One Year After FDA’s MDMA Rejection: Insiders and Observers Reflect on Lykos, the CRL, and the Path Forward

MDMA-assisted therapy for PTSD faced a major setback after the FDA issued a Complete Response Letter to Lykos Therapeutics, and this one-year anniversary reflection focuses on what insiders and observers think went wrong and what comes next. The piece revisits debate themes that have resurfaced across reporting and industry discussions, including whether outside pressure and advocacy efforts undermined the NDA versus whether company strategy and execution failed to meet expectations. In an interview-led deep dive, voices connected to the review process are gathered, including MAPS founder Rick Doblin, former Lykos leadership, members of the FDA Advisory Committee, critics of the program, and investors. The goal is to assess whether the FDA’s decision was surprising or justified, what Lykos should do differently in future study planning, and how the CRL decision rippled across the broader psychedelic development field.