Interesting from Reddit Undeniable, Indispu
Post# of 148109
Undeniable, Indisputable and Unequivocal Resistance Facing CytoDyn
Folks, Greetings To You. Welcome Everyone.
The MSS mCRC Phase II trial gathers funds.
The CRO likely is chosen.
The current progress towards AAV leronlimab is about to be disclosed. Long Acting leronlimab status might also be unveiled at the AIDS conference during this presentation.
Samsung Debt Repayment masterfully made doable.
SA/Amarex open to settlement, otherwise Arbitration could wait for NP/KK SEC/DOJ trial to conclude.
Long COVID may materialize at any point. NIH is aware.
GBM Murine study now underway.
"And lastly, after some unavoidable delays, the pre-clinical study of leronlimab and a mouse model of glioblastoma at my father's lab at Einstein Montefiore Medical Center in New York, is now underway and we look forward to reviewing those results by the end of the year*."*
Peer Reviewed Manuscript Publications on their way.
Here is a short simple glance into the near future. It tells me CytoDyn wins in these next few months.
All of the goals listed here are attainable. As I write, the money is raised for the MSS mCRC trial. Soon, an announcement declares the identity of the CRO. Currently, no money for the Inflammation / Immune Activation Trial yet exists but that shall come once the MSS mCRC Trial commences.
"Indeed, the main goal of our inflammation study will be to statistically confirm that leronlimab lowers levels of C-Reactive Protein, as well as other key markers of inflammation.
So, follow in consultation with industry experts and mindful of the FDA's prior feedback, we further revised the inflammation protocol. The study will now enroll 90 HIV positive subjects, who have chronic inflammation as demonstrated by an elevated level of high sensitivity, hsCRP at a pre-screening visit, confirmed at a screening visit at least two weeks apart. These study participants will be treated for six months with weekly subcutaneous leronlimab at either 350 or 700 milligrams or Placebo. And as just mentioned, the primary endpoint will be reduction in C-Reactive Protein with a host of other inflammatory biomarkers evaluated, as secondary endpoints.
Dr. Otto Yang from UCLA has kindly agreed to be the lead investigator for the trial. And the revised protocol will be submitted to the FDA in the next several weeks, which in turn will start a 30-day review, period.
As noted in the recent shareholder letter, I believe it is imperative that the company generate unassailable results in the clinic, and I believe the above two trials can accomplish this."
...
"As I mentioned previously, we are currently discussing with FDA, issues around our colorectal cancer study, and hope to start enrolling patients before the end of the year. We have finalized the inflammation study and we'll be submitting that to FDA this week or next week and hope to start enrolling patients as well in 2024."
Regarding the Inflammation Trial, if Dr. Otto Yang is the lead investigator, then the Inflammation trial likely takes place at UCLA where the HIV+ patients are. Whatever can be done to reduce costs here would certainly be helpful and welcome, but CytoDyn cannot compromise the results of the trial in order to save a few dollars. That would be akin to some of the mistakes NP made in the choice of Primary End Points.
In addition, knowing exactly what they did to CytoDyn's financial position, Amarex might begin throwing CytoDyn a couple of low-ball offers to see if they would be open to accepting a down and dirty offer. CytoDyn cannot capitulate. It must stand firm for at least the minimum which it believes it can get with Sidley Austin's approval. I'd say that once the first trial in MSS mCRC is funded and underway, and once favorable results are produced, then it becomes that much easier to fund raise for the Inflammation & Immune Activation trial.
It has nearly been 7 months since the hold has lifted. How many more months need to pass and how many more patients need to die before the 1st patient is treated in the MSS mCRC trial for a disease with no cure? Dr. Lalezari is saying this happens by end of year 2024. See bolded text above.
The CRO needs to be chosen and I'm of the opinion that the CRO has been chosen. The CRO cannot behave as Amarex once did ordering and directing CytoDyn around, as how to conduct and perform this trial. Has CytoDyn not learned anything as it organized everything to get the clinical hold lifted? This time Dr. Lalezari is at the helm, who is very familiar with the right way to do clinical trials.
