Category: Uncategorized
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FDA Releases MDMA Therapy Rejection Letter, MAPS Rick Doblin Responds
The FDA announced today that it will begin releasing future Complete Response Letters (CRLs) promptly after they’re issued and, in a rare move, published 89 previously unreleased CRLs from 2024 onward. Among them was the August 2024 letter to Lykos Therapeutics, which declined approval of MDMA-assisted therapy for Posttraumatic Stress Disorder (PTSD). For the first…
The Cole Memo 