First Wave BioPharma, Inc. announced that the U.S. Food and Drug Administration (FDA) is reviewing the Investigational New Drug (IND) amendment for the planned Phase 2 clinical trial of an enhanced enteric microgranule delivery formulation for adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP) as an IND protocol amendment. Under FDA's policy guidelines, the agency strives to complete its review of Phase 2 protocols within 60 days, but may take longer depending on available resources. The Company previously announced that it submitted the IND amendment to the FDA on November 30, 2022.

First Wave BioPharma has been in conversations with FDA and expects a forthcoming response around the end of January.