RE:RE:Promising Pathways Act (PPA)Accelerated Approval through the IRA and the Promising Pathways Act provide new mechanisms through the use os surrogate endpoints and biomarkers that give ONCY the way to achieve a rapid approval for pelareorep in a matter of months and without the need for further partnerships. The evolution for ONCY would be for their putative acquisition.
ONCY had licensed pelareorep to Adlai Nortye for China many years ago. Now with a Phase 3 in mBC ONCY would be exercising the provision of the agreement that will require an US$ 85 million payment for the agreement to be fully exercised.
Unfortunately there are posters here who are new arrivals that do not have a solid foundation of the facts, and instead are try to impose their opinoons and limited understanding of the ONCY's licensing history, for example, notwithstanding that the narrative has moved towards the expanded acquisition opportunities that have become available with a shifting regulatory environment. The FDA for example has become increasingly open to quick approvals for biological drug platforms like ONCY's pelareorep which seek to treat are diseases with unmet treatment needs, as already posted. All any new poster would need to do is read what had been posted before posting on matters that they don't seem to completely understand. Perhaps this post will help them along in conducting their due diligence.