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See Latest ArticlesU.S. Naval Medical Research Center Resubmits IND Application for Proposed 'RESUS' Clinical Trial in Trauma Patients in the Out-of-Hospital Setting
BioPure, 08/04/09
Biopure Corporation announced that the U.S. Naval Medical Research Center has submitted to the Food and Drug Administration a revised investigational new drug application to conduct a clinical trial of the company's oxygen therapeutic Hemopure for the pre–hospital treatment of trauma patients. The study is entitled "Restore Effective Survival in Shock". The RESUS trial was first proposed and submitted to the FDA in 2005. The proposed trial was placed on clinical hold at that time. It has been resubmitted repeatedly in response to FDA comments and to address comments made by the FDA Blood Products Advisory Committee at an open meeting held in December 2006. Each subsequent submission was placed on clinical hold.
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