No FDA MDMA-PTSD approval before Q3 2027 absent confirmatory mechanistic and clinical data.

Even setting aside the trial design problems, scientists still don't fully understand exactly how MDMA produces its therapeutic effects in the brain. The FDA wants both better clinical evidence and a clearer scientific explanation before it approves the drug. Political pressure and public enthusiasm won't speed up that process.

Unblinding and mechanism remain unresolved. Rigorous science can't be compressed to fit political timelines.