Pending · due 28 Jul 2027

The FDA approves BPL-003 (intranasal 5-MeO-DMT) on an application whose efficacy evidence contains only one Phase 3 trial.

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, when the approval letter, the FDA clinical review or the approved labeling (clinical studies section) lists exactly one adequate and well-controlled Phase 3 efficacy trial as the basis of efficacy; Phase 2 trials, open-label extensions and safety studies are not Phase 3 efficacy trials. An approval whose efficacy basis lists two or more Phase 3 efficacy trials resolves FALSE. A complete response letter, an FDA meeting agreement on a single-trial path, a designation or a filing acceptance is not an approval. FALSE at the deadline when no such approval appears in Drugs@FDA.

Resolution source: Drugs@FDA (approval letter, review documents and labeling); sponsor press release as a secondary source

Readings: 'Approval for 5-MeO-DMT with just one phase three trial' = an FDA approval of BPL-003 whose efficacy basis is a single Phase 3 trial; the number of trials is read from the approval documents, not from the sponsor's plan.; No indication is named in the words; any indication counts. The Phase 2b programme referred to was in treatment-resistant depression.; Base rate class is fixed per item from the asset's stage on each statement date; the event-level class is null.; 'I can actually see ... as one potential possibility' is a hedge on likelihood, not a condition.