FDA issues a Complete Response Letter for MDMA-assisted therapy, citing inadequate blinding controls and therapist fidelity data, requiring at least one additional trial before resubmission.

The FDA (the US drug regulator) will send back Lykos's MDMA-assisted therapy application with a Complete Response Letter — a formal rejection. The FDA will specifically cite two problems: the study wasn't properly blinded (meaning patients and therapists might have known who got real MDMA vs. placebo), and they don't have enough data on whether therapists followed the protocol consistently. This matters because it delays MDMA therapy by 3-5 years and signals the FDA is tightening its standards after the messy Lykos approval fight last year.

The FDA's post-Lykos credibility repair mode, combined with a published reassessment paper validating internal agency skepticism about blinding integrity, makes approval without cleaner data politically and scientifically untenable. Precedent from the 2024 AdCom rejection and ongoing REMS scrutiny reinforces this trajectory. This is more specific and falsifiable than the generic 'CRL' prediction: it names the cited deficiencies.