"....On the scientific side I have heard criticisms (mostly by Poc/CTW/OTH) about poor experimental design because of the ASSURE trail failure and that the trial was underpowered he claimed (hind sight is 20:20)...."

Toinv, I can't help you with the science, but I wrote back in July that I thought ASSURE was underpowered.

http://www.stockhouse.com/companies/bullboard/t.rvx/resverlogix-corp?postid=23952811

I was concerned about ASSURE being underpowered ever since I downloaded the Nicholls et al article in 2012. It's one of the questions I have about BETonMACE. To me it's an important question. IMO ASSURE was clearly underpowered.

The article I linked by William P. Coleman is excellent read. He's a top notch expert in clinical design and he explains very clearly in non-techie language how a trial should be powered and why executives typically make the mistake of underpowering their trials.