Immunomedics' ImmuRAID-CEA
Executive Summary
Company "believes that it has reached an understanding with the FDA" that data from a Phase III study of the monoclonal antibody-based imaging agent for colon cancer "will continue to be analyzed...to ascertain potentially approvable claims for the product...and what additional steps need to [be] taken to achieve approvability." Immunomedics received an FDA "non- approvable" letter for ImmuRAID-CEA in May