r/Livimmune•
MGK_2

Standing Tall and Confident

Welcome Back My Friends and Greetings to All of You.

The Peace Treaty Is Written. It is in the hands of the reviewers and approvers. "...the Company has submitted its revised HIV clinical trial protocol to the FDA. The Company believes this submission will lead to the removal of the clinical hold currently in effect*.*"

The Peace Treaty under FDA scrutiny for approval is the protocol for CytoDyn's 1st clinical trial. Once it is approved, the lifting of the second clinical hold on leronlimab immediately follows.

With an incoming FDA acceptance of the proposed protocol for the clinical trial slated for this month, then the hold on leronlimab lifts. The war CytoDyn has been waging for the past two years finally comes to an abrupt end with CytoDyn on top, victorious in their mission despite the odds stacked against them. Since Dr. Lalezari is as confident as he is, so I too am accordingly confident. CytoDyn now waits. It is again Under Pressure, but it is completely used to such high-pressure situations given all the scars on its face.

As many of you are already aware, given the work which CytoDyn recently submitted and the subsequent lifting of the first clinical hold on leronlimab, it can be understood that CytoDyn now operates in accordance with FDA standards. Opposite to how it once operated, CytoDyn now functions in conformity with the rules and regulations imposed by the FDA. Despite these somewhat stringent limits, CytoDyn is also very much goal oriented, and has a rather lofty ambition. They know precisely what they are after. They have already seen and appreciated in much anecdotal and even clinical evidence, their drug perform exceptionally well in the goal they have set for themselves. In addition, they are not alone in this quest. They also have incorporated the suggestions input by the FDA. "CytoDyn’s CEO, Dr. Jacob Lalezari stated, “Our HIV protocol has been revised and resubmitted following FDA input*, and will study leronlimab in HIV patients who have increased inflammation and immune activation, which causes heart attacks, strokes, and other vascular events. We believe this protocol will help* clarify the mechanisms by which leronlimab can be used as an immune modulator in HIV and a variety of other therapeutic areas*.”*" CytoDyn is not willing to compromise on this indication, and considerable effort has been invested in making it an absolutely perfect submission of the new clinical trial protocol. Therefore, CytoDyn's victory in entirely eliminating the second clinical hold placed on leronlimab is at hand, at our fingertips. CytoDyn is so close to all but putting this nemesis once and for all forever behind us.

Remember, this is the means by which CytoDyn remains independent. This new clinical trial establishes and solidifies CytoDyn as the sole provider of this unique, one of a kind, CCR5 Cytokine blocking medication as a powerful Attenuator of Inflammatory and Immune Activation. I don't believe that such a drug even exists. Auto-Immune disease, such as Lupus, Rheumatoid Arthritis, Polymyalgia Rheumatica, Psoriasis, Chron's Disease and the like are diseases that have Immune Activation turned way up. Even some of the drugs in use today, say for instance, TNF inhibitors, (Humira, Remicade, Enbrel, etc...), seem to work by enhancing the Tumor's advantage. Think about it, Tumor Necrosis Factor Inhibitor. Why would anybody want to inhibit that bio-chemical substance TNF that necrotizes tumors? Well, that is what is out there, solutions that just don't add up, that just don't make sense. CytoDyn is on the verge of something far more sensible, far more effective and something that works at the heart of the ImmunoRegulatory and ImmunoModulatory system that effectively modulates and attenuates the balance between Immune Activation and Inflammation back down from elevated levels to normal levels. The new clinical trial proves beyond a shadow of a doubt, that a patient's ramped up level of Immune Activation may be dialed way back down to normal levels, SAFELY. This coming clinical trial solidifies and positions CytoDyn as the sole provider of the only Attenuator of Immune Activation and Inflammation on Earth.

