Further to BDAZ's comments, I would agree that the FDA placement of the RVX file is an administrative issue. As I said in an earlier post when I asked the question of where RVX fell within the FDA Don said that they weren't sure and followed that up with comments to the effect that RVX has dealt with both sections (M/E and C/R) and he further commented that a problem for RVX is that there is no Epigenetics/Genetics section. He also mentioned that he felt that they will eventually end up in cardio/renal. I know there are some people who feel that what RVX has said is management "spinning" the fact that RVX can't get FDA ph3 approval and that there are "other" issues at play. While I can't definitely refute this assertion I have seen nothing that supports this assertion either. Given the fact that RVX has ph3 approval in Europe I agree with management that the smart decision is to start the trial which hopefully results in success and EMA approval and then gain FDA approval through the 21st Century Cures legislation before the US Senate now. Two to three years should be ample time to straighten the politics out, but who knows. Currently I know of a Canadian company (Cardiome) which has its' drug for sale in dozens of countries which accept EMA approval and yet is still waiting FDA drug approval even though it did a very successful FDA approved ph3 trial. To me this example very much supports RVX managements' course of action.

To Tundup's FDA vs EMA question. JMO but I think the best scenario would be to have ph3 approval everywhere as it is the most direct route to eventually accessing all markets however in RVX's case where BetOnMace will be a very long trial I think that getting started trumps waiting around for FDA approval. The results of the trial will stand on their own merits once the trial is completed. Again JMO but I would suspect that if BetOnMace is successful pharma will be all over this regardless of who approved the trial. Personally I think right now the biggest drawback of no ph3 FDA approval is that it would have resulted in a better current share price.

Regarding steering committees, they can be likened to a board of directors for trials and scientific direction. RVX's is definitely stellar but don't take my word for it look at where and what they have published, where they teach and other companies and institutions they have provided guidance to wrt scientific advancement in their fields of expertise.