Resverlogix
Past the rant about "hiding" the liver tox seen in ASSERT, people are correct to be cautious here. SUSTAIN hasn't been reported out in full yet, though management has been clear with us at least the rise in enzymes was transient and disappeared.
RVX-208 is a NME and a novel mechanism. apo-a1 boosting had its heyday in the early part of the last decade with Esperion, which we covered and made a a lot of money off of. All the BS with these CETP-inhibitors, which we also predicted, has confused the apo-a1 story for many people and taken the bloom off the rose of HDL-directed therapy (which RVX-208 is not, but that's a longer conversation).
Management indeed has a history. Hell, they had a toxic convertible when we started covering them and argued it was not a threat (now Don tells me to have CEOs considering toxics to call them so he can straighten them out). In the past four years, however, they got smart quick. They've been responsive to our questions, listened to our criticisms, took our advice into account, and generally have made smart moves. The best example of this is bringing Cleveland Clinic on board. It shows they are serious about generating quality data.
Regardless of how much management has improved over the last four years or how refreshing I find their attitude and excitement about RVX-208, the ASSURE trial is one big-ass binary event. Since almost none of us have access to options, that makes the risk even higher.
While I seriously doubt pharma will ignore stellar ASSURE data for long, I can also see the argument that drugs like RVX-208 are not the rage they once were. And even if they are, the Phase III clinical trial program any pharma is likely to launch will be expensive enough that pharma will want to be DAMN sure they know what they are getting before signing a deal.
Unless everything we know about the Reverse Lipid Transport pathway is wrong, I think the drug will work. Could everything we know about RLT be wrong? Sure. Could there be trial quirks in ASSURE that prevent us from seeing the signal? Sure. There is clearly risk here.
The bottom line is if ASSURE fails, anyone invested in RVX is going to get VERY creamed and, as investors, we HAVE to respect that.
David
Unless otherwise indicated, this is the personal viewpoint of David
Miller and not necessarily that of Biotech Stock Research, LLC.
We're on Twitter at BiotechStockRsr
