docj
1 day ago
From a couple days ago MGK_2:
Abrupt Turnaround
I liked u/Biotrends_USA recent post Collaboration With BP?, so this is my response.
Shareholders need to wait until the event we've been looking for begins; once it starts, it's over. The interaction, the trading of shares exceeds all rational expectation. How does that happen? Bidding War or Governmental Intervention.
Doesn't it seem as if a standstill is at hand? Neither side is giving up. Almost an unsolvable dilemma. Tremendous resistance remains in opposition against this molecule, but the promises that this molecule provides exceeds the resistance poised against it. The resistance wants to crush, destroy and demoralize, by stealing away investments and hope placed in the molecule.
There is no way CytoDyn partners together with the Puppet Master G. That particular company which heads up the short campaign against CytoDyn has got to be a pharmaceutical, so therefore, how could CytoDyn ever trust its chief nemesis, its arch rival? It certainly can not ever trust them, so then how could it partner up with them?
The SEC is supposed to intervene in order to prevent illegal market manipulation tactics. Even the stock brokerage houses which facilitate these illegal short trades are complicit. A new administration has come, but so far, no changes have been appreciated.
If these attacks ever do cease, then the parties could come to the table to work things out. I don't have any hope in this solution. How can the memories of what has happened be forgotten, which is necessary to arrive at a deal? If they can't be forgotten, how can a deal be arrived at? Though CytoDyn settled for a rather low settlement in Amarex, did they really have a choice? To get more would have cost more time and money and how much more could Amarex even pay?
Looking forward, how then can CytoDyn ensure to be fully protected from the onslaughts of G in a partnership deal with anybody? The only real evidence of a partnership deal is from the GF. If G is truly against anybody partnering with CytoDyn, then how do they feel about any current investment into CytoDyn or into leronlimab, even if that investment is given to OHSU? If that investment is put towards solutions which G wants domination over? How does G feel about any investment / grant made towards finding the Cure to HIV? Clearly, they are opposed, and CytoDyn is such a small target, with such great rewards if defeated, that they make a perfect target for big old G to rampage.
CytoDyn is too small to be supported and defended by many of the big names, though CytoDyn's potential pipeline is quite rich. It can not be denied that by some unknown means, CytoDyn has found a way to survive. Because of its main resource, otherwise known as leronlimab, through some of its specialty shareholders, as well as its myriad of shareholders, CytoDyn has found that amazing means to remain afloat, despite the constant barrage of fire which persists against it, yet, CytoDyn remains vigilant in putting up its own offensive and fighting back. CytoDyn has built up an arsenal of weaponry focused on their targets, aimed and honed square upon the Cure to HIV, treatment for MSS mCRC, mTNBC, GBM, Fibrosis, MASH, Alzheimer's Disease, Chronic Fatigue Syndrome and on and on.
How do they achieve this? There are some liquid reserves from a settlement with Amarex, but much of its current pipeline is being driven by unknown sponsors who are willing to run Pilot Trials in the various indications listed above, all of which incur zero cost to CytoDyn. CytoDyn's only responsibility is to provide the leronlimab for those unidentified sponsored Pilot Trials.
Lalezari has kept a very low profile. He certainly does not tempt G. He must make an occasional PR or two, but, he does not flaunt his findings. In fact, he may even be trying to suppress what he would otherwise, rather exaggerate. Lalezari purposely tries to minimize CytoDyn's vulnerability. By exploiting possibilities before they are quite ready, that would increase CytoDyn's vulnerability. Lalezari therefore does the opposite. He wants that vulnerability be kept to a minimum, so he remains tight lipped. Rather silent. Why does he do this? I think the answer lies in the answer to the following question. How can he trust G at all?
Whoever is manipulating the market against CytoDyn is the same entity as who ever turned Amarex against CytoDyn and is the same as whoever ran the ambulance chasers. It is that entity who is the Puppet Master and they are still out there continuing day in and day out in constant opposition against CytoDyn's advancement. This Puppet Master isn't going to give any amount, not even an inch. But neither is CytoDyn.
