I know that the FDA wasn't "gung ho" over this product and had concerns:
Biopure was forced into a position to continue raising money to fund the clinical trials in a variety of indications in hopes of getting Hemopure onto the market. Many of the clinical trials results were being revealed and in April 2003, the FDA put on a hold of a proposed clinical trial on Hemopure for the use in trauma patients in the hospital setting. The company did not disclose that their clinical trial was on hold to the public and tried to go for an in-hospital trauma trial designation as a separate investigational new drug application(INDA) from the pending biologic license application (BLA) for orthopedic surgery indication. In July 2003, the FDA did not approve Hemopure for orthopedic surgery and had major concerns about the materials submitted to support the BLA and safety issues. In August 2003, Biopure announces to the street through public statements that the FDA was favorable and caused the stock to go up 20%. The company continued with its misleading statements and was able to raise $35 million by December 2003 from the sales of common stock. Information was leaked about the incomplete and misleading documents between late October and end of December 2003, which led to the stock to drop by 66% from the August 1, 2003 stock price. [9]
The people indicted were: Thomas Moore, the former CEO, for making and approving misleading statements; Howard Richman, the former head of regulatory, did the same as Moore; and Kober, member of the General Counsel, for the drafting and approving misleading statements. The charge is for violating Section 17(a) of the Securities Act of 1933 and Section 10(b) of the Securities Exchange Act of 1934 ("Exchange Act") and Rule 10b-5 thereunder and with directly or indirectly violating Section 13(a) of the Exchange Act and Rules 12b-20, 13a-1, 13a-11 and 13a-13 thereunder, and charges Moore with violating Rule 13a-14 thereunder. The Commission is seeking injunctive relief, civil penalties, and an order barring Moore, Richman and Kober from serving as officers or directors of any public company. [9]
In April 2008, the Journal of the American Medical Association (JAMA) published a paper "Cell-Free Hemoglobin-Based Blood Substitutes and Risk of Myocardial Infarction and Death," which grouped clinical trials of Biopure, Baxter, Hemosol Biopharma, Northfield Laboratories, and Sangart and argued that these clinical trials should have been stopped. The FDA received data from individual studies that demonstrated increasing risk and should have led to terminations of trials. The paper revealed that several artificial blood products increased the risk of death by 30% and almost tripled the risk of heart attacks in 16 clinical trials. The current rule is that the agency has the right to keep the information of new products confidential for competitive reasons. The JAMA paper wants Congress to review this policy for the safety of the public. Biopure refutes these findings and has been active in defending their position. [10] On Biopure’s website, they have a section dedicated to commenting on the JAMA article. [11]