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DewDiligence

02/07/13 8:26 AM

#156597 RE: oc631 #156591

If GILD pursues approval in both genotypes do you agree the FDA would request separate filings due to the large disparity in SVR rates?

The FDA would discourage a combined filing, IMO; if GILD persisted with such an application, the FDA might restrict the label to gentotypes-1 and -2. However, as noted in #msg-84287176, I don’t GILD will put itself in this position.