One thing I do know is that a key reason why such trials take so long is that recruitment for such drugs is difficult.  This is mainly because people are worried about safety.  Since our drug has been shown to be safe, that hurdle melts away.  Recruiting will be a breeze.

Secondly, do note that there is currently not much any doctor can do for renal disease patients.  So eagerness to participate should be high, both from a patient point of view, as well as their doctors.

Third, given the very high hazard ratio from the renal trial, I think you won't need to worry about under powering this time around.  Eye balling the charts, it appears the gap opened up by 50 weeks.  So I think this trial, once started, can't take too much longer than 1 year. 

Fourth, from the Hepalink IPO document, it repeatedly talks about RVX is in "constant discussions with the FDA".  Now the only reason the FDA is talking nonstop with RVX is for our kidney disease drug.  To me, that means Breakthrough Therapy is a done deal.

Add all this up, and include the last press release from RVX...to me, this is the "clear path to commercialization".