Re: BETonMACE summary from Webcast 11/18/19
in response to
by
posted on
Nov 18, 2019 02:41PM
Thanks for this Bear. I have a different take on the data and would appreciate comments.
I see us having a clear drug for kidney disease. Page 21 is a stunningly great set of reasons why a Big Pharma will buy out RVX. However, offsetting this, is the fact that re Kidney Disease, this is considered only Phase 2...if I understand it right, Phase 3 will come in 2020. That will take another several months...and after that we can add 1 year to approval. The results are almost a foregone conclusion: I can't see how after such a long trial, any Phase 3 trial for only kidney disease will change anything. And it is more than enough to get the confidence up for anyone who wants to buy out RVX.
Since congestive heart failure and patients with low kidney functions behaved so well, that suggests to me that other end of life issues should also benefit. Like Dementia.
The problem is that while the rest of the date excluding CKD less than 60 is interesting...it shows no statistical signs of efficacy. My downbeat view is that we lost our CVD drug completing Phsae 3, but gained a kidney drug completing Phase 2. Maybe the CVD angle can be resusciated with extensive new tests...but it will have to be a much bigger bolt on trial...or even a completely different and full Phase 3 trial. This trial seems to have too many missing critical data on Alkaline Phosphatase, hsCRP etc. It is not just the power of the trial which is too low...there seems to be some incompetence in the collection of data. I sure hope I am wrong on this topic of data collection!
A way to fast forward our drug is that the FDA considers our drug a breakthrough in kidney disease...we speed through to approval much faster than expected.
The other data on our drug showing efficacy in low LDL is puzzling to me. I would have expected High LDL patients to show efficacy, not Low LDL. The whole premise of RVX208 was reverse cholesterol transport...and while HDL & LDL for the 2 groups went the right way...efficacy on low LDL is tough to explain.
IMHO, the market is freaking out because of its perception that we may have lost our CVD drug, and is not thinking of the kidney disease drug that we now have (and likely dementia drug), that we now own. Where the market may be completely wrong in its bearishness, is if the FDA gives us the green light for kidney disease...and hopefully dementia.
Iconoclast