Lykos reiterated its concerns about the “structure and conduct” of the June advisory committee meeting for its MDMA therapy for post-traumatic stress disorder as it prepares to formally challenge the US Food and Drug Administration’s 9 August complete response letter.
US FDA Advisory Committee Conduct Could Take Center Stage in Lykos Appeal of MDMA Rejection
Sponsor of psychedelic PTSD treatment will try rarely successful formal dispute resolution process after receiving a complete response letter.
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