Not admitted · Not a forecast
Rules 1.1.0 · as of 14 Sep 2026
Rick Doblin · Said 15 Jun 2018 · doblin-0069
Quote
Not a forecast
“The Agreement Letter is a written commitment by the FDA to approve MDMA-assisted psychotherapy for PTSD if our Phase 3 protocol design generates statistically significant results, and no new safety issues arise during Phase 3.”
Characterization of the FDA SPA Agreement Letter as a conditional commitment to approve.
Descriptive, retrospective, or a statement of preference; no future state asserted.