later → · All statements