Wednesday, October 22, 2014 4:32:59 PM
I think they will go after stoppage on the 2nd lookin using 175-200 patients to be sure they get the stat sig. based on phII if they don't get stat sig with 100/100 patients on the CG/TG then there might have been a problem with our phII. However, if phII was good it would seem we would see clear data at 200 patients. it would be silly to have any lookin after 200 patients because we are only talking another year after that for completion.
So, I think they were thinking 1st lookin is very early and making sure we are not getting screwed by anybody. 2nd lookin is as early as possible but to make sure we have the data we need. The dog and pony at the ASM was saying leave us alone if you don't hear anything til Dec 2016.
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