Given the negative panel vote today for Xarelto in ACS, JNJ looks pretty smart for submitting a separate NDA for Xarelto in the PCI sub-indication of ACS (#msg-75391993).
Advisory panel rejects Xarelto for ACS by 6-4-1 vote
Having Dr. Nissen opposing your drug on a panel of this nature is almost like stepping up to home plate with a count of two strikes.
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. Anyway, for now the 'nice call' goes to urche (#msg-69122895).