Take some time, get a cup of coffee, and read

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Take some time, get a cup of coffee, and read below!

Thank you MGK


Laying Low
Hi Folks,

Let's get right to it. There are a couple of points to make, so let's get started.

CytoDyn needs to tread lightly, and I believe they are. CytoDyn has a huge announcement to be made at the January MASH TAG conference, but it shouldn't be hollered from the roof tops, rather, maybe CytoDyn should be Killing It Softy.

"The results from this preliminary study demonstrated that high dose leronlimab was significantly better at reversing liver fibrosis compared to an IgG 4 isotype control and demonstrated a trend toward better fibrosis reversal compared to Resmetirom. The final results from that study have now also demonstrated that leronlimab (both high and low dose) was significantly better than Resmetirom at reversal of fat deposition (steatosis) in the liver. These exciting findings have been submitted as a late breaker abstract to the MASH TAG conference and, if accepted, will be presented at the meeting in January."

First concern is that Madrigal is hosting the conference. Secondly, There is a huge emphasis on GLP-1 Agonists. Third, no mention of CCR5 blockade. The Surmount-5 Clinical Trial that compares Tirzepatide to Semaglutide has come to a close and the results are likely to be discussed in the conference. The Big Pharma involved have no interest in hearing anything but GLP-1 Agonists.

But, CytoDyn is already aware of these GLP-1 agonists.

"In September, CytoDyn launched two follow up studies to confirm and expand on these preliminary results. The first follow-up study seeks to confirm the observations of the original study with larger cohorts of mice (12 versus the original 8/group) and will compare leronlimab with a GLP-1 agonist (Semaglutide) in addition to confirming the comparisons with Resmetirom*."*

I've discussed these GLP-1 Agonists in Mash Free For All, but if you're looking for more regarding MASH, consider, Vast Indication On The Horizon, Mash A Jewel Of Leronlimab, Mash Melee.

MJS719 makes a good point:,

"Dr. Mazen Noureddin was a consultant, advisor, and speaker for CytoDyn two years ago and today he is on the Scientific Advisory Board Committee for MASH-TAG Conference 2025.

Maybe we will have a great update on Monday as to the submission CYDY management made for the Thursday, January 9, 2025 conference.

January 6 is the deadline for submission and they had open spots 2 weeks ago, so maybe we will be presenting (although the current prospectus does not show it)."

CytoDyn certainly should present this keen information and the appropriate hearers of this information shall be present, there to see it, however, an excessive boasting of the results should not be done. Our competitors are being backed into a corner as we speak and we all know what happens to a wild animal when cornered. Let's not flaunt our highpoints too soon, but they shall be quietly disclosed.

There is very little out there that CytoDyn can trust. The only ones out there who they can trust are their AI collaborating partner, their CRO, their collaborating trial sponsors, their shareholders and themselves. There is no mention of a CCR5 blockade on the MASH-TAG prospectus. Nobody has a solution yet for liver fibrosis except CytoDyn, but it isn't being brought up. It seems as though it might even be suppressed for the time being. However, CytoDyn's fantastic news shall be discussed, mentioned and heard, but it won't be boasted upon, but the facts shall be conveyed.

"The second follow-up study involves the administration of CCL4, a drug that directly causes liver fibrosis in mice. This study will clarify if the observed reversal of liver fibrosis is restricted to the MASH/fat deposition pathway or might occur independently of the etiology of fibrosis (e.g. alcohol, viral hepatitis, etc.)."

When these facts are deemed to be truths, CytoDyn lands a Pulmonary Fibrosis Pilot Study that shall assess leronlimab vs the fibrosis caused by a Pulmonary Pathologic Process, IPF or Idiopathic Pulmonary Fibrosis.

"As a side note, we have been contacted by colleagues at a major academic institution who indicated that, if the liver fibrosis reversal results are confirmed in the follow-up studies, they would be interested in funding a pilot study of leronlimab in the treatment of patients with pulmonary fibrosis at their own center."

Including MASH and Pulmonary Fibrosis, CytoDyn has a slew of other focus points.

MicroSatellite Stable metastatic ColoRectalCancer Clinical Trial beginning in January

Two preclinical studies in TNBC

Follow-up preclinical study in GlioBlastoma Multiforme

Possible Pilot Study in GBM based on outcome of preclinical study.

Results of first MASH murine preclinical study to be presented in late breaking Abstract at MASH-TAG.

Two follow up MASH murine preclinical studies should conclude in January, 2025.

If liver fibrosis is reduced regardless of its cause, a major academic institution would fully fund a Pilot Study of leronlimab vs. Pulmonary Fibrosis at their own center.

