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Posted On: 05/04/2022 9:32:15 PM
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In case you wanted a quick refresher on CytoDyn:
https://www.reddit.com/r/LeronLimab_Times/com...;context=3
CytoDyn is an OTCBQ company has a history dating back to 2011 and it started with the prior CEO, Nader Poorhassan purchasing PRO140. CytoDyn owns the Intellectual Property, (IP) of the PRO140, (Leronlimab) monoclonal antibody molecule. Samsung manufactures Leronlimab for CytoDyn. Leronlimab is a subcutaneous injection dosed weekly in the home or as an IV infusion dosed at hospital or infusion center depending on indication. Leronlimab staunchly binds to the CCR5 cytokine effectively creating a CCR5 blockade lasting approximately a 3-4 week half life. Depending on the indication, it is dosed anywhere between once a week, to once a month, to once every 3 months. Leronlimab blocks 100% of the CCR5 cytokines as measured by Receptor Occupancy Testing and subsequently, the associated Innate inflammatory cascade is thwarted while allowing the Adaptive Immune Response to continue as usual. In HIV, it operates as a Viral Entry Inhibitor. Over 70 HIV patients, (one of whom is Charlie Sheen), have been using Leronlimab already now for over the past 7 years now without any Adverse Side Effects. The indications for this molecule are vast and numerous with the current indications having a value of nearly $330 billion annually.
Some of the indications currently being considered for Leronlimab are: multi-drug resistant HIV, monotherapy HIV, combination therapy HIV, long-acting PrEP HIV all of which worth nearly $10 billion. See Publication in “November 2021, Frontiers” “CCR5 Receptor Occupancy Analysis Reveals Increased Peripheral Blood CCR5+CD4+T Cells Following Treatment with the Anti-CCR5 Antibody Leronlimab”. See also the Publication, “June 2021, Nature Communications” “Antibody based CCR5 blockade protects Macaques from mucosal SHIV transmission”. In February 2018, CytoDyn hit the Primary Endpoint in the Leronlimab + Combination trial for HIV and achieved a p value of 0.0032, however, due to a negligent Clinical Research Organization, (CRO), CytoDyn has yet to complete the Biologics License Application, (BLA). CytoDyn has hired Sidley Austin Attorneys who are currently in arbitration with that CRO and have already obtained the trial data which they kept from us so we could not file the BLA, but that has been recovered. Sidley Austin is in arbitration for the damages against CytoDyn and the patients in the trial on account of the negligence the CRO did on the BLA.
Metastatic Triple Negative Breast Cancer is another indication for CytoDyn’s CCR5 blockade Leronlimab. CytoDyn conservatively values this indication at $50 billion. The global cancer therapy market was valued at $158 billion in 2020. It is expected to witness revenue of $268 billion in 2026. “CCR5, a seven trans-membrane G-protein coupled receptor (GPCR), is normally expressed only in the immune system; however, CCR5 becomes overexpressed in several malignancies and is overexpressed in breast cancer”.
CytoDyn has completed a Phase 1 metastatic triple negative breast cancer trial with 29 patients. 21 out of the 29 patients responded to the Leronlimab treatment as verified by increases in Cancer Associated Macrophage Like (CAML) cells and / or Circulating Tumor Cells (CTC). 21 of 29 patients remained alive at the 12 month point of analysis with only a series of (4) 700mg Leronlimab injections + carboplatin. Had these patients received Standard of Care, they would more than likely have died by the 6-7 months point. In the trial: “Compassionate Use Study of Leronlimab in Breast Cancer”, there was a 570-980% increase in Overall Survivability, (OS). Leronlimab doubled the stand alone Standard of Care: Paclitaxel for PD-L1 BC in Progression Free Survival, (PFS) and Overall Survivability, (OS).
Leronlimab in mTNBC after filing for Break Through Designation, (BTD) for mTNBC, almost became the new standard of care, being 3,600% better than chemotherapy, but was told by the FDA that Trodelvy had won that BTD. Trodelvy has a long list of adverse side effects, where as Leronlimab has no reported severe adverse effects and matched or obtained better results than Trodelvy. Currently, We currently estimate that Leronlimab’s OS exceeds 18 months.
See Publication, “January 2021 Breast Cancer Research” “Leronlimab, a humanized monoclonal antibody to CCR5, blocks breast cancer cellular metastasis and enhances cell death induced by DNA damaging chemotherapy”. “The efficiency of leronlimab binding to CCR5-positive human breast cancer cells was up to 98%” https://breast-cancer-research.biomedcentral....21-01391-1. “Prevents overexpression of CCR5 which promotes tumor invasion, migration, and metastasis. In the analysis of > 2200 breast cancer patients, > 50% of patient’s tumors were CCR5+. and > 95% of triple-negative breast cancer (TNBC) were CCR5+” (1) https://breast-cancer-research.biomedcentral....21-01391-1.
