Both phase-3 Albuferon trials met the prespecified statistical thresholds for non-inferiority to Pegasys; however, both trials had point estimates for Albuferon SVR that were worse than those for Pegasys: 48.2% vs 51.0% (a delta of -280 basis points) in the genotype-1 trial; and 79.8% vs. 84.8% (a delta of -500 basis points) in the genotype-2/3 trial (#msg-34043876).
In other words, Albuferon ought to be a shoe-in to be FDA approved, but these phase-3 trials have not exactly provided the kinds of data sets that would make a marketing executive salivate.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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