Quick question - if assay is good and accepted by the FDA, what happens next? is there another 3-6 months review period for FDA to review the whole BLA package? Or is it more likely a rolling review - i.e. FDA only reviews the additional assay data provided assuming they are satisfied with all the other data in the package sitting with them for ages.
Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-218
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