Jefferies Anticipates Next Key Event in the Oral Anticoagulant Space

In a report focusing on Bristol-Myers Squibb BMY, Jefferies said that it anticipates the next “key event in the oral anticoagulant space to be the US approval of Xarelto for post-orthopaedic VTE prevention (PDUFA date 4th July), as it would effectively de-risk the approval of the lead indication of SPAF in H2'11 (PDUFA 4th November), in our view.” “We note that one of the FDA's primary concerns when issuing the CRL previously for Xarelto in this indication was for off-label use in chronic indications, such as SPAF, until it received more long-term safety data from studies such as ROCKET-AF, which are now in hand,” Jefferies writes. Bristol-Myers Squibb closed Wednesday at $27.74.