Savient Pharmaceuticals has resubmitted its BLA to the FDA for Krystexxa as a treatment for chronic gout in patients refractory to conventional therapy. The submission received a complete response letter (CRL) in July 2009. The resubmission includes data from three consecutive manufacturing validation batches of the pegloticase API, additional and improved analytical methods for the control and release of pegloticase API and Krystexxa and other data which are designed to address the issues in...