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DewDiligence

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DewDiligence

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Re: genisi post# 142515

Thursday, 06/21/2012 6:01:29 PM

Thursday, June 21, 2012 6:01:29 PM

Post# of 252254
FDA issues CRL for Xarelto in ACS:

http://finance.yahoo.com/news/fda-issues-complete-response-letter-214500851.html

This outcome is not especially surprising insofar as the FDA advisory panel rejected Xarelto for this indication by a 6-4 vote (#msg-75925282).

JNJ has a separate NDA submitted for Xarelto in the PCI sub-indication of ACS, a bifurcation of the ACS indication that looks pretty smart in hindsight (#msg-75916451).

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

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