Global Formation of Power

CytoDyn is on a winning streak.

*"*CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that Max Lataillade, DO, MPH, has been appointed as Senior Vice President and Head of Clinical Development. Under his consulting agreement, Dr. Lataillade will lead the Company’s global research and development strategy and oversee end-to-end R&D activities to advance the Company’s clinical development pipeline.

Dr. Lataillade brings over two decades of in-depth research experience to the CytoDyn team, with robust expertise investigating novel drug products and therapies. He most recently served as Vice President, Head of Early Development and Global Research Strategy at ViiV Healthcare, where he oversaw its novel HIV oral and long-acting pipeline. Prior to that, he was Vice President and Head of Global Development for HIV at Bristol-Myers Squibb, having joined the global clinical research group in 2007 as an infectious disease and HIV specialist. Dr. Lataillade is also currently an assistant clinical professor and teaching attending at the Yale University School of Medicine.

“I am deeply enthusiastic to welcome Dr. Lataillade to the CytoDyn team. I have had several opportunities to collaborate with him over the past ten years and I believe his accomplishments in the industry and his skillset will help us progress our development pipeline,” said Dr. Jacob Lalezari, CEO. “I look forward to working with Dr. Lataillade to capitalize on both early and continued clinical results, and to help drive further success for the Company.”

Dr. Lataillade added, “I am ready to leverage my experience and background to pursue strategic development opportunities and advance CytoDyn’s clinical pipeline. By further developing leronlimab, I believe CytoDyn is poised to provide material benefits to patients suffering from a number of serious conditions. I look forward to working with Dr. Lalezari to drive the Company’s clinical development.”

Dr. Lataillade obtained his medical degree from the University of Medicine and Dentistry of New Jersey, completed his medical residency training at Temple University and Crozer-Chester Medical Center in Philadelphia in 2004, and finished his fellowship in Infectious Diseases and HIV at Yale University School of Medicine in 2007. He remains a practicing physician with a diversified practice."

The word "global" is mentioned 4 times in this Press Release. After securing the CRO for both upcoming trials, unawares of what would come next, CytoDyn hires Max Lataillade, DO, VP at ViiV Healthcare as the Senior VP & Head of Clinical Development at CytoDyn. If CytoDyn was planning on selling, would they do that by bringing on such an individual as this? By bringing Max on, can we not eliminate any/all buy out possibilities by Madrigal? I think we can. I already never thought that they could buy CytoDyn out and this new hire only confirms that unlikelihood. Licensing? Yes, by all means. Partnership? Less likely.

I find it interesting that CytoDyn now has 2 Senior VPs. Max as Senior VP & Head of Clinical Development while Cyrus Arman is the Senior VP of Business Operations. Overlap? Maybe.

"Under his consulting agreement, Dr. Lataillade will lead the Company’s global research and development strategy and oversee end-to-end R&D activities to advance the Company’s clinical development pipeline."

If there is overlap, Mitch Cohen would not be in favor of that. Max was brought on for a purpose and somehow, I'm thinking the word "global" might have something to do with it. Remember, Max comes from GSK who does not primarily deal with the FDA, but rather the MHRA (Medicines and Healthcare Products Regulatory Agency).

The BP I'm referring to here in "Convergence" is GSK.

"Now, this courting BP has already been threatened, they already have crossed the line. They already became wounded and have lost strength & power. They have already become sickly even, but not to the point of death. CytoDyn now is their opportunity to return to strength, to return to power, the possibility to revamp itself with Leronlimab. This opportunity gives them the strength to compete and to fight again against the empowered. Leronlimab shall give them the fire power they need to win in the coming wars.

We know that GSK has HIV drugs with expiring patents. We know that Gilead has been given great favor with regard to HIV and mTNBC. We know that GSK greatly seeks these indications, these avenues as well as Gilead, and we know that Leronlimab excels exceedingly in HIV and mTNBC. We also know that there are NDAs with respect to HIV and mTNBC. We know that GSK is falling out of grace with the FDA and remains closer to the MHRA, (Medicines and Healthcare Products Regulatory Agency), which is the UK equivalent to the FDA. GSK also has a new Chief Scientific Advisor Tony Wood who favors CCR5 antagonists as he has invented Maraviroc and he knows the power of the CCR5 antagonist mechanism of action."

