Cerus (CERS) To Present Phase III Trial Design On INTERCEPT to FDA On 11/16
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Cerus Corporation (NASDAQ: CERS) will present the proposed design for a U.S. Phase III clinical trial of the INTERCEPT Blood System for platelets at the upcoming November meeting of the FDA's Blood Products Advisory Committee.
Carol Moore, Cerus' vice president of regulatory affairs, quality and clinical affairs, said, "The proposed Phase III clinical trial design that we'll discuss with the Advisory Committee was created through close collaboration between Cerus and the FDA Office of Blood Review. We look forward to presenting the result of this joint effort to BPAC, and hearing their views on this significant step forward toward defining a US approval pathway for INTERCEPT pathogen inactivated platelets."
Cerus has previously announced that an additional Phase III platelet trial was anticipated to be necessary for US approval.
The Committee meeting is open to the public and discussion of the INTERCEPT trial is scheduled to occur the afternoon of November 16. Information about Advisory Committee meetings is available from the FDA's website at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.
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