r/Livimmune•
MGK_2

The Purpose

Welcome here All.

Disclaimer: This is my interpretation. This is how I see this unfolding. I hold this perspective because of the CCR5 blockade we own. You should form your own opinion though. There are hundreds of journal articles on the subject from which you may form your own perspective. The authority is what is written in those articles. Something as good as what CytoDyn owns shall not be laid waste.

The war with the shorts. The share price at rock bottom prices. The war with the Market Maker Manipulation is not what this is all about. What this is all about is what CytoDyn is doing right now and has been doing for the past 2 years, but with a twist. Now, instead of being both shackled and imprisoned, CytoDyn has been released from its holding cell, but hasn't quite yet managed to get the shackles removed off its wrists. CytoDyn remains though in a Preparatory Phase. CytoDyn is doing all this in preparation for the Purpose that they will be able to fulfill the ultimate goal of obtaining leronlimab approval. Inevitably, beyond the shadow of a doubt, this war shall be won. All battles, all fronts shall be overtaken and overcome, because the weapon we wield is unstoppable and that is my reasoning.

With that in mind, the next thing of Purposeful, preparatory importance is the lifting of the new hold of leronlimab on the indication of inflammation and immune activation. But to reach this goal, CytoDyn needs to submit the new clinical trial protocol for this indication and the FDA needs to approve that protocol. Then this interim hold shall be lifted which then enables CytoDyn to proceed in doing what it has been prevented from doing for the past 2 years, which is the execution and running of clinical trials. Specifically, CytoDyn is intending on carrying out the clinical trial that it is submitting for approval. The timeline being the end of January 2024 for CytoDyn's submission of the protocol. By the end of February for FDA approval which probably will go into March while the May-June time frame is slated for trial commencement. December 2024, trial conclusion if all goes well.

This intended indication is one which no other HIV drug maker is pursuing. Actually, it is an indication which no other Big Pharma is pursuing. CytoDyn is seeking to show that leronlimab is capable of significantly reducing and reversing long-standing inflammation within patients in whom inflammation currently is rampant, where inflammation is flourishing even, in patients within whom inflammation has been existing for years and years. CytoDyn shall show that almost immediately, upon the initiation and continuation of weekly leronlimab administration, that these Biomarkers begin continuing to reveal the opposite effect of inflammation; that inflammation is reduced and even reversed into its opposite form which is proliferation.

This is not such an easy indication to prove, by the way. As I have explained, within these patients, there are multiple Biomarkers at play at any one instant. Some Biomarkers work towards increasing inflammation, while others work towards increasing Proliferation. Some are activated for inflammatory purposes, some are activated for proliferative purposes, some are standing still, waiting to be activated. The goal is to determine a means by which the level of inflammation, proliferation and immune activation may be calculated. Biomarker evidence exists which shall be extrapolated to indicate and prove that leronlimab effectively can induces the appropriate biochemical changes within the body that induces a slow but steady reduction in both the rate of inflammation and the rate of Immune Activation while slowly but surely increases the rate of proliferation.

Once that equation or formula is determined, then prior to the trial commencement, the patient's blood serum is drawn, Biomarker analysis made, and the base line levels of these output variables provide the patient's baseline level of inflammation, immune activation and proliferation. These variables are calculated and derived with the use of the formula / equation. Then, the drug may be administered weekly, and initially, repeat serum samples are obtained, also weekly at least for the first 2 months to uncover the rapid changes in immune activation which are induced by leronlimab administration. Comparison may be made between each new serum blood sample and the baseline blood sample and also with the previous blood samples to uncover the overall changes/reduction in inflammation as well as the interval reduction in inflammation and immune activation and interval increase in proliferation. CCR5 Receptor Occupancy might also possibly be measured. After 2 months, the blood serum sample rate is lengthened to every 2 weeks for 2 more months and then after 4 months, sample rates would be monthly.

Because of the difficulty in the determination of this equation or formula, I believe CytoDyn will need to make use of their AI partner to obtain such an equation. I put down a raw concept of what that equation might look like towards the end of that article, but that was a gross and raw expression and would require significant refinement before it could become a working solution. Refinement based on the units of measure, based on normal human levels, based on levels of excess and levels of shortages of these Biomarkers. Possibly, the presence of one Biomarker should amplify or multiply the quantities of other Biomarkers or attenuate or Divide by the quantities of other Biomarkers or exponentially increase or decrease. etc...

That is why I'm thinking AI will be necessary to assist with the determination of this equation based on normal human levels of these Biomarkers in patients who are not inflamed. Possibly, before the trial starts in June, say in the months of March & April, blood samples from normal individuals are obtained to see the "Normal" or "Inactivated" interplay of these pertinent Biomarkers and with the help of AI, the formula may be derived from this database. Then, the blood work in these Inflamed patients may be compared to what is normal and also to their baseline as the trial proceeds. The calculated outputs of the equation will be compared to what is normal and also to their baseline measurements.

Once this trial is underway, CytoDyn can feel proud in this achievement, because the circumstances which they were forced to exit out from under, were no less than insurmountable. Yet, CytoDyn will be successful in overcoming them. Yes, this becomes the turning point, when the trial is initiated because, that would be the proof that CytoDyn found the avenue that leads to the commencement of the next steppingstone. The ordeal CytoDyn has been through over the last 2 years, and by the time the trial does initiate, it will be nearly 2.5 years, everything CytoDyn has done during this time would have been done for the Purpose to initiate this next trial. Then, CytoDyn shall be truly free. Free to operate towards a very meaningful goal. Free not to spin its wheels. Free to operate in Peace. Free to operate in Safety from enemy attack. All for the Purpose of leronlimab approval, not for CytoDyn's benefit, but for the worlds benefit.

