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Leronlimab Shows Early, but Promising Clinical Responses in First Two Patients Recovering from Stroke
October 26, 2020 6:00am EDT
VANCOUVER, Washington, Oct. 26, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today two patients have demonstrated noticeable signs of improvement following treatment with leronlimab (PRO 140) in helping their recovery from stroke.
The most recent stroke patient, a physician in Mississippi, requested leronlimab, which was administered to him under Mississippi’s recently expanded “Right to Try” statute. The physician’s son, commenting on his father, stated, “He is doing good. Yesterday, he received his second treatment. He said he has been feeling better, and he thinks it is working. He said parts of his body and face that have been numb are starting to change/wake up.”
Scott A. Kelly, M.D., CytoDyn Chairman of the Board, Chief Medical Officer and Head of Business Development, commented, “We are encouraged by leronlimab’s potential to help patients recover from stroke and traumatic brain injury. Independent research has concluded CCR5 is upregulated in neurons after stroke, blocking CCR5 induces motor recovery after stroke, and CCR5 antagonism may enhance learning, memory, and plasticity. CCR5 is rapidly becoming an important target for neural repair in stroke and traumatic brain injury. Our recent data that leronlimab crosses the blood-brain barrier with 70-75% receptor occupancy of the CCR5 receptors in the brain (Macaque model) is encouraging for the potential to enhance recovery in stroke and traumatic brain injury and explore a variety of central nervous system pathology.”
A second stroke patient was receiving treatment with leronlimab as part of her therapy for breast cancer. The treating physician noted her partial paralysis was mitigated relatively quickly, which may have been causally related to the posited role of CCR5 in stroke.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “Leronlimab’s ability to cross the blood-brain barrier potentially presents numerous opportunities for the treatment of patients suffering from diseases related to the central nervous system. Therefore, we are accelerating the filing of a Phase 2 protocol to evaluate leronlimab’s potential as a therapeutic for stroke recovery. We continue to focus our energies on our most important task of enrolling more patients in our severe-to-critical COVID-19 Phase 3 trial as quickly as possible. In addition to moving forward rapidly to complete our Biologics License Application for HIV, in multiple countries, our extensive plan includes filing a protocol and IND for Phase 2 clinical trials for both stroke and Long Haulers COVID-19 indications. We continue to strongly believe leronlimab has the potential to provide therapeutic benefit to patients suffering from a variety of diseases, and this incredible prospect drives our management team every day. CytoDyn is committed to fulfilling this obligation to patients of the world.”
Convalescent Plasma? Apparently doesn't reduce Covid mortality
. Assuming CD012 shows leronlimab reduces mortality as the data do date indicates, there will be plenty of need for leronlmab when it is approved whether it be in January or February or March.
Aside from the financial benefit for investors, sooner would be much better than later for all of us who will have difficulty in the coming months staying socially distanced. The infection rate is already skyrocketing around the world.
It would be nice, though clearly not likely, if the FDA were to ask for the interim results viewed by the DSMC so FDA can give leronlimab EUA consideration.
The therapy provided no benefit over usual care in 464 COVID-19 adult patients.
The therapy provided no benefit over usual care in 464 COVID-19 adult patients.
I have to come up and point out my elaborated views:
1. The long-awaited peer-reviewed manuscript, published by reputable Oxford Academic dated 20 Oct 2020 on Leronlimab, concluded:
"Leronlimab appeared safe and well tolerated. The high recovery rate suggested benefit, and those with lower inflammatory markers had better outcomes."
2. Following issuance of this prestigious Oxford journal and DSMC best possible recommendation, note that shorts paradigm has granulary shifted from (a) previously attacking Leronlimab science to (b) now find faulting of the personalities of NP.
3. Notwithstanding, the stock price have tumbled from 20 Oct 2020. Some investors who were over-expecting EUA to occur last week, may be disappointed and dumped the shares.