CytoDyn has an obligation to its shareholders and to its resource leronlimab. The SEC should intervene to keep it a fair playing field, but they, so far have failed, but they are now part of a new administration and hopefully, changes are soon to be appreciated soon. G is absolutely not in favor of any pro-leronlimab Big Pharmaceutical to come to CytoDyn's aid. Therefore, this particular partnership information remains under lock and key via NDA and CytoDyn hasn't let out a peep. G is dead set against any collaboration CytoDyn might make with any Big Pharma as they see any collaboration as a much stronger antagonist against their own goals and ambitions of HIV treatment. It is absolutely G's desire that CytoDyn never partners, thereby keeping CytoDyn small enough, without any substantial financial backing, in order to keep it at bay with the inability to ever put up a real fight. To ensure that CytoDyn never has a means by which to advance, or to substantially and drastically slow down and retard CytoDyn's advancement efforts to reach their goal that would really hit G where it counts, which is of course a leronlimab approval. This really is the battle here. A never ending circle till one comes out on top. For G, it is money very well spent to prevent a leronlimab approval, because they know what the cost to them would be if leronlimab were approved.
G can't give up their life blood. They have all sorts of HIV treatments, ART, HAART, long acting agents and they also have a treatment for mTNBC. Leronlimab is a direct competitor for these indications. G can not lose this part of their business, because, this is their entire business really. But leronlimab is a direct threat to all of that and G knows this. I don't think G is willing to give up even one, because if leronlimab received approval in just one indication, it receives indication in all, because by "off label use", leronlimab, with its clean safety profile, would be patient requested for everything and doctors would be willing to prescribe it, as it would in fact heal and patients would pay directly for the medication for the no side effects benefit.
So therefore, G remains persistent in hampering CytoDyn. But CytoDyn also continues on with its own goals and ambitions, albeit more slowly. Slowly, but surely, leronlimab shall be shown superior to G's current treatments. Little by little, it shall be made known, that leronlimab is the superior medication in all these indications. Bit by bit, these indications are again put back into CytoDyn's pipeline, as is currently being done in the mTNBC indication. Doesn't it feel good that the GF has CytoDyn's back when it comes to HIV. But as for mTNBC, who has CytoDyn's back? GSK? Merck? What about in Fibrosis? Madrigal? Novo Nordisk? Eli Lilly?
These are some threats to G, but these possibilities pose another reason why G should double down and could be why they are currently doubling down. CYDY went from $0.45 back to $0.25 in just 2 weeks. The problem at hand, the dilemma we face, is difficult. Almost unsolvable. Neither side is willing to compromise or to give even an inch.
With CytoDyn remaining on its own, without the aid of a partnership or buyout, this battle goes on forever. It is a slow downward spiral by attritional forces imposed by G, but G must remain prepared for a long drawn out war because CytoDyn has many sponsors to bring this drug to its fruition. As I said above, the fight appears to be at sort of a standstill, where a stalemate could be arrived at with minimal advancements made either way, yet the piss poor fighting continues on and on to no end. No answer to it exists except for...
The fact that NDAs do exist. The fact that CytoDyn has NDAs in place but they are keeping that information close to their vest. The information regarding partnerships and licensures. When this information is publicly released, it then leads to a bidding war. The bidding for this tiny company subsequently increases. Yes, this tiny company with zero income, with a large load of debt, and a compromised reputation, receives a bid over and above the value set in the NDA. Yes, it has become obvious, that CytoDyn has successfully and unceasingly worked to restore its reputation and has also branched out in multiple indications, proving its only resource to be effective in a variety of indications, making it extremely attractive to many Big Pharmaceuticals.
Yes, this tiny company actually draws a higher price than its value set in the NDA due to a bidding war. It is either this or Governmental Intervention that begins the Abrupt Turnaround for CytoDyn. These are my possible answers to the current unsolvable dilemma. A bidding war and/or Governmental Intervention fixes the problem. It strengthens CytoDyn so immensely and destroys G's counter opposition completely. This would allow CytoDyn to pursue its pipeline at a much more rapid pace.
A bidding war and/or Governmental Intervention immediately and within seconds dramatically increases share price. It makes it nearly impossible for shorts to try to cover. Gone are all the problems associated with the determination of how the treatments for these indications develop, because the courting entity has the know how and is capable of getting it done on their own.
I suspect that the winner of this bidding war is a large Big Pharmaceutical who is bigger than G, who can set the direction, and who can set the record straight. I see CytoDyn being bought up and then licensed out. The buying company would own CytoDyn, but wouldn't want to Trial each and every indication, so it therefore chooses to license out only the indications which it doesn't want.
