Savient On Track To Resubmit Krystexxa BLA In Early 2010, Exec Maintains
This article was originally published in The Pink Sheet Daily
Executive Summary
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.
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On the prowl for a buyer after the approval of Krystexxa for refractory gout, Savient Pharmaceuticals assured investors that they have enough product supply to launch by year-end and that it will set a premium price, though it was vague on when it will commit to an exact figure.