RE:RE:RE:RE:How does Accelerated Approval work According to the FDA’s Peter Marks, M.D., Ph.D. the FDA's Accelerated Approval provides small biotech's with a revenue stream to support on-going clinical development in "orphan" and "unmet treatment need" for diseases like pancreatic, breast, anal and colorectal cancers, which ONCY is currently conducting and in late stage clinical development, +/- immune checkpoint inhibitors.
ONCY has spoken of initiating enrolling between 180-200 patients in a monotherapy pelareorep + paclitaxel clinical/registration study ONCY speeds up the Accelerated Approval process by demonstrating to the FDA that ONCY is well into the implementation of a well designed clinical study, using already FDA agreed upon primary and secondary endpoints, that have resulted in previous Accelerated Approvals, as exemplified by Pfizer's Paloma and Daichii's Destiny successes.