Cerus (CERS +2.8%) says the FDA has accepted its proposed modular Premarket Approval application...


Cerus (CERS +2.8%) says the FDA has accepted its proposed modular Premarket Approval application shell - an outline of the application process defining the structure, content and timing of each module - for review of its Intercept Blood System for plasma. The agency's approval of a shell was required prior to initiation of a modular PMA submission, thus enabling CERS to proceed with an application that addresses multiple indications of plasma use for the system.

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