The FDA (Food and Drug Administration) will likely issue a Complete Response Letter (a rejection requiring major changes) for Lykos Therapeutics' MDMA-PTSD application before the end of 2026. The FDA already flagged problems in 2024: heart safety isn't being monitored well enough, the trial wasn't truly blinded (both patients and therapists knew who got the real drug), and there's potential for therapist misconduct. These are serious enough that a rejection is the most likely outcome.
MDMA's NDA (submitted by Lykos Therapeutics) already received an AdCom with mixed results in 2024, with reviewers flagging functional unblinding, abuse potential, and cardiovascular monitoring gaps. FDA precedent on novel psychoactive mechanisms post-ketamine controversy makes a CRL the most defensible regulatory outcome. No resubmission pathway has been publicly confirmed. This is specific, falsifiable, and grounded in documented regulatory history.