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PT556 – The FDA, MDMA, and Public Perception: Was the FDA Fair to Lykos?, with Rick Doblin, Ph.D.

Psychedelics Today

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Navigating the Psychedelic Frontier: MDMA Research Insights

This chapter explores the speaker's personal experiences and regulatory discussions surrounding the development of MDMA therapy, particularly with Lykos and MAPS. It highlights the intricate processes of transitioning from phase two to phase three trials, the challenges of dosage design, and the evolving FDA perspectives on psychedelic research. The dialogue also touches on the contrast between regulatory approaches in the U.S. and Europe, as well as the implications for future studies on both MDMA and cannabis for treating PTSD.

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