Submission to NIH for leronlimab to be included in Long Covid clinical trial

If not selected, then CytoDyn already has a pre-planned and fully funded Pilot Study on Chronic Fatigue Syndrome ready to roll.

Cornell Medical Center to run a Pilot trial in Alzheimer's Disease fully funded by outside foundation. The protocol is finalized and soon to be submitted for FDA and Cornell IRB approval.

LATCH is an HIV CURE based on the use of leronlimab and normal stem cells not requiring the CCR5-Delta 32 mutation. Complete final updates are due at the end of December, 2024 and Two Pilot studies are to begin relatively soon with HIGH Expectations for Success.

American Foundation for AIDS Research (amfAR)

Investigators in Berlin, Germany at their own research center.

The prioritization of the publication of our existing clinical data.

The CD10 manuscript describing the trial of patients with mild to moderate COVID-19 was recently published in Clinical Therapeutics.

The manuscript for the CD02 Phase 3 study in patients with multi-drug-resistant HIV has also just been accepted for publication by the Journal of Acquired Immune Deficiency Syndromes (JAIDS).

The CD12 manuscript (severe and critical COVID-19),

Paper 1 on the TNBC study results

Paper 2 on the TNBC study results

The MASH manuscript.

CytoDyn is preparing a draft manuscript summarizing the integrated safety data from the almost 1,600 patients who have now been treated with leronlimab.

So CytoDyn has a lot on its plate so it doesn't need to gloat about anything. The leaders at CytoDyn have enough going on behind the scenes without needing to spark up any rivalry in any of these other fronts, but MASH seems to be what is hot right now, so, let's let Big Pharma battle it out between themselves while CytoDyn lays low, out of the way of their punches.

CytoDyn wants each and every avenue here to work out just as they hope it should. Given that CytoDyn is not really running all things, CytoDyn is therefore dependent upon the proper execution of their trials to be successful. Take amfAR in LATCH and the Investigators in Berlin, Germany for examples. CytoDyn has high expectations because they were originally successful prior and now they want to repeat what they have already accomplished. So, therefore, we can have some hope and some trust that what they plan to do is all well and good, but can we guarantee it? Unfortunately not, but fortunately, CytoDyn shall have Max Lataillade, DO on the scene overseeing and ensuring the studies proceed according to protocol.

CytoDyn has brought on Richard Pestell, MD to oversee the oncology trials which include the MSS mCRC clinical trial, TNBC and GBM. Of course all of us know Syneos Health is the chosen CRO for this Phase II trial. In addition, Dr. Ben Weinberg from Georgetown University and the MedStar Health Alliance has agreed to be the lead Principal Investigator for the CRC study. We should be safe here given all the supervision involved ensuring the trial goes as planned.

CytoDyn is depending on Cornell Medical Center to run the Pilot Trial in Alzheimer's Disease according to the protocol. CytoDyn will only supply the leronlimab, but the protocol was written by CytoDyn. I would expect Richard Pestell, MD at CytoDyn to manage the Cornell Alzheimer's Disease Pilot Trial, as he has already done much work in GBM and both are brain borne disease, though vastly different.

So there are some things here that CytoDyn is not fully in control of, and therefore, we need to have some faith in the system and some trust in the sponsors that they know what they are doing and how to protect their work from sabotage.

In all of these trials, competitors need to stay away. These trials are not comparisons, they are assessments of how well leronlimab treats each condition. They are not determining what drug is better at treating the condition. However, I'll go as far as to say that CytoDyn really needs to expect some degree of sabotage given what has already happened. But, it must be ready to recognize that sabotage immediately and to immediately jump on and put a stop to it unlike the prior administration who allowed it to run rampant for years.

It is difficult for me to fathom that G could somehow interfere with the LATCH studies because they are carried out by a foundation set up to find a Cure for HIV and the counterpart in Berlin, Germany was already successful in the same LATCH study which they want to repeat. But you never know. I believe that Max Lataillade, DO is to be very much involved in both of these, standing guard, so I have much doubt that G could find a way to cross him.

I've talked in the past about RFK Jr coming on board soon and much of Big Pharma is not that pleased about this. This fact only heats them up even more. I'm not comfortable with Big Pharma being upset, but they are getting backed into a corner. This needs to happen, but over time, they hopefully simmer down.

Does this have any effect on how a prospective CytoDyn partner considers their current NDA with CytoDyn? I think it only improves matters because of the solutions a partnership with CytoDyn provides, especially a partnership with GSK. Where a partnership with CytoDyn could put ViiV ahead of G in HIV. A partnership with CytoDyn could give them a way in to treat MSS type tumors in ColoRectal Cancer, Pancreatic Cancer, Prostrate Cancer, Breast Cancer and more. A partnership with CytoDyn could give tremendous meaning to their currently insignificant MASH program.

