What Does FDA Expect from Lykos’ Next Phase 3 MDMA Study? (Part 2)

As Lykos plots a path to resubmitting its MDMA-assisted therapy for PTSD New Drug Application (NDA), we’re looking at what the additional Phase 3 study FDA has requested might look like, should the company raise the funds to conduct it. Having spoken to a source familiar with the high-level recommendations in the FDA’s response, we are running through a half-dozen specific trial design features…

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