At the close of the bidding war, that time period provides many a shareholder an opportunity to exit. Because, CytoDyn would then be owned and operated by another massive entity, larger than G, who acquires the majority of indications, but also chooses to license a few different indications out. These are my thoughts. Hopefully, you agree that this makes some sense.
The timing looks good. Definitely rapidly approaching. By either bidding war or Governmental Intervention, I see the current back and forth situation of strike after strike dissipating rapidly and coming to an end swiftly, as in one full swoop, resulting in the elimination of CytoDyn's opposition and the subsequent provision of all those things necessary so as to advance and develop leronlimab at a pace suitable for its various applications against human infirmity.
I think I share this hope with many here, so, this is just to affirm the reason why we wait. I hope this was helpful.
docj
1 day ago
Sunday post:
MGK_2
Game Changing
Loyal to Truth. This post was inspired by My69z.
Referencing this PR on July 9, 2024: CytoDyn Announces Amarex Settlement,
"The material terms of the settlement are as follows: (i) Amarex will pay $12,000,000 to CytoDyn, $10,000,000 was paid upon execution of the agreement and the remainder to be paid within the next 12 months; (ii) the surety bond, valued at $6,500,000, will be released to CytoDyn in full; (iii) all sums Amarex had claimed as due and payable, aggregating to approximately $14,000,000, will be eliminated, with no payment required from CytoDyn; and (iv) a mutual release of claims, resolving all legal claims between the parties."
Did we actually believe that CytoDyn only settled for just $12 million cash, the release of the $6.5 million surety bond and the elimination of all liability claims totaling $14 million to constitute the entirety of the settlement, when we knew full well that this was only a drop in the bucket of what the punitive and compensatory damages were actually worth? We all knew Amarex caused significant harm to CytoDyn and if justice got its way, was easily worth in excess of 10x this combined $32.5 million.
CytoDyn settled at this low figure, possibly because Amarex likely didn't have the more appropriate funds and their own insurance company also probably was tapped out and limited at $10 million. The $2 million probably came directly from Amarex, which is due by July 2025, together with the elimination of any liability claim and the release of the surety bond, is what was agreed to.
The claims against Amarex were severe and CytoDyn won the arbitration, so the judgement went in CytoDyn's direction. Even though the size of this settlement is paltry, it still represents a decimating blow to the loser. CytoDyn's case was very strong, and if they had the means to extract more, they would have. There just wasn't anything left on the table to take so as to justify an increase in the size of the settlement.
Truth was spoken that day, just not by the magnitude of the judgement. But CytoDyn seemed satisfied. Some expected CytoDyn to crumble under the sheer weight of the costs of litigation. But CytoDyn knew they were wronged and had the proof, and therefore, they proceeded with their claim.
From the most recent Press Release, CytoDyn Announces Promising Survival Observations In mTNBC, and since the entire PR pertains to this discussion, I'll repeat it here in its totality:
"VANCOUVER, Washington, Feb. 24, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced encouraging survival outcomes among a group of patients with metastatic triple-negative breast cancer (“mTNBC”) treated with leronlimab. Although mTNBC typically has a poor prognosis, observed survival rates at 12, 24, and 36 months after treatment with leronlimab compare favorably with reported life expectancy after treatment with currently approved therapies. In addition, the Company confirmed that a small group of patients who failed treatment after developing metastatic disease survived more than 36 months after receiving leronlimab, are alive today, and currently identify as having no evidence of ongoing disease.
Following the resolution of the Company’s dispute with its former CRO, CytoDyn obtained follow-up records from patients treated with leronlimab during the Company’s prior clinical trials in oncology. After confirming these patient outcomes, CytoDyn worked with consultants and key opinion leaders to summarize the findings and submit an abstract to the European Society for Medical Oncology (ESMO) Breast Cancer meeting taking place in Munich, Germany, from May 14 to 17, 2025.
“We are encouraged by the longer-term survival data to pursue this potentially paradigm-shifting therapeutic pathway for patients suffering from metastatic triple-negative breast cancer,” said Richard Pestell, MD, PhD, AO, the Company’s Lead Consultant in Preclinical and Clinical Oncology. “As a cancer therapeutic, leronlimab was well tolerated with remarkably infrequent treatment-related adverse events. These promising results suggest further studies with leronlimab are warranted to expand oncology treatment options and improve patient care.”
