Nice try though. No the FDA did not use the original data .
Frustrated, I see why the frustration. When data is collected from a clinical trial, it is analyzed and further scrutinized and many times "more data" is extracted from the original data.
For example: Many times a small biotech finds a "small subset" of patients that their drug works on from "prior data". The bottom line is the FDA based their decision to fast track Phase III based on the same data.
Now that data was analyzed/scrutinized by Peregrine and guess what? 60% MOS improvement in the 3mg Bavi arm vs the combined placebo/1mg Bavi arm. Further, this data "was indeed always part of the original data", and was presented to the FDA. I'll still debate that I disagree with your opinion and the fact is the FDA approved Phase III, fast tracked Phase III SunRise NSCLC and it could have been based on no other data, but the Phase IIb NSCLC data..
and that data is what Robert Garnick called as compelling Phase II data as he had ever seen.
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