Testimony, June 4, 2024
FDA advisory committee on MDMA, 2024
The transcript of the FDA advisory committee that reviewed Lykos Therapeutics' application for MDMA-assisted therapy for post-traumatic stress disorder. Hosted here are the chair's opening of the committee questions and the two votes: 2 to 9 against finding the drug effective, and 1 to 10 against finding that its benefits outweighed its risks, with each member's stated reasons. Members cited functional unblinding, expectation bias, the many trial participants who had used MDMA before, and reports of misconduct. The FDA declined to approve the application in August 2024.
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