Biotech Values

[justrpaul]

I'm not sure that 48 week control arms in a Phase III are that problematic in terms of a NDA filing. The treatment arm(s) would likely be 48 weeks, or 24 (12 of triple and 12 SOC) weeks of treatment and 24 weeks of follow-up. The control would be 48, plus 24, but I suspect the FDA would allow the submission at ETR of the control, if Vertex desired an early submission. The VR at ETR would be the best it would ever be for the control group. No one would argue the point. So, if the data recommended it, I suspect Vertex could submit a little after 48 weeks from the last enrollee.