CytoDyn believes that they will be the premier Oncology Company that decimates the tumor macro environment. Leronlimab prevents tumor angiogenesis by blocking CCR5; it also blocks CCL5 (RANTES), which promotes Vascular Endothelial Growth Factor (VEGF), which would lead to angiogenesis or the formation of the blood supply to support tumor growth. MD Anderson and other top oncology universities are currently studying breakthrough capability of Leronlimab and possible synergistic effects in oncology. See Publication, “April 2021 International Journal Molecular Sciences” “Update on Glioblastoma Biology, Genetics and Current Therapies: Novel Inhibitors of the G Protein – Coupled Receptor CCR5”.
Liver metastatic burden was decreased 59% in leronlimab-treated mice. Lung metastatic burden was decreased 87% in leronlimab-treated mice compared to IgG-treated animals (p=0.012). “Leronlimab reduced lung metastatic burden > 98% at 8 weeks (99.6%). Collectively, these results provide evidence that the CCR5 antagonist leronlimab reduces the formation of lung metastasis in a murine xenograft model.” https://breast-cancer-research.biomedcentral....021-01391- 1.
“CCR5 is over-expressed in breast cancer, gastric adenocarcinoma, prostate cancer, colorectal carcinoma, melanoma, Hodgkin lymphoma, head and neck cancer, gastric cancer, esophageal cancer, pancreatic cancer, acute lymphocytic leukemia, and other tumors.” https://cancerres.aacrjournals.org/content/79/19/4801.
A Basket Trial of 22 different cancers has been completed and as Leronlimab crosses the blood / brain barrier, it has shown significant improvement in brain metastases and even neurologic conditions like Alzheimer’s. CytoDyn is potentially partnering overseas for Multiple Sclerosis and Alzheimer’s disease.
Another Leronlimab indication is Non Alcoholic Steato-Hepatitis or NASH and NAFLD. As hepatocytes contain CCR5, and the cells that produce scar tissue in the liver also contain CCR5, Leronlimab subsequently blocks liver fat production, liver scarring and fibrosis of the liver. 75% fat reduction and 80ms average CT1 drop in fibrosis with double blinded 350mg dosing is a huge decrease in severe NASH patients which is evidence of resolution of fibrosis. 700mg data is complete but not yet unblinded and Top Line Results aren’t out quite yet. CytoDyn is looking for partnership to do a 1,000 patient Phase 3 trial for 700mg NASH trial once the 700mg Top Line Results are out and that can be any day now. CytoDyn values NASH as a $10 billion indication.
Another indication for Leronlimab is SARS-COV2 or Covid 19. CytoDyn holds the patent for CCR5 blockade in corona virus indications and severe inflammation for 40 years. CytoDyn conservatively values Critically Ill Covid and LongHaulers disease at $5 billion. Leronlimab has treated over 80 individuals as eIND patients and more than 200 people in the Philippines under Compassionate Special Purpose. CytoDyn conducted a US Covid 19 trial and would have met the Primary Endpoint, but was forced by the FDA to only give 2 subcutaneous doses over the critical 1 month period when 4 doses should have been given, (one dose every week). Leronlimab has amazing efficacy in trials when dosed weekly. To combat the efficacy, the FDA only allowed 1 weekly dose of Leronlimab for only 2 of the 4 weeks of the Covid-19 Critical Trial which resulted in a near miss in our p value of 0.052.
Leronlimab had shown 81% survival rate in critical Covid patients the first two weeks of the allowed doses. The Data Safety Monitoring Committee, (DSMC) noted no safety issues and yet no halt was done. The trial was recommended to continue, knowing that patients would not get injected for 2 remaining weeks and these patients were allowed to regress with no medicine for the last 2 weeks of their trial period. Some even ended up dying on account of this malfeasance. In addition, the DSMC allowed the unfair pairing and age stratification discrepancy amongst the patients. The older you were with Covid, the more you were likely to die, and a vast majority of the elderly were curiously in the shorted Leronlimab arm, while the placebo arm was full of patients under 50 years of age, yet this was allowed even though FDA commissioner Janet Woodcock famously stated, “People say they want placebo-controlled trials, but I always ask them: 'Would you be willing to die to give a p-value?”. Another bizarre coincidence, was that one of the 3 DSMC members had been a former Gilead employee, a direct competitor of CytoDyn. As a result of the obvious workings of the FDA in collusion with Big Pharma to combat Leronlimab’s efficacy, CytoDyn headed outside of the US to the Philippines and Brazil.
Simultaneous with Covid-19, a 13D uprising was happening within the company. 13D was making manipulative efforts toward investors indicating that they had a plan to see approval; while all the time, they were discounting management as bad on multiple accounts. 13D succeeded in hurting the reputation of the company. For example, every positive announcement of CytoDyn was matched by 13D announcements belittling management’s efforts. To spy on the company, and further hurt CytoDyn’s reputation, a 13D plant, had infiltrated CytoDyn headquarters to “help” the company. Self proclaimed CCR5 expert, Bruce Patterson, MD, took a non-disclosure agreement, NDA with the CytoDyn and later tried to claim the IP for Leronlimab for himself. He tried stating that the patent for leronlimab rightfully belonged to him. Accomplishing nothing during his contracted tenure, he went on Ted Talks and spoke highly of the drug. Friends of Bruce Patterson began to pump the stock, only to somehow know when to sell and short it in a timely response exactly as Citrons short attack began. That was shortly followed by ambulance chasing lawsuits against CytoDyn which were completely fraudulent and which did not amount to anything. After pumping and dumping the stock, 13D plants on message boards started to hound and take over CYDY investor boards like Yahoo Message Board and Reddit. They portrayed themselves as investors who would “finally” see us over the botched BLA they claimed CytoDyn management was 100% responsible for when they knew all along that the CRO purposely botched the BLA in their favor. In the end, 13D did not succeed because they failed to abide by the public by-laws of the company and also failed miserably to file with the SEC properly. Many investors believe this wasn’t an actual attempt, but was rather purposely done to hurt the company for easier acquisition.
