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Posted On: 01/07/2021 9:40:30 AM
Post# of 148903
The following is a lengthy, but very insightful post from a Facebook group regarding yesterday’s call that I thought the group might enjoy.
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Yesterday's update call was the most encouraging information & experiences I've heard from the CytoDyn team yet.
First off, I don't go into these calls expecting announcements for major catalysts; I expect that news to come in PR. These calls are an opportunity to get more detailed and comprehensive updates on the company's holistic efforts in advancing Leronlimab across its various indications and elucidating shareholders on other relevant company operations. I have never been invested in a company that is dedicated to such direct and thorough correspondence with its shareholders on a semi-regular basis. I can appreciate some investors are only interested in resulted-oriented market-moving news, and that the process-related updates provided in these calls can be spun as delays, failures, or "pumps" by bashers and short-sellers, but the sincerity and forthrightness presented to shareholders in this fashion is what makes me feel more like a participant in this investment vs just a spectator who clicked a buy button on my trading platform. I feel truly "invested".
I may come off like a CytoDyn "cheerleader" by the tone and degree of many of my posts, and by how rigorously I moderate the FB groups, but I consciously strive to remain objectivity about my investments, especially ones with bigger positions or ones I consider to be more speculative at this stage in the company's progress. My initial and ongoing confidence in CYDY is a result of extensive due diligence into the science of Leronlimab. I don't think there is a video or article or medical report or testimonial on the internet that I have not watched or read at this point (and there is A LOT of material out there about Leronlimab now). There are shorts claiming that CytoDyn is running a "stock scam", but it's utterly ludicrous to think that this company has been running a confidence game with "snake oil" for over ten years, with countless endorsements by doctors, patients, scientists, and financial investors if the company's efforts and data were not cogent and legitimate. It typically takes over 10 years and 2 billions dollars to bring a new drug to market, and CytoDyn has been persistent in this laborious and patient journey, doing so without the support of the major financial and lobbying machinery in the biotech section. As a business model, it's the tortoise-race strategy, which takes confidence, patience, resiliency, and grit. I don't just invest this bullishly in a product, I invest in a company's culture, attitude, and philosophy. CytoDyn's vision, mission, and methods have passed the stress test of commitment and confidence in their own efforts, and the product they're dedicated to bringing to market by those very efforts.
I literally got goosebumps where I heard Nader's opening statement, how he brazenly condemned the shorts for "shorting human life" and he reminded shareholders of Leronlimab's proven and unique MOA. If I ever get "nervous" about this investment, which isn't that often anymore, I just need to step back from my stock portfolio and acknowledge that this drug has groundbreaking potential, and it's never ever been closer to the finish line of its long development, trial, and regulatory journey, and its within tangible reach of the start line for commercial sale and application. And that feeling was deeply reinforced by Nader's opening remarks, and it was compounded further when Scott Kelly read the testimonials from the three patients (or that of their close family members) who have been treated recently with Leronlimab. The Covid-19 patient was astounding: three approved treatments failed after their first 10 days of treatment to prevent advancement to a more severe stage of the infection, causing the patient to go on ECMO for 45 days and suffering end-stage pulmonary fibrosis. Then within 5 days of Leronlimab's administration just before Christmas, he was off ECMO, he's been taken off sedation, oxygen & ventilation, all his affected functions are normalizing, and he's progressing toward being taken from the ICU to the ward. My heart was bursting from the gratitude and sincerity in the words of this patient's wife. The colon cancer patient who went from a Stage 4 diagnosis in May to his oncologist reporting that he was cancer-free by Christmas. And the bladder cancer patient who started Leronlimab 9 weeks ago via Right-To-Try protocol, as a last-ditch effort after being told earlier this year that he had just 6 months to live, and now his cancer has not spread beyond its borders, extending his life to 9 months now, with his doctor is convinced LL curtailed the cancer's threat and he now has hope that his patient could get through this. Oh. My. God. We spend so much time talking about this drug, that it's easy to forget that most people do not know about, nor can they access it easily yet (the UK patient with Covid got the drug only because his wife took the doctor to court when he wouldn't recommend an experimental drug). There is no doubt in my mind that these testimonials are entirely truthful and a result of the effects of Leronlimab. These may only be anecdotal accounts but, to these patients, this is as real as it gets. We will soon have the clinical data that proves these effects in larger sample sizes in cancer and hopefully Covid, and we're already knocking on the door for HIV approval after 6 years of monotheraphy and hundreds of patients successfully advancing the drug to its BLA application stage, which - as Nader emphasized - is a guaranteed approval as long as they follow the guidance and protocol of the FDA to complete the BLA and receive a PDUFA date. 2020 may have felt like Leronlimab is a major Covid play (which it very much is), but I was grateful that this call to kick off 2021 punctuated the progress and timelines for its primary indication, as that is the primary reason to see CYDY as an investment and not a gamble, which incidentally backs Nader's bold assertion that CytoDyn has become a low-risk/high-reward investment. That may sound like sizzle but all the