Tundup,

Unfortunately my science background is of no use here. These are more administrative questions. From a science perspective, there are many endocrinology/metabolism disorders that lead to increased risk of CVD/Renal diseases. So it seems like quite an arbitrary grey area to me and much more of bureaucratic issue than a biological/scientific one. I have no experience with FDA or EMA or any drug agencies (other than the annoying annual DEA controlled substance licence I have to renew for my lab's research). I don't do human subject research and never been involved in a clinical trial in any way, shape or form. So I can't help you with your FDA or EMA question. I think in due time we will get clarity on this from Resverlogix, but I won't expect this clarity prior to trial launch. My best advice is just sit tight for now and we shareholders can badger Resverlogix for these answers once BETonMACE begins. Take solace in the fact that we have a stellar international steering committee for the trial and that the trial design looks solid.

Best,

BearDownAZ