Savient On Track To Resubmit Krystexxa BLA In Early 2010, Exec Maintains
After a Sept. 14 meeting with the FDA, the biotech is confident it can satisfy all points in a complete response letter - including the gout therapy's REMS.
After a Sept. 14 meeting with the FDA, the biotech is confident it can satisfy all points in a complete response letter - including the gout therapy's REMS.