time, effort, money, and science invested in Leronlimab has now made it steak. "Rock-solid data" was put on record and unless the entire CytoDyn team wants to spend their twilight years in prison for securities fraud, they are clearly referencing irrefutable science that their trials have revealed and have earned the company ongoing correspondence with and guidance from the FDA, who can't be easily duped, as much as shorts want to push this distortion narrative that there is "no data" otherwise the drug would already be approved... well, there is no approval yet because most trials are still ongoing, and HIV needs to complete its BLA. The shorts really must think that most shareholders are clueless about the approval process, assuming that many investors only got in for Covid and never did any recon or DD on the patient and discreet nature of the trial and approval process, especially at the pre-revenue stage. I truly hope that correspondence in our groups have come to give shareholders confidence that investors are informed and short-sellers are merely predators of naivete, posting bogus articles and charts that they literally make up the information assuming that shareholders don't know the difference between false and accurate reports.
I was very moved by the audio testimonials of the 9 HIV patients who have been taking Leronlimab for 2.5 years and experiencing their quality of life improving and literally getting a new lease on life with no side effects (which they needed to suffer through with previous treatments). I read a Tweet by one short after who said he literally laughed out loud at how silly it was to play those tapes (well, we already knew some shorts have no human empathy). These patients have had viral loads reduced by 90% post-induction period (after 10 weeks), T-counts returning to normal levels, physical symptoms disappearing, emotional confidence and the profound optimism of being alive, something that healthy people take for granted everyday. The fact that over 300 patients have been using only Leronlimab for over one year, with no other therapy and no side effects, is groundbreaking. HIV treatment has always been a minimum of three different treatments, and it's involved oral pills that have SAEs, so CytoDyn's achievements in HIV treatment is astounding, and they now just need to navigate the incredibly precise and expensive process of its BLA because a drug approval of this nature needs to be held to the highest standard given the population it will treat as well as the revenue it can generate for a company. And CytoDyn's commitment to Leronlimab in HIV prevention, not just treatment, is an additional application within the same indication, with a $3.6 billion market on prevention alone, which CytoDyn could dominate in market share with only a once-per-month injection. And that's on top of the $5-10 billion that's anticipated in revenue for treatment in the first year upon approval and manufacturing upgrades. What this is ultimately leading to is essentially a cure for HIV, given that if there's a bone marrow transplant, and Leronlimab covers the CCR5, the new immune system could be Delta 32, and then we're talking about the trifecta for LL in HIV: prevention, treatment, and cure (for the bone marrow transplant population, which is 10% of HIV patients in the US). And their HIV paradigm will address liver disease caused by HIV, as well. Wow. Just wow. The imminent prospects of LL, both medically and financially, are a game-changer for the industry and the company.
On a more personal note, HIV hits close to home for me because I lost one of my best friends to HIV in 2006. His name was Patrick Donohoe and he was 30 years old when he died. He had a T-count under 10 but this young man continued to live his life to the fullest, volunteering for causes he was passionate and supporting his friends, even strangers, every chance he had. He would say that the only thing he has to live for is to help others because he is beyond saving and he's not going to stop doing what he can to make a difference until his last breath. And I was there when he breathed his last breath. And it was devastatingly sad to see his body reduced to pratically a skeleton, because he had some much to offer this world but there was nothing in the medical world that could save him. He tried various treatments but the side efforts made him so sick and weak that he would rather just live out his last days letting his body naturally deteriorate instead of having to deal with the pain of a chemical eating away at him, too. I did the AIDS LifeCycle ride from San Fran to LA in 2012 in his honor, which was a 550-bike ride raising money for the cause. And when I was introduced to CytoDyn, and I heard it was a groundbreaking HIV treatment, and I did my research to realize it was in the late-stages of approval, and I knew this can be a way for me to continue to support that quality of life in that community. It was too late for Patrick, but he would want me do what I can for people who can still their lives extended, because his mission was about making sure others succeeded, even if where he had failed. So you bet your ass that I'm committed to this company and this drug, and my investment will not be threatened by time or short distortion or a lack of gratitude for CytoDyn's efforts or any of the forces out there that are challenging the application of this drug for selfish reasons. Shorting human life is an unforgivable travesty, and if the people that do it genuinely don't believe in Leronlimab science then they simply haven't done the work to learn about it or they are overly cynical of CytoDyn's intentions, and that must be brought about by having no direct contact with people who have died from these diseases or just a general apathy for human life. I will still happily buy shares as a result of their manipulation, but I will not be joining them in Hell when karma gives them a life-threatening illness that even Leronlimab can't save them from. But I wouldn't wish that on anyone, and I know that no external factors can capsize CytoDyn's efforts with getting Leronlimab to market that this point; there is just too much growing awareness and support within the medical community, too many devout and devoted shareholders, and too great of a demand for this unique biological panacea.
