Industry and Researchers Respond to ICER Report on MDMA-Assisted Therapy, Which Maintains Lykos’ Clinical Evidence Is “Insufficient”

Save the date: the FDA will hold an advisory committee meeting to review Lykos Therapeutics’ New Drug Application (NDA) for MDMA-assisted psychotherapy in the treatment of PTSD on June 4th, 2024. The purpose of FDA advisory committees is to provide “independent, expert advice” to the agency [1]. In this case, it will be the agency’s Psychopharmacologic Drugs Advisory Committee (PDAC) that is…

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