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Post# of 9772
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jb_118

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jb_118

Re: io_io post# 796

Monday, 10/08/2007 12:02:41 PM

Monday, October 08, 2007 12:02:41 PM

Post# of 9772
My bet is that DORB did a poor job in the preparation of their NDA. If the ODAC is any indication, they didn't make a good presentation of the 10-day (post hoc) guarantee period, and the probably didn't have any answer for the differential (and inconsistent between trials) effect in myelos vs. non-myelos.

When you're talking about failing a primary endpoint these unexplained effects give one less confidence that there isn't type1 error in the DORB analysis.

IMO approval/approvable will hinge on how well DORB can defend their data on these two points. In the ODAC they were inadequate.

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