The manufacturing strategy for Leronlimab in regards to HIV application and the FDA-approved rolling submission process for the BLA was encouraging to hear on the call. The non-clinical part is ready for submission, and the 4 jurisdictions (US, UK, UE, Canada) are anticipated to happen in the 2nd quarter of 2021. If they hit this timeline, and the applications are submitted properly, that would result in a PDUFA date for late 2021, which likely means Leronlimab will become the SoC in HIV treatment in the biggest markets in the world in 2022. HIV is a $30+ billion market, and it's conceivable that CytoDyn will have the safest and most effective self-administed treatment within that market. The cynics out there may still believe that Big Pharma won't let that happen, but at this point Big Pharma can't suppress Leronlimab, it can only try to buy it. The leverage that CytoDyn will have in that discussion would be like David's slingshot. Who knows if CytoDyn will submit to a buyout (or a partnership), or rather choose to grow into one of the most prominent biotech companies in the world with its 12-year patent for Leronlimab, but either scenario will reward shareholders with riches beyond imagination, especially the wise investors accumulating shares at a single-digit price in the highest volume their risk tolerance and financial appetite will allow.
If EUA for Covid happens, Nader will fly to S. Korea to negotiate the expediting manufacturing with Samsung because their deal was put in place pre-Covid and was designed for HIV manufacturing, and OWS has been in contact with CytoDyn to support if the drug gets EUA. Everyone seems to bee well aware that the demand for LL will far exceed the supply if the drug proves efficacious in reducing mortality, so it's great to hear they are already considering ways to maximize the contribution they can make to fight against Covid-19. I read this short's Tweet after the call that tried to spin this potential Samsung renegotiation as a result of not being able to pay their bill. It's utterly asinine to present it that way after how it was characterized on the call, and when shorts make such ridiculously obvious distortions, that's when we know how desperately they are reaching with their negativity, and it further confirms that nothing they say can ever be trusted or taken at face value.
It was fantastic news that other countries in need, like Brazil, Turkey, Pakistan, and Indonesia, have recently reported that they can approve LL in Covid without CD12 data, because the CD10 data is a more encouraging result for them than other drugs in that population. And the fact that CytoDyn isn't just going to turn over their limited supply upon this initial request, namely because they are so close to determining their effectiveness in saving lives in last-stage infection patients vs just preventing infections that may not proceed to that stage anyway, really speaks to the confidence in the drug in its more critical population. This also provides a hedge for a Covid application for Leronlimab. I agree with Nader that it's best to see if the US wants LL first, and not just because he feels indebted to the US for what it's done for him, but more because 1) the US is the worst off in deaths, 2) it will be able to best afford LL's true value, and 3) I like the leverage that it provides in seeking a US EUA in case the data is on the cusp of optimal p-value. It's good to hear that CytoDyn will explore these options as a possible revenue stream and application in Covid but they will reserve the right for LL to the US (and possibly the Philippines) first.
The Philippines submission is expected to be done by mid-January, so that news could be a prelude to the analysis from the unblinded CD12 data, and CytoDyn is teed up to deliver 1.2 million vials to any country that can approve marketing. So some form of revenue in Covid sounds like a foregone conclusion, but given we are so close to determine the drug's effectiveness in the most vital population, it will be the first determination, with other viable options waiting in the wings, if need be. This was a tremendous update for Covid-19 usage of LL.
