The Food and Drug Administration has told Biopure ( BPUR) that it will complete its review and act on the company's biologic license application for the experimental blood substitute Hemopure by Aug. 29. The company submitted its application last July 31. The timeline is actually being pushed out, because according to FDA performance goals in the Prescription Drug User Fee Act, the agency has up to 10 months from the submission date to act on the application, making the original action due date June 1 of this year. But Biopure said that during the review process, it had to respond to FDA questions regarding the application. The agency classified the company's latest responses in mid-May as additional analyses of previously submitted data, which gives the FDA up to three months beyond the original action due date to review the material, Biopure said in a press release. RealMoney columnist Adam Feuerstein has reported extensively on Biopure's prospective blood substitute, including
possible Hemopure side effects. Last month, he questioned the company's chances of getting the drug approved by the FDA without a recommendation from an advisory committee. Shares of Biopure were up 14 cents, or 2.4%, to $5.87. The stock's 52-week range is $2.18 to $8.30. The biotech sector itself was also higher, with the Nasdaq Biotech Index and the Amex Biotech Index each climbing 2%.