Pending · due 7 May 2029
Rules 1.1.0 · as of 14 Sep 2026
Christian Angermayer · Said 7 May 2026 · angermayer-0164
Quote
“It saves time. Uh, it's not years, but also it's going to be quick anyway. It's going to be from now on like two to three years max.”
AlphaNooner, May 2026. Viewer asks whether Breakthrough Therapy status shortens the BPL-003 approval timeline; Angermayer says approval is 2 to 3 years max from now.
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 BPL-003 (5-MeO-DMT)
- 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 ›
- 7 May 2029 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 › · “It's going to be from now on like two to three years max”
- 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 going to be”
- 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 ›
- btd_to_approval · 0.72 · 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 0.36 (window shorter than the median 48 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-0120 · deadline 7 May 2029 · bin A
Registry entry
The FDA approves BPL-003 (intranasal 5-MeO-DMT) for any indication.
TRUE on the date the FDA approval letter or Drugs@FDA entry (or the sponsor's approval announcement) for a new drug application for BPL-003 (intranasal 5-MeO-DMT, mebufotenin), for any indication and under any sponsor name, is dated. A complete response letter, a breakthrough therapy designation, a positive advisory vote or a filing acceptance is not an approval. FALSE at the deadline when no such approval appears in Drugs@FDA.
Resolution source: Drugs@FDA; sponsor press release as a secondary source
Readings: No indication is named in the words; any indication counts. The program discussed is in treatment-resistant depression.; Approval under any sponsor name (Beckley Psytech, AtaiBeckley, atai Life Sciences or a successor or acquirer) counts; the entry is on the asset.; Not mapped to E-0029 (any regulator approves any atai psychedelic): the asset here is BPL-003 alone, and an approval of another atai program would not resolve this event.; Base rate class is fixed per item from the asset's stage on each statement date; the event-level class is null.
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 ›
- 7 May 2029
- 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 14 Sep 2026
- Resolver note
- Drugs@FDA holds no approved product with the active ingredient mebufotenin (5-MeO-DMT) as of 2026-09-14. BPL-003 is still in clinical development: the sponsor reports a successful End-of-Phase 2 meeting, Phase 3 ReConnection-1 and ReConnection-2 starting in Q2 2026, and planned topline readouts in early 2029. No new drug application has been submitted, so no approval letter can exist. Breakthrough Therapy Designation (October 2025) is not an approval. Eli Lilly completed its acquisition of AtaiBeckley on 2026-09-11; approval under a successor name would still count, but none has occurred.
- Evidence
- Drugs@FDA query for active ingredient MEBUFOTENIN (openFDA): NOT_FOUND, No matches found · 14 Sep 2026
- Drugs@FDA: FDA-Approved Drugs · 14 Sep 2026
- BPL-003 Phase 3 Program Initiation on Track for Q2 2026 Following Successful FDA End-of-Phase 2 Meeting; AtaiBeckley Highlights Key Pipeline Milestones at 2026 Investor Day · 10 Mar 2026
How to read
Registry
Timeline
1 claim against 11 events in the field.
Regulatory decisions