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Message: Something Doesn't Add Up

Hi SanFran.

I think we know why the billionaires are in and seem quite happy and the reason is the science. This company has made continuous progress in developing, patenting, and, over the past 2 years uncovering and understanding the MOA of rvx-208 and it's cascading epigenetic effects.

This information has been published in a number of presentations. BDAZ has explained the power of the information about how rvx-208 works.

The focus on MACE as the primary end point represents a significant change and is a focus on life saving and quality of life issues AS WELL AS huge savings to the health care system. Based on post hocs we know that rvx-208 in combination with Crestor in patients with DM and CVD and low HDL achieved a statistically significant relative risk reduction of 77% and this was also functionally significant. Specifically, MACE events in the control group (Crestor only) were about 20.6% at 210 days. MACE events in the test group (rvx-208 + Crestor) were only in the 5% range. This is a huge success which could be extrapolated to the full market and based on some estimates the market is in the $billions annually.

So to put the functional significance into perspective lets take a hypothetical disease population with the following characteristics.

  1. Contorl group has a MACE level of 2% at 210 days (length of dosing for ASSURE and SUSTAIN).
  2. Test group ends up with a MACE level of .46% after 201 days.
  3. Let's suppose the sample sizes in each group were large enough to be statistically significant at the 99% confidence level (p=0.01).
  4. Then the relative risk reduction would be 77%.
  5. However, this only represents a 1.54% absolute reduction in MACE whereas with rvx-208 + Crestor the level was about 15% points - ten times larger than the example!

I'm not a scientist but to put the "primary end point" into perspective recall that in the Fierce Biotech article about PCSK9 blockers evolocumab, alirocumab and bococizumab all lower LDL but it is unknown if these drugs reduce MACE. These drugs are going to market!!!

  • I'd much rather be invested in a drug like rvx-208 which does reduce MACE in combination with Crestor within very large and growing patient populations (DM, CVD and low HDL). PLus a related disease, CKD, may well receive benefits.
  • Also RVX holds long term patents for rvx-208 + rosuvastatin (Crestor) in many countries.

I do believe that there is a gap in understanding between the investment community and the scientific community regarding the potential power of epigenetics and the fact that RVX has been exploring epigenetics for at least 8 to 10 years.

Currently, communications from RVX is to the scientific and pharma markets. Their communications means very little to investors, IMO. But we all know this. I believe their reason is that they believe they have a blockbuster and the wider investment public is irrelevant. There will be a point where there a bidding war between BPs and Ken Dart and NGN understand this.

The Hepalink deal was a very significant achievement.

So for me I'd give that following ratings at this time;

  • Management - C+ and will become a B with the next regional deal and with a a CVR deal an A+++.
  • Science - B+++ and will become an A+ with phase lll BETonMACE approval by the FDA. Also, announcement of the first dosing in the European Union will be a significant achievement.

Regarding a Zenith IPO I would say don't count on it for a few years. I have some info that the firm commitment by Don in the Zenith update for a 2015 NASDAQ Zenith listing has shifted from a definite commitment to a "it would be nice" type of positioning.

GLTA

Toinv

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