Acurx updates phase 3 readiness for ibezapolstat in c. difficile infection based on recent fda and ema communications

Following the previously announced successful end of phase 2 meeting achieving agreement with fda on non-clinical and clinical phase 3-readiness, acurx has now also received written positive feedback from fda regarding acceptability of our cmc (chemistry manufacturing and controls) plan and data package proposed to support the phase 3 clinical program acurx has initiated the scientific advice procedure with the european medicines agency (ema) to discuss the readiness for initiation of the phase 3 clinical program in the european union (eu). acurx has been notified that we should expect to receive the final written advice letter in the coming few weeks acurx is also in the process of discussing the pediatric development plans for ibezapolstat in c.
ACXP Ratings Summary
ACXP Quant Ranking