GILD—Could failure to achieve GT3 labeling for Sofo/Riba, within the pooled data filing, delay approval for GT2 patients? Is it possible GILD would be required to refile the Sofo/Riba NDA for GT2?
I don’t think so. The data appear solid enough in GT2 to warrant approval on the current review cycle.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”