RE:RE:TrialsWith an Accelerated Approval, the FDA requires that the sponsor initiates a post confirmatory clinical trial (sometimes called a Phase 4) - effectively replacing the traditional Phase 3 nomenclature with that of one termed a "Registrational Enabling Trial" . The Registration Enabling Trial is an extention of the Phase 2 and precludes the need for a new ttrial.This is the last step in the process, as already has been emphasized. In the process the FDA grants an early marketing opportunity through an Accelerated Approval, that is subsequently converted to a full approval when the post confirmatory (aka Phase 4) data is completed and the data submitted.