We know continuance of test (as recommended by DSMC) incurs operating costs of USD35m per quarter.
4. Assuming CYDY gets first approval (either from MHRA, or FDA who may choose to see the unblinded data for S/C clients) by end of Dec 2020, mathematically the share price should only reduce by 1.9% per quarter (representing the USD35m cash burning per quarter) from USD2.7 (market cap USD1.54b on 20 Oct 2020, assuming 570m o/s shares) to USD2.6. The fact is that the share price now is oversold at USD2.4.
5. Psychologically, it is up to us longs, where we want the share price to go. It is a self-fulfilling prophecies. If you longs don't sell, the shorts have nothing to buy. So my message to longs, be strong, hold your shares and don't sell.
6. Also I have a genuine question for you longs. Do we choose to believe (a) the shorts (who we never see their face or profile publicly), eg. Jillian, CYDY Scam, John, P No Kio, etc. (still I don't comprehend why Nick publicised his personal email to NP, and if by doing so a more effective result will be achieved) or, (b) those doctors (whose face we know and they have public profile at national/international level), including:
a. Dr. Bruce Patterson, Ex-Head Virology, Stanford University - see his presentation at TEDx.
b. Gero Hutter, who cured the first HIV patient through bone marrow transplant (the Berlin Patient, Tim Brown recently RIP due to cancer, not HIV which was cured)
c. Dr. Otto Yang who treated 30 EIND patients with Leronlimab at UCLA hospital, and published the Oxford journal.
d. Mahboob Rahman, who just joined CYDY as Chief Scientific Officer (ex-Novartis, Prizer, Johnson & Johnson), an adjunct Professor at University of Pennsylvania. Dr. Rahman has a record of 16 approved BLAs.
These doctors world reputation is not as cheap as the shorts, these doctors will not agree to support Leronlimab, if they don't have strong convictions of the safety and efficacy of Leronlimab. Hope by now you longs are convinced how despicable the shorts are, compared to these world doctors.
7. The shorts only want to buy your shares at discounts. Then, they will dissappear, gone with the wind. And you longs will regret, if you blink your eyes.
What are the shorts business on this board anyway? The shorts don't have noble mission to save your money. They continually confuse, plant seeds of doubts, etc. to the weak hand investors.
If the shorts don't believe in Leronlimab, they can sell. As simple as that. And, also for me the more the weak hand investors sell the better, so we can clean up and the true longs can continue to hold the fort strong, without noise pollution from shorts, many of which are ungrounded.
8. What about NP sell [88%] of his shares? Assuming this is true (needs to do research), note:
a. More recently he bought back (check the 10-K filing with SEC - need to double check)
b. This divestment is an alternative to fund the business expansion over the years, but can still be justified to the extent:
(i) the market capitalization has also increased over the last 5 years. And, indeed it has improved from USD96m (Dec 2016) to USD1.4b (Oct 2020) (do your own research, please Google, do not just trust me)
(ii) Apportioning [12% - need to double check] of NP share ownership in CYDY current market cap of USD1.4b translates to USD168m, which is higher than USD96m when NP owned [100%] in 2016 - needs to do some research.
(iii) If we apply the highest CYDY share price USD9 a few months ago, NP share value would be USD615m, way higher than USD96m in 2016.
9. Did NP become poorer by his divestment? No, he became richer, and on stronger ground, he is now sorrounded by calibre scientific advisors to support Leronlimab get the regulatory approvals.
10. Then, if the above is the case what is the relevance of NP [88%] divestment that shorts continue to bash? Nothing, nothing at all, except noise pollution.
11. Remember longs, it is a self fulfilling prophecies. Do not sell your shares, the short will have nothing to buy. It is up to us longs to drive the share price.
12. Be patient till end of Dec 2020 or Mar 2021, I do believe some positive outcome will prevail.
From a true blue blood CYDY investor.
