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Re: genisi post# 142323

Monday, 05/21/2012 3:35:26 PM

Monday, May 21, 2012 3:35:26 PM

Post# of 257253
Nice call—Xarelto looks like a good bet for approval in ACS at the lower dose (according to the FDA briefing docs at #msg-75808358). Still, I find it curious that JNJ submitted a standalone sNDA for Xarelto in the PCI component of ACS (#msg-75391993), and I wonder if the FDA ought to review the two Xarelto ACS submissions together and whether the advisory panel will opine on this question.

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