Enanta Pharmaceuticals Inc (ENTA)

[willyw]

Thank you for pointing that out.

I had read that thread earlier in the day, but had not really integrated it into my thinking about some of these future trials.

It really used to mess up the HCV trials, add lots of expense and add many months to a cohort/trial arm.

Consider 12 weeks of incivek for a G-1 might be compared to a 48 week course of SOC with Peg/RBV.
To top it off, the SVR's were based on 24 week End Of Treatment (EOT) PCR's.(so a simple cohort 12 week incivek arm might take 1.5 years minimum to complete.)

The FDA has streamlined some of the approval process for HCV. I hope they keep it simple and economical. Fortunately, adding a 8 or 12 week new comparator arm will not seriously delay an 6 or 8 week cohort.
I hope we don't see 12 week comparators for 4 week cohorts, but if what you say could happen, we may.

What kind of notice will we see if this takes effect? Or is it a done deal already?