Hey OTCShotCaller, that is quite the rap sheet! I figured you had some deep knowledge regarding clinical trials and the overall FDA approval process and I'm sure I will be leaning on you over the next few months as new information comes out and we speculate the timeline.
Here is my attempts to answer some of your questions, but I do welcome UB, CrabberMike and others to chime in.
1). do you foresee that ITV-1 will be rolled out as an adjunct therapy to Clone-3 or a stand alone therapeutic for HIV prophylactic prevention?
I think both. The company issued press releases stating that they believe in a synergistic effect with the combined technologies. I think this is the primary aim for the merged company. Considering that both drugs were developed independently, and are at different stages, they can be stand alone as well. I believe ITV-1 already passed the toxicology analysis in Bulgaria hence why ImmuneBooster which contains ITV-1 is already being marketed as a dietary supplement -- I actually purchased some online.
2). do you believe that revenue from ITV-1 will begin to fall to ENZC's bottom line relative to its current use outside of the U.S. as the company is awaiting its approval in the U.S. by the FDA...and if it that is part of the plan at Texas A&M?
Yes, I do believe we will start seeing revenues related to ITV-1 but before we do, Charles needs to determine the business model. They have several options, they could sell the product directly for the intended use applications and/OR they could license the technology to a manufacturer with an established foot-print to market and sell their product. I think they are going to go for the royalties approach as creating the subsidiaries are indicative as such. This keeps their core competency in research & development where they want to strengthen without having to build a commercial team (account managers, supply chain, customer service, etc).
3). Do you perceive that the Primate Studies for Clone-3 have already taken place at U.C. Davis or is that something that's still in the works.
I think this is something still in the works. From the Oct 14. PR they stated the following:
Final testing of BioClonetics’ anti-HIV recombinant mAbs in PBMC neutralization assays are being conducted to be followed by animal trials at the California National Primate Research Center, UCDavis (Davis, CA).
The Companies plan to conduct binding studies combining the therapeutics produced by both companies to evaluate the beneficial effects and increased binding capability of the BioClonetics Clone 3 antibodies to multiple HIV isolates.
PBMC based in-vitro neutralization studies will be conducted with the Enzolytics ITV-1 peptide in combination with the BioClonetics Clone 3 antibodies. Based on the results, the best combination with be tested in primate studies at the California National Primate Research Center University of California, Davis, California.
4)... my point is I am not sure what Phase Clone-3 is presently in?? What's your take on this?
I am hoping that the only Phases for Clone-3 to pass through are III-IV which should take less than 1-year, but it depends on A LOT of factors
Great question, I don't know the answer to this neither butI do hope you're right. Maybe UB has better insights here. I do however think that we were "selected" to participate at TAMU due to our potential COVID application. Everything happened so fast in these past 2 months to have been a coincidence with the global pandemic. Had it not been for COVID, would we have progressed as fast? I am purely speculating here, but I think COVID is whats getting us through the door for HIV. I suspect we may eventually get a EUA for the COVID application with an even more accelerated timeline highlighted under Operation Warp Speed.
Also - I completely agree with your price projections, 2021 is going to be a great year! I suspect we will have all of our filings by end of next week, and will be current the week after.
