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FDA · United StatesLast August, Lykos Therapeutics announced that the U.S. Food and Drug Administration (FDA) had issued a Complete Response Letter (CRL) to its new drug application (NDA) that sought to have MDMA-assisted therapy approved for PTSD. In real terms, the agency had rejected Lykos’ first shot at getting the drug approved. After a period of intense reporting last year, we shifted focus to what the future… SourceSee the Story
One Year After FDA’s MDMA Rejection: Insiders and Observers Reflect - Psychedelic Alpha
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