Completely independent of my investment, I wonder why the process for the resubmission of the BLA and the potential approval takes so long. The CRL was received on July 31, 2009 and Savient had a Type A meeting with the FDA on September 14, 2009. Today we heard reiteration of the 1st quarter 2010 BLA resubmission and a potential 3rd quarter 2010 KRYSTEXXA decision. All of this occurring after a 14-1 vote recommendation of approval given by the Arthritis Advisory Committee. So the CRL is received on July 31, 2009 and patients have to wait until the third quarter of 2010 for potential approval. Seems almost insensitive to the clear needs of people who are suffering from the disease. I don't understand what can possibly take Savient so long and I have even less understanding of a potential additional 6 month delay from the date of resubmission before the FDA votes for approval. How much new material/data do they need to know and go over before a decision is made? Bad enough that the long investor must wait, but there are people who are suffering now. Where is the sensitivity and concern for them?


Dooby