Xarelto “Complete Response” No Surprise, But Does FDA Want Data, A REMS Or Both?
Approval could be pushed out to 2010 if the agency wants to review data from the ATLAS study, which completed too late to get into the NDA package.
Approval could be pushed out to 2010 if the agency wants to review data from the ATLAS study, which completed too late to get into the NDA package.