Each drug trial and treatment requires an approval from the
FDA, to the best of my knowledge. In that regard, the
FDA so far as Vertex may
approval a plan for treating naives, a separate plan for treating past TX failures, and I assume there is one for co-infected (HCV &HIV) as well. Right now there is a current trial for BID dosing, but approval will be based on 3X daily and at some point twice daily may see an additional application.