Enanta Pharmaceuticals Inc (ENTA)

[oc631]

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

The FDA will question the added value each combination brings to the existing HCV market. First generation oral therapy was safe, tolerable, and clearly more efficacious than interferon-based therapy. Open-label studies were guaranteed since there was no approved all-oral comparator. The landscape is changing.

There's a lot of speculation here. I'm not sure if the FDA will release written industry guidance for these changes (if they do come to bear). Another possibility is a large time gap between the release of a individual sponsor's Phase-2 data and the introduction of their Phase-3 design. An indication discussions with the FDA aren't going well.