In this Issue Lykos CEO Provides AdComm Feedback to FDA Commissioner Cybin Plans to Fight Functional Unblinding with ‘Firewall’ Doblin Charts a Future for MAPS
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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
Final rules from DOR’s Natural Medicine Division governing Natural Medicine Businesses come in at just over 100 pages. For the purposes of this article, we’ve
July 12th: NMAB Combined Subcommittee Meeting The July 12th meeting of the combined subcommittee began with DORA Program Director Lorey Bratten providing updates on behalf
Independent data-driven reporting, analysis and commentary on the psychedelics space: from business and drug development through to policy reform and culture. Subscribe AnnuallySubscribe Monthly Already
In this Issue MindMed Tops Up Healthy Cash Balance with $75M Raise; Eyes Adding Depression to Pipeline? atai Approaches Phase 2 for DMT and R-MDMA
As I reported on Friday evening, Lykos looks set to appeal the FDA’s decision. The company said it will request a meeting with the agency to ask
While a CRL is a rejection of the NDA in its current form, it’s not a total snubbing of MDMA-assisted therapy. The CRL, which is
In her 2023 book, I Feel Love, journalist Rachel Nuwer charts the history of how MDMA ‘emerged from the shadows to the forefront of a