What Does FDA Expect from Lykos’ Next Phase 3 MDMA Study? (Part 1)

Following FDA’s refusal to approve Lykos Therapeutics’ MDMA-assisted therapy for PTSD New Drug Application (NDA), a key question is what the company might do next. In its Complete Response Level (CRL), the agency requested that Lykos conduct a fresh Phase 3 study in order to clarify the safety and efficacy of the intervention. Questions of whether the company would be able to raise that money…

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