While 13D was successfully belittling CytoDyn, Leronlimab had been working exceptionally well in the Philippines, but in right in line with the 13D attempted overtaking, the FDA had timely written a public letter reprimanding CytoDyn for portraying anecdotal evidence as “evidence based medicine”. This led to another perfectly timed short attack which occurred 15 minutes following the release of the FDA letter. In addition, all the good news of the Philippines was outdone by the FDA letter which was also encouraged by the Pilipino ‘YouTube’ doctors who also supported the 13D movement.
CytoDyn moved Covid overseas to Brazil for a trial. The Covid 19 trial is currently on going in Brazil. CytoDyn has improved 18 out of 24 symptoms in Long Covid patients in an exploratory trial. Leronlimab is potentially the answer to 30-50% of Covid survived patients that suffer from Long Covid. CytoDyn is looking for partnership for Long Haulers.
Leronlimab’s potential disruption to Big Pharmaceutical Industry is similar if not bigger than what Amazon was to in disrupting the retail industry. Saving the lives of people or extending their lives is more critical and valuable during these times than the retail industry ever was.
Investors believe that the FDA, Big Pharma, Big Money, Big Media and Dark Money are in cahoots with each other, slow walking CytoDyn’s trials and trying to dim the lights on anything positive about CytoDyn and / or Leronlimab, thereby cornering them into a position needing to partner or to get acquired. Many frivolous lawsuits and a failed 13D take over seem to be coordinated to hurt the stock value to make negotiations better for those trying to partner or acquire the company.
The FDA recently had CytoDyn completely re-vamp their entire website and had them remove anything and everything including previous Press Releases and prior Publications which could potentially be construed as advertising of the drug Leronlimab as safe and / or effective, even though the drug has saved lives; the fact that there’s no reported severe adverse effects, and the drug has been safely used by HIV patients for over the past 7 years. This FDA imposed statue doesn’t help patients, or retail investors, but it does help Big Pharma, and Big Money like hedge funds or BlackRock who own Big Pharma who would profit from shorting the company.
Many long investors are staunchly bullish on Leronlimab and its capacity to effectively treat many indications and believe that despite the massive opposition that CytoDyn has been facing, the truth of the numbers which Leronlimab produces, cannot be disregarded, especially, when so many patient’s health are infinitely improved without any adverse side effects of taking the drug. Long CytoDyn investors believe that the FDA and Big Pharma cannot indefinitely suppress the facts about Leronlimab and that Leronlimab shall be approved on its own merit in short order.
The last 1/3 of the HIV BLA is currently being put together with the audited data that the previous CRO was forced to provide by court injunction as a result of Sidley Austin’s handiwork. The management of CytoDyn is diligently working to assemble this redacted BLA for HIV in short order. The 700mg NASH Topline Data Report shall also be released soon. The mTNBC phase 2 trial continues to run as a Fast Track Designation, but the BTD for mTNBC is no longer being pursued as the FDA is not supporting this since Trodelvy by Gilead took that regardless of its inferiority to Leronlimab.
We feel that once the BLA for HIV is filed and / or the NASH 700mg Top Line is released, the CYDY share price will rise swiftly. In addition, under pressure, CytoDyn terminated the previous CEO Nader Poorhassan and currently, does not have a CEO. The Board of Directors is currently looking for a CEO. The Scientific Board is packed with doctors who feel Leronlimab is the answer on the indications discussed above and for numerous other indications not here in discussed. The Board of Directors is working on keeping the company afloat amidst the negativity and attacks made by the FDA, by Big Pharma and by Big Money. Certainly, it is understood exactly why there is such staunch opposition to CytoDyn and to Leronlimab and that reason is because Leronlimab is so effective at what it does as a CCR5 blockade, while being harmless to the patient. The stakes are enormously huge because the size of these markets are immense, exceeding the range of $200-300 billion.
As of late, there has been tremendous pressure on the stock price. The price has been falling on a day by day basis for months. It has been as high as $9 in 6/2020, but quickly fell from there. The price had held at $3-5 when there was excitement and when 13D had not revealed themselves. Once 13D made their presence known, it has just been a never-ending downhill slide, lower and lower. Currently, CytoDyn trades for $0.25 and every shareholder is under water. Big Money shorts the stock day after day, by over 50% of daily trade volume. There is no relief in sight as these big entities want CytoDyn dead. They want Leronlimab gone. They do not want it as a competitor because they know they cannot overcome it if it were to arise, so their hope is to crush it now and not give it a chance to grow.
