Protest?

So, as I've mentioned many times before, go out and live. Enjoy the start of Spring. Why? Because the stock price won't be dabbling down here for that much longer. When it starts to run, you're gonna want to be here, but for now, while it is down here in the dumps, go out and about. This is a journey. We are climbing a spiraling ladder upward. We'll get there in due time down the road.

Welcome All of you who are interested in following the yellow brick road towards leronlimab's ultimate approval. All of us are excited for this to happen. But at the same time, live your life.

I don't know if any of you were able to catch what phoenixblaze posted on ST yesterday: Tucker Carlson & Dr. Patrick Soon- Shiong Interview. This was a pretty serious interview and one which fully depicts what CytoDyn faces. In essentially the same way that Big Pharma blocks CytoDyn, so it too has also blocked Dr. Soon-Shiong's ideas and his company, ImmunityBio (IBRX). Because of a few incredible things he accomplished in his past, he has amassed a fortune, but instead of just living his life with those tens of billions of dollars, he decided to pursue medicine much further. He has come to understand the notion that our Immunity is at the heart of disease. ImmunityBio is oriented around this notion. This focus on inflammation and the immune system has really agitated Big Pharma because Dr. Soon-Shiong has been able to achieve his goals, by using his own wealth to search for cures. Most start ups would have been crushed, but he directed his own funds towards his convictions. He has gained incredible knowledge and he has the money to take his beliefs to the edge of approval and beyond. Already, he has one FDA approval for Bladder Cancer. But it took over 10 years to win. They have given him great resistance and have prevented any federal government funding though his trials would yield cures.

Many of the things he says in that video, you would think he was talking about leronlimab. He talks about the Immune System. He talks about Inflammation. He talks about T-Cells, Natural Killer Cells, and so many similar things that we talk about when discussing leronlimab. His drug targets cancer as does ours, but his drug uses specialized T-Cells while ours targets CCR5. He already won FDA approval for Bladder Cancer, but he believes the drug could be used for practically all cancer.

In consideration of the Mechanism of Action which I've written about, and after listening to Dr. Patrick S-S, I'm beginning to think that the Mechanism of Action which is at work in these once Stage IV mTNBC patients who today remain alive over 3 years later, with no evidence of disease, has to do with the Natural Killer Cells that become sensitized to the cancer and now and into the future remain at work, indefinitely, preventing cancer's return. A reason I'm leaning towards Natural Killer Cells is in addition to what Dr. Patrick S-S says, but also partially due to this statement from here:

"...leronlimab restrained the development of tumor metastasis in murine xenografts in Nu/Nu mice which lack functional T cells*. The nude mouse (nu or Hfh11nu or Foxn1nu)* lack a thymus due to a mutation in the FOXN1 gene. The absence of a thymus means that there is no production of T cells*; therefore, they are* unable to activate the different types of immune responses (adaptive) during the implantation of cancer cells. These mice lack antibody formation, cell-mediated immune responses, and delayed-type hypersensitivity responses but produce NK cells, resulting in a reduced capability of killing virus-infected or malignant cells. Our studies suggest therefore that T cell participation is not necessary for the anti-tumor function of leronlimab observed in the current studies but do not exclude a potential role for NK cells which express CCR5. Furthermore, as leronlimab is a humanized antibody that does not bind murine cells, it is most likely the effect seen with leronlimab is mediated directly on the human breast cancer cells, rather the local murine tumor environment."

What the above is saying is that leronlimab was able to restrain tumor metastasis without the help of T-Cells. In this research article, they are saying that the virus infected or malignant cells were likely killed by Natural Killer Cells which were sensitized to the virus or to the cancer. T Cell participation was not necessary for leronlimab to accomplish this restraint of tumor metastasis. Therefore, possibly Natural Killer Cells which were sensitized to the mTNBC are what remains ensuring no return of that cancer for at least the 3+ years following the treatment with leronlimab.

