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Late-Breaking News? At issue in the case are Biopure’s disclosures about Hemopure, a blood substitute. -July 2002: Biopure files an application with the FDA to use Hemopure in orthopedic surgeries. -March 2003: Biopure asks the FDA for permission to test Hemopure for a second use, on trauma patients. -April 2003: The FDA declines to let Biopure go forward with the trauma trials, citing safety concerns about Hemopure. The company does not disclose this news. -July 30, 2003: The FDA tells Biopure that its review of the Hemopure application for orthopedic surgeries is “complete,” and that the treatment has not been approved “at this time.” The agency cites 220 unanswered questions about Hemopure. -August 1, 2003: Biopure announces that the FDA has “completed its review” of Hemopure, and that the company is encouraged by the agency’s “comprehensive feedback.” -December 2003: Biopure discloses the Hemopure trial ban and announces that it is under investigation by the SEC. Source: Court documents

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