During this time and even from prior to that, CytoDyn has been displaced away from what it should have been focused on. Were all the previous years a waste? No, the previous years were not a waste. Unbelievably, all the work done did not result in an HIV approval, nor will that work lead to such. An excess of $1 Billion lost to a sabotaged trial, but a portion of which soon shall be recovered. But the accumulation of that work did reveal the capacity which this drug holds. Regardless, that should not discount the hurt and harm which has been caused to many shareholders here. Many counted on the HIV for MDR BLA, not just shareholders, but patients as well. This BLA was worked on for years and years only to be entirely botched. Now, when the data has finally been straightened out, enough time has been given to the enemy to make our drug unnecessary, obsolete even for this indication, so the entire indication was scrapped.

Many were thinking that with the lift of the hold, the BLA would be resubmitted, but instead it was canned. Now the hope is this new indication and this pending formula. This is what is important now. This shall lead to the commencement of this coming trial. This trial will justify everything CytoDyn has done in these past 2 -2.5 years and it will allow CytoDyn to feel confident going forward. As I said above, inevitably, this war shall be won by CytoDyn. The trial shall initiate, and the preliminary results prove out the thesis.

CytoDyn must do what it must do. Yes, It will take CytoDyn time. But you never know who/what might step in at any moment to speed the work up. You just never know. Right now, the benefit of this difficult indication is that it has zero competitors. All the competitors do not exist. When it is seen that CytoDyn has an indication that nobody else is involved in, an indication with zero competitors, do you think that makes CytoDyn look attractive as a partnership candidate or as a buyout candidate? Certainly, Big Pharma is aware that the indication does not only serve HIV transexual patients. That it can also serve the majority of inflamed patients who have high active immunity. Diabetes sufferers, Rheumatoid patients, Patients suffering with Cancer, MASH, Covid, etc... You never know, right Pitt?

I suspect that once CytoDyn actually proves that the formula works, when it can show, beyond a shadow of a doubt that with the administration of leronlimab, a patient laden with the burden of inflammation, is quickly restored back to a level of minimal inflammation, to a level even of proliferation, who is at normal levels of immune activation, that then will be the moment when CytoDyn is recognized as a massive takeover candidate. That is how valuable this work is to uncover this equation. Right now, it is also a candidate, but once that is achieved, the uncovering of that equation which proves out this indication and that it shall accomplish what it is intending on doing. What it is intending on doing is no small indication. There are tons of merit behind the reasoning and justification to determine this formula. The elimination of inflammation is no small feat. There will be demand, big demand. And Big Pharma will be watching.

Once that happens, the world opens up to CytoDyn because it will be given a place where it can operate free from the interference of its enemies. And none of its enemies will be able to touch it because none of its enemies are even in the space. None are even attempting to reduce inflammation. None of its enemies have anything to do with the reduction of immune activation. None can take an inflammatory state and transform it into a proliferative state. I think this is why most of us are here. Because it is inevitable. It is going to happen. It can be at any time you know, but the closer we get, the more likely it does happen. Many amazing things could happen between now and the end of the year. Once this concept is proven, it is just a matter of getting it done. As time passes, more will be revealed and uncovered. If the news which follows is attractive enough, it could be bought out before the trial even begins, during the trial or after the trial ends. Once that happens, Cytodyn's enemies have no chance left and they are eliminated from the race.

Consider if no hold ever had to be lifted. Consider if no new indication had to be pursued. What would CytoDyn now be doing? Would CytoDyn even have Dr. Jay Lalezari leading it? The same as it ever did was to chase our tails. Now, this is being led by the FDA. It is being guided and yes it will take time, but it is to achieve an inevitable goal of leronlimab approval. Everything has a purpose. Everything has a role towards the achievement of this goal. 2 years ago, CytoDyn made up its mind to overcome what Amarex did to it. CytoDyn made up its mind to achieve what so many are thinking is the impossible. The approval of leronlimab. The purpose of this is not to win the war for CytoDyn. No, the purpose is to win the war for humanity, against the expensive Big Pharma drugs with one small and finite indication with minimal solutions and benefits. This new indication that CytoDyn shall prove out clears the path for leronlimab approval, for CytoDyn buy out and partnership because this new indication has no competition. All of CytoDyn's enemies are cleared out with this indication.

Without this new indication, CytoDyn would be dealing with BP on the other indications over and over again. We need to wait for this indication to be proved out. Then we can worry about MASH, Cancer, Covid, Alzheimer's, etc... Dr. Lalezari thinks he can get the protocol out by month's end. He said it and I believe it. FDA has 30 days. They probably will take longer. But, they get back to us before the end of the 30 days. They are helping us in the intended Purpose. Once it is proved out, we are golden. When this indication is behind us, CytoDyn is master over all those other indications: Over MASH, Over Cancer, Over Covid, Over Alzheimer's, etc...It is inevitable. This is how I see it. This is how I put it together. I have the same window as you. So, I'm speaking to you on my same level. No looking glass, just what I see unfolding as my understanding of all this. Read the journal articles yourself and see what CCR5 blockade is capable of. That authority is available to all. I'm just figuring out what that really means when it comes to the owner of the IP of the greatest CCR5 blockade of all. And I put it here for scrutiny, so I can get it correct.

Posted Jan 2, 2024, 12:36 PM UTC

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