Void · Condition unmet
Rules 1.1.0 · as of 14 Sep 2026
Christian Angermayer · Said 8 May 2024 · angermayer-0176
Quote
“if we produce the clinical data in phase three which we supposed I'm very confident to do yeah and by the way again in all the stages before we've produced it then it's an automatism that the FDA not a politician the FDA as a regulator will say the data is that good it's doing what it's supposed to do like yeah we've considered everything we're going to approve the drug”
After Earnings, May 2024. Angermayer says approval is not political: if atai produces Phase 3 data, which he is very confident of, FDA approval follows automatically.
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 ›
- A major regulator approves an atai psychedelic therapeutic
- 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 8 May 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 · “it's an automatism that the FDA ... will say ... we're going to approve the drug”
- 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, conditional, 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-0029 · deadline none · bin A
Registry entry
The FDA or another major regulator approves a psychedelic therapeutic developed, owned or partnered by atai Life Sciences for any indication.
TRUE on the date the FDA approval letter or Drugs@FDA entry, or the approval entry in the database of another major regulator (EMA, MHRA, TGA or another national agency), or atai's approval announcement, is dated for a psychedelic therapeutic, for any indication, that atai Life Sciences (or its successor company) developed, owns, or holds under a licence, co-development or partnering agreement at the time of approval. A psychedelic therapeutic is a compound its sponsor or the regulator describes as a psychedelic or an entactogen; esketamine and ketamine are excluded. A complete response letter, a positive advisory vote or opinion, a filing acceptance, a designation, or a compassionate or special-access scheme is not an approval. FALSE when no such approval appears in Drugs@FDA or another major regulator's database by the deadline.
Resolution source: Drugs@FDA or the approving regulator's database; atai Life Sciences press release as a secondary source
Readings: 'if we succeed, and if we medicalise psychedelics' = FDA approval of an atai-affiliated psychedelic; FDA, not atai, decides approval.
How to read
Coder C
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 ›
- 8 May 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
- No FDA, EMA, MHRA, TGA or other approval exists for any psychedelic developed, owned or partnered by atai Life Sciences or its successor AtaiBeckley (a Lilly subsidiary since 2026-09-11). FDA's 2026 novel approvals list holds no psychedelic or entactogen; the company's Q2 2026 10-Q calls itself clinical-stage; Lilly's July 2026 deal terms place BPL-003 (mebufotenin, 5-MeO-DMT) in Phase 3 and VLS-01 (DMT) in Phase 2b, with CVR payments contingent on future US approval. COMP360 (Compass Pathways, in which atai held only a shrinking equity stake, not a licence or partnership) is still in rolling NDA submission with modules due in Q4 2026 and no approval. The Drugs@FDA search form cannot be queried by GET, so the FDA approvals list was used instead.
- Evidence
- Novel Drug Approvals for 2026
- AtaiBeckley Inc. Form 10-Q for the quarter ended June 30, 2026 (clinical-stage company; pending Lilly merger) · 7 Aug 2026
- Lilly to acquire AtaiBeckley (Form 8-K Exhibit 99.1): BPL-003 in Phase 3, VLS-01 in Phase 2b, CVR contingent on future US approval · 16 Jul 2026
- Lilly completes acquisition of AtaiBeckley for mental health drugs · 11 Sep 2026
- Compass Pathways second quarter 2026 results press release (Form 8-K exhibit): COMP360 NDA rolling submission underway · 5 Aug 2026
How to read
Registry
Receding horizon
Angermayer promised A major regulator approves an atai psychedelic therapeutic 3 times; it has not happened.
Cluster E-0029
Timeline
1 claim against 60 events in the field.
Regulatory decisions