Replies to post #142515 on Biotech Values

[DewDiligence]

Xarelto—Looks like a CRL is coming next month and I don't know how long it will take to come up with the 'missing data' and if it's even possible without another clinical trial.

A possible remedy is to merge the NDA in ACS with the NDA in PCI, as was conjectured in #msg-75391993.

That plus not having Dr. Nissen on the next advisory panel might be enough to do the trick :- )

For now the 'nice call' goes to urche (#msg-69122895).

Agreed.

[DewDiligence]

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).