RE:ONCY's bought deal to support 2 Phase 3 studiesAn Accelerated Approval of the doublet of pelareorep + paclitaxel in the treatment of ER+/Her2- mBC would be based on the already demonstrated surrogate endpoints / biomarkers of mPFS and mOS that the FDA had directed ONCY to achieve. I have already posted on how this developed and the direction that the FDA is taking in support of the use of surrogate endpoints in accelerating the approval of immunotherapeutic agents, like pelareorep.i
It is unfortunate that some on this message board keep overlooking this fact and instead keep focusing on OS, notwithstanding the FDA's current view that OS data can be reported on long after the drug is approved for use, entirely based on the surrogate endpoints data that I referenced above.