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New Approaches to Psychedelic Clinical Trials Could Overcome Regulatory Hurdles

Lykos Therapeutics was earlier this year denied approval for their MDMA formulation developed to treat post-traumatic stress disorder. The FDA advisory panel that rejected the application cited various issues as their basis, including sexual misconduct during the clinical trials, concerns about the drug’s potential for abuse, and a failure to submit data requested.

Soon after, Lykos let go of…

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