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Cyclo Therapeutics, Announced Outcome From Its Recent Type C Meeting With The U.S. FDA To Discuss Full Data Review Of Trappsol Cyclo Clinical Development Program To Date And Proposed Strategies For Statistical Analysis For Phase 3 Study, TransportNPC

Author: Benzinga Newsdesk | December 18, 2023 10:20am

Ongoing pivotal Phase 3 study ("TransportNPC™") evaluating Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C1 (NPC1)

FDA feedback provides direction for the comparative interim analysis

With aligned strategy, interim analysis data readout is anticipated for Q1 2025

FDA and Cyclo Therapeutics to meet in the first half of 2024 for pre-NDA meeting

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