RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:CVRs (and more on why I don't like them)
I can't see how there is ANY chance of a trial starting in July. Maybe naming a site or PI, but certainly not dosing anyone.
As far as the patents are concerned, I think that is less of an issue. As long as they stay on track and get this thing approved (assuming the Pii data repeats), they should be eligible for patent term extension due to regulatory delays.