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JustDaTruthB..!!!
It’s a welcome change to see a post about CYDY and Leronlimab..On this forum.
Thank you..!!!
Monroe..Most knowledgeable TRUE..!!!
In addition..Dr Jay has treated 100’s of HIV patients with Leronlimab. Some of these patients received Leronlimab for years at a time.
Could the Clinical Response of these individuals to Leronlimab, have been the reason Dr Jay chose to target ‘Inflammation’ in our upcoming study.
Why did the FDA help in developing our Protocol? Did the FDA acknowledge the validity of the evidence Dr Jay has based our Protocol on, and are therefore going out of their way, to be helpful to CYDY ?
5.95akadawson-m.. True my friend..!!!
What’s more?
Well..Jay’s two for two for meeting deadlines, so far.
Are we witnessing our GOAT, in real time?
Can’t wait to hear more from Jay, come next Tuesday’s CC..!!!
misiu 143.. The more money you generate for the shorts..The longer they’ll stay on this board..!!!
Please..Please refrain from engaging them..!!!
d0lphint0m..Could you please explain the implications of this chart..!!!
Are we still in the running for the ‘Golden Cross’..!!!
Thank you..!!!
Monroe 1..!!!!
Dr Jay, Cyrus make a great one two punch ..true..!!!
However..!!!
The biggest believer in Leronlimab is by far ..Dr Hansen..!!!
The 3 working together, as they’re doing now, makes it a dream team.
My opinion about the contributions of our CYDY Board Members, Scientific Advisory Board..!!!
Well..The less said..The better..!!!
My heartfelt request to these ‘parasites’ ( CYDY Board Members, Accountants, Attorneys) we’ve carried on our backs these last few years is..!!!
Give CYDY a break..!!!
For one year starting today..!!!
Accept a salary of 30,000 shares of CYDY on a monthly basis..!!!
Get CYDY to $2 by the end of the year..!!!
Each member would be handsomely rewarded..!!!
Our cash burn rate on useless self serving accountants, attorneys, CYDY Board Members has gotta be zero dollars for one year..!!!
IMHO
Question for D0lphint0m ( Misiu can’t stop singing your praises on another group we’re in ).. Rich 2.. TommyBoyTrader..!!!
If we achieve the Golden Cross..Is the next level 40-45 cents before a pullback..!!!
Or..!!!
Do we go to 70-80 cents..with a slight pull back at the 42 cent mark..over the next 6 weeks..??
Assuming the ‘Full Hold’ on our Immune Activation HIV trial is Lifted by Mid February..!!!
Thank you..!!!
rich2..!!!
Some of the ‘bashers’ on our board, were at one time ‘die hard’ longs..!!!
Leronlimab has been thru the wringer. Inept management, insatiable greed, ‘criminal’ oversight by ‘favourites’ of those in power had CYDY on its knees!!!
However..!!!
The drug works..Period..!!!
It’s what has kept us longs in the stock, far past the point any sane individual would touch it with a 10 foot barge pole..!!!
I believe we’ve turned the corner..!!!
IMHO
rich2.. Dunno anything about charts!!!
Just that Leronlimab is a generational drug !!!
Finally finding its way into the hands of a scientist who appreciates its value.
If Dr Jay can steer clear of trouble from the ‘politics’ at CYDY..!!!
We can finally be on our way..!!!
IMHO.
5.95akadawson-m.. Got it..!!!
Gotta Transition to ‘Here Comes The Sun’ by the Beatles..!!!
More appropriate..!!!
What you crying about $5.95 akadawson..??
Our hold is lifted..!!!
We finally have one person Dr Lalezari, who works for a living..!!!
We’re now A-Ok..!!!
TommyBoyTrader ..was wondering whether D0lphint0m and you would consider..!!!
Conducting a reeducation program for our resident bashers..!!!
As they’re forced to seek employment in the near future..??
D0lphint0m..Thank you. Much appreciated..!!!
d0lphint0m.. In plain English please..!!!
Do you mean we gotta go down some more..first..!!!
Or..!!!
Our uptrend is A-Ok..??
Well Misiu 143..!!!
It didn’t take long for you, to break your New Year Resolution.
Block the low lives.
If you don’t read the garbage they post, you won’t feel compelled to respond.
