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 tasked with reviewing Lykos’ data package and considering how the investigational treatment might be used in practice.
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