16 hours ago, Nick made remarkable comments. The most important in my opinion were the following: Quote: „Based on the Bayh-Dole Act of 1980, any institution, academic or otherwise, whose research is funded by federal grants holds the Intellectual Property licensing rights to the outcome of its research. This in turn means that the people who worked on an idea that ultimately became a commercial product by a third party receive licensing royalties as are the institutions that they worked for. “People” include those in management positions who are always listed as authors in scientific publications, albeit at the bottom, and in this context NIH/NIAID satisfy the definition of research institutions. In turn, this creates an inherent conflict of interest as the introduction of a new drug may have a direct personal financial impact on those who decide, or at least influence the decision, as to whether the new drug should be approved.“
If Nick´s interpretation is correct, you – all citizens of the US - should protest! In my humble opinion this is unconcievable and not compatible with elementary principles of a democratic state. Governmental Institutions or people should not have financial interests in decisions they make as part of their work for the public (a judge should not benefit from his judicial decision)! Is it really "pay to play"?
If Nick´s interpretation is correct, bring it to your national media!
(PS: I don´t know, if its better in Germany, i only can hope it is)
But in the light of this it is no surprise, that FDA gave full approval to Remdesivir - on the basis not of the „solidarity trial“ (which showed no benefit of remdesivir over SOC) but on a trial funded by the National Institute of Allergy and Infectious Diseases and others (ACTT-1 ClinicalTrials.gov number, NCT04280705.).
As Elisabeth noted in her reply, (quote) „Dr. Robert Whitley, who was recently appointed as director of the DSMB's, served and may still be on the board of Gilead, collecting about $500,000 per year. Gilead has multiple studies ongoing with remdesivir in combination with other CCR5 inhibitors, monoclonal antibodies and other drugs. Gilead gets funding through the government.“
In an other source: Quote: „Ekaterina Cleary, lead data analyst and research associate at the Center for Integration of Science and Industry, wrote in a piece for Stat News:
Research from the Center for Integration of Science and Industry, with which I am affiliated, determined that between gathering knowledge behind remdesivir’s chemical structure and molecular target, the NIH invested as much as $6.5 billion between 2000 and 2019.
But Gilead is still heavily entangled with NIH:
„ACTIV-1 IM is a randomized, placebo-controlled trial that uses an adaptive master protocol. One of the hallmarks of master protocols is that they allow coordinated and efficient evaluation of multiple investigational agents as they become available. This enables maximum flexibility to swiftly weed out drugs that do not demonstrate effectiveness, identify those that do in a short time frame and rapidly incorporate additional experimental agents into the trial.
The ACTIV public-private partnership selected three agents for the study from a pool of over 130 immune modulators initially reviewed based on several factors, including their relevance to COVID-19, strong evidence for use against inflammatory reaction and cytokine storm and availability for large-scale clinical studies. The initial agents are infliximab (REMICADE), developed by Janssen Research & Development, LLC., one of the Janssen Pharmaceutical Companies of Johnson & Johnson; abatacept (ORENCIA), developed by Bristol Myers Squibb; and Cenicriviroc (CVC), an investigational late-stage agent developed by AbbVie.“
But there is not only ACTIV 1, there are ACTIV 2 to ACTIV 5 (with other bigger Pharma Companies):
All in all it seems very frustrating, but maybe it explains, why NP is speaking always so polite and complementary about FDA (bring statistic evidence and FDA will give you approval), because he knows about the previously mentioned connections.
Maybe Cytodyn should do it´s long hauler study with FDA (NIH) to improve the chance to get approval!
The World of Leronlimab: For all investors -
(Gathered by other)
Potential Catalysts w/ Est. Dates 10-24-2020
COVID P2 – CD10 Mild / Moderate
- Philippines FDA EUA Submission – ?
COVID P3 CD12 Severe / Critical
- US FDA Interim 293 Enrollment – ?