Remember instead, the desperate times of your son laying in the parking lot for hours, as the hospital had no room even in the hallways for critical patients.
Remember the drug that gave you your son back.
Fight to have this drug be available to ordinary folks.
PLEASE..don’t get sidetracked by folks ‘baiting’ you to make a few bucks.
For all on this board..I was on the phone with Misiu daily, during her fight to save her child.
As were a bunch of well wishers from IHub.
Stay on message Misiu..!!!
Please..!!!
Misiu 143..!!!
Dr Jay is the reason our 22 month hold has been lifted.
PERIOD..!!!
It’s entirely possible , Dr Jay is the brain behind this absolutely fabulous New Protocol of Immune Activation and Inflammation.
In my humble opinion, our ‘hold’ would’ve lasted for 6 months maximum, if Dr Jay had taken over as CEO, the day the hold was implemented.
I understand folks are enamored by ‘Superstars’ that CYDY could potentially bring on board.
Give me an honest, hardworking Scientist, who understands Leronlimab like no other, who’s used Leronlimab to save lives, who puts his reputation on the line for his belief in Leronlimab, who is respected and in turn respects the officials of the FDA.
Give me Dr Lalezari.
Since 2012..!!!
Well, I finally found something to disagree on, with a CYDY Long..!!!
Misiu is one tough lady.. Brilliant Physician, but boy can she hold her own, in real life.
It’s actually quite amusing to watch Pre school level kids argue with a College Professor..!!!
Help..??
Hmmm..!!!
d0lphint0m..It’s great to see you back for good this time, hopefully..!!!
I’ve always loved and admired your expertise with charts..!!!
With our hold lifted..Where do we advance to ..on some positive News hitting in the near future..??
Chumppunk..much appreciated..!!!
Cometh the hour Cometh the man
On 11/30/2023 the sword of Damocles was finally lifted off our head, by the FDA.
Our past transgressions including Investigator brochures, Aggregated Safety Data etc were rectified, presented to, analyzed by, and finally approved by the FDA, to their satisfaction.
Our Nightmare of 22 long months, has ended.
The Partial Hold on HIV has been lifted.
Our new HIV ‘inflammation based’ protocol could cause a paradigm shift in the Field of Modern Medicine.
The fact that the FDA recognizes the immune modulating ability of Leronlimab, and have chosen it to be the prototype in this vast new exciting field of Medicine is incredible, to say the least.
The close collaboration between Dr Lalezari and the FDA , to develop and fine tune the protocol to give definitive actionable results, is extremely encouraging.
By definition if an IND application is not approved by the FDA within 30 days, it is considered to be under ‘Clinical Hold’.
Therefore our new HIV ‘inflammation’ protocol is under ‘Full Clinical Hold’ while Dr Lalezari and the FDA hammer out the details..ad nauseum..!!!
The ‘amended inflammation’ protocol should be in the FDA’s possession next month.
Approval of the protocol by the FDA..Leads to automatic Removal of the Clinical Hold on the protocol, by the FDA.
We’re off to the races..Or..as in Monroe’s case..to the beaches..!!!
IMHO.
Misiu 143..!!!
Excellent summary of Dr Jay’s presentation..!!!
We owe the FDA and Key Opinion Leaders in HIV a mountain of debt..!!!
Let me explain..!!!
HIV patients regardless of ART maintain a level of inflammation that is never completely eradicated..!!
Transgender..Even more..!!!
If Leronlimab is to show proof of quelling the inflammatory Biomarkers in this subset of individuals..!!!
It is analogous to us doing 15-20 Studies on various indications..All at once..!!!
The key component of Neurodegenerative Diseases..Cardiovascular Disorders..Renal Disorders..Pulmonary ( Asthma..COPD ) etc..!!!
Boils down to one essential Patho Physiological process..!!!
INFLAMMATION..!!!
This new study on ‘inflammation’ could show signals in so many different organ systems.. that we could be inundated with partnership requests..for the rest of our existence..!!!
And ..!!!
I’m not talking about partnering in the HIV population..!!!
But..!!!
In the care of the General Population..!!!
This study is genius..and saves 8-10 yrs of future Exploration of Leronlimab’s potential..!!!
My only request of Dr Lalezari would be..!!!
