...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Free
Message: Statistical Considerations

Agreed on that one but I can't comment on Don as I've said enough about him. I'm sure he is incredibly stretched and I've always believed he has the best of intentions for everyone. Remember, he has family in this. Obviously the incentive of driving a share price of $8 as per Beacon would generate about $36,000,000 for him if he could cash out. However, in my opinion, Don does not appear concerned with share price to raise capital (my evidence - no NASDAQ, no effective IR). He knows this is a much bigger game...in my opinion.

Opinion - I believe, without 1 ounce of proof, that Don understands that the potential of this entire package (IP, scaffolds, blood bank, processes, multiple indications, completed trials, etc) of science is worth far, far more than $8/share. And, my opinion, I believe that is why Don is having a very tough time with deals. As critical as I have been of Don I do believe he is tough and is not going to sell out cheap. He does not have to sell out. I believe (my opinion) that he will get the money for the trials. Fact - He always has!

Hartland, your post and the reply really got me sobered up and I can't get it out of my head. It really got me thinking because I have been far too positive. 

  • My opinion - I still feel very positive about the science of epigenetics and apabetalone.
  • Why (these are my observations and opinions and I am an expert in nothing) - Many factors such as the post hoc analysis, the discovery of the multimodal modal MOA of apabetalone, the many indications that apabetalone may apply to, the independent scientific research publications, the quality of the steering committee, the quality of the scientists involved with RVX and Zenith, the fact that we now know that other companies such as ABBVie (big money) are now into this territory, the results of the initial CKD trial in Australia, the funding by Eastern, NGN and CD Ventures, what appears to be a vote of confidence by Hepalink to get a big chunk of this company (my opinion - not a fact but they saved the company and now own 43% (fact) and I believe they want all of it (opinion). In the current study we have 6 successful DSMB reports. In my opinion this is very positive...think about what if the last one raised concerns? The DSMB said keep the ship going just as it is pointed! (my opinion -- great news).

But now that I am sobered up;

  • In my opinion we know nothing from a statistical reliability POV about apabetalone and 3 point MACE from the post hoc analysis of the combined trails (check the details for yourself - BDAZ did an excellent job or dissecting the numbers a long time ago). These trials were of approximately 6 months in length with small sample sizes. The 5 point MACE results were highly significant in very important sub groups AND this, in turn, seemed to lead to the design of the BoM trial.

But with input from the steering committee and I believe even the FDA (way back then) the primary end point of BoM became 3 point MACE.

So in simplistic terms we have a much longer trial with some patients already being treated up to 120 weeks (?4 times pervious trials). (opinion or question - this seems to be a much smaller trial that other CVD trials with CEPT inhibitors...I do not know if that is true but that is my recall).

So the top line results, it seems, will be based on the time to first MACE test (SOC + apabetalone) vs control (SOC) and (per most scientific research) this will be determined at the 95% confidence level (good...at least it is not 99%). I'm a mathematician and statistician (not a bio statistician) so I'm not qualified to understand the underlying statistical tests. However, if the statistical variances are large in one or both test and control groups even if there is a numerical difference in favour of apabetalone it may not be significant at the 95% confidence level.

  • This can occur even though there are highly statistically significant differences in key subgroups.

From what I understand (please correct me if I am wrong) 5 point MACE, which we know allot about, will not be presented at the top line analysis. I truly hope I am wrong.

So, if the simple total sample statistical difference for 3 point MACE turns out to be not significant at the 95% confidence level the stock price, just like (in my opinion) June of 2013 which I lived through and I didn't sell a share, will be the new reality sometime at the end of Q4 2018 or beyond.

  • My opinion is that the stock will be killed right then and there (pure conjecture - not facts) even though the IP and the potential will remain huge (in my opinion).
  • The story at this stage, if it happens, will be very interesting to say the least.

I have not sold a share nor do I intend to. I'll be here to see this out. 

Hartland, again thanks for your question! It really flushed things out for me. Hopefully I can get over my posting disease and just become a reader of the great posts on this site.

GLTA and thanks to all!

Toinv

Share
New Message
Please login to post a reply