FDA Provides Further Regulatory Guidance To Acurx Pharmaceuticals For The Ibezapolstat Clinical Development Program
ACXP•FDA guidance on ibezapolstat development program
Aug. 3 (Reuters) - Acurx Pharmaceuticals Inc ACXP.O:
- FDA provides further regulatory guidance to Acurx Pharmaceuticals for the ibezapolstat clinical development program, including the potential for a single Phase 3-trial registration plan and a trial design to support both treatment and reduction of recurrence of C. difficile infection
- Acurx Pharmaceuticals receives FDA guidance on a single Phase 3 trial NDA for ibezapolstat in CDI
- Acurx Pharmaceuticals - FDA agrees NDA filing possible for both treatment and recurrence reduction with successful trials
- Acurx Pharmaceuticals - FDA open to pre-NDA discussion after single Phase 3 trial if efficacy results are robust
Source text: ID:nPn4CcpHla
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