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What will be the FDA's decision on MDMA-assisted therapy for PTSD by August 31, 2025?
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Resolution / Starting Odds
Approval without restrictions • 25%
Approval with restrictions • 25%
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Rejection • 25%
FDA official announcements and press releases
Story
FDA Rejects MDMA for PTSD Treatment, Requests More Research
Aug 9, 2024, 09:21 PM
The U.S. Food and Drug Administration (FDA) has rejected the application for the use of MDMA-assisted therapy to treat PTSD. The decision marks a setback for the psychedelic space, as the agency has requested an additional Phase 3 study to further investigate the safety and effectiveness of MDMA. Lykos Therapeutics, the company behind the application, will need to conduct further research to address the FDA's concerns.
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