Pending · due 31 Dec 2027
Rules 1.1.0 · as of 14 Sep 2026
Christian Angermayer · Said 4 Feb 2026 · angermayer-0025
Quote
“the voucher in any case wouldn't have changed anything more or less, and that "the FDA is allowing … to submit data on a rolling basis, which should get Compass a decision potentially late this year or early next year"”
Endorses a COMP360 FDA decision in late 2026 or early 2027 and says the missing priority voucher is immaterial; also says the coming years will be a watershed for the field.
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 action (approval or complete response letter) on the COMP360 NDA for treatment-resistant depression
- 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 2027 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 › · “late this year or early next year”
- 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 · “should get Compass a decision”
- 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, 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-0058 · deadline 31 Dec 2027 · bin B
Registry entry
The FDA issues its action (approval or complete response letter) on Compass Pathways' new drug application for COMP360 (psilocybin) in treatment-resistant depression.
TRUE on the date of the FDA's first action on Compass Pathways' new drug application for COMP360 (psilocybin) in treatment-resistant depression, in either direction: the approval letter as dated in Drugs@FDA (or in Compass Pathways' approval announcement), or a complete response letter as dated in Compass Pathways' announcement of it. The event is about the FDA reaching its decision, not the direction. A filing acceptance, a PDUFA goal date, an advisory committee vote, a review extension, a refuse-to-file letter or withdrawal of the application is not an action; if the application is never submitted, no action occurs. FALSE at the deadline when neither an approval in Drugs@FDA nor an announced complete response letter is dated by then. Resolution source: Drugs@FDA for an approval; Compass Pathways' press release for a complete response letter.
Resolution source: Drugs@FDA (approval); Compass Pathways press release for a complete response letter
Readings: Quoted words endorsed as his own. 'A decision' is any FDA action, not approval. 'Early next year' read via the year row.; 'a decision' = an FDA action letter of either kind; this event is distinct from an approval event on COMP360.
How to read
Coder C
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 2027
- 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 action as of 2026-09-13. The COMP360 NDA is not yet fully submitted: Compass's Q2 2026 results (Form 8-K exhibit filed 2026-08-05) state the rolling NDA submission and initial review are underway, with final submission expected in Q4 2026 and a commercial launch expected in H1 2027 subject to FDA approval. Drugs@FDA queried through openFDA returns no psilocybin product and no COMPASS sponsor entry; EDGAR shows no later Compass 8-K reporting an approval or complete response letter. The April 2026 rolling-review grant and national priority voucher are not actions under the criterion.
- Evidence
- openFDA Drugs@FDA API query for generic name psilocybin: 'No matches found'
- Compass Pathways Announces Second Quarter and First Half 2026 Financial Results and Business Highlights (Form 8-K Exhibit 99.1) · 5 Aug 2026
- EDGAR filing index for COMPASS Pathways plc (CIK 0001816590): no 8-K after 2026-08-05 reporting an FDA action
- Compass Pathways Announces FDA Granted NDA Rolling Review Request and Awarded Commissioner's National Priority Voucher · 24 Apr 2026
How to read
Registry
Timeline
1 claim against 20 events in the field.
Regulatory decisions