Cybin Inc. applauded recent comments from Dr. Martin Makary, Commissioner of the U.S. Food and Drug Administration (FDA), regarding the importance of accelerating and prioritizing research on psychedelic therapeutics. Dr. Makary identified psychedelic drug development as a top agency priority.
The FDA Commissioner's call emphasizes the agency's openness to innovative treatments that show promise, even if they challenge traditional medical understanding. This public endorsement provides welcome validation for companies like Cybin, which are conducting rigorous clinical work in this frontier area.
Cybin's CYB003 deuterated psilocin program, currently in Phase 3 development, has already been granted FDA Breakthrough Therapy Designation for the adjunctive treatment of Major Depressive Disorder. This positive regulatory sentiment could further expedite drug development timelines and the path to market for Cybin's clinical-stage programs.
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