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Post# of 252302
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Re: DewDiligence post# 104074

Monday, 09/13/2010 6:25:01 PM

Monday, September 13, 2010 6:25:01 PM

Post# of 252302
Sure, off the top of my head I can't think of another CML trial that separated pts into multiple cohorts based on disease phase and mutation status. Don't get me wrong, I like this design as it may reduce the risk in terms of gaining approval in one or more cohorts as opposed to the all or none that is more typical in registration trials. Furthermore, I found the use of different endpoints for each of the cohorts somewhat unique and in line with the idea that this lessens the trial risk. (btw, hats off to rkrw, biomaven et al who made the right call on the SPA not being necessary)

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