Recently, ViiV and Exavir settled this issue to the disadvantage of ViiV. In addition, ViiV is left without a long acting HIV antagonist. A few months down the road, Max VP at ViiV Healthcare becomes Max SVP at CytoDyn who just so happens to own a long acting CCR5 blockade / HIV entry blockade very much inline with what ViiV was after in Exavir.

Max is well known to Big Pharma, especially in HIV. He is well known to Wall Street. He is well known to Hedge Funds. His name gets around quickly. News of his hire at CytoDyn spreads quickly and widely. I'm sure Madrigal has become quite aware now as well, so they need to change their game plan if they were ever thinking that CYDY looked mighty fine as a nice cheap BO target. Somehow, I think Max's hire puts CA on edge.

GSK has an interest in MASH.

"GSK only has one NASH program. They have a HSD17B13 silencer, which encodes THE 17β-HSD type 13 enzyme. 17β-HSD13 is a liver-enriched, hepatocyte-specific protein that is found in higher levels in patients with non-alcoholic fatty liver disease (NAFLD) and it enhances lipogenesis, furthering fatty liver. However, there are some issues associated with this target for NASH therapy. Mainly, HSD17B13 gene knockout mouse models didn’t protect the livers of mice in NASH models induced by high-fat and alcohol-induced steatotic damage, while one study showed that HSD17B13 deficient mice developed late-onset fatty liver when being fed normal food. While population studies have found correlations between this gene and liver disease in humans, there is a lack of placebo-controlled clinical research suggesting that this approach is valid. In addition, GSK is going to need to address multiple aspects of NASH—steatosis and inflammation as well as, potentially, fibrosis*. CytoDyn recently release leronlimab’s NASH01 results at EASL (European Association for the Study of the Liver). The study was short but despite that, showed improvements in metabolic and inflammatory factors, with the one dose of leronlimab improving PDFF and cT1.* This drug might be a perfect drug to put into combination with other NASH drugs to add to GSK’s immunology portfolio*. It is also very common for HIV patients to develop NASH; HIV drugs usually have adverse effects on the liver rather than improving the liver, which would set leronlimab apart in the HIV field.Leronlimab is also a potential therapy for other immunological diseases that GSK is focused on such as neurodegenerative disease and rheumatoid arthritis. The drug is in preclinical testing in multiple sclerosis and the company* has also been contacted “by multiple academic institutions for access to the drug to conduct preclinical studies in glioblastoma multiforme, Alzheimer's disease, and others,” so the drug is a pipeline or a platform in and of itself."

Boy, that last sentence is coming to life before our eyes, isn't it? What does Lalezari do with SMC as they discuss the prior murine study? I'm thinking he shall want to pursue HepatoCellular Cancer, HCC. That study takes 20 weeks. But, in consideration of the recent hire, wouldn't they also want to look at combining with GSK's drug?

|| || |GSK4532990 †|Non-alcoholic steatohepatitis/Metabolic dysfunction-associated steatohepatitis (NASH/MASH)|Phase II|HSD17B13 RNA interference|

I think Max would be inclined to make that happen. Remember Blok's bonus? Any connection with GSK? Not sure. Something is coming through though...

Is CytoDyn softening? Are they making compromises? I think so because they know they need to partner. This hire is almost a statement that CytoDyn shall be seeing something of the sort in the very near future through this GSK / CytoDyn liaison recently brought on board.

Like Pitt said 2 years ago, this article is very pertinent today. GSK and CytoDyn have very similar objectives. CytoDyn has of course only 1 molecule with a myriad of capacities while GSK could use what leronlimab has to augment many of their treatment modalities. Here is GSK's Pipeline and it shares with CytoDyn these indications: Infectious Diseases, HIV, MASH and Oncology. GSK desperately needs for these indications to become successful in the coming years. They have the resources to insure that this happens provided they have the right drug to combine with that would permit for that to happen. Given Tony Wood's knowledge of the CCR5 blockade leronlimab and given that he is aware of what a perfect CCR5 blockade it is and given he knows all about the benefits of CCR5 blockade through his study of Maraviroc which he invented and then sold to Pfizer, he knows all too well, through all the research articles on leronlimab what a superior CCR5 blockade leronlimab in fact is. Well, Tony Wood is Head of R&D for GSK and he would love to get his hands on this CCR5 blockade, leronlimab and Max shall oversee end-to-end R&D activities to advance CytoDyn's clinical development pipeline. I think they will be seeing eye to eye.

