RE:RE:RE:RE:RE:RE:RE:RE:NEW POST IN LIFE SCIENCESFurther to your email from Sarah, With BetOnMace being a trial that will commence on a phased in basis over a number of months, there is a possibility that the trial could start in Europe and Asia and still get FDA approval and then add some US sites which would be in the cohort which are the late starters. This of course could only happen if RVX has designed their trial so as to meet any FDA concerns.
Something else to consider is what pharma considers important in the trial. I'm only speculating here, but if pharma has given RVX trial specifics as to what would make RVX-208 an attractive candidate to partner with or buy then to me it is important to get the trial started ASAP. If, as some have suggested, the FDA may want to see two ph3's anyways, may as well get one out of the way and perhaps get approval in the EU and be able to sell there, start earning revenues and continue to work with the FDA at the same time. One Canadian biotech that is doing just this is Cardiome, they have been selling their AFib cardio-conversion drug for almost 2 years, now in about 50 countries, but are still awaiting FDA approval. In their case they had a succesful ph3 FDA approved trial but at their panel review their NDA was rejected (after a positive approval vote, 6-2 in favour of approval) because the acting director of the Cardio/Renal section had some concerns. My long winded point is you never know what may happen so there is some merit in my mind to just getting on with this. Of course FDA approval would be most desirable and would do wonders for the stock price. One wonders how much the length of this process has to do with the FDA vs how much might be due to RVX management inefficiencies as they never seem to be able to get it together. That being said with MIcheal Sweeney involved RVX should be fairly well organized at least with respect to the trial. Sure be nice to get a shareholder update in this regard.