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Re: DewDiligence post# 163011

Monday, 06/24/2013 8:14:34 PM

Monday, June 24, 2013 8:14:34 PM

Post# of 257659
PTLA: I think this study by itself is fine, but unlikely to get approved for VTE prevention by this one study alone.

For reference, Xarelto got approved for VTE prevention after hip surgery based on two studies, one is similar study Xarelto 35-day vs enoxaparin 12+-2-day, the other one is Xarelto 35-day vs enoxaparin 35-day; for VTE prevention after knee surgery based on only one study, Xarelto 12+-2-day vs enoxaparin 12+-2-day.

By the way, I wonder if they are doing this study by themselves to get a partner on board. This really isn't for small biotech.

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