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Cerus Announces Submission of Final Module in PMA App Process for INTERCEPT Platelets

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Cerus Corporation (NASDAQ: CERS) announced today that it has submitted the
third and final module for its Premarket Approval (PMA) application to the
U.S. Food and Drug Administration (FDA), for review of the INTERCEPT Blood
System for platelets. The INTERCEPT platelet submission was completed at the
end of the second quarter as projected in Cerus' regulatory timeline.

“We are extremely pleased to have met major US regulatory milestones with the
INTERCEPT plasma PMA currently under FDA review, and now, the initiation of
the review process for INTERCEPT platelets. FDA has indicated that it has all
the information needed to proceed with its PMA filing review for INTERCEPT
platelets.” said Carol Moore, Cerus' senior vice president of regulatory,
quality and clinical affairs. “We are committed to working with FDA in
completing the application reviews.”

“In light of our recent regulatory progress in the US, Canada and Mexico, we
are excited about the prospect of accessing the North American market,” said
William 'Obi' Greenman, Cerus' president and chief executive officer. “We
continue to focus our efforts on launch preparation, including the expansion
of our commercial team, launch material preparation, and organizing key
events. When we receive these approval decisions, our commercial team plans to
be ready.”

Posted-In: News FDA Press Releases

 

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