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jq1234

10/25/10 6:15 PM

#107199 RE: DewDiligence #107198

I don't remember another company tried to start post-approval type pivotal trial for sNDA even before NDA was submitted. VRTX basically tries to demonstrate noninferiority to a drug that not even submitted NDA.

genisi

10/26/10 5:16 PM

#107272 RE: DewDiligence #107198

I think that the on treatment response-guided therapy in this study is based on negative HCV RNA at week 4 only.