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friendofthedevil

01/08/17 7:02 PM

#5075 RE: Fred Kadiddlehopper #5074

My recollection is that "trending" was Helen's word and it is purposefully vague. I doubt the FDA was specific in that Feb 2015 meeting either. So, I have to put my own interpretation on it. I would guess 'trending' means data that looks like it will show OS eventually but the N isn't quite there yet. Unfortunately, the combined Stage 1&2 OS KM curve isn't sufficiently trending, IMO.