RE:RE:How does Accelerated Approval work By ONCY beginning the process of 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, with 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.
Now there is room for one or two with 2 and potentially 3 registration studies to be pursued both in monotherapy and in combination with other I/O agents. The monotherapy registration study offers ONCY the freedom to operate and removes any restriction for the company to partner with one Big Pharma company or another.
An Accelerated Approval results in the creation of a revenue stream for ONCY and an accretive asset for any Big Pharma acquirer of ONCY. And because of this capital opportunity eventually happening, I think that the latter Big Pharma acquisition will happen sooner than later and well before an Accelerated Approval is even announced.