- US FDA Interim 293 Completion – Enrollment +42 Days
- US FDA Interim 293 Readout – Enrollment +63 Days
- US FDA Interim EUA Submission – ?
- US FDA Interim EUA Ruling – ?
- US OWS / Funding / Grants Update – ?
- UK MHRA Enrollment Update 4 Sites – ?
- UK MHRA UPH Urgent Public Health Submission Update – ?
- UK MHRA Interim EUA Submission – ?
- UK MHRA Interim EUA Ruling – ?
- UK MHRA PIM (=BTD: Promising Innovative Medicine) Ruling – ?
- UK MHRA EAMS (Early Access to Medicines Scheme) – ?
- UK MHRA Clinical Trial Enrollment Update (5-10 sites) – ?
- Philippines FDA EUA Submission – ?
- EU EMA – ?
- Mexico NIH – ?
- Israel MOH – ?
- Canada HPFB – ?
* The US FDA may demand full Phase 3 enrollment (390)
COVID P3 - CDxx Moderate
- US FDA Protocol Submission – On Hold ?
- US FDA Enrollment – ?
COVID P2 CDxx Long Hauler
- US FDA Protocol Acceptance (~70 Patients) – ?
- US FDA Enrollment – ?
COVID Funding / Partnerships
- 11-Big Pharma License / Partnership Update – ?
- Small Pharma License / Partnership Update: Asia, Brazil, China, India, Europe, Middle East, Northern Africa – ?
- eIND – 11-Patients Dr. Bruce Patterson
- eIND – 11-Patients Dr. Harish Seethamraju
- eIND – 30-Patients Dr. Otto Yang
- eIND – 5-Patients Dr. Nicholas Agresti
- CD10 – Phase 2, Lead Author is Dr. Seethamraju (not submitted yet)
COVID Miscellaneous Items
- Samsung Biologics Shipment (50k + 300k + 900k) Update – ?
- Mainstream Media Update – ?
- IncellDx Companion Assay Kits – ?
- Brazil ANVISA COVID Trial Update – ?
- US FDA P3 Combo BLA Receptor Occupancy Response – ?
- US FDA P3 Combo BLA Multidisciplinary Review – ?
- US FDA P3 Combo BLA Submission – ?
- US FDA P3 Combo Priority Review Update – ?
- US FDA P3 Combo Ruling– ?
- US FDA P3 Mono Protocol Update – ?
- UK MHRA P3 Combo (Mono?) Pre-BLA Meeting – Oct 26
- UK MHRA P3 Combo (Mono?) BLA Submission – ?
- UK MHRA P3 Combo (Mono?) BLA Ruling – ?
- EU EMA Combo (Mono?) Pre-BLA Meeting – ?
- EU EMA Combo (Mono?) BLA Submission – ?
- EU EMA Combo (Mono?) BLA Ruling – ?
- Canada HPFB P3 Combo (Mono?) Pre-BLA Meeting – Nov 9
- Canada HPFB P3 Combo (Mono?) BLA Submission – ?
- Canada HPFB P3 Combo (Mono?) BLA Ruling – ?
- US FDA P2 HIV Cure Trial Update – 2020-2021 ?
- US FDA P2 PrEP Trial Update – 2021 ?
- Mexico NIH – ?
- Israel MOH – ?
- CD01 P2 Ext-Monotherapy (5 patients 6 years) Dr. Sacha
- Cure Animal study Dr. Jonah Sacha
- CD02 P3 With primary endpoint achieved
- CD03 Phase 3 Ext-Mono (~215 - 1 year, 40 2-4 years)
- PrEP – Animal study Dr. Jonah Sacha
- US FDA Response to Basket 700mg Change – ?
- Creative Microtechnology Analysis of Basket Trial for BTD – ?
- US P2 mTNBC Trial Update – ?
- US P2 Cancer Basket 22 Trial Update – ?
- US FDA BTD Ruling mTNBC – ?
