Brief: FDA Provides Further Regulatory Guidance To Acurx Pharmaceuticals For The Ibezapolstat Clinical Development Program
BRIEF-FDA Provides Further Regulatory Guidance To Acurx Pharmaceuticals For The Ibezapolstat Clinical 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 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
Further company coverage: ACXP.O
((Reuters.Briefs@thomsonreuters.com;))
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Brief: FDA Provides Further Regulatory Guidance To Acurx Pharmaceuticals For The Ibezapolstat Clinical Development Program