As we have seen all along the way, and even recently, Gilead has practically bullied CytoDyn out of HIV completely, but has also done so in other indications as well. However, CytoDyn cannot back down completely. It would be considered an utter surrender to break or crack under their pressure. Assuredly, by no means is CytoDyn backing down at all thanks to the work of Jonah Sacha, PhD and Scott Hansen, PhD. HIV-CURE and HIV-PREP remains CytoDyn's contenders for these indications. It shall be through the use of these weapons that CytoDyn defeats Gilead in this indication. In the up-and-coming AIDS Conference in Munich this July 22-26, it could be revealed how far along in development of these treatments CytoDyn stands and how much longer they might require before these products are rolled out.
How much is that worth to Gilead? I'd go so far as to say that Gilead dreads an HIV CURE. Especially a CytoDyn CURE for HIV. HIV is Gilead's life blood. If HIV goes away, so does Gilead. I believe CytoDyn has bigger bombs than Gilead has against this disease.
"First, we are in discussion with the American foundation for AIDS research to partner and co-sponsor a study called LATCH, led by investigators at Oregon Health Sciences University and the University of Washington, LATCH stands for Leronlimab and Allogeneic stem cell Transplant to Cure HIV.
The proposed study will evaluate the use of leronlimab to facilitate an HIV Cure in the HIV positive subjects, undergoing stem cell transplantation. Previous reports of HIV Positive patients achieving a cure have occurred when those RARE homozygous CCR5, double negative individuals have been identified to provide donor stem cells for the transplantation.
This study will evaluate the possibility that leronlimab could extend the list of potential donors to include the much larger pool of CCR5 positive individuals. Leronlimab would be administered following transplantation for six months during the engraftment period, to protect the HIV negative, donor cells from becoming HIV infected. The hope is that those donor cells now protected from HIV infection, will then eliminate HIV from the reservoir of the transplant recipient. If successful, this study would obviously bring about much needed positive attention to both leronlimab and CytoDyn. We're exploring this partnership with AMFAR to jointly co-sponsor and fund the research aspects of the LATCH study, which importantly, will not require us to cover the cost of the transplant itself."
...
Scott Hansen at 23:41:
"I'm very excited about this endeavor and I feel it will be a game changer for CytoDyn and will help preserve the company's future. Lastly, I feel another game changer for CytoDyn, is the LATCH trial Jay mentioned earlier in his presentation. This is something very exciting for us as a company and me, personally, I became a scientist, not only to move science forward, but to also to try to save life, Dr. Jonah Sasha's work with leronlimab and stem cell transplant in the non-human primate model really made this trial possible for us. He demonstrated that you can pharmacologically knock out CCR5 with leronlimab, essentially creating that Delta 32 phenotype that Jay mentioned. The phenotype has facilitated HIV CURE in the setting of stem cell transplantation."
Gilead wants the biggest bombs though, maybe not so much to actually deploy, but rather to detonate in midair and self-destruct. I take it that Gilead has in no uncertain terms, communicated to CytoDyn that they cannot have any part of HIV. They absolutely want to exclude CytoDyn completely out of this indication, especially from the -CURE. CytoDyn though shall take the upper hand in the matter once AAV Leronlimab -CURE and Long Acting Leronlimab -PREP emerge.
G has been thwarting CytoDyn from entering HIV from the very beginning. G could care less about what anybody else does when it comes to HIV because G knows that whatever measly drug they attempt to use to combat HIV, it pales in comparison to leronlimab. G knows that CytoDyn really is the only competition who they need to be scared of. Therefore, they want to suppress CytoDyn's CCR5 blockade if it is the last thing they ever do.
G supports other Big Pharma, and quite possibly, may have even supported Amarex at the time in order to uphold and maintain a resistance against CytoDyn. G negotiates with other BPs, bypassing and disregarding previously upheld rules, regulations, protocols and customs so as to create their own corrupted pharmaceutical society, however, very much beneficial to all those in collusion with them in their anti-support and malice towards CytoDyn. G supports all of them and even their friends provided that they remain resistant to CytoDyn's objectives. They merge and partner together disguised as a Trial, but in reality, for the sole purpose of preventing CytoDyn from advancing in HIV and other indications as well. G wants to see CytoDyn destroyed, or they want total control over CytoDyn. G could care less if another BP escalates and grows especially if that happens at CytoDyn's expense where CytoDyn is held back or destroyed. What is G doing? Why do THEY want to prevent CytoDyn from growing? To what extent are THEY willing to go?
