RE:There's a reason I only post about the chart....Hi ledrog. Interesting perspective. Thanks.
The reason that I am replying, other than to say thanks, is that I am also getting the same perspective regarding certain groups or individuals loading up. I mentioned something like this in a post a few weeks ago. I've been doing some checking on this hypothesis but don't have solid evidence.
Different investors have different objectives. Personally, I'm long.
I think the odds for success in the BETonMACE phase 3 trial are very high IMHO and I am a mathematician/statistician and not a scientist so DYOD. My reasons are as follows.
- The post hoc SUSTAIN/ASSURE analysis of diabetes mellitus patients with CVD that discovered relative risk reduction (RRR) of MACE of 77% is extremely important discovery because this is a huge problem with obesity and hence type 2 diabetes growing at exponential rates.
- The RRR target in the BETonMACE trial is set at a level much lower and I recall it might be 30%. (this data is in previous posts with replies by the science posters) So I did some calculations based on the combined SUSTAIN/ASSURE analysis to calculate the functional significance (the actual level of MACE in patients treated with rvx-208 and Crestor) and to roughly 12 to 14% MACE levels after 210 days in the combined trials. So I asked the science posters if in BETonMACE in the control group (Crestor only) had MACE levels of 20% and in the rvx-208 + Crestor group had MACE at 12% to 14% each at day 210 would thus be considered a functionally (as opposed to statistically) significant finding for BP and the answer was YES. (note, statistical significance will be a function of sample size at any point in the trial). This implies a greater probability of achieving the primary end point is much higher than in the SUSTAIN/ASSURE analysis and would be of value to BP.
- In the combined SUSTAIN/ASSURE post hoc anaysis the MACE rates in the control group(Crestor only) began to accelerate with an exponential pattern starting at day 150 so who knows what would have happened after 210 days? In the test group (Cretsor + rvx-208) MACE was low and increased at a diminishing rate through the trail.
- I have started to understand the significance of choosing MACE as the end target. In ASSURE rvx-208 TAV (total atheroma volume) and 10mm worst occluded TAV were met at very high statistical significance with p<.001. Additional secondary lipid biomarker endpoints such as HDL and ApoA-I were also met 10.73% p<0.001, 11.69% p<0.001, respectively. Change in PAV - The RVX-208 treated group had -0.4% median plaque regression (p=0.08) but the target was -.6%. My point is the key biomarkers may not be reflective of the true biochemical pathways nor in fact may be the PAV targets. BUT MACE reduction regardless of how it was achieved was significant and it is a bottom line variable - it outwardly improves and probably prolongs lives.
- The trial design is progressive. That is not the right word but what it means is that at various times in the trial they can tally up test vs control MACE and get an idea of the trend before the targeted endpoint.
- The scientific team seems strong.
- NGN and Eastern have been continuous supporters.
So if people or groups are quietly accumulating shares I think I understand why.
I'm becoming an earworm to myself...this is stuck inmy head so I need to find a new tune.
GLTA DYOD IMHO
Cheers
Toinv