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Re: iwfal post# 74846

Monday, 03/23/2009 11:44:05 PM

Monday, March 23, 2009 11:44:05 PM

Post# of 257257
VRTX ZGEN etc. re role of interferon in HCV combination therapy:

With this data [from the Telaprevir PROVE-3 study], I would now state that thesis with more confidence - making it a predict.

Clark, do you care to retract this statement in light of today’s thread on the iVillage ZGEN board? I’m not being sarcastic and the question is straight-up, not rhetorical.

Further to the discussion of the PROVE-3 data (#msg-36464842), there is more to say beyond today’s thread on the ZGEN board. That PROVE-3 lacked a Telaprevir monotherapy arm or monotherapy portion of an arm is not in any way irregular; rather, it is consistent with the FDA's general policy toward HCV drug candidates. You are not apt to see an FDA-sanctioned HCV trial in which patients receive any kind of monotherapy for a period as long as 12 weeks inasmuch as such a trial design would be unethical.

I would immodestly suggest that you reread #msg-36466697 and do a little more homework before you make further predictions regarding the HCV arena. Regards, Dew


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