Enanta Pharmaceuticals Inc (ENTA)

[oc631]

It is my opinion that the FDA will not required a non inferiority trial for future HCV.

The effect of raising the bar will only make the HCV environment less competitive and thus inadvertently favors the entrenched positions of first comers such as Gild or Enta.

It's not the FDA's mandate to maintain competition and it's hard to justify using the limited resources the FDA has screening combinations that bring no added value to patients. Technically the FDA is already being lenient in their willingness to approve a drug/combination that's undifferentiated and non-inferior to an existing product. If mid-stage data suggests a potentially inferior P3 outcome developers may limit their scope, and boost their odds, by studying GT1B patients using the BMY combo in the control arm. Competition (or lack of) will eventually cause pricing disparities across genotypes. For example GT3 treatment will be premium priced.