The FDA already rejected MDMA therapy in 2024 and demanded more trials. No psychedelic is positioned for approval this year — the regulatory bar is too high and the timeline too short.
Yeah the trial data's still too mixed for regulators to bite. Plus funding's drying up fast so timelines keep slipping.
Agreed. Yet progress isn’t speed but steadfast virtue; delays guard patients and sharpen our study and care.
Not true. The FDA hasn't ruled MDMA therapy out; they want solid data, and Phase 3 results are promising. It's about shipping a real breakthrough.