So hypothetically speaking, GSK enters into a collaboration with CytoDyn. With Max as SVP, he has lots of control and can make big decisions at CytoDyn. How does the collaboration between the two companies proceed? Somehow, the desires and wishes of GSK need to become the goals of CytoDyn. If GSK is to get what they want out of this, they need to control CytoDyn to some degree and this is first step.

GSK just wants to be successful and they know they can be if they had this molecule. Well, CytoDyn needs a partnership and if this is how you get a partnership, by hiring the top executive of your competitor, then, that is somewhat of a softening. That is a compromise. This is going so far so good. It looks like it shall work. CytoDyn is softening is outer shell. It is walking with renewed confidence now that it has know how from its new SVP. CytoDyn can take its next steps with more confidence and assuredness.

CytoDyn wants to operate as a BioPharmaceutical. It wants to develop and distribute leronlimab. It wants to do that safely and securely. CytoDyn wants to establish leronlimab as an approved medicine for use against a host of disease which include many forms of cancer, the steatosis and fibrosis of MASH, the prevention and cure of HIV and the elimination of inflammation and the reduction of immune activation in many disorders like long haulers and chronic fatigue syndrome.

Because of all these ambitions that CytoDyn has, in years past, it faced many obstacles and hurdles imposed by the FDA and many shorts. CytoDyn's own CRO Amarex was in on the sabotage, but today, CytoDyn won a very small victory in the settlement with Amarex enabling the hiring of this DO. CytoDyn is not demanding of the FDA any apologies for what it did in days past. They are not demanding that the warning letter be removed from its website. In fact, CytoDyn is behaving very well towards the FDA ever since the hold was imposed and to this very day. CytoDyn is not making any more waves; it is not stirring up any more controversies or problems for itself. CytoDyn is looking for peace to pursue and accomplish its unchanging and consistent objectives.

Doesn't a collaboration between GSK and CytoDyn make CytoDyn even appear better in the site of the FDA? Does it allow CytoDyn to "save face"? Does the protection that GSK affords, play any part in CytoDyn's move? Max is brought on as SVP. Powerful position in Global capacity. He has power overseas as well. Is CytoDyn making a statement that they could be pursuing a Global approval through a man who has tremendous experience in working world wide? Max can tell you all about his experience Globally. Is that where CytoDyn is headed? Which countries? How many countries?

Why will these countries side with Max? Because they already know him. Why would they side with leronlimab? Because they already know leronlimab. Remember what Nader was doing? Does Tony Wood at GSK believe that Max can achieve this? I think he does and I think that is why he was sent.

If all of this speculation is true, then right now is the dividing time. Any country that buys into Max's proposals is pro-leronlimab and any country that doesn't engage is anti-leronlimab. Despite all that CytoDyn has done in reparation, it is not overtly clear what they will do when push comes to shove. So he is global. He does not need to depend on this regulatory agency. He already is very familiar with the MHRA. By this means, CytoDyn is not reliant on any one regulatory agency. CytoDyn can come back and make its full vengeance without even being approved by this agency.

So again, CytoDyn has many things going on, but this last PR takes the cake. It has provided a mark of division of what we had been considering to what we shall now consider anew. Yeah, there are very many things going on, but where does Max go with all these studies, these Pilot trials and clinical trials in all of these indications? These are the new questions. But CytoDyn is still winning and they aren't letting up. Kind of interesting.

But not sure as to what comes next. But something is and shall take place. Still have all the bashers and naysayers that never cease even if an approval was granted tomorrow. Their arguments are circular, saying the same things over and over, like a wheel, round and round, over and over again.

Lalezari is chief over all this and he approves. I think he sees the future and has made the right move in bringing on Max. I believe he sees this as CytoDyn's future and means to ultimately get leronlimab approved. He must be favorable to approaching new nations and new agencies of approval. He knows very well that this is in no way a "Hail Mary". It is a strategic move which who knows, may have been engendered by Cyrus himself as his way of getting around the mandates of this regulating body who made him chase his tail for a year or more and who drove him so sick that he required a multi month leave of absence. This way they would not have the credit for such a massive approval that leronlimab shall be, putting the US back years and years before that would happen while Europe had it so much earlier.

Still need to have patience and hang in there, because there is not anything other than what we know of already. We fight off the naysayers until the news comes. Don't know what happens next. CytoDyn is still fighting a war and right now it is winning. Here, I feel a compromise has been made which now takes it down a different path. I feel like Max shall be bringing leronlimab to the world and there shall be those that receive him and those that do not. By using this method, CytoDyn shall find its success. Let's wait and see. We will stay focused on what is happening.