RE:RE:How does Accelerated Approval work would be of major interest... sure... but without validated biomarkers and statistically significant data relating said biomarker to OS, then NO Accelerated Approval will be forthcoming..
Not from EMA, SFDA, CFDA, FDA or Health Mongolia... ONCY have stated they will run a regular Phase III...
what is your obsession with accelerated approval when ONCY management discount it themselves.. who are you propping up this p os for Mrs Matt ?