RE:AA ?If you understand what I had been posting you would have seen the evidence that the issuance of an Accelerated Approval to pelareorep would result in an immediate revenue stream that would be applied towards the Phase 3 confirmatory study and preclude the need for any subsequent capital raise.
Furthermore we already know that checkpoint inhibitor monotherapy is ineffective due to an immunosuppressive TME, which ONCY's pelareorep is able to remodel in advance of CPI administration, thus making the pelareorep + CPI combination synergistic in comparison to either drug, as a monotherapy.
In addition, the BRACELET-1 study demonstrated that pelareorep is an active agent . The pelareorep + paclitaxel combination was more effective than paclitaxel alone, indicating that pelareorep enhanced the combination over either drug as a monotherapy.
Also, were ONCY's request for an Accelerated Approval be granted, Big Pharma would likely step in to aquire the company, since their control of a Phase 3 confirmatory clinical trial would likely be their preference. At that point Big Pharma would be responsible for the cost of the trial, as they would own the company. Their trial costs would be further offset by the ongoing post-approval revenue stream of pelareorep, and the CPI that they potentially own.