Dr. Jacob Lalezari, CEO of CytoDyn, added: “These provocative observations of improved survival in patients with mTNBC and prior treatment failure in the metastatic setting, including reported clearance of disease in a group of long-term survivors, provides early clinical evidence of leronlimab’s potential impact in the treatment of TNBC and other solid tumors. I expect the Company’s oncology efforts to accelerate in the coming months, with further announcements in both mTNBC and colorectal cancer.”
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."
With regard to mTNBC while discussing the Basket Trials, In the December 14, 2021 Conference Call, Nitya Ray spoke:
"27:60 Nitya Ray: The BTD application that is submitted is 28 patients from 3 different trials. And out of the 28, 6 had brain metastases. They are all mTNBC patients. So we have submitted all of the results, including all of the patients with brain metastases, now with the FDA and FDA is reviewing it and we are waiting for FDA to respond for BTD application and we expect to hear from them in about 2 weeks. 2-3 weeks. Our CTA application I believe was submitted on November 5. So by January 5, we should hear from FDA. and then we are going to discuss with FDA and see that forward with brain metastases. Now, these are not the only patients with brain metastases because these are mTNBC patients. But, we have other patients in the Basket Trial and not mTNBC, with brain metastases. And so we are very excited about what is happening with these patients. And so we are going to discuss this with the FDA and we do plan, after we receive the response from the FDA on the BTD application that is submitted, we are going to plan for perhaps another BTD just focusing on the brain metastases."
r/Livimmune - Game Changing
In expectation of the results of the mTNBC Clinical Trial, on September 5, 2022, I prepared the following: In Preparation For The Coming Results On mTNBC and wrote therein:
"Come 9/16/2022, we should be able to learn what the more refined PFS is for these 21 patients and what the more refined Overall Survivability is for these 21 patients. The study started 4/22/2019. By 7/19/21, the PFS was 8 months and the OS was 36 months. Since then, 13 months have passed. All in All, the patients were not very healthy. It was a combination of Compassionate Use, brain metastasis and patients had failed 2 other treatment protocols. Patients were treated differently, and may only have received up to 4 doses of leronlimab + carboplatin total while some other received much more, however, leronlimab may have been dosed even after PFS endpoint was reached and after the cancer had returned which may have extended OS. Hopefully, all of this is documented in the results of the trial. From the 7/19/21 PR, we currently had a PFS of 8 months and an OS of 36 months. Since November 2021, the PFS was recalculated to be 6.5 months and the OS became 12.5 months. 10 months have passed since then. Come 9/16/22, could the OS go to 20+ months?"
(How was CytoDyn able to put out in that PR a PFS of 8 months and an OS of 36 months if that period of time had not already passed? In short, they extrapolated.)
But the results of the mTNBC Clinical Trial were never released on the Estimated Study Completion of 9/16/2022. Why not? Knowing now what I didn't know then, I can say now that the data had to have been withheld. CytoDyn never said anything about why they didn't provide these crucial results, but that important data was due then, but it was never presented. Now, with the recent PR, it becomes clear that Amarex withheld the data, so CytoDyn had nothing with which to present. In fact, they had no presentation on 9/16/2022.
The settlement likely gave CytoDyn access to crucial clinical trial data which was previously unavailable to CytoDyn due to the dispute with Amarex. This is supported by the recent announcement of encouraging survival outcomes in metastatic triple-negative breast cancer (mTNBC) patients treated with leronlimab. Why would Amarex hide this data that was crucially important to all of humanity? In an effort to ruin CytoDyn's credibility? In an attempt to paint CytoDyn as duly incompetent? They no longer can claim that CytoDyn stopped payment, because they in fact lost the arbitration. Therefore, what is the truth here? Was there another reason they kept the information?
How much pressure was Amarex really under? Who were they in collusion with? Will this ever be uncovered and revealed? Could or Would the decision of the arbiter bring this information about? Yes, absolutely. What did Amarex need to do to avoid the decision of the arbiter? Settle.