- US FDA BTD Ruling Basket 22 – ?
- Taiwan Cancer Basket Trial Update – ?
Other Active Indications
- US P2 GvHD Trial Update (Goal: 5 Patients) – ?
- US P2 NASH Trial Update – 1st Patient Nov ?
- US P2 MS Trial Update – ?
- US P2 Stroke Update – ?
- US Alzheimer’s Trial Update – ?
- Science Advisory Board Update PR – ?
- Investment Bank Update – ?
- NASDAQ Uplist Update – ?
- Next Capital Raise – ?
- Right to Try Act (State-based) Update – ?
Potential Additional Trials:
As reported from time-to-time by CYDY
- Septic Shock
- Traumatic Brain Injury
- Various Autoimmune Diseases
- IBS Inflammatory Bowel Syndrome
- Autoimmune Hepatitis
- US HIV P2 Cure – (see above) 2020-2021
- US HIV P2 PrEP – (see above) 2021
- HIV Mono Therapy (see above) 2020
I played a little with the known data of the interim analysis from the CD12 analysis. We know that 45 people died. With the eIND results of Otto Yang's trial we know that 4/23 people died, that is 17.3% and that in some very critical patients. In the CD12 trial, certainly less critical patients were also involved, so that the death rate can be assumed to be less than 17%. This means that in 130 LL patients, a maximum of 22 patients died. This means that in the placebo group a minimum of 23 patients (35.38%) died. If this is true, the p-value is below 0.05, but it is not known whether the patients died within 28 days. Someone also mentioned here that in interim analyses according to the Haybittle - Peto boundary, the p-value of 0.001 must be met in interim analyses. We are above that with about 0.0032. But maybe some patients died after 28 days and therefore the p-value is much higher and only in the 42-day observation the maximum is 0.0032.
If we now calculate with 293 patients (75%), then we get a mortality of 17% with 32 patients in the LL group. If we assume that the mortality in the placebo group will decrease slightly to 34% (33 patients out of the 98), we get a P-value of 0.0008, enough to end the trial.
The FDA could be jumping the gun here in the face of the pandemic, and at times, softening certain rules after the Remdesivir disaster. If it comes out later that the p-value in the 1st interim analysis was so low (even if it was higher than 0.001), when you look at the mortality at 42 days, I don't know what arguments the FDA has left.
Do I have a mistake in thinking here?
@Dante, your right, but to get OWS (or other public funding), Cydy should/must apply for it.
Did they do that? I dont know.
Tomorrow is the BARDA industry day, a virtual conference, with a list of 52 pages of attendees. A lot of BARDA People, but also many universities, biopharma companies (not yet CYDY) and also investment companies and press/media. This could be a great opportunity to get greater visibility and contacts to persons of influence.
Maybe if a lot of us bring this event to CYDY-management, they will apply, they have about 10, 11 hours to do that.
Wolfgang (from Germany)
CYDY press release from GlobeNewswire: Leronlimab Shows Early, but Promising Clinical Responses in First Two Patients Recovering from Stroke.
SO EXCITED about tomorrow and the next few weeks. 1. We have UK MHRA meeting tomorrow to discuss UK approval of Leronlimab for HIV and COVID. Then there is the FDA possible unmasking trial to decide if EUA approval, then Philipeans applying for EUA, Then submitting for long haulers very soon.
Tough enrolling ? Been there, can do that:
June 28th, 2017
FDA Accepts Marketing Application for Review from Amarex Clinical Research on a Rescue ICU-Related Trial
Germantown, MD, USA – Amarex Clinical Research is working with a late stage company on a treatment for patients with an ICU-related indication. Amarex took over managing the entire trial services; regulatory, medical monitoring, patient recruitment, site finding and data management from another CRO that was experiencing difficulty in enrolling subjects into the trial. Amarex prepared and submitted the application to the FDA.