I believe that with such a vast cloud of BP witnesses who watch CytoDyn ever so closely, what they are fixing to learn is that they are about to be left up a creek without a paddle. They are fixing to learn that they won't be able to compete with this Attenuator of Immune Activation and Inflammation. Yes, leronlimab does not interfere with the Immune System's capacity to develop all the appropriate defenses, such as all the anti-bodies and all the bio-chemical mechanisms employed against pathogens but does allow for a functional and life preserving bypass of the unnecessary and unwarranted severe and critical level of Inflammation that is associated with the ImmunoRegulatory process in cases of severe, critical stresses and insults imposed upon the body. This type of drug that Attenuates Immune Activation and Inflammation and also permits the ImmunoRegulatoryModulatory cascade to fully carry on while attenuating the Inflammatory Cascade does not exist in the world aside from leronlimab. This is the road being paved today by CytoDyn and this road is full of potholes for competitors who might try to do in part what leronlimab does in whole. Only leronlimab paves this roadway smooth, competitors just get bounced off trying to compete or are plagued with flat tires. This is why they are so scared of the drug and of the coming trial. While leronlimab is ready to lay down the asphalt, they don't even know where the road to be paved begins or ends.

It appears that CytoDyn comes out on top very soon with the FDA acceptance of CytoDyn's new clinical trial protocol. Peace therefore stands right around the corner. With the acceptance of the new clinical trial protocol, as cream rises to the top, so does a new standard in health care also begin its ascent to rise to the top, being a standard with no competition. After the burden of proof is made, many companies shall want to own what is CytoDyn's. Had CytoDyn not been so burdened with debt, plagued with censored anecdotal accounts and all the rest of the associated turmoil, it would have been a much different story today. It is what it is. Via pressure of one form or another, they attempt to confiscate for themselves that which does not belong to them. They attempt in whatever manner they can conjure up, to keep the hold in place upon leronlimab or to keep the trial from commencing. These are their tactics. They seek to find problems with the submitted protocol or find ways how to interfere with the parameters of the protocol. But CytoDyn owns the IP. It has money coming in. It does not have to bow its head or concede to any Hostile or unfavorable deal. That is, my friends, in a nutshell, why Mr. Mitch Cohen is on board. To prevent such Hostile Takeovers. Who would have thought? A finished company like CytoDyn requires the likes of a Mitch Cohen to demand for it top dollar? Why? For humanitarian reasons. The molecule is that important for the future of mankind's health care. Cohen needs to prevent a CytoDyn division, at least one in which such a low-ball bid offer could be made. The company remains intact as one complete unit, until it successfully partners or is bought out with a substantial offer which takes all facets of the company along in the buyout, thereby incorporating everything in with the buyer.

This is what Interim Executives say about their company and about their executives.

The company is selective about working with truthful individuals who provide the full situation and are at a point of transformation*. Companies seeking interim executives are* either experiencing a problem or are about to have a major breakthrough, requiring additional resources*. A* bias for action is a key characteristic sought in companies that work with interim executives. Interim executives need to demonstrate a strong bias for action as well*.*

Companies that work with interim executives are usually at a point of transformation*, either facing challenges or on the verge of significant growth requiring additional resources. A key characteristic of good fits for interim executives is a* bias for action, where the company's board and ownership are also inclined towards implementation and execution*. The third defining point for a great match between a company and an interim executive is the* potential for big impact, emphasizing the need for significant results rather than minor changes.

The key qualities needed in interim executives are strong operations, implementation, and execution abilities*, which should also be reflected in the company's board and ownership. A great match between a company and an interim executive* must have a significant impact, and the engagement should not be approached as simply finding a warm body to fill a seat. Interim executives are only engaged in projects that have a huge impact, such as saving or improving companies and operations*, as well as contributing to incredible growth, new product launches, and overall improvement to teams, communities, and the world. The deployment of great talent in interim executive roles is crucial, similar to how a private equity fund carefully deploys its investments, as there is only one chance to recommend where these executives should work, and it must be with great impact.*

In my humble opinion, it is amazing that we are still talking about a hold on leronlimab. Now, I understand that it is a hold on the clinical trial protocol, but a hold none-the-less. Now, why is it held?
It is still held because of the implications or consequences of freeing up this particular Attenuator of Immune Activation and Inflammation out from under their lock and key. Why has leronlimab been placed in solitary confinement? Because of the sheer consequences of this new indication. Mitch Cohen realizes the utter vast potential of this drug and works to prevent any Hostile Take Over attempts while working towards a fair and successful merger and/or acquisition. He realizes that CytoDyn is on the threshold of winning this battle that frees CytoDyn up to begin its work on the new clinical trial and therefore he prepares financial contracts which rapidly and tremendously escalate CytoDyn's inherent value following the hold lift.

