Could there be a change in primary endpoint? I
Post# of 148278
I agree that this is a very strong possibility #generactor.
Quote:
That would be my guess as most likely because moving the "change in clinical status" endpoint up to co-primary seems to fit as a recommendation for a potential regulatory path forward. The DMSB could have decided that the mortality endpoint was going to be too difficult to hit as mortality rates have improved with time.