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News Breaks
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November 17, 2009
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| 05:05 EDT |  | CERS |
| theflyonthewall.com: | BPAC issues positive opinion for Cerus' Phase III Intercept trial | | Cerus Corporation announced that the FDA's Blood Products Advisory Committee, or BPAC, rendered a positive opinion on the proposed hemostatic efficacy and safety endpoints for a potential U.S. Phase III clinical trial of the INTERCEPT Blood System for platelets. The Committee disagreed with the safety margins for the trial proposed by Cerus, and recommended that the trial design include more stringent safety margins for comparing INTERCEPT-treated platelets and conventional platelets. In addition, the Committee rendered a positive opinion on a proposed pathway forward in which successful completion of the proposed Phase III trial would be followed by a post-marketing randomized control study and concurrent staged roll-out of the product. :theflyonthewall.com |
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February 1, 2012
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| 08:33 EDT | | CERS |
| theflyonthewall.com: | Cerus, Ilex BioTech report INTERCEPT system approvals in Israel | | Cerus Corporation and Ilex BioTech Ltd. announced that the INTERCEPT Blood System has received regulatory approval in Israel for the treatment of platelets and plasma intended for transfusion. The INTERCEPT Blood System is designed to provide increased protection from a broad range of transfusion-transmitted pathogens, including bacteria and emerging pathogens such as the dengue and chikungunya viruses. :theflyonthewall.com |
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