Consider now the affected manuscripts. They probably do require tweaking. From the 12/14/2023 Webcast:
"00:33:19, Dr. Jacob Lalezari:
I've also recently reviewed the cancer data. And it is urgent that we get CD07 (mTNBC) published for that, again, provocative single benefit. So publications, are getting a protocol finalized, off hold, begin the process to implement, get these publications, including the NASH study, the long COVID study, submitted for peer review. I had talked to folks at NIH some years ago about our COVID data in the ICU population. They've been waiting to see the data in a peer reviewed format. And so that's a huge priority for me. And then at the same time, there's no reason why we cannot aggressively pursue partnerships to extend the research platform for leronlimab. And I will commit to that wherever that makes sense. So those are the significant events that, you know, I'll be looking for over the next, you know, two to six months."
r/Livimmune - Game Changing
From the 3/5/2024 Webcast:
"7:07: Turning now to the commitment to prioritize publications of our existing clinical data. I am pleased to announce that we are moving forward with the submission of (4) manuscripts in the coming weeks including (2) papers with 8 of 10 women with triple negative breast cancer. A paper in patients with multi-drug resistant HIV and a paper in patients with Mild to Moderate Covid-19.
7:40: The 1st publication will report on the observations that 8 of 10 women on the 3rd line therapies for triple negative breast cancer had either stable disease or a partial response after 6 months of combined treatment of leronlimab with a chemotherapy agent called carboplatin. This result compares favorably with historical controls.
8:09: The 2nd publication will report (2) further observations that suggests that leronlimab may have a role in the treatment of triple negative breast cancer. First, in the pooled analysis of 28 patients, there appeared to be a signal on the dose response. The patients on the higher 525mg dose of leronlimab, had a modestly increased progression free and overall survival compared to the 350mg dose.
Second, I think most provocatively, the pooled analysis showed that after receiving an initial dose of leronlimab, patients divided into one of two categories. About 25% of the patients had an increase in Circulating Tumor Cells, these are cells that are measured in the blood and can be referred to as CTCs. While about 75% of the patients had a decrease or absence of these CTCs in the weeks following the first dose of leronlimab.
9:17: That differentiation in CTC response in turn appeared to identify which patients subsequently responded to leronlimab with improved progression free and overall survival. Indeed, I believe the data on CTC response, is perhaps the most compelling part of the leronlimab story in triple negative breast cancer and could provide the basis for a screening test to identify which patients are most likely to respond from leronlimab in a follow up study.
I say all this to say, Why did Amarex keep data away from CytoDyn? Why was it part of the settlement to provide data to CytoDyn which had already been due them 3 years earlier? They claim they were withholding it because CytoDyn didn't pay, but since CytoDyn won the arbitration, their argument is null and void and that data rightfully belonged to CytoDyn all the while. Therefore, following the settlement, that data has been transferred to CytoDyn.
" In addition, the Company confirmed that a small group of patients who failed treatment after developing metastatic disease survived more than 36 months after receiving leronlimab, are alive today, and currently identify as having no evidence of ongoing disease.
Following the resolution of the Company’s dispute with its former CRO, CytoDyn obtained follow-up records from patients treated with leronlimab during the Company’s prior clinical trials in oncology. After confirming these patient outcomes, CytoDyn worked with consultants and key opinion leaders to summarize the findings and submit an abstract to the European Society for Medical Oncology (ESMO) Breast Cancer meeting taking place in Munich, Germany, from May 14 to 17, 2025.
“We are encouraged by the longer-term survival data to pursue this potentially paradigm-shifting therapeutic pathway for patients suffering from metastatic triple-negative breast cancer,” said Richard Pestell, MD, PhD, AO, the Company’s Lead Consultant in Preclinical and Clinical Oncology."
The survival data for mTNBC patients is indeed remarkable. Some patients who had failed prior treatments for metastatic disease survived beyond 36 months, are currently alive, and show no evidence of active disease. This outcome is particularly significant given the aggressive nature of mTNBC and limited treatment options available.
Was there something behind that data they wanted to keep from CytoDyn? What did that data show? This is what I'm thinking. The fact that leronlimab eradicates metastatic disease to the brain? The fact that OS could not be definitively stated because patients were still alive? The fact that Circulating Tumor Cells essentially vanished after treatment with leronlimab?
