FDA issues formal Complete Response Letter on MDMA NDA resubmission by Q4 2026, citing therapist fidelity data gaps — approval pushed to 2028 at earliest.

The FDA will issue a second rejection letter (called a Complete Response Letter) to the company seeking MDMA approval, likely by the end of 2026. The FDA's concern will focus on whether therapists actually stuck to the treatment protocol and whether patients could tell they were receiving real MDMA versus placebo. This delays MDMA approval to at least 2028. This matters because it signals the FDA's bar for approval is higher than initially thought—the agency wants ironclad proof of proper therapist conduct.

Lykos Therapeutics received a CRL in August 2024. Any resubmission triggers a 6-month FDA review clock. Persistent gaps in therapist conduct monitoring and unblinding contamination documented in the 2024 AdCom make a second CRL the base case. Resolution is binary and public: either a CRL is issued or it isn't. 'Pushed to 2028 at earliest' is a downstream inference that should be dropped from the falsifiable claim — the core prediction is the CRL by Q4 2026.