The powers that be are very strong, and they are crushing the CYDY share holder base and many are abandoning ship, thereby leaving themselves without a means to make back their losses. However, if Chris Recknor, MD on the Board of Directors indicates that he has all the data he needs to submit the BLA for HIV, CytoDyn sails again. Once he gives the NASH 700mg Topline Data and the data proves out the astounding expectation that liver fat and fibrosis are significantly and truly reduced by leaps and bounds, CytoDyn sails again and rises with the tide. There are other Leronlimab trials coming to a close, for various indications, in the proximal future as well. So it’s now, sort of a race. Will the shorts tank the stock to zero before Recknor makes these announcements, or will it be the other way around?
Chris Recknor already believes that he has all the data necessary to make a prepared BLA for HIV acceptable to the FDA. He also believes the 700mg NASH data is exceedingly superior to even the 350mg data which was itself was exceptional. He just has to continue the audit with the CRO for Pharmaco - Vigilance. Therefore, it is conceivable that the CytoDyn board may be toying with the shorts, as a kind of foreplay to generate a massive short squeeze. They may be purposely permitting the market makers to bring the share price down, penny by penny on a daily basis, when they already possess the overwhelmingly good news in their back pockets, again, to set up a short squeeze; Recknor just may be waiting for confirmation. Big Money unwittingly maintains its shorting position, holding nearly 50,000,000 shares traded short, lowering share price daily, lower and lower with no end in sight, trading short over 50% daily volume, with their only intent to put CytoDyn 6’ under. It seems everyone is against this company, at least that’s what it seems, but the Board of Directors, quite possibly possess something, very big, up its sleeve.
Long shareholders of CYDY believe that a lot of action will happen in the near future. A lot should be unfolding soon. There is a lot of conflict currently because Leronlimab is such a wonderful medication, yet, it is hated by Big Pharma and by Big Money because it works so well and can have a huge deleterious impact on some big name drugs for big money indications & on some big name funds who own the companies which make those drugs for those indications. Therefore, a good solution for both parties is to graft CytoDyn and Leronlimab into the Big Pharma world and for CytoDyn to uplist to the NASDAQ so it may be purchased by Big Money as well. For this to happen, Long time share holders believe that multiple partnerships with various big name pharmaceuticals on their indications would benefit those multiple pharmaceuticals simultaneously. It would also benefit the big money funds who own those partnering with CytoDyn. Another option would be to partner with a larger non-pharmaceutical, such as Samsung who caters to the pharmaceutical industry and then Samsung would assimilate the partnership with CytoDyn with Big Pharma and Big Money thereby enabling which ever Big Money like Black Rock owning Samsung to benefit.
The partnerships won’t happen until the Amarex arbitration is at a minimum, cleared up a bit. That will take an utterance from Dr. Chris Recknor in conjunction with the CRO for Pharmaco – Vigilance, that he will be able to submit a successful BLA for HIV based on the audited data they received from Amarex. In addition, the 700mg NASH data Top Line results need to be revealed and they need to show astounding numbers revealing that Leronlimab obliterates Fat and Fibrosis in the liver, hands down. Lastly, after these things are revealed, then a new CEO may be brought on.
Needless to say, CytoDyn is currently searching for a CEO. With the versatility of Leronlimab, CytoDyn believes that their path forward is to develop multiple Pharmaceutical partnerships made with companies in varied fields, (ranging from HIV, to Oncology to Liver Disease & beyond), to use Leronlimab in combination therapy with their approved drug to augment its effectiveness for their specific indications.
CytoDyn is currently searching for a CEO who has serious connections in the Pharmaceutical Industry. The CEO needs to have a special drive to help people deal with awful diseases such as HIV and Cancer. He would have a deep ambition for, and personal goals of helping humanity with cures for patients with cancer, HIV, and also for treating the numerous maladies which Leronlimab successfully combats by blocking CCR5. The CEO would learn and understand the mechanism of action of Leronlimab and clearly understand the complexity, the versatility, flexibility and extensive usefulness & broadness of the applications which Leronlimab easily addresses.
As such, this CEO would help humanity by delivering Leronlimab to the people through his own, previously established, network of connections. He would bring CytoDyn together with a diverse group of Big Pharmaceutical companies into partnerships to treat a variety of their indications. Through his direction, and using Leronlimab’s versatility, CytoDyn would enter into partnerships with Big Pharmaceuticals on indications that those Big Pharmaceuticals specialize in, helping them to achieve their goals while CytoDyn achieves theirs.
The CEO would be versed in business and medicine. He would understand patent law. He would have published many papers. A great passion of his is to help people fight disease through the use of medicine and health care. He would do this by bringing multiple companies together, (even those who may be rivals with one another), into a sort of “coalition” through CytoDyn with the augmentation of Leronlimab to the current treatment regimen.
