there are just better values out there if a portfolio needs an antiviral company. I had VRTX from $9 to somewhere around $44 in October '06. Wall street machinations could take it down to $12 or so sometime this summer. There is no good support on the chart down to there. (unless some buyers decide to pick a price and defend it...but why would they...if the momentum is going to carry them to the bargain basement)
I feel like the IDIX shares I have been buying all season are comparable to VRTX at 9 three years ago.
I would think this would not be an insurmountable target for some combination of Protease/polymerase with SOC and wonder why it is not pursued more? I wonder if the Boceprevir experience along with the fear of combining too many agents has put too much doubt on this possibility in the near term.
It would be curious if telaprevir does not have stellar PROVE-3 results but goes on to have comparable Phase 3 results in terms of both efficacy and safety (as Phase 2) while along the same time-line some other combination does get compelling results in earlier (phase 2) studies for some classification of patients for fail to get an SVR while having a more favorable safety profile. Would the FDA approve both in different patient populations or put the two drugs against each other possibly delaying one till it is further developed?
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.