RE:RE:RE:MACE RESULTS
Unfortunately from a regulatory standpoint, its not that simple. You can't just add up the two patient populations and looke at MACE numbers. Different inclusion/ exclusion numbers, different dosing levels, starting baseline levels etc. In the Assure trial, adverse event rductions was very favorable but not statistically significant, which is why they looked at combining the data.
The main question that will need to be addressed is whether the FDA will require them to re-do a phase II study using their definition of MACE as a primary endpoint or proceed into a phase III trial. This will be the lynchpin for how much interest there is from both a partnering and or go it alone investment standppoint.