@Phaedrus Thanks mate I think it answers all of my questions. If my reading is correct then assay submission is classified as a Class 1 Resubmission which has a 2-month review period.This in turn would meand that the best announcement we can get in the coming days is that FDA has set a target goal date sometime in May this year for a determination on gvhd for kids. We'll find it in short order indeed.
Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-263
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