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DewDiligence

09/07/12 10:27 AM

#148306 RE: DewDiligence #145237

JNJ resubmits Xarelto NDA in PCI sub-indication of ACS:

http://finance.yahoo.com/news/janssen-research-development-submits-complete-120000837.html

This NDA, which is separate from the rejected Xarelto NDA in ACS per se, was voluntarily withdrawn by JNJ in July 2012 (#msg-77346396). In today’s PR, JNJ confirms that the additional information in the resubmission for PCI is in response to questions raised by the FDA in the June CRL rejecting the NDA in ACS (#msg-76856261).