Rejecting the strenuous pleas of the U.S. Navy, an FDA advisory panel has rejected Biopure's bid to test the blood substitute Hemopure on civilian trauma patients. Voting 11 to eight against the move, the experts concluded that the risks exceeded the potential benefits of the trial. Blood substitutes are a highly controversial therapy, in large part because they need to be tested on trauma victims without their consent. The Navy has been backing Biopure's program, though, saying that a blood substitute would save soldiers' lives in wartime. The FDA is not bound by the panel's vote, but it rarely overrules the experts who advise the agency. The agency has already blocked Hemopure trials on three separate occasions.
The rejection is a bad blow for Biopure. The developer already expects its accountants to raise questions about its ability to continue as a viable concern and has told investors that it will burn through its current cash reserves sometime next summer. Biopure needs new capital to go on, but may find that particularly difficult without the FDA's approval for a trial.