Biopure Corporation announced today an update regarding a meeting with the Medicines and Healthcare products Regulatory Agency (MHRA) addressing the Company's pending application for marketing authorization for Hemopure(R) [hemoglobin glutamer - 250 (bovine)].
The meeting, held on May 29, was attended by Biopure scientific representatives and the pharmaceutical and clinical assessors from the MHRA. The subject of the meeting was manufacturing and quality. The pharmaceutical assessor accepted Biopure's proposed strategies for answering pending questions and provided clarification. The company is confident that it can resolve all of these issues satisfactorily. No new issues were raised.
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