Biotech Values

[DewDiligence]

VRTX – Is this a consequential revelation?

Below is an excerpt from VRTX’s 10Q report,
which was filed yesterday (emphasis added).

>>
We recently have submitted to the FDA interim data from our PROVE 3 Phase 2b clinical trial in patients who did not achieve SVR with previous interferon-based treatment, together with a proposed Phase 3 clinical trial design for evaluation of telaprevir-based treatment in this patient population. We believe that it will be necessary for us to conduct a Phase 3 clinical trial in order to obtain regulatory approval for telaprevir-based therapy in HCV genotype 1 patients who have failed prior interferon-based treatment.
<<

Are the PROVE-3 data that VRTX has seen less than stellar? Or is the above language merely boilerplate conservatism? I’m not sure.

How strong must the SVR data in PROVE-3 be to enable FDA approval of Telaprevir in the treatment-refractory setting without a phase-3 trial? My own opinion, FWIW is in #msg-26290780.