This is a big deal. To get the hold lifted is to unlock the handcuffs on CytoDyn which is to free up leronlimab for clinical trials. This allows CytoDyn to again participate back in the game of clinical trials. It allows leronlimab to make a name for itself, in an indication which nobody has yet ventured into. Like the Starship Enterprise, To Boldly Go Where No Man Has Gone Before. That is toward an indication that Attenuates Immune Activation and Inflammation. CytoDyn is fixing to enter this vast and broad indication alone, through a narrow door of HIV infected transgender females and CIS gender males who have high levels of Inflammation and Immune Activation. As the trial proceeds, and as proof is uncovered that leronlimab is successful in the goal it is chasing, so it also becomes increasingly more attractive to the cloud of BP witnesses. Many companies might not believe CytoDyn at the current moment but do demand proof, and as CytoDyn makes its case, companies quickly become increasingly more willing to pay that much more with what they learn until eventually, their offers become very acceptable to CytoDyn's BoD and CytoDyn shareholders.

Why am I thinking that the new clinical trial is to be executed much more simply than I originally considered? Dr. Lalezari wants to KISS. Keep It Simple Stupid. The trial definitively defines leronlimab's capacity to attenuate Immune Activation and Inflammation, but it does so in a simple to understand manner. Certainly, the GBM study, run by Dr. Lalezari's father, shall be executed rather quickly, given that the study is a murine (mouse) study. Remember, 1 human year = 1 mouse week. So, in essence, a mouse/murine study is about 52 times faster than a human trial. Once the murine study is over, it gets transformed into a Phase II human clinical trial in GlioBlastoma Multiforme.

I'm thinking Mr. Mitch Cohen, Leadership Team was a result of Mr. Migliarese being too expensive while at the same time Cohen with the experience that handles the coming mergers and acquisitions. Mr. Mitch Cohen, as he accomplished in his past, so shall he in our case perform once again. "Mr. Cohen also has experience in public accounting with an emphasis on financial audits of hedge funds and mergers and acquisitions engagements." Cohen can work behind closed doors undisturbed by shareholders, undisturbed and away from the FDA, doing the necessary work to make it a safe abode and a peaceful abode. Shareholders are looking for higher share prices and that is what Cohen intends on delivering eventually. To boot, Cohen is likely presenting arguments while negotiating with Amarex for a settlement. I'd say he is involved in that too.

CytoDyn is at a position where it appears that it is going to win. Why else did CytoDyn bring on Mitch Cohen? Surely, if they believed they would still be struggling with getting the hold lifted, they wouldn't bother bringing on a mergers and acquisition specialist. Doesn't that act alone speak to their utter confidence in their submission? The lifting of the second hold should happen this month. That lift of the hold brings with it immense Peace. Even now, there is significant accumulation of the stock at these prices. When this Peace is being spoken of, no longer shall leronlimab have any restrictions placed on its use. Patients can feel that it is perfectly safe. CytoDyn has Mitch Cohen along with Dr. Lalezari at the helm pulling the trigger, intent on winning this war. Shareholders are getting excited about getting the drug back, and about the return of clinical trials. Cohen now wards off any attempt at Hostile Takeover by bolstering CytoDyn's internal strength, with the preparation of contracts for merger and acquisition. CytoDyn stands tall and confident against any and all unwanted antagonists. CytoDyn stands tough, on its own, capable of defending its ground.

At least, this is the way I see it unfolding. Seems to be coming together, and now it is forming a tip. Things are falling into place. Lalezari took the reins and executes the plan flawlessly. Don't take my word for it. Do your own research and due diligence. Next incoming event should be the positive feedback received from FDA.

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Posted Feb 11, 2024, 2:29 PM UTC

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