RE:RE:RE:New Press Release - Oncolytics Biotech® Announces Productive FDA Type C Meeting on its Metastatic Breast Cancer ProgramQuentin30 - as usual you're wrong again on many things including on Accelerated Approval and biomarkers/surrogate endpoints, since these markers apply to pelareorep in combination with immune checkpoint inhibitors, like anti - PD-(L)1.
The FDA has agreed to the breast cancer registration study to be designed on PFS as the primary endpoint, which ONCY has already already showed a 32.8% improvement over the control arm of paclitaxel monotherapy, with OS as a secondary endpoint,
ONCY will be reporting on the 2 year OS data soon.
Earlier ONCY reported that the confirmed mOS rate at 1 year was 37.5% for the pelareorep-paclitaxel doublet vs. 13.3% with paclitaxel monotherapy.