RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Blackout on RVX: Probably
Biotech is my field of expertise. More specifically Apoa-1 is my focus, so I am very familiar with this protein and the many approaches to using it.
I have held a position in RVX for several years. I was not a fan of the trial designs as I do not believe that regression is the correct endpoint nor is IVUS the best tool anymore, however, I know why they did it. I was VERY surpised with the MACE numbers shown in the last trial. Very impressive for short duration and a small number of patients. These results were better than statins showed when they got approved. However, it was analysis after the fact, so thay have to conduct a study and show this effect prospectively.
My honest opinion is that it is a very interesting compound. Because of the positive safety profile, it is worth a PIIc study. I worry about getting funding for this trial. once a compound fails, it is always very difficult for that stigma to be removed. The combo statin piece is interesting, but I don't think its really that big of a deal. Everyone on RVX-208 will also be on statins. Just because there is a patent on combo administration, doesn't mean you can prevent someone from being prescribed RVX and a statin. Plus this combo drug is a new compound. It will have to be advanced through clinical trials. Its not like RVX is going to stop its 208 program simply to only advance the combo piece. RVX will live or die by its ability to get RVX-208 into a PIIc trial without too much destructive financing. I am not a fan of all the splitting technology out and planned future IPO's. I want to see 100% of money and management resources going towards a Piic trial. That is it.