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Re: Protector post# 194805

Wednesday, 10/22/2014 4:32:59 PM

Wednesday, October 22, 2014 4:32:59 PM

Post# of 345787
IMO they did not want to wait for 150-200 patients to see if the trial was on track (no sabotage). I think they learned their lesson. I wouldn't be surprised if the 1st lookin is based on 100 patients. I do not think that is enought o get them stat sig (they needed 80 on the treatment side in phII).

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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