Replies to post #57428 on Enzolytics Inc (ENZC)

[Island Life]

Wow. GREAT READ. Had to read it a couple of times. Lots of good information. Thanks for taking the time to write this OTC

[UncleBilly]

Great Post! Longs and Bulls will be rewarded! So much upside here. Way over sold! Godfather and OTCShotcaller! Thank you both for the great posts.

[cybermich]

Great post.

I read GF's post yesterday asking for your take on things.. so I have been following this conversation:).. look forward to GF's response.

Exciting times ahead for ENZC.

[HOLYGRAIL]

Damn.....now that's knowledge.....thanks

[HOLYGRAIL]

I must confess......when i first heard about enzc in nov, i read most of your posts.....thanks again

[Catpole]

Outstanding information! Your expert opinion is greatly appreciated.

[VwapWickHunter125x]

Sorry OTC but do you have a linkedin profile we can look at?

[fb454]

Tremendous! Thanks for continually sharing your expertise with us.

[Jisep]

That’s awesome! Thx:)

[God_Father]

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.

[jaiguruji7]

Awesome post OTCShotCaller, totally agreed brother. TSUNAMIC SHIFT coming very soon, lots of multi-multi millionaires will be created soon and this stock and the merged companies will make history.

[maperatpogi]

Great! This $ENZCboard is truly amazing!
DD comes at best.

[bluebird50]

Great post.... yesterday someone was calling ENZC becoming current as a nonevent as far as price.... nothing could farther from the truth! It opens up to a whole new group of investors as well as them dropping news!
I’m excited to be in on this one and enjoyed reviewing your experience in this field!

Thanks

[elvis-is-here]

OMG...this is huge information:
https://www.protheragen.com/available-projects/a-neutralizing-antibody-against-multiple-hiv-strains/


From OTC Shot Caller's post:

"What throws me however is that it appears that early phase studies are already under way with the Contract Research Organization (CRO) Protheragen which shows it transitioning from Discovery to Pre-Clinical. https://www.protheragen.com/
"

[elvis-is-here]

All Souls Doubt, agreed, liked: "Quote:
Collaboration Opportunity
Protheragen Inc. is actively seeking partnership for our business partner to further develop Cl3hmAb. Potential collaboration can be strategic alliance, licensing, or marketing agreement.

[God_Father]

Reposting from OTCShotCaller inorder to sticky. Thank you for your insights;


Yes, thank you for that much appreciated!

I have worked with many clinical trials groups throughout the country at several university medical centers where various pharmaceutical companies placed their candidate drug trials in double blind randomized controlled enrollment groups on patient volunteers that fit the clinical criteria for the specific trials. At times we had up to five or six trials going on simultaneously that required a vast assembly of support staff. These were mostly Phase III-IV trials we conducted and reported on. Our group did not "work" for any of the pharmaceutical companies as we were all university medical center staff.

I do have some questions to pass by you:

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?

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?

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.

4). My perception is that Clone-3 will need to pass through all 4 Clinical Trial Phases before it can reach the commercialization phase, and that the Investigators at Texas A&M will have to apply for a new drug application i.e. an Investigational New Drug (IND) with the FDA before studies can commence. What throws me however is that it appears that early phase studies are already under way with the Contract Research Organization (CRO) Protheragen which shows it transitioning from Discovery to Pre-Clinical. https://www.protheragen.com/

So this leads me to believe that all that may be needed is Phase III/PhaseIV. All 4 phases of Clinical Trials are NOT always done at the same center, which I am most familiar with. Some drug companies contract out first to CRO's to save cost for early phase drug trials, and the CRO does ALL the filing for a IND with the FDA, hires clinical staff, and even has their own PIs in-house. So it takes a lot of time and responsibility out of the equation. So 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.

I doubt very seriously if Texas A&M would be conducting Phase I/II trials for reason they are mostly about FAST TRACK and would likely not place a candidate drug from the beginning because it is extremely time consuming and expensive. I can see them performing Phase III-IV however and for them that would be a breeze and as time progresses preliminary results should start making news within 6 months time by Mid-June IMO.

The main thing for right now is for major funding to come into place from multiple sources and for that news to hit soon. I don't think it would take more than 1 month MAX for that to happen, because it must come early in the unfolding of these events. When that happens, I can predict that a BigPharm will suddenly appear that's interested in becoming a partner for marketing and commercialization with licensing rights. This is what happened with Cytodyn which caused their PPS to sky rocket from 0.26 to $10 way before they were well into their various phases of testing.

IMO news release of a BigPharma partner is going to send the PPS well into the dollar range which I anticipate will happen by Spring or Summer next year 2021 if not earlier. When that happens we should transition to NASDAQ.

Within 12 months by the end of 2021 I fully expect that all phases of trials will be wrapping up with a trail of positive news in the wake of it all that will consistently cause a rise in the PPS with each and every news release. I anticipate these positive news releases will begin to come out by the end of the 1st Q 2021 and that the PPS should be North of $2 by then. Just with the STOP SIGN DOWN the PPS should explode into the $1-$1.50 range with the massive influx of new investors that are cash heavy for this type of play.

As you know there are already several physicians in this play who have plenty of money to invest. Some guys can easily throw $100K+ in with the blink of an eye. I have a colleague who is considering making the play when the positive news begins to come out of Texas A&M and I'm certain he's not the only one, and when that happens, he will likely invest North of $250K which to fund managers is a drop in the bucket.

When Fund mangers get involved there will be mega-millions pouring into this company weekly.

With these events transpiring moving forward over the next 12 months I fully anticipate that the PPS will be North of $10, possibly a lot higher, i.e. all phases completed and reported, BigPharma named as partner, fund managers investing early in, financial world whales swarming this stock continuously,etc.

As with me, I will continuously build my position regardless of what the PPS is at any given time. To me, it really doesn't matter, but RIGHT NOW of course is the best time at the ridiculously low PPS, but that won't last long!

When that STOP SIGN comes down it's going to be a WHOLE NEW GAME!!! 100% Guaranteed! The MM won't be able to hold it down any longer due to the enormous BUYING pressure flowing into the stock DAILY!!

Will there be dips, consolidations, etc? Of course, but nothing like we've been seeing with the MM and his basked of short sell dumping of shares plunging down the PPS artificially like a plumber. His days will be ending real soon so I hope he's looking for another stock to flush!

I'll look for your reply.

Thank you

Be well and prosper...