Re: HGSI / Albuferon / microcapfun, et al
I’ll have to eat my hat because I was under the impression that the phase-3 Albuferon trials had SPA’s that specified non-inferiority to Pegasys as the primary goal and specified a (two-sided) non-inferiority delta of 12%, which was met in both trials.
But now I see that you posted on Yahoo that HGSI does not in fact have an SPA for either phase-3 trial! If this is the case (I don’t doubt you), how could executives at HGSI assert that the FDA had agreed to an NI delta of 12%? They must have known that, absent an SPA, such informal agreements with FDA staffers are close to worthless. I took the company’s very specific assertions about the NI delta as evidence that there was an SPA and hence I never thought to check that they actually did. Mea culpa!
Given the absence of an SPA, I must retract my statement that Albuferon was a shoo-in to be approved and go instead with your 50/50. Moreover, I noted your mentioning on Yahoo how NVS was M.I.A. following the data release, and I agree that this can’t be good. Regards, Dew
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