Re: Resverlogix Special Meeting Jun 30 9am MDT
in response to
by
posted on
Jun 30, 2015 04:36PM
Bfw,
Good point about the MACE numbers presumably including both those dosed with atorvastatin or rosuvastatin. In my best recollection, I don't recall RVX ever publicly presenting the MACE numbers for those only on rosuvastatin or only on atorvastatin. Does anyone else remember differently? Perhaps there is still cardiovascular benefit of RVX-208 + atorvastatin despite the seemingly more potent synergism with rosuvastatin. Maybe the statistics for the MACE were stronger by including patients from both statin groups. I imagine that the numbers were getting kind of sparse when they kept adding more filters (low HDL vs. moderate HDL, diabetic vs. non-diabetic, rosuvastatin vs. atorvastatin, etc.).
Here's a question. Can the European leg and China leg of the BETonMACE trial begin even while US FDA approval is still pending? In other words, is FDA approval required for the proposed BETonMACE phase III trial to be run as a Phase III outside of the US? We've posed these questions on the board before and I would love for RVX to blog about this topic.