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After an FDA rejection, here’s what’s next in the psychedelics pipeline

cafead

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  • cafead   Aug 28, 2024 at 11:42: AM
via The psychedelic drug field hit a setback this month when the Food and Drug Administration rejected Lykos Therapeutics’ application for approval of an MDMA-assisted therapy.

The rejection was not entirely unexpected, after advisers to the FDA had recommended against approval for several reasons, including concerns over drug abuse, alleged sexual misconduct during testing and Lykos’ failure to collect certain data the FDA requested.

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