At a recent FDA advisory committee meeting, regulators expressed frustration with Lykos for not tracking positive feelings such as euphoria in their MDMA-assisted therapy for PTSD. Missing data on addiction potential was a major concern for the FDA. Lykos executives claimed they misunderstood instructions, but former employees said the company was aware of the requirement and failed due to disorganization. Employees waited for protocol approval while executives dealt with other issues. The FDA is concerned about the lack of data and clarity on addiction potential. Employees and executives seem to have different explanations for the failure to collect necessary data.
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The inside story of how Lykos’ MDMA research went awry
