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Re: DewDiligence post# 74767

Thursday, 03/19/2009 4:02:46 PM

Thursday, March 19, 2009 4:02:46 PM

Post# of 257253
Xarelto addendum: The most outspoken critic during the panel discussion does not think total VTE (i.e. symptomatic + asymptomatic) is a valid clinical endpoint. He holds this view despite the fact that total VTE is the primary metric the FDA has used for decades to evaluate anticoagulant applications and the fact that the FDA agreed to making total VTE the primary endpoint in all four of the Xarelto phase-3 studies.

Fortunately for JNJ and Bayer, no one else on the panel shared this viewpoint. (The other No vote was for a different reason.)


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