This trial was challenging to enroll, as patients were presenting in a critical care setting. The trial came to Amarex after two years with minimal enrollment. In that first year, Amarex exceeded the enrollment of the past two years combined, and then averaged more than triple the enrollment in the years afterwards getting the trial back on track and completing the enrollment.
“We are very gratified to hear that the FDA has accepted this application for review” said Amarex’s CEO, Kazem Kazempour, PhD. “This trial was a real challenge, and we at Amarex are very proud of the creativity and drive that was utilized to solve the enrollment problems inherent with this study. We look forward to working with our client to see this application through to approval.”
About Amarex Clinical Research, LLC
Amarex is a global full service Contract Research Organization (CRO), whose leadership team has over 60 years of conducting biomedical research, and has been involved in executing over 400 clinical research projects in over 35 countries. Their knowledge and experience in conducting comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs, FDA Applications Submissions, Compliance Audits, Clinical Operations, Adaptive Study Designs, Biometrics, Statistical Analysis, Data Management and General Consulting has enabled Amarex to take its clients through the entire process from initial product concept to FDA approval. Amarex’s goal is to help its clients bring their products to the market as quickly and efficiently as possible.
The pre-print paper on the large WHO Solidarity study that showed no mortality benefit of 4 drugs to include remdesivir is now available. Note the Solidarity study mentions that monoclonal antibodies will be added. I’m reaching out to the WHO on inclusion of leronlimab and suggest others do the same. Will publish contact info once I obtain.
To all of you who reacted to my Open Letter to Dr. Pourhassan I’d offer a few additional and final comments:
1. I am of the school that “you do not say something in order to speak, rather you speak in order to say something”. Words and context do matter.
2. I am amazed at the propensity of people to immediately pigeonhole me as a short, pseudo-long, working for BP, “undecided”, etc. If you really had made an effort to internalize my message to Dr. Pourhassan those of you who attacked the messenger would have likely reacted differently. A proper public discourse requires more than the reflex reaction of a video game.
3. As the sophistication of investors who are being addressed in public by Dr. Pourhassan grows there is an increasing expectation that certain communication norms are satisfied. One does not learn this in business school, it comes with experience and from a few hard knocks along the way. Pointing out some of these norms with pertinent examples was the thrust of my message. And while it may have been perceived by some as critical my intent was for it to be constructive.
4. Interestingly, there has not been a single argument against any of the 10 suggestions that I made that might help Dr. Pourhassan interface better with investors or prospective investors. And definitely, I do not underestimate his , or for that matter anyone else’s, capacity to learn, adjust, and improve otherwise I would not have bothered writing the letter in the first place.
5. My intent was not to tell Dr. Pourhassan how to run Cytodyn, as some of you mindlessly and liberally extrapolated from my comments, and there is absolutely no hint of that anywhere in my message, quite the opposite.
6. It would have been highly presumptuous, if not immoral, for me to speak as to Dr. Pourhassan’s character or ethics. I only know him from his public events, have never met him, and I assume that he is a fine human being trying his best to carry on with his duties.
7. The timing of my message was strictly related to my own time availability to write it and nothing else.
8. My hope in putting my message out on a public board vs sending it in an email was that someone within the walls of CYDY might read it and ultimately my message might reach Dr. Pourhassan. An email message such as the Open Letter sent directly to me would never cleared the spam filter of my company. Besides, I thought that some of you might find a few elements of value in it as I occasionally find when I read other people’s posts.
9. Finally, I know I may not be able to convince you of it being true but my involvement with Cytodyn as an investor is exactly as I described it in my message.
Koksal was busy for a minute and not checking the board. Had the chance for a small role in Borat but had to turn it down. I'm here now to set the record straight and get everyone back on track...
