RE:RE:RE:RE:RE:RE:Background to Gilead's $21 Bln acquisition of Immunomedics Briliant... and only 5 years since Phase III green light... just remind us all again of how much time ONCY has saved by setting up for a shorter Phase III..?
I thought the point of statistically significant data from a randomised trial meant it only had to be repeated at scale to satisfy the FDA... which is exactly what ONCY recieved by way of a SPA.
So, ONCY could have run a Phase III without a CPI with more patients and taken 5 years. Or it could reduce the numbers and use a CPI and take 4 years.
So without CPI, ONCY would likely be submitting its BLA in Q1 2023
with a CPI ONCY will be submitting its BLA in Q1 2026
brilliant.