What about the Basket Trial of various tumor types? Recall what Nitya Ray was saying. He wanted to gain BTD on metastatic Brain tumors. There were other tumors in that Basket Trial which could potentially reveal additional positive data. CytoDyn's access to the follow-up records of patients previously treated with leronlimab in oncology trials such as the Basket Trial could lead to even more discoveries across various cancer types
The mTNBC results I was looking for in September of 2022 should soon be revealed at ESMO in May of 2025. Shouldn't these all inclusive results also be incorporated in the (2) mTNBC manuscripts planned for publication as well?
Amarex agreed to provide this missing data which they sat on for years which they knew rightfully belonged to CytoDyn. But, they used the data similar to how hostages are used to negotiate with. As a means to augment the settlement agreement, which they knew fell far short of what it rightfully should have been, then they agreed to provide that data. But the value of this lost and forgotten data could become much more valuable than the one time payment. So that could be why CytoDyn agreed to the terms of the settlement agreement.
Certainly, this is not a fair resolution, but do CytoDyn shareholders have a choice? Not really. We hold and hope for the best. But, if what has been seen thus far holds true going forward, leronlimab becomes the treatment / cure for mTNBC plain and simple. 4 years of OS with no sign of ongoing disease = Cure.
At the time of settlement, they may not have realized that the return of the data which rightfully belonged to CytoDyn was worth far more than the $32.5 million in cash, eliminated liability and returned surety bond.
What else can we expect to come forth from this lost data? Actual OS of mTNBC patients to exceed even what was calculated through extrapolation? 36 months going on 48 months. Cure of mTNBC? The fact that leronlimab eradicates metastatic Brain tumors as Nitya Ray pointed out. How the addition of leronlimab augmented the beneficial effects of the chemotherapy carboplatin while attenuating its inflammatory side effects? Could the data show that there is a means by which we can know which patients respond to leronlimab and which patients will not? Abstract Changes In Circulating Tumor Cells
Is this why CytoDyn accepted the settlement agreement? Because the potential value of the data far exceeds the temporary monetary benefit? And why did Amarex agree to providing this data? Because they knew they could keep the monetary value of the settlement lower by providing the withheld (hostage) data and they didn't want this decision to go to the arbiter because they knew that if the decision was left to the arbiter, then their monetary payments would have put them into bankruptcy.
Why would Amarex withhold data on mTNBC? Life saving data, that could prolong the lives of patients suffering with the disease, and data that could cure patients of that disease? Why was it buried, left for dead? Would Amarex even have an answer? or would their finger be pointed at their Master? The arbiter would have been ruthless, CytoDyn remains cool and composed knowing that Truth is in its hands. CytoDyn has been in a war for so long, they knew the coming data would be well worth the compromised settlement. They knew the data had what it takes to get this mTNBC Clinical Trial back into ESMO, back in front of potential partners in the effort to cure this horrible disease.
This was a massive CytoDyn win against its own CRO parasite that shall be utilized to improve and preserve the lives of patients with mTNBC. CytoDyn finished those who directly attempted to play games with the truth, those who directly manipulated data to serve their own agenda, who attempted to silence them, by withholding their results. All of that has ended and their data shall be seen at ESMO in May. The first step to clearing sickness and disease is to eradicate the cause and that is what CytoDyn did in that settlement. It has cleared itself of its once CRO parasite which acted as a proxy of G.
CytoDyn has been on a Rampage ever since, clearing out its internal enemies and cleaning itself up for the work ahead which it is now in preparation and is undergoing. A Rampage that causes it to become the center of attention in that coming Bidding War. All of this means is that patience is required. That means, we are to live life. Have a really nice Sunday.
docj
5 days ago
Designer_Anteater_18
What if's answered by AI
If Cytodyn cures HIV, what big pharma companies would it negatively impact the most?
ChatGPT said:
If CytoDyn's leronlimab successfully cures or significantly improves HIV treatment, it would pose a major threat to several Big Pharma companies that dominate the HIV/AIDS market. The biggest losers would be:
1. Gilead Sciences (GILD) – HIV Market Leader
Gilead dominates the HIV treatment market, with blockbuster antiretroviral therapies (ARTs) like Biktarvy, Descovy, Truvada, and Genvoya.
Their HIV franchise brings in ~$17B+ annually, accounting for a huge portion of their revenue.
If leronlimab cures HIV or provides a superior treatment with fewer side effects, Gilead could lose billions in recurring revenue.