Dr. Lalezari is very much focused on getting the peer reviewed manuscripts published. This is one of his greatest aims. He does this in the background. Without making waves. He had to deal with bouts and still is, but he persists in this endeavor for good reason. These manuscripts are our stepping stones we place our feet upon for stability and keep us from slipping. They are solid ground upon which we can place our trust. They are building blocks, verifiable evidence and proof of our claims. They work together to provide that upward stairway we need to climb up out of the hole we dug ourselves into. Little by little, they are published, one by one and he announces the progress made and posts the Published Manuscripts on the webpage. That is what I mean by laying low.

What time are we in such that we might judge where we are? I feel that CytoDyn specializes where others just squander their time. CytoDyn has the answer to liver steatosis & fibrosis. It has the answer to Pulmonary Fibrosis and any cause fibrosis. It has the answer to Micro Satellite Stable type tumors as well as MSI type tumors. It has the answer to HIV Cure with LATCH. It should do exceeding well in the mCRC clinical trial and hopefully do well in GBM and Alzheimer's Disease. If chosen, it does well in Long Covid, but if not, it does even better in Chronic Fatigue Syndrome. All of these are disease entities that nobody really can touch while leronlimab has high expectations for success in each of them.

RFK Jr. coming in really is only making it more difficult for these Big Pharma drug companies to compete the way they used to and that upsets them at least for some time. Their efforts against these diseases won't succeed without attacking the disease at their core, at the CCR5 heart and this inability greatly frustrates their efforts. Without leronlimab, they lack the proper weapon. At the MASH-TAG conference, they assemble themselves together in unison, proclaiming their successes, lifting their heads high, devising crafty counsel against the truth like they did originally which led to the clinical hold. What else lies up their sleeves? I don't trust them at all anymore as you can tell.

I'm calling for CytoDyn to keep its head down but to remain vigilant. Lay low, and protect your place at every angle, from every perch, every situation. They are not for anything which CytoDyn has lined up. CytoDyn needs to be aware of this and needs to be protective of each and every goal it has. With RFK coming on board, the plans of CytoDyn's enemies could be falling apart quickly, especially with CytoDyn's sustained progress.

You got to wonder what G shall do when CytoDyn announces an HIV Cure via LATCH. That could be this year 2025.

"The LATCH protocol is scheduled to complete final updates at the end of December, and we look forward to the launch of this program in 2025."

Just think about it. Remember, G doesn't want an HIV Cure. They want to treat the disease indefinitely, even if it is only every 6 months. ViiV wants a Cure. Bill and Melinda Gates Foundation want a Cure. Max Lataillade wants a Cure. But not G. G knows that CytoDyn is very close to that Cure.

I think that after this MASH-TAG conference, these companies walk away with an understanding that if they want to address MASH in all its stages, and address actual liver fibrosis, then they'll need leronlimab. But how they handle that knowledge remains the question. CytoDyn has Melissa Palmer, MD hepatologist to answer all their questions and to excite and escalate their expectations. With the preclinical data in her hand, she is devouring it all and will have news for all of us and the waiting BP industry. Who knows, she might even manage the upcoming Pulmonary Fibrosis Pilot Trial as well.

Personally, I'm thinking great things are about to happen. This month or next, it begins, when all hell breaks loose. Yes, very interesting. They shall realize that they require leronlimab to do their dirty work. They begin to understand that they have nothing unless they can dissolve fibrosis. Unless they can halt metastasis. Unless they can block endothelial growth and the formation of a collateral blood supply to tumors. Unless they can control Macrophages. Unless they can cure HIV. How do they react when these realizations truly confound them? Dazed and confused. They believe they act properly and in accordance to what they see happening around them. But they make the wrong moves, the wrong decisions, unless they begin to see eye to eye with CytoDyn.

Amarex is gone. G no longer has them as their weapon. Anything they put up to throw CytoDyn off their mark, shall now fail in utter shame to them. Blinded in their frustration, Confused in their aggression, they blunder in their undertaking. What undertaking? Another collusive sabotage? Fake stories, made up misunderstandings. Something arises out from their conspiracy. I never underestimate how low they can and do stoop.

However, I'm thinking one of them comes to the batter's box and opens up with an offer, maybe only a single or maybe a homer, I don't know. Seems to me, GSK would be the perfect fit and could it be this month? All we can do is hope. Hope that BP's actions work against them.

This is how it is coming together for me, that in one fine day, unbeknownst to them, that this massive boulder rolls down the slope of the mountain, and nails the shorts square behind their knees thereby propelling CytoDyn skyward. This is my interpretation of what is currently happening at CytoDyn. I'll leave it there.

CytoDyn Inc (CYDY) Stock Research Links

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