Make it a one year trial instead of only of 6 months duration..!!!
Give Leronlimab time to show beyond a shadow of a doubt..!!!
Leronlimab is of vital importance to the Human Race..!!!
We have not even touched on Cancer yet..!!!
IMHO
d0lphint0m..Cannot wait to see your charts soaring skywards in the near future.
Misiu..Hmmm..Misiu’s one tough cookie. Besides being a brilliant physician, she’s one of the nicest people one could ever hope to meet.
bwolfy2002.. Any idea how Scooter’s long calls on HGEN are faring..??
So Misiu..Why do lowlifes such as Cyder get kicked off Investor Hangouts, so as to allow legit investors to focus on the science and future of our miracle molecule Leronlimab..???
$5.95 akadawson-m..!!!
Please don’t bust the bubble the shorts live in. They got nothing else to hang onto..!!!
Monroe1…Leronlimab may prove to be the Vitamin of the future..!!!
Most downstream effects of most ailments are due to immune dysregulation. Whether it be Diabetes.. Hypertension..Traumatic Brain Injury..Obesity..!!!
Most of the Cancers in our population are due to our immune surveillance failing to spot them.
Most of the 30,000 odd deaths due to Influenza..Pneumonia on a yearly basis are not due to the organism causing them..instead due to the dysregulation of our immune system.
Most Neurodegenerative diseases such as Alzheimer’s..Parkinson’s..Amyotrophic Lateral Sclerosis could prove to be due to a Dysregulated immune system.
I won’t even begin to talk about Asthma..COPD or the various forms of Arthritis..!!!
These disorders absolutely need to be addressed on an individual basis.
However..!!!
The aftermath of these disease processes could be vastly mitigated if an individual is on a monthly or 6 monthly dose of a long acting Leronlimab..!!!
IMHO
I
https://www.mdpi.com/2072-6694/15/9/2661
CCR5 (C–C chemokine receptor type 5) is a seven-transmembrane GPCR highly expressed in TNBC patients. CCR5 is also a prognostic biomarker. One cohort study found that approximately 95% of TNBC patients were CCR5+, compared to the percentage of patients positive for CCR5 with other breast cancer subtypes [68]. It was observed that when the promoter region of CCR5 gets methylated, CCR5 protein results in overexpression [69]. It was further observed that overexpression of CCR5 results in increased Ca2+ signaling, which facilitates cellular migration in cancer cells. CCR5 also plays an important role in cell growth, proliferation, and the differentiation of immune cells by activating the PI3K signaling pathway, thereby inducing the activation of PDK1 and AKT [68]. Various studies showed that CCR5 overexpression is also positively associated with tumor immune cell infiltration via the activation of effector T-cells and tumor suppressor genes, and repression of YAP1 oncogenic pathways [69].
Recently, it was observed that blocking CCR5 results in anticancer activity. Such a phenomenon was showcased by the emergence of a humanized monoclonal antibody, Leronlimab (PRO 140), and CCR5 antagonist, maraviroc or vicriviroc. It was observed from the preclinical trial that the binding of Leronlimab to human CCR5 leads to the blockage of the CCR5-mediating signaling pathway, thereby preventing TNBC cell invasion [70,71].
Additionally, various in vitro and in vivo studies demonstrated that blocking or knocking down CCL5/CCR5 is harmful to metastatic tumors like TNBC, and thus limits their metastases. In May 2019, Leronlimab (PRO 140) was granted Fast Track Designation by the FDA for its application as a combination therapy with HAART for HIV-infected patients. Recently, Leronlimab has been filed as a drug of choice with the FDA for the treatment of CCR5+ mTNBC patients [72]. The filing was supported by the data from the second patient dosed with Leronlimab (Pro 140) under an emergency investigational new drug (IND) application granted by the FDA in September 2019. It was revealed that the TNBC patients receiving Leronlimab (PRO 140) exhibited no indication of metastases in the lungs and brain during the treatment [73]. In a similar context, phase Ib/II clinical study is ongoing for combining leronlimab with carboplatin (chemotherapy) for the treatment of CCR5+ mTNBC (NCT03838367). The preliminary studies showed an acceptable tolerability and efficacy with an increase in overall survival (OS) and progression-free survival (PFS) [7]. It was observed from the study that the patients who received leronlimab showed a significant 400–660% increase in 12-month PFS, as well as a 570–980% increase in 12-month OS, with a 72% decrease in circulating tumor cells [74].