DO NOT jump ship now that everyone is jumping on...Dr Mahboob
DO NOT believe that an OTC will never bring a blockbuster to market...CYDY has already proven the product works in HIV as a combo therapy and more HIV indications are being studied. We already know that market is bigger than $1B
Chiral pharma is motivated to bring the product to the philippines and they will do so successfully in the very near future
Like Koksal said, if you need your money immediately, you might have an issue. Otherwise, set it and forget it my friends. CYDY is the real deal...Koksal knows
I would like to encourage CYDY investors to offer their constructive criticism privately. All criticism is opinion based until proven otherwise. Proclaiming your criticism publicly is a direct attack on the company your invested in.
How does it help your investment? The team at Cytodyn are busy. Just think about what they need to accomplish. They ARE NOT searching through stock market message boards for advice on how to do their job better. If they were looking for advice, they would hire a reputable consultant.
As an investor, you want your company to succeed. Creating negativity around the CEO is counter productive. It doesn't help the company in any way, shape or form.
If you want to help CYDY, let's help potential new investors understand why we're all invested.
I invested into CYDY because I believe in Leronlimab. I believe in it because so many reputable scientists also believe in it. I believe in it because of the anecdotal, and at this point, irrefutable evidence that Leronlimab is 100% safe and effective in saving COVID-19 critical patients lives and those suffering from HIV.
Then there's the many other indications like cancer, Nash, Alzheimer's, longhaulers, and a couple more.
Oh yeah, it's proven that 70% crosses the Blood brain barrier. That opens the doors for many other indications including one already mentioned in longhaulers.
Again, please, I encourage everyone to keep their opinion based constructive criticism private, otherwise, you may, inadvertently, hurt the company's reputation, and that hurts your investment.
Please help spread this message. We need to do away with all the opinion based negativity and focus on the truth that Leronlimab is a safe and effective drug and the team is improving and working hard to help save lives, and to make it's investors a lot of money.
Our go-to @ Amarex:
" While at the Food and Drug Administration (FDA) as a statistical reviewer, he received several awards for innovative problem solving and teamwork. During his tenure at the FDA, Dr. Kazempour also worked as a Senior Staff Fellow and as a Mathematical Statistician responsible for supervising and conducting independent statistical analyses of clinical trials and reviewing statistical sections of submitted protocols and statistical analyses. Dr. Kazempour has received multiple recognition awards from the FDA for his contributions in the drug approval process".
" He has made presentations to FDA, and FDA advisory committees on more than 30 different drugs".
28 min mark of Sept. 22nd, Been, NP & Kelly. NP's comments on pandemic, DSMC & FDA, reflects 100% of where Interim sits with FDA. NP was politely saying then, what he just said again ------ the FDA should be looking & taking everything into consideration.
Even under the FDA's own comments on their policies, i do not see how Leron does not qualify for early approval with DSMC saying we are trending.
Maybe that will be a total surprise news release.
MHRA meeting tomorrow.
Full Long Hauler protocol filing this week --- (only MAB to do this ).
WHO considering MAB trials.
Potentially more national coverage.
I offer this partial lift from another stock's PRs with the comment that name, Biogen, is associated with the drug being tested the company is optomistic about progress with the FDA.
By contrast, published data show that PMN310, ProMIS' antibody candidate for Alzheimer's disease, is highly selective for the toxic oligomer of amyloid-beta, positioning it as a second-generation drug candidate with more precise targeting capabilities and a potentially improved safety and efficacy profile.
Despite aducanumab's modest treatment benefit, the white paper argues that FDA approval is likely based on the following:
-- FDA has encouraged Biogen to submit its application, granting it Priority Review; has endorsed continued clinical use of aducanumab in an open-label study, and; has demonstrated a willingness in the past to approve drugs despite limited data in instances where the unmet medical need is significant.
Doesn't this fit the bill for CYDY??????????????????????????/
In a class by itself
Due to its selectivity and target specific mechanism of action, Leronlimab allows chemokine binding (CCL3, CCL4) at therapeutic doses and does not have agonist activity of the CCR5 receptor (it does not activate the immune function of the receptor). This target specificity separates Leronlimab from other CCR5 antagonists. Other advantages of Leronlimab include improved safety profile, longer half-life, and less frequent dosing.
