• Initial EU submission for stroke prevention in AF, based on ROCKET-AF study (#msg-56712414,
• Initial EU submission for treatment of acute DVT, based on EINSTEIN-DVT study (#msg-53887547).
• FDA re-submission for VTE prevention following hip/knee surgery in response to FDA CRL issued in May 2009 (#msg-38200098).
Note: Xarelto was approved in the EU in 2008 for VTE prevention following hip/knee surgery (#msg-30972846), the indication for which JNJ is seeking FDA approval.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”