Nader Poorhassan had set the stage, but that stage is now closing, marked by his termination. The new CytoDyn marked by partnerships begins with the incoming CEO. CytoDyn is currently in transition.
https://www.reddit.com/r/LeronLimab_Times/com...;context=3
CytoDyn is an OTCBQ company has a history dating back to 2011 and it started with the prior CEO, Nader Poorhassan purchasing PRO140. CytoDyn owns the Intellectual Property, (IP) of the PRO140, (Leronlimab) monoclonal antibody molecule. Samsung manufactures Leronlimab for CytoDyn. Leronlimab is a subcutaneous injection dosed weekly in the home or as an IV infusion dosed at hospital or infusion center depending on indication. Leronlimab staunchly binds to the CCR5 cytokine effectively creating a CCR5 blockade lasting approximately a 3-4 week half life. Depending on the indication, it is dosed anywhere between once a week, to once a month, to once every 3 months. Leronlimab blocks 100% of the CCR5 cytokines as measured by Receptor Occupancy Testing and subsequently, the associated Innate inflammatory cascade is thwarted while allowing the Adaptive Immune Response to continue as usual. In HIV, it operates as a Viral Entry Inhibitor. Over 70 HIV patients, (one of whom is Charlie Sheen), have been using Leronlimab already now for over the past 7 years now without any Adverse Side Effects. The indications for this molecule are vast and numerous with the current indications having a value of nearly $330 billion annually.
Some of the indications currently being considered for Leronlimab are: multi-drug resistant HIV, monotherapy HIV, combination therapy HIV, long-acting PrEP HIV all of which worth nearly $10 billion. See Publication in “November 2021, Frontiers” “CCR5 Receptor Occupancy Analysis Reveals Increased Peripheral Blood CCR5+CD4+T Cells Following Treatment with the Anti-CCR5 Antibody Leronlimab”. See also the Publication, “June 2021, Nature Communications” “Antibody based CCR5 blockade protects Macaques from mucosal SHIV transmission”. In February 2018, CytoDyn hit the Primary Endpoint in the Leronlimab + Combination trial for HIV and achieved a p value of 0.0032, however, due to a negligent Clinical Research Organization, (CRO), CytoDyn has yet to complete the Biologics License Application, (BLA). CytoDyn has hired Sidley Austin Attorneys who are currently in arbitration with that CRO and have already obtained the trial data which they kept from us so we could not file the BLA, but that has been recovered. Sidley Austin is in arbitration for the damages against CytoDyn and the patients in the trial on account of the negligence the CRO did on the BLA.
Metastatic Triple Negative Breast Cancer is another indication for CytoDyn’s CCR5 blockade Leronlimab. CytoDyn conservatively values this indication at $50 billion. The global cancer therapy market was valued at $158 billion in 2020. It is expected to witness revenue of $268 billion in 2026. “CCR5, a seven trans-membrane G-protein coupled receptor (GPCR), is normally expressed only in the immune system; however, CCR5 becomes overexpressed in several malignancies and is overexpressed in breast cancer”.
CytoDyn has completed a Phase 1 metastatic triple negative breast cancer trial with 29 patients. 21 out of the 29 patients responded to the Leronlimab treatment as verified by increases in Cancer Associated Macrophage Like (CAML) cells and / or Circulating Tumor Cells (CTC). 21 of 29 patients remained alive at the 12 month point of analysis with only a series of (4) 700mg Leronlimab injections + carboplatin. Had these patients received Standard of Care, they would more than likely have died by the 6-7 months point. In the trial: “Compassionate Use Study of Leronlimab in Breast Cancer”, there was a 570-980% increase in Overall Survivability, (OS). Leronlimab doubled the stand alone Standard of Care: Paclitaxel for PD-L1 BC in Progression Free Survival, (PFS) and Overall Survivability, (OS).
Leronlimab in mTNBC after filing for Break Through Designation, (BTD) for mTNBC, almost became the new standard of care, being 3,600% better than chemotherapy, but was told by the FDA that Trodelvy had won that BTD. Trodelvy has a long list of adverse side effects, where as Leronlimab has no reported severe adverse effects and matched or obtained better results than Trodelvy. Currently, We currently estimate that Leronlimab’s OS exceeds 18 months.
See Publication, “January 2021 Breast Cancer Research” “Leronlimab, a humanized monoclonal antibody to CCR5, blocks breast cancer cellular metastasis and enhances cell death induced by DNA damaging chemotherapy”. “The efficiency of leronlimab binding to CCR5-positive human breast cancer cells was up to 98%” https://breast-cancer-research.biomedcentral....21-01391-1. “Prevents overexpression of CCR5 which promotes tumor invasion, migration, and metastasis. In the analysis of > 2200 breast cancer patients, > 50% of patient’s tumors were CCR5+. and > 95% of triple-negative breast cancer (TNBC) were CCR5+” (1) https://breast-cancer-research.biomedcentral....21-01391-1.