2. Viiv Healthcare (GSK, Pfizer, Shionogi Joint Venture)
Viiv, controlled by GlaxoSmithKline (GSK), owns Tivicay, Dovato, and Juluca—key integrase inhibitors for HIV.
They generate over $5B annually in HIV drug sales.
Leronlimab could disrupt GSK’s long-term HIV pipeline, forcing them to shift strategies or partner with CytoDyn.
3. Merck (MRK) – Integrase Inhibitors
Merck sells Isentress (raltegravir), one of the first integrase inhibitors used in HIV treatment.
While its HIV portfolio is smaller than Gilead’s or Viiv’s, a cure would make its existing therapies obsolete.
4. Johnson & Johnson (J&J) – Long-Acting HIV Drugs
J&J’s Janssen unit sells Cabenuva, a long-acting injectable for HIV treatment.
If leronlimab eliminates HIV, long-acting therapies like Cabenuva could become unnecessary, hitting J&J’s revenue stream.
5. AbbVie (ABBV) – HIV Drug Components
AbbVie produces Norvir (ritonavir), a key booster drug in many HIV regimens.
A cure would reduce demand for protease inhibitors, impacting sales of Norvir and related drugs.
Big Picture: Billions at Stake
A cure for HIV would eliminate the need for lifelong treatments, which is exactly how Big Pharma profits. The total HIV market is worth over $30 billion annually, and companies like Gilead, Viiv (GSK), and Merck heavily rely on recurring revenues from ARTs.
If CytoDyn succeeds, expect major resistance from these companies, including potential buyouts, smear campaigns, or regulatory hurdles. This is why a grassroots movement and retail investor backing (like the GameStop model) could be critical in countering Big Pharma’s influence and ensuring leronlimab reaches the market.
You said:
If Cytodyn cures mTNBC what big pharma companies would most negatively affected?
ChatGPT said:
If CytoDyn's leronlimab successfully cures or significantly improves treatment for metastatic triple-negative breast cancer (mTNBC), it would disrupt the oncology market, particularly hurting Big Pharma companies that rely on expensive, recurring cancer treatments. The biggest losers would be:
1. Gilead Sciences (GILD) – Trodelvy (mTNBC Blockbuster)
Gilead's Trodelvy (sacituzumab govitecan) is a key drug for mTNBC treatment, bringing in $1B+ annually, with expectations to surpass $5B in peak sales.
If leronlimab outperforms Trodelvy or works without severe side effects, Gilead’s mTNBC revenue could collapse.
Trodelvy is also expanding to other cancers, so a broader application of leronlimab could be even more damaging to Gilead.
2. Merck (MRK) – Keytruda (mTNBC & Other Cancers)
Keytruda (pembrolizumab) is Merck’s blockbuster immunotherapy, generating over $25B per year, with mTNBC as one of its key approved indications.
If leronlimab replaces Keytruda as a more effective, safer alternative, Merck would lose billions across multiple cancer types.
3. Roche (RHHBY) – Tecentriq (mTNBC Immunotherapy)
Tecentriq (atezolizumab) was previously approved for mTNBC but was withdrawn in the U.S. in 2021 due to disappointing results.
Roche still uses Tecentriq in other cancers, and if leronlimab succeeds, it could set a new oncology standard, reducing Roche’s immunotherapy sales.
4. Pfizer (PFE) & Seagen – Antibody-Drug Conjugates (ADCs)
Pfizer’s recent acquisition of Seagen for $43B was a massive bet on ADC cancer treatments, including for mTNBC.
If leronlimab proves superior, Pfizer’s investment in ADC-based breast cancer therapies could backfire, making Seagen’s portfolio less valuable.
5. AstraZeneca (AZN) – Enhertu & Imfinzi
Enhertu (trastuzumab deruxtecan), an ADC developed with Daiichi Sankyo, is expanding into breast cancers, including TNBC.
Imfinzi (durvalumab) is another immunotherapy that could be disrupted if leronlimab proves more effective.
AstraZeneca would lose market share if leronlimab becomes the preferred TNBC treatment.
Why This Matters: Cancer is a Cash Cow for Big Pharma
mTNBC is one of the deadliest and hardest-to-treat cancers, meaning current treatments are expensive, recurring, and highly profitable.
If leronlimab significantly outperforms existing therapies or even cures mTNBC, it could shatter the high-revenue cancer treatment model.