Something I think is important to acknowledge is that the CD12 trial reached completion, and did so with no modifications to the trial parameters and protocol, nor any safety concerns. Reaching trail completion in this fashion is rare, and it bodes very well for the trial's prospects of showing favorable results. And trials with large molecules, like Leronlimab, are statistically more successful in moving to the application phase than smaller molecules, with an average approval success rate of 74%. Additionally, studies have shown that large molecules like recombinant proteins failed more often than monoclonal antibodies in transition from Phase 3 testing to regulatory review, with a success rate of 83% for MABs and only 66% for recombinant proteins. So, the fact LL made it this far in the trial historically bodes well for efficacy results. We have no way of knowing yet how the 87+ deaths will be broken down within the two arms of the trial, but I've already seen charted speculation online. I saw short claiming it's impossible to reach p-value, and then he presented some charts that looked like he drew it up himself on his computer and just inserted data that serves his agenda, assuming no one will do the legwork to disprove the credibility of "studies" he is drawing the data from. It was a laughable attempt to discredit the trial efficacy. Did Nader sound concerned by that number in regards to how it could play out in the data for the LL arm? Not one wink. In fact, he remained bullish on CD12 for the US, while making sure we know there is other countries eager to get LL, since CytoDyn can't control or predict the FDA's decision. CD12 was just one aspect of the holistic nature of the call, and it was clear to me that this call was new year's scheduled to cover a broad array of updates and topics, as indicated by the litany of items listed on the agenda in the PR. If anyone was expecting it to be more Covid-centric, then I simply think you didn't read the PR carefully enough to realize it was a big agenda with a limited time to cover it all.
I listened to the call while a small FB Messenger group of CYDY investors did live commentary during it. It quickly became apparent to me that some shareholders only care about Covid data and Nasdaq uplisting right now. They didn't seem to care about the patient updates and testimonials, or the updates on cancer, HIV, NASH, etc. I think that 2020 was just so engrossed in ongoing Covid trials and delays, and now we are at the cusp of completed Phase 3 trial, that there's just some anxiety about an immediate result, for both financial and humanitarian reasons. And that's all understandable. I just needed to check out from that group because I work hard to remain focused on the entire picture with this investment and I don't want to devalue favorable updates because they aren't geared enough toward the more immediate payoffs. I can appreciate many longs were financially triggered when Covid popped their portfolios but not enough to cash them out yet, and now all that patience they once had has been diluted by volatile stock price that makes or loses them tens of thousands of dollars a day. But I would like to point out that anyone who was in this stock in Dec 2019 or earlier will never see a loss on this investment - how many investments in a pre-revenue company can have shareholders say that? I think never growing impatient is a healthy approach to an investment like this, otherwise the emotional toll can just be too stressful and disappointing, and there was literally nothing to be disappointed about from that call, despite what will surely happen to the stock price at open when shorts and weak-hands control the trading activity (and incidentally provide another potential buying opportunity for those who still want more shares). I had already ear-marked end of 2021 for a PDUFA date based on the expectations that were being slow-rolled by the company toward the end of last year, and I always considered Nasdaq most likely won't happen till revenue is guaranteed, so it was encouraging to hear the company is still so dedicated to meeting the criteria before that.
With three published papers on LL, two more pending, 60 eIND Covid patients that resulted in FDA fast-track designation for Covid trials, eIND re-instatement now that trials have been filled, OLE use beyond eIND, an insurance code for Vyrologix going into effect on 1/21, one week away from completion of a Phase 2b/3 trial that passed 2 DSMC interim checks for safety & efficacy and no modifications to the trial, and an expedited Long-Hauler trial in what will be the largest Covid-affected population and has more volunteers than the trial can support, do you see why the shorts are ramping up the chatter surrounding Covid right now. They will post fabricated charts trying to disspell the possibility that LL can reach its p-value with 87 deaths in the CD12 trial, they will throw shade on the CD10 Phase 2 trial not ending up in EUA,. when CytoDyn didn't even apply given it didn't hit its primary endpoint (Phase 2 is designed to determine how to best determine Phase 3 endpoint assignments) and thus the FDA recommended a Phase 3 with 60 moderate patients with NEWS2 as the endpoint but couldn't offer EUA off a 84-patient Phase 2 trial in a non-critical population for a drug with limited supply and is currently in a Phase 3 trial for a more vital population (and seeing Relief Therapeutics get rejected EUA for their Phase 2 trial just goes to show that Phase 2 isn't going to cut it for an emergency authorization), and shorts will continue to exploit the naivete surrounding shareholder knowledge for SEC filing, debt repayment, stock dilution, irrelevant employee history, frivolous lawsuits, etc. It's just another day at the office for them, and these are their tactics performed behind anonymous accounts.