Moreover, compassionate Use (NCT04313075) and the Basket Study (NCT04504942) were performed to evaluate the safety and efficacy profile of leronlimab at 12 months [75]. In compassionate study (NCT04313075) 2020, leronlimab (PRO 140) was combined with the treatment of physician’s choice (TPC) which included eribulin, gemcitabine, capecitabine, paclitaxel, nab-paclitaxel, vinorelbine, ixabepilone, or carboplatin for the treatment of CCR5+ mTNBC [76]. In the Basket Study (NCT04504942) of 2020, leronlimab (PRO 140) was administered to CCR5+ locally advanced or mTNBC patients. In this study leronlimab (PRO 140) was administered in continuation to the standard-of-care chemotherapy or radiotherapy [77].
Buddyboy 20.. Respect..!!!
The vision Cyrus is exhibiting is awesome. I was and am reluctant to give up on our quest on getting Leronlimab approved for Covid.
The immunomodulation orchestrated by Leronlimab in critical Covid is the reason it has no equal.
Within the next 2 years, there is approximately a 30% chance of a variant of Covid causing havoc in the US.
Within the next 2 years Leronlimab, through Cyrus’s efforts, could be a household name in the world.
Whether it be NASH or Cancer or a Neurodegenerative disease. Leronlimab will be recognized for what it is.
Cyrus’s efforts to get our Aggregated Safety Data submitted appropriately, as requested by the FDA, is the single most important thing he has accomplished.
The fact Cyrus is going after NASH and Cancer with a single mindedness that is difficult for CYDY shareholders to comprehend, is laudable.
NASH and Cancer are here to stay. No ebbs or flows in the patient population needed to fill our trials.
The fact that Cyrus could walk away from Covid, and concentrate instead on NASH and Cancer shows me the maturity and brilliance of the man.
IMHO
$5.95akadawson-m…!!! Anyone know who this Hansen guy is..???
https://news.ohsu.edu/2017/01/25/vaccine-technology-developed-by-ohsu-scientists-acquired-by-industry-leaders
The very fact that safety was appropriately the major concern of the FDA , in our initial ‘Hold’ .
The FDA again has responded within 30 days of our final submission of their 5 concerns, with queries about risk / benefit and now, inquiring about a ‘New Protocol’ for HIV.
Would that be the case if ‘issues’ were indentified in our ‘Aggregated Safety Data’..??
The fact that ‘safety’ appears no longer to be a concern for the FDA, implies we should soon be able to explore ‘other’ indications , whether that includes HIV or not.
IMHO
Misiu 143..!!!
Leronlimab is incredible in many different spheres of Medicine.
The fact that our Safety Data is finally tabulated and presented appropriately to the FDA , means the flood gates to exploring numerous diverse indications will start to open this year.
Cancer ..NASH..NASH in HIV ..Will just be the start of numerous indications we’ll eventually be approved for.
IMHO
Copied and pasted below :
VIR Biotechnology – has high probability of being the 3rd party biotech company that Cytodyn has entered into a joint development agreement with to develop one or more longer acting molecules targeting CCR5. There are multiple links linking Scott Hansen, other prominent OSHU scientists, OSHU itself and VIR Biotechnology.
10q: April 10, 2023
“In March 2023, as part of its conveyed long-term development and value creation initiatives, the Company made efforts to pursue the continued development of a longer-acting agent. In furtherance of this initiative, the Company entered into a joint development agreement with a third-party company to develop one or more longer-acting molecules. In addition to potentially leading to a modified therapeutic that will have greater acceptance by patients, the services provided by the third party may yield extended intellectual property protection, thereby increasing the value of the Company’s patent portfolio.”
Investor Update: April 11, 2023
Cyrus Arman:
12:56: Additionally, we have also formally established Dr. Scott Hansen as our Head of Research and Basic Science. Dr. Hansen is currently an Associate Professor at OHSU. and within this newly formalized role, Dr. Hansen will support our clinical development activities, related to biomarker and assay development for future clinical trials, as well as supporting and leading some of our earlier stage efforts, geared towards the development of longer acting molecules targeting CCR5.
