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DewDiligence

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DewDiligence

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Re: DewDiligence post# 137995

Monday, 05/21/2012 1:10:00 PM

Monday, May 21, 2012 1:10:00 PM

Post# of 252484
FDA briefing docs for Xarelto in ACS:

http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ucm304754.htm

http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ucm285415.htm

The panel meeting is 5/23/12; the PDUFA date is in late June. Note that JNJ has submitted a separate Xarelto NDA for the (partially overlapping) indication of PCI secondary to ACS (#msg-75391993).

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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