Other call news reported that CytoDyn is ahead of schedule in their NASH trial, with the first patient already reaching their 2nd injection, 25 patients in screening, 20 patients scheduled for MRIs, and multiple sites being activated for the trial, all done during a global pandemic.
They are having breakthrough designation discussions with FDA regarding cancer this month. They have 9 patients enrolled. Nader is really pumped about the LL prospects for cancer this year.
GvHD trial had good results in animal models but had difficulty enrolling in human trials due it needing to be placebo controlled. It could take over 3 years to fill this trial, so it is not the focus and will be put on hold for now, especially given there are already approved drugs treating GvHD. Shorts will just say this trial failed, when it's an entirely logical and strategic decision when it comes to best managing time and resources across the indication prioritizes and practicalities for success. So when shorts bring up GvHD, you know they are grasping at straws and just trying to sow doubt in any possible way they can, even the areas that the company has transparently admitted their reasons for not currently moving forward.
Stroke, MS, and Alzheimer will all start trials this year!
NASDAQ has seven quantitative listing criteria in their initial listing guide, only one of which is stock price above $4. The biggest hurdle for CytoDyn is achieving positive shareholder equity of $5 million. It was at positive $2.7 million at the end of August, and the next quarter will be reported by next week. The plan is to cure the shortfall in equity soon, but the decision is still under the discretion of NASDAQ at the end of the day. Mike spoke to them a couple days ago, the prospects remain optimistic, the company is committed to handling the shareholder equity concern, as well as any other quantitative needs that may be report back by NASDAQ, so CytoDyn remains committed to the uplist process, and it just remains an ongoing process given the company has to proactively meet all the necessary criteria, which isn't all that easy at this stage in their growth.
The explanation about the insider stock sales that precluded the Q&A was precisely what has been discussed by informed investors on various boards. It was deemed legitimate and common action by company employees exercising premeditated stock sales, they were filed legally and publicly, they were in no way a result of insider trading, and these kinds of filings are predictable cannon fodder for shorts to exploit since they assume most people don't understand what's going on when employees sell stock. It's just another example of shorts lying in order to spread doubt amount shareholders so they can more effectively short the stock.
The Q&A was packed with information about the CD12 trial, but it all comes down to the analysis of the unblinded data which will initiate on Jan 13 and CytoDyn will issue a report as quickly as possible.
The eIND requests have been very high and doctors are working with the FDA to treat as many patient as possible.
LL's target in the virus is CCR5 and not the spike protein so the drug will remain effective in new strains. No one is sure yet if the new strain will adversely affect the vaccines. The S. African strain is the most concerning for the vaccine effectiveness right now.
They have only one item left on the Philippines' EUA requested list which will be done in the next 9-10 days. If anything changes, shareholders will be updated. Expectation is to submit for EUA there in 10-15 days from now.
There are 2.5 million vials of LL secured for 2021, and 2.5 millions for 2022, and those numbers could be increased if need be.
Repaying capital requires giving warrants. CytoDyn was trusted with 100 million shares in the shareholder vote last year. They will be repaying loans by exercising warrants when money needs to be repaid which, at the current stock price, is 2.5 million shares per month. This is the most minimal dilution that can occur when it comes to maintaining ongoing company operations. This is transparent standard practice under the financial circumstances of the company, and this arithmetic can be done by anyone. It's reasonable and necessary to continue to fund the company in this manner until it starts to generate revenue.
The correction in PR earlier this week was merely to correct a typo. Shorts tried to say it was the company hiding bad news about the eIND protocol. Another weak attempt of them, which makes the shorts look uninformed and desperate.
2021 has even greater potential for the company and its shareholders than 2020 did. The train is moving full steam ahead. It may not always be at the speed of some people's portfolio expectations but all indications point to forward progress with the company and upward progress with the stock.
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Yesterday's update call was the most encouraging information & experiences I've heard from the CytoDyn team yet.