CytoDyn believes that they will be the premier Oncology Company that decimates the tumor macro environment. Leronlimab prevents tumor angiogenesis by blocking CCR5; it also blocks CCL5 (RANTES), which promotes Vascular Endothelial Growth Factor (VEGF), which would lead to angiogenesis or the formation of the blood supply to support tumor growth. MD Anderson and other top oncology universities are currently studying breakthrough capability of Leronlimab and possible synergistic effects in oncology. See Publication, “April 2021 International Journal Molecular Sciences” “Update on Glioblastoma Biology, Genetics and Current Therapies: Novel Inhibitors of the G Protein – Coupled Receptor CCR5”.
Liver metastatic burden was decreased 59% in leronlimab-treated mice. Lung metastatic burden was decreased 87% in leronlimab-treated mice compared to IgG-treated animals (p=0.012). “Leronlimab reduced lung metastatic burden > 98% at 8 weeks (99.6%). Collectively, these results provide evidence that the CCR5 antagonist leronlimab reduces the formation of lung metastasis in a murine xenograft model.” https://breast-cancer-research.biomedcentral....021-01391- 1.
“CCR5 is over-expressed in breast cancer, gastric adenocarcinoma, prostate cancer, colorectal carcinoma, melanoma, Hodgkin lymphoma, head and neck cancer, gastric cancer, esophageal cancer, pancreatic cancer, acute lymphocytic leukemia, and other tumors.” https://cancerres.aacrjournals.org/content/79/19/4801.
A Basket Trial of 22 different cancers has been completed and as Leronlimab crosses the blood / brain barrier, it has shown significant improvement in brain metastases and even neurologic conditions like Alzheimer’s. CytoDyn is potentially partnering overseas for Multiple Sclerosis and Alzheimer’s disease.
Another Leronlimab indication is Non Alcoholic Steato-Hepatitis or NASH and NAFLD. As hepatocytes contain CCR5, and the cells that produce scar tissue in the liver also contain CCR5, Leronlimab subsequently blocks liver fat production, liver scarring and fibrosis of the liver. 75% fat reduction and 80ms average CT1 drop in fibrosis with double blinded 350mg dosing is a huge decrease in severe NASH patients which is evidence of resolution of fibrosis. 700mg data is complete but not yet unblinded and Top Line Results aren’t out quite yet. CytoDyn is looking for partnership to do a 1,000 patient Phase 3 trial for 700mg NASH trial once the 700mg Top Line Results are out and that can be any day now. CytoDyn values NASH as a $10 billion indication.
Another indication for Leronlimab is SARS-COV2 or Covid 19. CytoDyn holds the patent for CCR5 blockade in corona virus indications and severe inflammation for 40 years. CytoDyn conservatively values Critically Ill Covid and LongHaulers disease at $5 billion. Leronlimab has treated over 80 individuals as eIND patients and more than 200 people in the Philippines under Compassionate Special Purpose. CytoDyn conducted a US Covid 19 trial and would have met the Primary Endpoint, but was forced by the FDA to only give 2 subcutaneous doses over the critical 1 month period when 4 doses should have been given, (one dose every week). Leronlimab has amazing efficacy in trials when dosed weekly. To combat the efficacy, the FDA only allowed 1 weekly dose of Leronlimab for only 2 of the 4 weeks of the Covid-19 Critical Trial which resulted in a near miss in our p value of 0.052.
Leronlimab had shown 81% survival rate in critical Covid patients the first two weeks of the allowed doses. The Data Safety Monitoring Committee, (DSMC) noted no safety issues and yet no halt was done. The trial was recommended to continue, knowing that patients would not get injected for 2 remaining weeks and these patients were allowed to regress with no medicine for the last 2 weeks of their trial period. Some even ended up dying on account of this malfeasance. In addition, the DSMC allowed the unfair pairing and age stratification discrepancy amongst the patients. The older you were with Covid, the more you were likely to die, and a vast majority of the elderly were curiously in the shorted Leronlimab arm, while the placebo arm was full of patients under 50 years of age, yet this was allowed even though FDA commissioner Janet Woodcock famously stated, “People say they want placebo-controlled trials, but I always ask them: 'Would you be willing to die to give a p-value?”. Another bizarre coincidence, was that one of the 3 DSMC members had been a former Gilead employee, a direct competitor of CytoDyn. As a result of the obvious workings of the FDA in collusion with Big Pharma to combat Leronlimab’s efficacy, CytoDyn headed outside of the US to the Philippines and Brazil.
Simultaneous with Covid-19, a 13D uprising was happening within the company. 13D was making manipulative efforts toward investors indicating that they had a plan to see approval; while all the time, they were discounting management as bad on multiple accounts. 13D succeeded in hurting the reputation of the company. For example, every positive announcement of CytoDyn was matched by 13D announcements belittling management’s efforts. To spy on the company, and further hurt CytoDyn’s reputation, a 13D plant, had infiltrated CytoDyn headquarters to “help” the company. Self proclaimed CCR5 expert, Bruce Patterson, MD, took a non-disclosure agreement, NDA with the CytoDyn and later tried to claim the IP for Leronlimab for himself. He tried stating that the patent for leronlimab rightfully belonged to him. Accomplishing nothing during his contracted tenure, he went on Ted Talks and spoke highly of the drug. Friends of Bruce Patterson began to pump the stock, only to somehow know when to sell and short it in a timely response exactly as Citrons short attack began. That was shortly followed by ambulance chasing lawsuits against CytoDyn which were completely fraudulent and which did not amount to anything. After pumping and dumping the stock, 13D plants on message boards started to hound and take over CYDY investor boards like Yahoo Message Board and Reddit. They portrayed themselves as investors who would “finally” see us over the botched BLA they claimed CytoDyn management was 100% responsible for when they knew all along that the CRO purposely botched the BLA in their favor. In the end, 13D did not succeed because they failed to abide by the public by-laws of the company and also failed miserably to file with the SEC properly. Many investors believe this wasn’t an actual attempt, but was rather purposely done to hurt the company for easier acquisition.
