Revelation Biosciences Reaches Agreement with FDA on Gemini Approval Pathway for AKI

Core Viewpoint - Revelation Biosciences, Inc. has reached an agreement with the FDA on an approval pathway for its treatment Gemini for Acute Kidney Injury (AKI) [1] Group 1: FDA Agreement - The agreement includes a clinically relevant and objective composite endpoint that comprises death and/or the need for dialysis [1] - Positive data from a single well-controlled Phase 2/3 adaptive design clinical study, involving approximately 300 patients, will be sufficient for the submission of a new drug application (NDA) [1]