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 one step closer to delivering a potential life-saving therapy to patients who need transfusion in situations when blood is not available.”

Northfield submitted the BLA for PolyHeme on October 29, 2008, based on its inclusive development program, including data from its Multicenter Phase III randomized, double-blind trial involving 720 trauma patients. Conclusions from this study were presented at the American College of Surgeons, appeared online in the Journal of the American College of Surgeons in November, and are planned for publication in next month’s print edition.

The stock is currently trading at $1.03, up 90.74%, with approximately 1.7 million shares traded.

Let us hear your thoughts below:

Last 5 posts by QualityStocks

• Omnicity Corp. (OMCY.OB) Ensuring Effective Support for Growing Customer Base - November 25th, 2009
• Clenergen Corp.’s (CRGE.OB) Management Leads Innovative Push into Renewable Energy - November 25th, 2009
• Spending Growth Rises as Inflation Seems Manageable to Fed Despite Job Market - November 25th, 2009
• Stock Guru Featured Company: Quasar Aerospace Industries, Inc. (QASP.PK) - November 25th, 2009
• Stock Guru Featured Company: DecisionPoint Systems, Inc. (DNPI.OB) - November 25th, 2009