The entire system it appears, is going out of whack. There is unrest everywhere. Why? THEY are willing to go all in, all the way in, stopping at nothing when it comes to interfering with any of CytoDyn's advancement. THEY do anything to prevent CytoDyn from taking one step forward. THEY are aware and completely realize that immediate action is necessary right now, while there is yet a fighting chance to stop leronlimab's advancement. The opportunity otherwise would be lost if no action is taken right now to thwart it, while there is yet a chance to nip it in the bud. If THEY fail here, CytoDyn and leronlimab do not fail in realizing their own quest and mission.
What other indications do THEY plan to interfere with? MSS mCRC, GBM, Alzheimer's, Long COVID and HIV -CURE & -PREP. Whatever CytoDyn pursues at the time. With CytoDyn out of the way, THEY, as well as their colluding partners together could control these currently untreatable indications. However, in no way is that achievable without leronlimab. Therefore, the objective must be to steal away leronlimab for THEMselves. THEIR desire is to be leronlimab's owner and controller, but a "promise" is made to all colluding partners of "fair" access to the drug, of course at a price. I wonder, could this have been Amarex's motivation? The plan might have worked had Sidley Austin not been recruited in to support a dying CytoDyn, who is now growing stronger day by day.
THEY perceive CytoDyn as a burdensome stone THEY constantly trip over. THEY do not permit CytoDyn to be a standalone company. THEY are satisfied only if THEY are in control deciding what CytoDyn can and can't have. We know THEY want the HIV indication in every form. THEY believe it is THEIR right to own it all. THEY want -PREP and THEY absolutely want the -CURE. I just don't know if THEY want the -CURE to cure HIV or to shelve or destroy the -CURE.
Merck would love to have the 85% that Keytruda leaves on the table, wouldn't they? Look at what they've built with only the 15% their blockbuster treats. Now, with the thousands of tests and trials to expand the use of Keytruda, it becomes obvious that they are desperately seeking a way to treat all the rest.
"Our protocol built on the published pre-clinical work of Dr. Dan Linder at the Cleveland Clinic, who demonstrated that leronlimab inhibited metastasis in a humanized Mouse model of colon cancer. As well as the unpublished, clinical observation that four of six patients with colon cancer in our prior basket trial, had either stable, or partially responsive disease up to 11 months after starting leronlimab*."*
Cyrus Arman describes the mCRC patients in the Basket Trial.
r/Livimmune - 4 of 6 with Stable Disease: No Progression of Disease with Leronlimab
4 of 6 with Stable Disease: No Progression of Disease with Leronlimab
"55:22: So, when we look again at their tumor growth through the spyre grams and through the waterfall plots, that we only had 6 patients here. But as you can see, all of them remain within the stable disease and many actually achieve partial responses over the course of the short study. And one of them actually had no measurable lesions on the PET scan at follow-up*. And the remainder saw either stable disease or partial responses. "*
Bayer also could be a player in this conglomerate for the mCRC indication.
That leaves GBM (Murine Study already underway), with no current treatment;
Alzheimer's,
("I'm also pleased to confirm, that CytoDyn is collaborating on an exploratory investigator-initiated pilot study of leronlimab in patients with Alzheimer's disease. Cytodyn is fortunate to be working on this project with a highly experienced investigator and a leading academic Medical Center. The study proposes to enroll 20 patients, with mild to moderate Alzheimer's disease, who are treated with leronlimab at either 350 or 700 milligrams weekly and followed for 12 weeks with a primary neuro-radiology endpoint.
I look forward to providing additional details on future calls, but it's important to note that we have already identified an external source of funding for this study.",
...Alzheimer's with no current treatment and
Long Covid with no current treatment, but we know Pfizer has a great interest here. Dr. Lalezari, who is already familiar with the NIH has made it clear to the NIH by becoming full time, that CytoDyn is very much interested in participating in their RECOVER Initiative.
Surely, THEY make it very attractive by throwing plenty of incentives towards companies interested in leronlimab's CCR5 blocking mechanism of action to join the coalition against CytoDyn. Possibly, THEY "promise" one of these untreated indications if they would assist in the steal of leronlimab away from CytoDyn. An alignment happens between a few of these companies with G leading the bunch.