AN OPEN LETTER TO DR. POURHASSAN (Part 1)
Dear Dr. Pourhassan:
By way of introduction, I, like you, immigrated to the US some 35 years ago to go to graduate school, speak with an accent, but I do not think with one. I, like you, hold a PhD in science and have been an executive in a NYSE listed company so I fully understand what it takes to satisfy the various company stakeholders, including the BOD, shareholders, employees, suppliers, partners, etc.
I bumped into CYDY accidentally a few months back through a link to Dr. Patterson’s paper. Not being my field of expertise I gave it to my wife to decode it for me. My wife is a PhD in molecular immunology with research experience in juvenile diabetes, lupus disease, and cancer having worked at some of the most prestigious research institutions in the US. After a few minutes of studying Dr. Patterson’s paper she proclaimed: “You know, this could be used for a lot of other autoimmune diseases and could even be taken prophylactically by people over 60 as most of them get afflicted by autoimmune diseases. I can see it becoming the botox-equivalent of the autoimmune system, if they let it”. At the time my wife was totally unaware of HIV or any of the other potential indications of LL which form the broader investment thesis in CYDY.
My wife’s last conditional sentence bothered me so I prompted her to expand on it, here is the deal. Based on the Bayh-Dole Act of 1980, any institution, academic or otherwise, whose research is funded by federal grants holds the Intellectual Property licensing rights to the outcome of its research. This in turn means that the people who worked on an idea that ultimately became a commercial product by a third party receive licensing royalties as are the institutions that they worked for. “People” include those in management positions who are always listed as authors in scientific publications, albeit at the bottom, and in this context NIH/NIAID satisfy the definition of research institutions. In turn, this creates an inherent conflict of interest as the introduction of a new drug may have a direct personal financial impact on those who decide, or at least influence the decision, as to whether the new drug should be approved. Indeed, the health sciences machinery of which Big Pharma is a part is extremely fraternalistic, incestuous, and corrupt.
I have since done my own independent research on Cytodyn and have accumulated a number of shares now approaching 80K with a minimum of 5-year investment time horizon. Along the way, I have watched every public CYDY event since March and I have come to “know” you somewhat. Unquestionably, you need to be congratulated for your foresight, single-minded focus, resolve, and perseverance that took an unknown molecule and have brought it to the cusp of something potentially very big. But as Cytodyn knocks on the door of the premier league, there are certain adjustments that you need to personally make while addressing the public because, plagiarizing the title of a published book, “what brought you here is not going to get you there”. Here are some suggestions:
1) Limit your use of superlatives. The word “fantastic” that you commonly use carries a huge weight and for most people it implies something that is two standard deviations out of the ordinary, which is rarely the case. Words like “positive” and “encouraging” are far more appropriate for the vast majority of the cases.
2) Never express an affinity for your colleagues in public. In a recent event you introduced Dr. Kelly as “my favorite Board member”. Dr. Kelly as an executive of the company and yourself should be singing from the same hymn sheet and there is an expectation of zero dissonance between the two of you. What message does this comment send to the other independent board members or to those who listen regarding your relationship with the other board members?
3) Never comment about the stock price in public. Yes, the stock price can be manipulated and driven to extremes on either side of what it should be based on a reasonable valuation of the company. But to my knowledge, CYDY has never put up any financial model of revenues and profitability over time on which such valuation can be based so any references as to what the stock price should be is pure speculation. If you really want to support the stock price, rather than trying to talk it up, I would advise that you, along with the other executives and the BOD, should instead consider buying the stock in the open market. Spending a modest amount on the order of ~$200K should be more than enough to send a very powerful signal to the market. After all, the only reason an executive buys his company’s stock is to make money.
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