RE:RE:Pfizer reshuffles executive with focus on I/O Should read: Suneet Varma
ONCY has reached a time in its clinical development plan which has satisfied the FDA's May 2018 request to identify a biomarker for ONCY's Immune Molecule Platfor (pelareorep). The FDA's request has been met though the AWARE-1 WOO clinical study and with the fulfillment of this requirement, the agency offered a confirmation that only one Phase 3 trial would be required for securing apporoval for pelareorep, instead of the two (2) that are normally required.
These events give any Big Pharma a big advantage in the acquisition of ONCY at this time, since a BLA could be filed for an accelerated marketing approval for pelareprep in breast cancer on the strength of the Phase 2 Bracelet-1 study results. Any Phase 3/4 confirmatory study would consequently include the patients that had already been enrolled in the Bracelet-1 Phase 2 study, making a Phase 3/4 confirmatory study relatively easy to complete, as pelareorep is being simultaneously marketed by virtue of the above conditional approval.