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Re: dewophile post# 109681

Wednesday, 12/01/2010 2:17:19 PM

Wednesday, December 01, 2010 2:17:19 PM

Post# of 257253
Bleeding incidents always have to be addressed in clinical trials of anticoagulants, but I’m expecting that, in phase-2b, bleeding will be will addressed via a distinct safety endpoint rather than as part of the (less precise) efficacy/safety composite endpoint that was used in EMINENCE.

Even if you take the (reasonable, IMO) position that the 50 IU/kg dose in EMINENCE was not better than the other two doses because the lower event rate for the primary endpoint stemmed from fewer incidents of minor bleeding, you can’t say that the 50 IU/kg dose was worse than the other doses in terms of both efficacy and safety. So I will be surprised if the 50 IU/kg dose is not one of the doses to be tested in phase-2b.

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