First off, I don't go into these calls expecting announcements for major catalysts; I expect that news to come in PR. These calls are an opportunity to get more detailed and comprehensive updates on the company's holistic efforts in advancing Leronlimab across its various indications and elucidating shareholders on other relevant company operations. I have never been invested in a company that is dedicated to such direct and thorough correspondence with its shareholders on a semi-regular basis. I can appreciate some investors are only interested in resulted-oriented market-moving news, and that the process-related updates provided in these calls can be spun as delays, failures, or "pumps" by bashers and short-sellers, but the sincerity and forthrightness presented to shareholders in this fashion is what makes me feel more like a participant in this investment vs just a spectator who clicked a buy button on my trading platform. I feel truly "invested".
I may come off like a CytoDyn "cheerleader" by the tone and degree of many of my posts, and by how rigorously I moderate the FB groups, but I consciously strive to remain objectivity about my investments, especially ones with bigger positions or ones I consider to be more speculative at this stage in the company's progress. My initial and ongoing confidence in CYDY is a result of extensive due diligence into the science of Leronlimab. I don't think there is a video or article or medical report or testimonial on the internet that I have not watched or read at this point (and there is A LOT of material out there about Leronlimab now). There are shorts claiming that CytoDyn is running a "stock scam", but it's utterly ludicrous to think that this company has been running a confidence game with "snake oil" for over ten years, with countless endorsements by doctors, patients, scientists, and financial investors if the company's efforts and data were not cogent and legitimate. It typically takes over 10 years and 2 billions dollars to bring a new drug to market, and CytoDyn has been persistent in this laborious and patient journey, doing so without the support of the major financial and lobbying machinery in the biotech section. As a business model, it's the tortoise-race strategy, which takes confidence, patience, resiliency, and grit. I don't just invest this bullishly in a product, I invest in a company's culture, attitude, and philosophy. CytoDyn's vision, mission, and methods have passed the stress test of commitment and confidence in their own efforts, and the product they're dedicated to bringing to market by those very efforts.
I literally got goosebumps where I heard Nader's opening statement, how he brazenly condemned the shorts for "shorting human life" and he reminded shareholders of Leronlimab's proven and unique MOA. If I ever get "nervous" about this investment, which isn't that often anymore, I just need to step back from my stock portfolio and acknowledge that this drug has groundbreaking potential, and it's never ever been closer to the finish line of its long development, trial, and regulatory journey, and its within tangible reach of the start line for commercial sale and application. And that feeling was deeply reinforced by Nader's opening remarks, and it was compounded further when Scott Kelly read the testimonials from the three patients (or that of their close family members) who have been treated recently with Leronlimab. The Covid-19 patient was astounding: three approved treatments failed after their first 10 days of treatment to prevent advancement to a more severe stage of the infection, causing the patient to go on ECMO for 45 days and suffering end-stage pulmonary fibrosis. Then within 5 days of Leronlimab's administration just before Christmas, he was off ECMO, he's been taken off sedation, oxygen & ventilation, all his affected functions are normalizing, and he's progressing toward being taken from the ICU to the ward. My heart was bursting from the gratitude and sincerity in the words of this patient's wife. The colon cancer patient who went from a Stage 4 diagnosis in May to his oncologist reporting that he was cancer-free by Christmas. And the bladder cancer patient who started Leronlimab 9 weeks ago via Right-To-Try protocol, as a last-ditch effort after being told earlier this year that he had just 6 months to live, and now his cancer has not spread beyond its borders, extending his life to 9 months now, with his doctor is convinced LL curtailed the cancer's threat and he now has hope that his patient could get through this. Oh. My. God. We spend so much time talking about this drug, that it's easy to forget that most people do not know about, nor can they access it easily yet (the UK patient with Covid got the drug only because his wife took the doctor to court when he wouldn't recommend an experimental drug). There is no doubt in my mind that these testimonials are entirely truthful and a result of the effects of Leronlimab. These may only be anecdotal accounts but, to these patients, this is as real as it gets. We will soon have the clinical data that proves these effects in larger sample sizes in cancer and hopefully Covid, and we're already knocking on the door for HIV approval after 6 years of monotheraphy and hundreds of patients successfully advancing the drug to its BLA application stage, which - as Nader emphasized - is a guaranteed approval as long as they follow the guidance and protocol of the FDA to complete the BLA and receive a PDUFA date. 2020 may have felt like Leronlimab is a major Covid play (which it very much is), but I was grateful that this call to kick off 2021 punctuated the progress and timelines for its primary indication, as that is the primary reason to see CYDY as an investment and not a gamble, which incidentally backs Nader's bold assertion that CytoDyn has become a low-risk/high-reward investment. That may sound like sizzle but all the time, effort, money, and science invested in Leronlimab has now made it steak. "Rock-solid data" was put on record and unless the entire CytoDyn team wants to spend their twilight years in prison for securities fraud, they are clearly referencing irrefutable science that their trials have revealed and have earned the company ongoing correspondence with and guidance from the FDA, who can't be easily duped, as much as shorts want to push this distortion narrative that there is "no data" otherwise the drug would already be approved... well, there is no approval yet because most trials are still ongoing, and HIV needs to complete its BLA. The shorts really must think that most shareholders are clueless about the approval process, assuming that many investors only got in for Covid and never did any recon or DD on the patient and discreet nature of the trial and approval process, especially at the pre-revenue stage. I truly hope that correspondence in our groups have come to give shareholders confidence that investors are informed and short-sellers are merely predators of naivete, posting bogus articles and charts that they literally make up the information assuming that shareholders don't know the difference between false and accurate reports.