ImmunityBio has made some grand claims. Just listen to that video with Tucker and Patrick. Similar to CytoDyn's grand claims. At times, he almost sounds like NP. CytoDyn now talking HIV Cure and mTNBC Cure. We're really rubbing their noses in it, aren't we? Well, in fact, I think we are maintaining a nice, low profile. I think even Patrick Soon-Shiong had also maintained a low profile, yet, they kept him in check as they have held us down as well. ImmunityBio was able to get their drug approved for Bladder Cancer, but that is not enough. He was forced to submit a 700,000 page BLA including over 10 years of work.

The more we disclose, the more we leave our selves open for attack. That is the more they want to tear us down. CytoDyn does not want to spark any fights or ignite any fires. CytoDyn doesn't want to piss anyone off. They don't want to antagonize or upset, so they aim to keep a low profile, hunker down, and focus unnoticed on the job at hand. They do however, need to inform their shareholders. But, by doing so, they also feed their enemies with pertinent information which could lead to upsetting a specific BP. And that could lead to unexpected attack.

In May, Big Pharma will learn that leronlimab has a Mechanism of Action which can virtually render it as a Cure to mTNBC. Assuredly, that kind of information certainly puts them on edge, especially G, because, G has the SOC Trodelvy for mTNBC. But, even worse, when this information about a Cure for mTNBC gets to the public's ears, to the patients who are suffering with the disease, that a Cure very much so exists, then very possibly, Protests might arise. These women could very well protest requesting to bring leronlimab out for their immediate use. Once they get a hold of the safety profile, they could even request the rapid approval of the drug, or even make request for the combination use with Trodelvy.

If such a Protest were to arise, would RFK act upon it? Would the FDA's Makary respond? I think they could and possibly even would act to hasten leronlimab's approval for an early use. Depends how many are Protesting. What if it goes country wide? What if there are protests in all the states? What if it lasts for days, weeks or months? Something like this would hit G hard, especially if the FDA reacts in favor of those doing the protesting.

"Based on these survival observations, the Company has initiated two pre-clinical studies in mTNBC that will evaluate possible treatment synergies between leronlimab, an antibody-drug complex treatment (sacituzumab govitecan), and an immune checkpoint inhibitor (pembrolizumab). The Company will also continue to perform follow-up testing on the group of mTNBC survivors who currently identify as having no evidence of ongoing disease."

What if the results of the murine study shows that combining leronlimab with Trodelvy is VERY helpful? If in response, a Protest develops, would G be nudged to partner? What if the murine study shows that chemotherapy is not even necessary when leronlimab is combined with Trodelvy? That is an even more compelling reason why G might want to partner, if chemotherapy itself possibly might be avoided.

Trodelvy is an Antibody Drug Conjugate (ADC). It in fact does deliver chemotherapy, but it does not deliver chemotherapy to the whole body, it just delivers it targeted and specifically to the cancer. Cancer cell death is induced by delivering this Chemotherapeutic ADC specifically to the cancer cell. Therefore, Trodelvy is monotherapy as it already is chemotherapy, but specifically targeted chemotherapy. The reasons for a partnership between G and CytoDyn are growing increasingly stronger.

It's possible that if a Protest does develop and if Trodelvy is somehow improved in combination, and if the FDA becomes responsive to the people protesting and pushes for an early release of leronlimab in some capacity for these patients, I'm thinking both G and CytoDyn could consider a partnership if the price is right with restrictions and limitations imposed. Depends how hard G is hit by all of this and how they believe they need to act to save the indication for themselves. The only solution they would have is to combine with leronlimab, if the murine study shows that the combination doubles or triples OS and PFS. The study will do so. It has to. It is already a fact that leronlimab augments the effects of chemotherapy. It improves chemotherapy's effectiveness. Leronlimab enhances cell killing by DNA damage-inducing chemotherapy agents used for breast cancer treatment. So, the combination of leronlimab + Trodelvy shall probably be a good one.

May 15 is approaching fast. Seems like the announcement is gonna be a bombshell. The results of the Murine Study will be known by then. G will be made aware of the results too. Seems to me, G might have some thinking it might need to start doing if they want to keep this indication.

