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FDA Closes Inspection of BioXcel’s TRANQUILITY II Trial Site, Reinforcing Data Integrity

March 3, 2025 Elisa Clay No comments yet

BioXcel Therapeutics (BTAI) announced that the U.S. Food and Drug Administration (FDA) has officially closed its inspection of a single site involved in the TRANQUILITY II Phase 3 trial under 21 C.F.R.20.64(d)(3). The FDA’s designation of “Voluntary Action Indicated” (VAI) signals that while minor issues may have been identified, no regulatory action is required, further […]

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