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The Scientist: NewsBlog:
iGEM bactoblood
Posted by Alla Katsnelson [Entry posted at 3rd November 2007 11:58 PM GMT]
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Software sales enginner by Manny Freitas [Comment posted 2007-11-29 16:15:20] Check out Biopure "artificial blood solution"
LINK "hemopure & Okyglobin" They have approval in S.Africa and before the UK "Biopure Submits Complete Response to U.K. Regulatory Body on Marketing Application for Hemopure(R) CAMBRIDGE, Mass., Nov. 8 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) announced today that it has submitted a complete response to the provisional opinion letter issued by the United Kingdom Commission on Human Medicines (CHM) arising out of CHM's review of Biopure's application for marketing authorization for Hemopure(R) [hemoglobin glutamer - 250 (bovine)]. The indication requested in the response is for the treatment of acutely anemic adult orthopedic surgery patients under 80 years of age when blood is not readily available or not an option. As stated in prior releases, the Company submitted its application to the U.K. authorities in July 2006. The company received a provisional opinion letter in December 2006, which contained the CHM's questions and requests for additional analyses. Biopure met with the Medicines and Healthcare products Regulatory Agency (MHRA), the decision making body, in September 2007 to review its proposed responses to key questions and subsequently finalized the responses. Once an applicant responds to the Commission's questions it generally takes four to six months for the agency to make a final determination. If marketing authorization is granted, the company could seek registration of the product in other member states in the European Economic Area through the Mutual Recognition Procedure." Regards M.Freitas Comment on this blog |