Sorry Bungler...Did not see your previous post..
The question at hand seems to be was this outfit coding the 2 different dosages of bavi, or were they coding and labeling the bavi as well as the placebo. Is there a second CRO that was in charge of coding and labeling the placebo only? That would be doubtful. And being that PPHM had limited access due to the nature of the trial, they certainly would not have handled it.
So the question I pose to you is this: If the CRO not in charge of the Placebo labeling, coding, etc then who was?
My fear is that patients that were thought to be getting bavi were actually getting the placebo.
In the spirit of trying to remain objective and looking from all angles, looking at Shan's 9-7 Survival Chart, a mixup involving only the bavi arms would certainly explain the inconsistencies in the OS data.
That said, do we know of any similar situations whereby the FDA allowed a review of potentially flawed data?
Market Data 
Markets 
AI