While 13D was successfully belittling CytoDyn, Leronlimab had been working exceptionally well in the Philippines, but in right in line with the 13D attempted overtaking, the FDA had timely written a public letter reprimanding CytoDyn for portraying anecdotal evidence as “evidence based medicine”. This led to another perfectly timed short attack which occurred 15 minutes following the release of the FDA letter. In addition, all the good news of the Philippines was outdone by the FDA letter which was also encouraged by the Pilipino ‘YouTube’ doctors who also supported the 13D movement.
CytoDyn moved Covid overseas to Brazil for a trial. The Covid 19 trial is currently on going in Brazil. CytoDyn has improved 18 out of 24 symptoms in Long Covid patients in an exploratory trial. Leronlimab is potentially the answer to 30-50% of Covid survived patients that suffer from Long Covid. CytoDyn is looking for partnership for Long Haulers.
Leronlimab’s potential disruption to Big Pharmaceutical Industry is similar if not bigger than what Amazon was to in disrupting the retail industry. Saving the lives of people or extending their lives is more critical and valuable during these times than the retail industry ever was.
Investors believe that the FDA, Big Pharma, Big Money, Big Media and Dark Money are in cahoots with each other, slow walking CytoDyn’s trials and trying to dim the lights on anything positive about CytoDyn and / or Leronlimab, thereby cornering them into a position needing to partner or to get acquired. Many frivolous lawsuits and a failed 13D take over seem to be coordinated to hurt the stock value to make negotiations better for those trying to partner or acquire the company.
The FDA recently had CytoDyn completely re-vamp their entire website and had them remove anything and everything including previous Press Releases and prior Publications which could potentially be construed as advertising of the drug Leronlimab as safe and / or effective, even though the drug has saved lives; the fact that there’s no reported severe adverse effects, and the drug has been safely used by HIV patients for over the past 7 years. This FDA imposed statue doesn’t help patients, or retail investors, but it does help Big Pharma, and Big Money like hedge funds or BlackRock who own Big Pharma who would profit from shorting the company.
Many long investors are staunchly bullish on Leronlimab and its capacity to effectively treat many indications and believe that despite the massive opposition that CytoDyn has been facing, the truth of the numbers which Leronlimab produces, cannot be disregarded, especially, when so many patient’s health are infinitely improved without any adverse side effects of taking the drug. Long CytoDyn investors believe that the FDA and Big Pharma cannot indefinitely suppress the facts about Leronlimab and that Leronlimab shall be approved on its own merit in short order.
The last 1/3 of the HIV BLA is currently being put together with the audited data that the previous CRO was forced to provide by court injunction as a result of Sidley Austin’s handiwork. The management of CytoDyn is diligently working to assemble this redacted BLA for HIV in short order. The 700mg NASH Topline Data Report shall also be released soon. The mTNBC phase 2 trial continues to run as a Fast Track Designation, but the BTD for mTNBC is no longer being pursued as the FDA is not supporting this since Trodelvy by Gilead took that regardless of its inferiority to Leronlimab.
We feel that once the BLA for HIV is filed and / or the NASH 700mg Top Line is released, the CYDY share price will rise swiftly. In addition, under pressure, CytoDyn terminated the previous CEO Nader Poorhassan and currently, does not have a CEO. The Board of Directors is currently looking for a CEO. The Scientific Board is packed with doctors who feel Leronlimab is the answer on the indications discussed above and for numerous other indications not here in discussed. The Board of Directors is working on keeping the company afloat amidst the negativity and attacks made by the FDA, by Big Pharma and by Big Money. Certainly, it is understood exactly why there is such staunch opposition to CytoDyn and to Leronlimab and that reason is because Leronlimab is so effective at what it does as a CCR5 blockade, while being harmless to the patient. The stakes are enormously huge because the size of these markets are immense, exceeding the range of $200-300 billion.
As of late, there has been tremendous pressure on the stock price. The price has been falling on a day by day basis for months. It has been as high as $9 in 6/2020, but quickly fell from there. The price had held at $3-5 when there was excitement and when 13D had not revealed themselves. Once 13D made their presence known, it has just been a never-ending downhill slide, lower and lower. Currently, CytoDyn trades for $0.25 and every shareholder is under water. Big Money shorts the stock day after day, by over 50% of daily trade volume. There is no relief in sight as these big entities want CytoDyn dead. They want Leronlimab gone. They do not want it as a competitor because they know they cannot overcome it if it were to arise, so their hope is to crush it now and not give it a chance to grow.
