Northfield Laboratories Inc.’s (NFLD) Application for PolyHeme Accepted for Filing and Granted Priority Review
Today before the opening bell, Northfield Laboratories announced that the U.S. FDA has approved the filing of the Biologics License Application (BLA) for PolyHeme®, the company’s investigative human hemoglobin-based red cell substitute developed to treat life-threatening red blood cell loss when red blood cells are not available. The company also announced that the FDA has chosen the submission for Priority Review, with the intention to review the application by April 30, 2009. Steven A. Gould, M.D., Chairman and Chief Executive Officer, stated, “Filing of our BLA for PolyHeme with Priority Review is a key milestone for Northfield. We are now…