Biotech Values

[iwfal]

RVX - David, thanks for responding

It's clear the drug produces apo-a1.

Agreed.

Whether it creates enough of it and/or whether the creation triggers the beneficial cascade that results in maturity to a1-HDL that can uptake fats and offload them into the liver is what ASSURE will tell us.

Agree that the risk is whether it creates enough of it - and whether that amount (or any amount) is actually beneficial. But...

disagree that ASSURE will necessarily tell us (the retail investor). RVX has made the primary endpoint the non-placebo controlled regression vs baseline. And the patients are being forced onto either Rosuvastatin or Atorvastatin as part of the protocol - and probably most at 1/2 max. As you can see from the below cite, for example, there is a reasonable chance that they hit stat sig on change vs baseline even if RVX-208 is almost worthless (since 1/2 max Rosuvastatin and Atorvastatin are, by themselves, fairly potent drugs).

http://circ.ahajournals.org/cgi/content/meeting_abstract/120/18_MeetingAbstracts/S963

My problem with RVX as a company is that they seem to put out a lot of misleading data and hide the more meaningful, but much less flattering, data. E.g.:

1) citing the very poorly done paper that says 1 mg/dl of Alpha-1 correlates to 26% reduction in CHD events. And not talking about the later, larger, checkset'd, and overall much better paper done by the same authors that shows a much less compelling 1 mg/dl of alpha-1 correlates to 3.3% reduction in events. (As an aside - that first paper is one of the best published examples I've seen of someone ineptly running a big complex statistical tool very poorly and producing garbage out the other end)

2) not giving the complete dataset topline on any trial - e.g. in the original trial ASSERT trial they just gave selected results from some subgroups. And for SUSTAIN, whose primary endpoint was HDL reduction, they gave just the p value and a few secondary p values. This allows the retail investor to continue to quote the HDL reduction of the ASSERT subgroup of a subgroup of the middle dose data. They can argue SUSTAIN was "a safety trial" - but the the original primary and secondary endpoints were originally HDL profile related. And SUSTAIN represents the biggest/longest treated population - the data (e.g. trends vs time) would be of interest to everyone (e.g. retail investor and md)

All that said - given that the drug does actually do what it was designed to do then if the Apo-1A is, in fact, the magic RLT device then it is possible that IVUS is stat sig. It is a wildcard that works both ways. But my concern is whether they will be forthright if the placebo controlled results tell them it is worthless. I'd bet no - that they will not be forthright.