13:33: As a part of those efforts, we have also recently entered into a joint development agreement with a 3rd party Research and Development Biotech company to develop one or more longer acting molecules targeting CCR5. So, in addition to potentially leading to an improved or modified therapeutic, that, we believe that would have greater acceptance by both patients and physicians and this could help to yield extended intellectual property section that would increase the underlying value of our patent portfolio.
1. https://news.ohsu.edu/2017/01/25/vaccine-technology-developed-by-ohsu-scientists-acquired-by-industry-leaders
Excerpts:
A first-of-its-kind vaccine technology platform developed by renowned scientists at OHSU in Portland, Oregon, has been acquired by Vir Biotechnology, a San Francisco-based biotech startup backed by leading industry investor ARCH Venture Partners and the Bill & Melinda Gates Foundation, a leading funder of global health initiatives.
The vaccine platform is the brainchild of a team of scientists at the OHSU Vaccine and Gene Therapy Institute, or VGTI, including Jay Nelson, Ph.D.; Klaus Frueh, Ph.D.; Scott Hansen, Ph.D.; and Louis J. Picker, M.D. The acquisition, which includes a merger with the OHSU startup TomegaVax Inc., is a critical step in translating a basic science concept pioneered at OHSU into a portfolio of commercial vaccines that have the potential to protect against and cure some of the world’s deadliest infectious diseases, including HIV, malaria, hepatitis B, papillomavirus and tuberculosis.
The vaccine platform is based on a unique model that uses the common herpes virus cytomegalovirus, or CMV, as the viral vaccine vector to deliver a knock-out blow to the various pathogens.
Research at VGTI was first made possible through a state-funded Oregon Opportunity Grant. The research has since been funded primarily through grants from the National Institutes of Health’s National Institute of Allergy and Infectious Disease, and the Bill & Melinda Gates Foundation, which has committed $46 million in grants to support Picker’s work at VGTI.
Both Picker and Frueh will serve as scientific advisors to Vir, and Frueh will serve on the Vir board of directors. As part of the acquisition, OHSU holds equity in Vir, which is expected to announce an initial public offering within the next few years should the vaccines prove successful in human clinical trials. Frueh, Picker and colleagues will continue their basic science research at OHSU, with the goal of fine-tuning the vaccine technology in their pre-clinical work.
Vir is adopting a broad technological portfolio, including the viral vectors obtained through the acquisition of TomegaVax, Inc. to create cures and treatments for emerging diseases, deadly viruses and drug-resistant bacteria using immune programming. ARCH Venture Partners, whose co-founder Robert Nelsen conceived and led the formation of Vir, has committed to invest up to $150 million.
2. https://news.ohsu.edu/2021/03/25/hiv-vaccine-candidates-mysteries-unlocked-20-years-later
“OHSU and several individuals have a significant financial interest in Vir Biotechnology Inc., a company that may have a commercial interest in the results of this research and technology. These individuals include Picker, Frueh, Sacha, Malouli, Hansenand Hancock.”
3. Scott Hansen received compensation from VIR Biotechnology which he was required to report: https://projects.propublica.org/dollars-for-profs/disclosures/oregon-health-science-university-scott-hansen-nih-4080
4. Vir Biotechnology 10k: https://investors.vir.bio/node/10076/html
Symbol on NASDAQ: VIR
“Enabling global access to our future medicines. We have established relationships with organizations seeking to make a global impact like the Bill & Melinda Gates Foundation, BARDA, the NIH, and the NHS to further enable and facilitate access to our future medicines and to support our clinical development efforts. We will continue to pursue additional relationships like these moving forward.”
VIR cash: As of December 31, 2022, we had cash, cash equivalents and investments of $2.4 billion.
VIR debt: We had no debt outstanding as of December 31, 2022.
Master Exclusive License Agreement with OHSU
5. Founding of VIR:
https://www.prnewswire.com/news-releases/vir-biotechnology-launches-to-cure-treat-and-prevent-challenging-infectious-diseases-using-latest-advances-in-immunology-300386841.html
“Lead investors include ARCH Venture Partners and the Bill & Melinda Gates Foundation, and will be joined by others including sovereign wealth funds, public mutual funds and prominent individuals and family offices. ARCH Venture Partners, whose co-founder Robert Nelsen conceived and led the formation of Vir, has itself committed to invest $150 million.”
