Replies to post #157806 on Biotech Values

[DewDiligence]

Re: Xarelto’s second FDA rejection for ACS

The arithmetic in paragraph E) of #msg-82279707 looks safe for the time being :- )

[DewDiligence]

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.

[DewDiligence]

FDA briefing docs skeptical on Xarelto for secondary prevention following MI:

http://finance.yahoo.com/news/fda-staff-cautious-j-js-140008169.html

The advisory panel meeting is on Thursday.

[DewDiligence]

FDA advisory panel votes 10-0 against Xarelto for secondary prevention of MACE (i.e. prevention following a recent MI):

http://in.reuters.com/article/2014/01/16/us-johsonjohnson-idINBREA0F1OY20140116

The panelists did not find the data from a single trial convincing, especially when considering that some data points were missing.

The panel’s decision has no effect on Xarelto’s approved FDA indications for AF/stroke prevention and VTE treatment/prevention.