The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

By Amanda Conti

On August 9, Lykos Therapeutics received a Complete Response Letter (CRL) from the FDA, stating the agency will not currently approve its application for midomafetamine (MDMA) to treat post-traumatic stress disorder. Here, AgencyIQ unpacks the announcement and analyzes potential implications throughout the psychedelic enterprise.

A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions.

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