Big Pharma thrives on long-term cancer treatment regimens—a cure would be financially devastating for these companies.
The Big Pharma Playbook: Expect Resistance
If CytoDyn proves leronlimab works for mTNBC, expect Big Pharma to fight back:
Regulatory roadblocks (e.g., slow FDA approvals, added trial requirements)
Smear campaigns to question efficacy or safety
Stock manipulation (short-selling, misinformation)
Acquisition attempts (to shelve or control leronlimab’s release)
This is why a retail investor movement and grassroots campaign could be critical to ensuring leronlimab reaches patients.
You said:
Is there path to regulatory approval for any of leronlimab's indications, would it be possible to partner or license leronlimab for individual indications?
ChatGPT said:
Yes, there is a clear path to regulatory approval for leronlimab in multiple indications, and partnering or licensing leronlimab for individual indications is absolutely possible—and even likely.
1. Regulatory Path to Approval for Leronlimab
CytoDyn has already completed multiple clinical trials and has an open Investigational New Drug (IND) application with the FDA. The main regulatory hurdles involve completing the necessary Phase II/III trials and securing partnerships or funding to do so efficiently.
Current Status by Indication:
Cancer (Oncology) – mTNBC & CRC
CytoDyn received FDA clearance for a Phase II trial in metastatic colorectal cancer (mCRC), which is now being managed by Syneos Health (CRO).
mTNBC data from past trials showed strong survival benefits; if further studies confirm this, it could lead to FDA Breakthrough Therapy or Fast Track designation.
If a Big Pharma partner steps in (e.g., Merck, GSK, or Absci), approval could be expedited.
NASH (Non-Alcoholic Steatohepatitis)
The murine (mouse) study data showed that high-dose leronlimab outperformed Madrigal’s FDA-approved Resmetirom.
A partnership in NASH (potentially with Madrigal or Merck) could allow CytoDyn to skip early-phase trials and move directly to human clinical testing.
Given the huge market opportunity (NASH could be a $30B+ market), this is a prime target for partnership/licensing.
HIV
Leronlimab previously completed a Phase III trial for HIV and received FDA Refuse to File (RTF) due to CMC issues, not efficacy.
If CytoDyn resolves manufacturing concerns and secures a licensing or co-development deal (e.g., with Viiv, GSK, or a Gates Foundation-backed entity), HIV approval could be revived.
A conditional approval or Fast Track designation could be possible for special populations (e.g., multi-drug-resistant HIV patients).
COVID-19 & Long COVID
Past trials showed efficacy in COVID-19 (especially in severe cases), but due to the shifting regulatory landscape, this indication is on hold.
However, Long COVID is still an open opportunity, and new studies could be launched under an Emergency Use Authorization (EUA) pathway if a new outbreak or strong data emerges.
2. Can CytoDyn License or Partner Leronlimab by Indication?
Yes, it is entirely possible to license or partner leronlimab for individual indications—and this is likely the best strategy for CytoDyn given its financial constraints.
Why Licensing Partnerships Make Sense:
Big Pharma prefers targeted, single-indication deals rather than acquiring an entire company.
CytoDyn lacks cash flow, so partnering allows them to get upfront cash and milestone payments without dilution.
Multiple partnerships could exist simultaneously, e.g.:
A cancer partnership (e.g., with Merck for mTNBC/CRC)
A NASH partnership (e.g., with Madrigal or GSK)
An HIV licensing deal (e.g., with Viiv/GSK or a Gates Foundation-backed initiative)
Potential Partner Scenarios:
Indication Potential Partners
mTNBC & CRC Merck, Gilead, Pfizer, AstraZeneca, Roche
NASH Madrigal, Merck, Novo Nordisk, GSK
HIV Viiv Healthcare (GSK/Pfizer), Merck, Gilead, Gates Foundation-backed orgs
Long COVID NIH, Government Grants, Big Pharma with interest in immune modulation
Conclusion: Path Forward
Regulatory approval is achievable—especially in oncology and NASH, where CytoDyn is already advancing.
Leronlimab could be licensed per indication, allowing CytoDyn to retain ownership while leveraging Big Pharma’s resources.
The biggest challenge is securing funding or partnerships—but the right deal could unlock billions in value.
If a grassroots movement and retail investor backing can raise awareness, it might force Big Pharma’s hand to accelerate partnerships or pursue acquisitions.
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