“The founders of Vir Biotechnology sought to create a new kind of immunology company that could leverage the power of monoclonal antibodies to develop new treatments for infectious diseases. They believed that monoclonal antibodies had the potential to be a highly effective tool in the fight against infectious diseases, and that the technology was underutilized in the development of new therapies.”
“Vir Biotechnology has a research collaboration agreement with OHSU's Vaccine and Gene Therapy Institute (VGTI) that allows the two organizations to work together to develop new therapies and vaccines for infectious diseases. Under this agreement, Vir Biotechnology has access to VGTI's expertise and research capabilities, while VGTI benefits from Vir Biotechnology's resources and expertise in the development of monoclonal antibodies.”
6. About: https://www.vir.bio/about/
“We were founded with the mission of creating a world without infectious disease.
We are a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Infectious diseases are one of the leading causes of death worldwide and the cause of hundreds of billions of dollars of economic burden each year. We believe that now is the time to apply the recent and remarkable advances in immunology to combat infectious diseases. Our approach begins with identifying the limitations of the immune system in combating a particular pathogen, the vulnerabilities of that pathogen and the reasons why previous approaches have failed. We then bring to bear powerful technologies that we believe, individually or in combination, will lead to effective therapies.” Ex
Misiu..9.95 from 5.95..???
Inflation..??
Buddyboy 20..!!! What a great idea..Alzheimer’s..!!!
Do you know of anyone stuck in the past?
Poor Soul..!!!
With no hope of comprehending the present or appreciating the future.!!!
What a Godsend Leronlimab will be ..!!!
IMHO
Misiu143.. 5.95 akadawson-m..!!!
Think about it..!!!
Why are we all here..??
It’s the spectacular results in various indications that Leronlimab has achieved, that makes us believe..!!!
With the right management, folks who are from and firmly embedded in the industry, Leronlimab has nothing but blue skies ahead..!!!
IMHO
So what have we accomplished in the last year ?
Every person in our C-Suite who should never have been there..has been replaced by competent ‘industry insiders’
We no more look or behave like a ‘Mom and Pop’ outfit.
Data generated by sites has been found to be reliable and ‘showing positive signals’ of various indications including NASH and Cancer.
Big Pharma relationships, something our current C-Suite occupants have an abundance of.. are paving our way to future Clinical Trials in numerous indications.
Amarex ..after a review of an independent third party of its work ..appears to be a slam dunk.
A respectful close bond is being forged with our FDA.
Our monthly burn rate has been drastically cut to ensure we keep our lights on till the end of this year.
What’s not to like?
IMHO
My 2 Cents..!!!
HIV hold lifted in the next week..!!!
What if ..the FDA asks for more information..?? Information perhaps that we’re unable to provide..??
Where does that leave Cytodyn..??
Does that mean we are unable to pursue NASH..Cancer..Covid..or other indications..??
Not at all..!!!
We were able to pursue all these indications a year ago. We’re absolutely allowed to pursue them today.
To potential partners ( in other indications).. lifting of the hold on HIV would have looked great..BUT IS NOT AND HAS NEVER BEEN NECESSARY..!!!
Big Pharma can look at our 1700 patients dosed. Look at our SAE’s..AE’s..!!!
There is no ..NADA..safety signals..!!!
So what have we lost..?? One indication HIV (temporarily)
We have a C Suite now..geared towards moving forward..!!
We will..!!!
IMHO
Mountainman 5..Respect..!!!
Your posts are as intuitive as they are informative.
I’m assuming you ‘feel’ The ‘hold’ should be lifted in a couple of weeks, coinciding with the announcement of our NASH trial and Cancer partnership..!!!
Assuming we get our First approval by 2024.. !!!
When do you think we hit $100 a share..??
Considering the enormous number of indications Leronlimab WILL be used for OFF-LABEL..!!!
Mr Hankey..Respect..!!!
Very well researched..and..very helpful to a lot of investors genuinely interested in our drug.
In fact..!!!
Your post reminds me of the time our board was used for disseminating important information about our molecule..!!!