FDA "Breakthrough" Ruling on Magic Mushrooms, Explained by Scientists

by Peter Hess

...Kelan Thomas, Pharm.D., an associate professor of clinical sciences at Touro University California, co-authored a Journal of Psychoactive Drugs review of psilocybin-assisted therapy in 2017, in which he and his team predicted the compound’s role in the future of psychiatry.

“I was very surprised that the FDA has already granted Breakthrough Therapy designation just two months after they approved the study design,” Thomas tells Inverse. “Usually the FDA wants to evaluate data from the drug sponsor’s phase 2b trials before granting Breakthrough Therapy designation, but perhaps data from the previous psilocybin clinical trials that were summarized in my 2017 review article were sufficient evidence.”

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