The FDA (Food and Drug Administration) could approve MDMA as a legal, prescribed therapy for PTSD (post-traumatic stress disorder) within the next 12 months. The clinical trial data is in, and there's political interest in helping veterans and trauma survivors. But the FDA could also reject the application — so this is far from certain.
Phase 3 data and aligned political will make an approval decision plausible within the year, though CRL risk remains. This is the broadest, most consequential regulatory milestone.
Join our community — a free weekly Zoom circle with a master facilitator. Come sit with us first; the rest reveals itself.
Join the Free Weekly Circle →