Re: Positives & negatives
posted on
Sep 16, 2015 04:33PM
Hi Toinv,
I won't add to Bear's responses which are all well made.
One thing that I will say, and apologies if this has already been discussed, but my understanding now is that Assure failed because i) PAV simply doesn't work very well and in hindsight it was a bad end point to use and 2) the trial was too lipids focused.
The spectacular MACE results could never have been a result of RCT since the timeline was too short. This is not to say that RVX does not have a beneficial impact on lipids (it has been proven to raise ApoA-1 and HDL etc) but that the astonishing MACE results were due to reduced vascular inflammation.
The ongoing issue with getting a wider acceptance in the industry/BP is because the vast majority of the medical community is still very lipids focused. But this is changing and will continue to do so. I am sure we will get a tipping point at some stage.
I am sure RVX is choosing its patient population very very carefully for this BOM trial. It now has a very good idea of which patients it works best in (diabetics with low HDL and high inflammation).
And to be clear, this is not a really a lipids trial (hence my guess at the admin issue with the FDA). RVX is targeting a duabetic subsection patient group.
If BOM succeeds then I am sure a longer trial will then be done to show lipids results and then the market opportunity will expand.
I think this is a sensible strategy. It is incremental and focused and RVX is making sure it gives itself the highest chance of success in BOM. This is a far cry from Assure where RVX was trying to hit the mother of all home runs on the first pitch! But rest assured if BOM is a success it will still be a home run, and likely the first of many.
I think RVX has got a lot smarter since those dark days of Assure.
tundup