RE:RE:RE:RE:RE:How does Accelerated Approval work ONCY has reported positive final results on the chosen surrogate endpoint of PFS and mOS, and therefore there are no apparent FDA restrictions on ONCY's ability to apply for an Accelerated Approval at anytime.
With an Accelerated Approval the FDA grants a conditional marketing approval and the 'condition' that a post marketing approval confirmatory trial be conducted to confirm the data of that served as the basis for the Accelerated Approval. With a positive outcome of the post approval confirmatory trial, the FDA then grants FULL APPROVAL that is consistent with the definition of a registrational study (BLA) in the normal course of biologic drug approvals (ex. Accelerated Approval).