The powers that be are very strong, and they are crushing the CYDY share holder base and many are abandoning ship, thereby leaving themselves without a means to make back their losses. However, if Chris Recknor, MD on the Board of Directors indicates that he has all the data he needs to submit the BLA for HIV, CytoDyn sails again. Once he gives the NASH 700mg Topline Data and the data proves out the astounding expectation that liver fat and fibrosis are significantly and truly reduced by leaps and bounds, CytoDyn sails again and rises with the tide. There are other Leronlimab trials coming to a close, for various indications, in the proximal future as well. So it’s now, sort of a race. Will the shorts tank the stock to zero before Recknor makes these announcements, or will it be the other way around?
Chris Recknor already believes that he has all the data necessary to make a prepared BLA for HIV acceptable to the FDA. He also believes the 700mg NASH data is exceedingly superior to even the 350mg data which was itself was exceptional. He just has to continue the audit with the CRO for Pharmaco - Vigilance. Therefore, it is conceivable that the CytoDyn board may be toying with the shorts, as a kind of foreplay to generate a massive short squeeze. They may be purposely permitting the market makers to bring the share price down, penny by penny on a daily basis, when they already possess the overwhelmingly good news in their back pockets, again, to set up a short squeeze; Recknor just may be waiting for confirmation. Big Money unwittingly maintains its shorting position, holding nearly 50,000,000 shares traded short, lowering share price daily, lower and lower with no end in sight, trading short over 50% daily volume, with their only intent to put CytoDyn 6’ under. It seems everyone is against this company, at least that’s what it seems, but the Board of Directors, quite possibly possess something, very big, up its sleeve.
Long shareholders of CYDY believe that a lot of action will happen in the near future. A lot should be unfolding soon. There is a lot of conflict currently because Leronlimab is such a wonderful medication, yet, it is hated by Big Pharma and by Big Money because it works so well and can have a huge deleterious impact on some big name drugs for big money indications & on some big name funds who own the companies which make those drugs for those indications. Therefore, a good solution for both parties is to graft CytoDyn and Leronlimab into the Big Pharma world and for CytoDyn to uplist to the NASDAQ so it may be purchased by Big Money as well. For this to happen, Long time share holders believe that multiple partnerships with various big name pharmaceuticals on their indications would benefit those multiple pharmaceuticals simultaneously. It would also benefit the big money funds who own those partnering with CytoDyn. Another option would be to partner with a larger non-pharmaceutical, such as Samsung who caters to the pharmaceutical industry and then Samsung would assimilate the partnership with CytoDyn with Big Pharma and Big Money thereby enabling which ever Big Money like Black Rock owning Samsung to benefit.
The partnerships won’t happen until the Amarex arbitration is at a minimum, cleared up a bit. That will take an utterance from Dr. Chris Recknor in conjunction with the CRO for Pharmaco – Vigilance, that he will be able to submit a successful BLA for HIV based on the audited data they received from Amarex. In addition, the 700mg NASH data Top Line results need to be revealed and they need to show astounding numbers revealing that Leronlimab obliterates Fat and Fibrosis in the liver, hands down. Lastly, after these things are revealed, then a new CEO may be brought on.
Needless to say, CytoDyn is currently searching for a CEO. With the versatility of Leronlimab, CytoDyn believes that their path forward is to develop multiple Pharmaceutical partnerships made with companies in varied fields, (ranging from HIV, to Oncology to Liver Disease & beyond), to use Leronlimab in combination therapy with their approved drug to augment its effectiveness for their specific indications.
CytoDyn is currently searching for a CEO who has serious connections in the Pharmaceutical Industry. The CEO needs to have a special drive to help people deal with awful diseases such as HIV and Cancer. He would have a deep ambition for, and personal goals of helping humanity with cures for patients with cancer, HIV, and also for treating the numerous maladies which Leronlimab successfully combats by blocking CCR5. The CEO would learn and understand the mechanism of action of Leronlimab and clearly understand the complexity, the versatility, flexibility and extensive usefulness & broadness of the applications which Leronlimab easily addresses.
As such, this CEO would help humanity by delivering Leronlimab to the people through his own, previously established, network of connections. He would bring CytoDyn together with a diverse group of Big Pharmaceutical companies into partnerships to treat a variety of their indications. Through his direction, and using Leronlimab’s versatility, CytoDyn would enter into partnerships with Big Pharmaceuticals on indications that those Big Pharmaceuticals specialize in, helping them to achieve their goals while CytoDyn achieves theirs.
The CEO would be versed in business and medicine. He would understand patent law. He would have published many papers. A great passion of his is to help people fight disease through the use of medicine and health care. He would do this by bringing multiple companies together, (even those who may be rivals with one another), into a sort of “coalition” through CytoDyn with the augmentation of Leronlimab to the current treatment regimen.
Nader Poorhassan had set the stage, but that stage is now closing, marked by his termination. The new CytoDyn marked by partnerships begins with the incoming CEO. CytoDyn is currently in transition.
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