Not admitted · Outcome already public
Rules 1.1.0 · as of 14 Sep 2026
Rick Doblin · Said 9 Feb 2024 · doblin-0207
Quote
Outcome already public
“Today, with the notification that the FDA will evaluate MDMA-assisted therapy for PTSD for potential approval as early as August 2024, and backed by decades of research incubated by MAPS, we are celebrating the therapists and subjects who participated in the Phase 2 and Phase 3 studies and the team at Lykos Therapeutics on the historic accomplishment they have achieved.”
MAPS congratulates Lykos on NDA acceptance with priority review and a PDUFA date of August 11, 2024. Doblin states FDA will evaluate for potential approval as early as August 2024.
The outcome had been publicly determined or announced by the deciding body or sponsor on the statement date.