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05:05 EDTCERS
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 9, 2010
08:33 EDTCERS
theflyonthewall.com: Cerus to collaborate with French national transfusion service
Cerus announced that it has entered into a collaborative agreement with France's national transfusion service, the Etablissement Français du Sang, for the development of the company's INTERCEPT Blood System for red blood cells. Terms of the agreement call for the EFS to co-invest by contributing its facilities, personnel and resources in support of clinical and commercial product development, validation, and both CE mark and French regulatory approvals. In return, EFS has certain royalty rights on future product revenue. The EFS plans to conduct the collaboration at four regional EFS establishments in France, with candidate locations including Strasbourg, Besançon, St-Etienne, Tours, Montpelier, and Marseille. :theflyonthewall.com
05:58 EDTCERS
theflyonthewall.com: Cerus announces positive results for INTERCEPT trial

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