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"We look forward to the opportunity to discuss the comprehensive data package of investigational MDMA and how, if approved, it may be used as a prescription treatment in combination with psychological intervention in adults with PTSD," the statement continued In briefing documents released on Friday, the FDA said that based on the clinical trial data submitted by Lykos Therapeutics, "participants appear to experience rapid, clinically meaningful, durable improvement in their PTSD symptoms." However, the federal health agency also noted concerns that the drug has the risk of causing "patient impairment" and the potential for "serious harm" as a result of impairment

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