RE:RE:ONCY’s Phase 1b/2 mPC results compared over 2019 to 2023You can not find this compartive on ChatGPT. Results from 2019 vs 2021 vs 2023 in ONCYs Phase 1b/2 pancreatic cancer studies, first evaluating pelareorep in combination with pembrolizumab in advanced pancreatic cancer, and then in ONCYs GOBLET Phase 1/2 clinical trial evaluating pelareorep in combination with atezolizumab + gemcitibine + nab-paclitaxel in advanced/metastatic pancreatic cancer, have demonstrated reproducibly and improvement of results in the treatment of a (rare) disease with an unmet treatment need.
So these emperical improvements are certainly enough for ONCY to file an Accelerated Approval request with FDA using the PanCan Phase 3 as the confirmatory study. As I stated, I believe this is the FDA marketing approval that Matt spoke of during the recent Q3 finacials conference call. Filing may follow as soon as / or even before ONCY announces the start of the Phase 3, since the Phase 3 would be considered the confirmatory study.