Acurx announces successful fda end-of-phase 2 meeting and phase 3 readiness for ibezapolstat in the treatment of c. difficile infection

Agreement with fda reached on key elements to move forward with our international phase 3 clinical trial program agreement also reached with fda on complete non-clinical and clinical development plan for filing of a new drug application for marketing approval planning continues to advance ibezapolstat into international phase 3 clinical trials for treatment of c. difficile infection (cdi) sme (small and medium-sized enterprise) designation has been granted by the ema (european medicines agency), which allows acurx to benefit from fee incentives and other support from the ema for eu marketing authorization acurx is now preparing to submit requests for guidance to initiate clinical trials in the european union, the united kingdom, japan and canada ibezapolstat has previously received fda qidp and fast-track designation from fda staten island, n.y.
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