RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:FTHX HEARTLAND /MY SENTIMENTS EXCATLYHi GV.
Yes, BETonMACE FDA approval would be great. However, let's keep in mind that the zen3694 mCRPC trial is an FDA approved trial for prostate cancer. So that means the Zenith Resverlogix team has a strong relationship with the FDA. Zenith and Resverlogix are essentially the same companies (I'll get beat up for saying this) but the scientific platforms and underlying epigenetic scaffolds are similar (I need the science people to chime in here if I am wrong).
Don has stated that they are still working with the FDA for approval of an apabetalone trial for MACE or other conditions.
I had the impression that the FDA has still not gotten their heads around BET inhibition for MACE but various cancers are another issue and with the FDA approval of the zen3694 mCRPC trial it may open doors for MACE.
Also, there are fairly new regulations in the USA that almost provide quick FDA approval of drugs that test successfully in approved clinical trials in other countries. One of the science posters had explained this months ago and I forget what the law is called. However, if the futility analysis is passed you can bet that interest from BP and others will accelerate dramatically as will interest from respectable independent analysts.
I've begun to realize that, obviously, the scientific possibilities with these companies is far more complex than anything I can imagine and hence the business strategies are very complex. As I have posted previously I beleive that the Hepalink deal was a brilliant chess move by Don to the possibility of downstream marketing by RVX and leverage against BP. This could extend to various Zenith and RVX compounds as well.
I'm still not sure why there has not been a move on the rvx-208 (apabetalone) + rousastatin patents with AZ but this is still a possibility and the futility analysis will fuel this.
So I remain long. I do feel strongly that the science will pay out.
Also, I am encouraged by the enthusiasm of the entire team at RVX and Zenith. They all know they are on a very hot path.
I think we all agree that the shortfalls are on the communications side of both businsses. I am fairly sure that there is lots going on behinds the scenes in terms of business issues and I know and respect that RVX and Zenith cannot divulge certain information. However, improvements could be made on this issue.
We know the RVX share price is grossly undervalued. I believe that the RVX brand is viewed as a single compound brand (rvx-208/apabetalone) and is strongly associated with the "failed" ASSURE trial. IMHO, while ASSURE failed to meet the PAV regression target because the trial was underpowered and they picked the wrong target, the post hocs re MACE have been remarkable. I am so excited by the science and post hoc analysis that I feel strongly that the science will drag this company forward.
Lack of NASDAQ access, visibility and credibility is a clear drag on share price and the fact that Don does not seem to care makes it worse. However, the flip side of Don not seemingly caring is an indication of the huge upside that Don see's in the value of these companies. It is quite clear that Don, Eastern and NGN are not going to sell out cheap. In fact, with the Hepalink deal, the impending next regional deal and the structuring of Zenith Capital these companies may well become downstream producers and marketers with a steady flow of epigenetic compounds to markets based on many indications.
So while I have been very critical of Don I am fully behind the science. Also, Don seems to have provided strong team spirit and a positive culture and this is essential in a very complex business.
Cheers
Toinv