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Savient Pharmaceuticals announced that on September 14, the company completed a Type A meeting with the FDA to discuss the complete response letter received by Savient on July 31 regarding the company's Biologics License Application,BLA, for KRYSTEXXA as a treatment for chronic gout in patients refractory to conventional therapy. Based on the results of this meeting with the FDA, Savient believes that the FDA supports its approach to resolve all issues cited in the CRL. The meeting also confirmed that the FDA does not expect further clinical trials to be required as a result of Savient's reversion to the original manufacturing process to produce the Phase 3 clinical trial material for KRYSTEXXA, provided that no significant differences are observed between the material produced with the validated Phase 3 process and the Phase 3 clinical trial material. Savient, therefore, continues to believe that it can meet its previously discussed timeline of filing the resubmission in response to the CRL in early 2010. :theflyonthewall.com