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DewDiligence

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Re: jq1234 post# 157806

Friday, 06/28/2013 3:19:24 PM

Friday, June 28, 2013 3:19:24 PM

Post# of 257257
FDA issues second CRL for Xarelto in PCI sub-indication of ACS:

http://finance.yahoo.com/news/fda-issues-complete-response-letter-123000493.html

Counting the separate CRL JNJ received for Xarelto in ACS per se in Mar 2013 (#msg-85274478), Xarelto has now received three CRLs in all relating to ACS. It seems likely the FDA is going to want another clinical trial in order to approve Xarelto for either ACS or the PCI sub-indication of ACS.

The EU approved Xarelto in ACS (#msg-88290069) in what may be a Pyrrhic victory for Bayer, which owns the ex-US commercial rights.

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