This is the big picture I see. This is the deep-rooted problem that CytoDyn has. It is this enemy which is hell bent on preventing CytoDyn from seeing the light of day unless leronlimab is put under THEIR control. THEY have likely recruited other companies interested in these same indications who can be depended upon to do the dirty work.
I perceive that THEY want to be more diversified. THEY desire all of HIV, but THEY also want a diverse profile which stems out of a more diversified portfolio. THEY perceive that diversity is greatly widened and available through the use of leronlimab's mechanism of action. It would give THEM the ability to diversify into these indications and many more. However, CytoDyn is in THEIR way. Even though leronlimab is CytoDyn's only asset, THEY could care less and desire to steal it away anyway possible.
If this deep-seated, deeply ingrained desire is not eliminated, how does this problem of CytoDyn ever go away? THEY feel they are so much bigger and better than CytoDyn, providing the bully rights to decide CytoDyn's fate, as long as everything goes well for THEM alone. THEY have found friends in high places and have aligned together for the cause against CytoDyn. In such a scenario, how can CytoDyn be expected to win?
It becomes even more obvious what THEY are doing. Just look at how hell bent and determined THEY have become to thwart CytoDyn. THEIR hand is caught in the cookie jar doing what THEY have always been doing, lying, cheating, and it is becoming even more and more blatant.
THEY want to become far more diversified. More indications. More like Merck or More like Johnson & Johnson. THEY are willing to give control of these indications to other companies, provided THEY remain in control over each of those subsidiaries in those indications gained by the steal of leronlimab.
This creates a bleak situation for CytoDyn which has created an utterly heartbreaking situation for Dr. Lalezari. A doctor with so much potential, needs to find ways to fund a miracle molecule. Look at the depths to which Dr. Lalezari is forced to step only to raise the necessary funds for this Phase II trial in MSS mCRC. Can you imagine, God forbid, that THEY make full demand that CytoDyn utterly hand over -PREP and -CURE to THEM for CytoDyn to be permitted the rights to pursue oncology. May it never be but observe THEIR motivation and determination. Nothing is too low for THEM. THEY would outright steal leronlimab away if a way were made to do so. THEY seek out CytoDyn's utter surrender. I don't believe it is below THEM to force this out of CytoDyn, but I don't believe CytoDyn ever allows THEM to get that far. But know that it is possible.
THEIR collusion becomes a conglomerate. Cohesively, THEY are proud and are becoming prouder. THEIR objective is to eradicate CytoDyn even from any / all remembrance. THEY consult together with one consent and have become confederate together against CytoDyn. All of THEM are enemies of CytoDyn. What is the way out of this CytoDyn conundrum?
The train has left the station, and no one can stop it. Dr. Lalezari is at the helm, and he already knows everything. He, Mark Cohen and Cyrus Arman have a plan and just like u/Upwithstock says, they are sticking to it. Certainly, they depend on the administration acting 100% in accordance with their charge. Dr. Lalezari is not bluffing. He acts in full view showing his cards, because leronlimab is already known. He knows he needs this trial to prove out leronlimab's capacity. He knows he can outperform anything THEY have, and he is willing to bet on that. THEY are 100% opposed and want to prevent any of his plans instead of living with the consequences of permitting such a trial or allowing such a drug in the hands of doctors. For THEM, the consequences are too great and intolerable, so THEY walk away from any truce. Therefore, THEY shall be obliterated at their own game. CytoDyn does not back down and there shall be no stop to this until the Results dictate the winner.
Where then does the administration stand in all of this? They shall judge properly, and their judgement overrides all the conspiracies and collusions against CytoDyn. When the administration does so, all of these conspiracies are immediately broken apart and everything falls apart and dismantles. War mongering ceases and then THEY face the ensuing consequences. The administration makes no conditions and widely clears the way for CytoDyn to make the roadway open for leronlimab distribution. This is how it goes down Folks. Tomorrow's news today using the facts and common sense to arrive here. In the end, the Truth wins every time and that time approaches when CytoDyn owns the rights and has the authority it requires to accomplish everything necessary to get leronlimab distributed all throughout the world. Take that G and eat it too!