BARDA DRIVe EZ-BAA (EZBAA - 22-100-SOL-00003)

enerate the necessary data and information to support an initial FDA meeting to align on the regulatory strategy. The contract scope includes early-stage formulation and analytical development of the drug product; nebulizer characterization including flow rates and particle size distribution; bioana

lytical development to support non-GLP studies using the proposed test article including PK, dose range finding, and chlorine exposure proof-of-concept (POC); and development of an overall regulatory strategy. This scope of work is expected