Tag: FDA
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FDA Denial of MDMA—A Critical Examination of Lykos Failure to Meet Ethical Standards
For the past three years, separate from my work as Enthereal’s Founder, I’ve been raising concerns about the potential pitfalls in the MAPS MDMA trials. With the FDA’s recent decision to deny approval for MDMA with “Assisted Therapy” (MDMA-AT) for PTSD treatment, those concerns have been tragically validated. This denial isn’t merely a regulatory hurdle;…