ACXP ACXP - FDA Provides Further Regulatory Guidance to Acurx Pharmaceuticals for the Ibezapolstat Clinical Development Program, Including t
ACXP ACXP - 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
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12:02:59 PM UTC
SquawkNews
ACXP 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 single phase 3 trial NDA for ibezapolstat in cdi - FDA agrees NDA filing possible for both treatment and recurrence reduction with successful trials - FDA open to pre-nda discussion after single phase 3 trial if efficacy results are robust
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