On another note, but also in consideration of G, just because nobody is discussing it, I would think Jonah Sacha PhD is making good headway in his multiple grants in the research of HIV. Multiple variations of leronlimab are being discovered thanks to Scott Hansen, PhD and then patented, thanks to Tyler Blok. That urging on by the GF has not quieted just because we are not hearing anything from that side of the fence. No, they remain intensely honed in on HIV Cure and CytoDyn is their gateway. Therefore, who is concerned? G, because they don't have a Cure. They have a very good 6 month long acting HIV-PrEP, but not a Cure. G certainly will not be happy with any progress made here by CytoDyn or by the GF, so therefore, they will interfere with any CytoDyn progress when it becomes necessary.

Jonah is on this on a daily basis. He is primarily focused in on HIV-Cure and HIV-Reservoir formation and eradication. He is also working with Stem-Cells, because of the LATCH trials. Scott Hansen assuredly assists him in providing the various molecules necessary for his work, but Scott is primarily focused in on long acting leronlimab.

Long acting leronlimab is a means by which to provide a long course of leronlimab treatment with only one dose. For instance, the entirety of treatment for mTNBC potentially could be treated with only one or two long acting leronlimab injections assuming a half life of 9 or 12 months. The same goes for MSS mCRC.

Putting all this together, it seems that in cancer, once the tumor is eradicated by leronlimab + chemotherapy, then the Natural Killer Cells may have established the necessary memory to ensure that the cancer can not return. This may be the same mechanism of action in MSS mCRC as it is in mTNBC. I don't see why it would be any different provided both cancers are CCR5 dependent. I would tend to think that the Mechanisms of Action are identical in that Natural Killer Cells keep the cancer from returning, but the chemotherapy is necessary to kill the tumor during treatment. It is during that time when the Natural Killer Cells develop that memory necessary to identify all parts of that specific tumor. In mTNBC, the chemotherapy is Trodelvy while in MSS mCRC, the chemotherapy is trifluridine and tipiracil (TAS-102; Lonsurf).

In all of this, I see the FDA coming around. Dr. Lalezari says they are on our side.

"In terms of the regulatory process, I am confident that our collaborative relationship with the FDA has placed us on a positive trajectory. To accelerate progress in oncology where feasible, we’re establishing an oncology advisory board to ensure we are exploring the fastest and most responsible pathway(s) forward. We will continue to look for opportunities to solicit feedback regarding our development process from both KOLs and the FDA. Maintaining strong relationships and credibility with the FDA and industry partners remains a top priority as we chart our future course."

RFK and Dr. Marty Makary are the new administration. I think the only way this moves forward is by the MAGA protocol. What is good for the public? Cures. Whether it comes from the GF, whether it comes from G, whether it comes from CytoDyn, or from Pfizer, Merck or GSK, if it helps the public, then it moves forward. We know what leronlimab does. This is how the FDA justifies its existence for the next 4 years.

RFK is getting rid of pocket stuffing, kick backs. There will be significant dismantling of the departmental agency. They have no choice. RFK is running the dismantling. This weakens BP including G. It doesn't take a genius to figure that if the FDA is changing towards a more MAGA oriented ideology, then, wouldn't BP tend to become suppressed in the way it deals with CytoDyn?

What if CytoDyn does exceedingly well in MSS mCRC? What if it blows the doors off the trial? With this incoming FDA, how would you expect G to react? Remember, G is not involved in mCRC. But good news for CytoDyn in any indication is bad news for G regardless. G is the head of the snake.

Protests could arise. Definitely need to know the climate. It's hard to say how G would react if such protests were to come about. How much protest would need to develop and be tolerated before they react? How do they react? If the drug is as good as we think it is, and there is much indication that it is, then, what is G's way out? Is there even an out? Would anyone reading this be OK with a partnership with G? Only if the price is right and conditions were very restrictive. Any shelving or slow walking causes them to lose their investment and the contract is over and done.

So, in consideration of all of this, just let things happen as they shall. No answers as of yet, but plenty of conjecture. This is our journey. We'll keep going. It's going to happen, most likely when we least expect it. Can you imagine if it comes down to a bidding war between GF and G?