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Re: exwannabe post# 63741

Monday, 06/06/2016 8:55:55 AM

Monday, June 06, 2016 8:55:55 AM

Post# of 699582
Exwannabe,
Sorry, just read your IV post, in no way did I mean to imply that they will attempt to remove the crossover and revamp Ph 3. I think they are advocating to keep the same trial but add OS as a co-primary endpoint. I realize that the crossover confounds it and so I have my doubts that regulators will accept that particular change. If that doesn't occur, then they may still need to add patients as both arms are living longer, and they may need a larger pool of patients to reach their secondary endpoint. I do not think they will be adding anywhere near Pyrr's numbers, his responses always seem so pessimistic. But that's also out of my scope, so not sure how many they'll need, but my guess is a few months of enrollment. :)
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