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Biotechnology Business
U.S. Navy Requested Operations Trial on FDA Hold
January 16th, 2009
Biopure Corporation (NASDAQ:BPUR) announced that the Food and Drug Administration has advised the U.S. Naval Medical Research Center ("NMRC") by letter that it may not initiate a clinical trial of Biopure's product Hemopure [hemoglobin glutamer - 250 (bovine)], under a proposed protocol submitted to the FDA on November 21, 2008. As previously announced, the Navy had filed a protocol for a proposed trial for the resuscitation of operational casualties with severe hemorrhagic shock without availability of blood transfusions ("Op RESUS"). While the FDA letter acknowledges that the proposed trial addresses some of FDA's concerns previously communicated, it gives three...
Source: Health Business Week (2009-01-16)
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