I was very moved by the audio testimonials of the 9 HIV patients who have been taking Leronlimab for 2.5 years and experiencing their quality of life improving and literally getting a new lease on life with no side effects (which they needed to suffer through with previous treatments). I read a Tweet by one short after who said he literally laughed out loud at how silly it was to play those tapes (well, we already knew some shorts have no human empathy). These patients have had viral loads reduced by 90% post-induction period (after 10 weeks), T-counts returning to normal levels, physical symptoms disappearing, emotional confidence and the profound optimism of being alive, something that healthy people take for granted everyday. The fact that over 300 patients have been using only Leronlimab for over one year, with no other therapy and no side effects, is groundbreaking. HIV treatment has always been a minimum of three different treatments, and it's involved oral pills that have SAEs, so CytoDyn's achievements in HIV treatment is astounding, and they now just need to navigate the incredibly precise and expensive process of its BLA because a drug approval of this nature needs to be held to the highest standard given the population it will treat as well as the revenue it can generate for a company. And CytoDyn's commitment to Leronlimab in HIV prevention, not just treatment, is an additional application within the same indication, with a $3.6 billion market on prevention alone, which CytoDyn could dominate in market share with only a once-per-month injection. And that's on top of the $5-10 billion that's anticipated in revenue for treatment in the first year upon approval and manufacturing upgrades. What this is ultimately leading to is essentially a cure for HIV, given that if there's a bone marrow transplant, and Leronlimab covers the CCR5, the new immune system could be Delta 32, and then we're talking about the trifecta for LL in HIV: prevention, treatment, and cure (for the bone marrow transplant population, which is 10% of HIV patients in the US). And their HIV paradigm will address liver disease caused by HIV, as well. Wow. Just wow. The imminent prospects of LL, both medically and financially, are a game-changer for the industry and the company.
On a more personal note, HIV hits close to home for me because I lost one of my best friends to HIV in 2006. His name was Patrick Donohoe and he was 30 years old when he died. He had a T-count under 10 but this young man continued to live his life to the fullest, volunteering for causes he was passionate and supporting his friends, even strangers, every chance he had. He would say that the only thing he has to live for is to help others because he is beyond saving and he's not going to stop doing what he can to make a difference until his last breath. And I was there when he breathed his last breath. And it was devastatingly sad to see his body reduced to pratically a skeleton, because he had some much to offer this world but there was nothing in the medical world that could save him. He tried various treatments but the side efforts made him so sick and weak that he would rather just live out his last days letting his body naturally deteriorate instead of having to deal with the pain of a chemical eating away at him, too. I did the AIDS LifeCycle ride from San Fran to LA in 2012 in his honor, which was a 550-bike ride raising money for the cause. And when I was introduced to CytoDyn, and I heard it was a groundbreaking HIV treatment, and I did my research to realize it was in the late-stages of approval, and I knew this can be a way for me to continue to support that quality of life in that community. It was too late for Patrick, but he would want me do what I can for people who can still their lives extended, because his mission was about making sure others succeeded, even if where he had failed. So you bet your ass that I'm committed to this company and this drug, and my investment will not be threatened by time or short distortion or a lack of gratitude for CytoDyn's efforts or any of the forces out there that are challenging the application of this drug for selfish reasons. Shorting human life is an unforgivable travesty, and if the people that do it genuinely don't believe in Leronlimab science then they simply haven't done the work to learn about it or they are overly cynical of CytoDyn's intentions, and that must be brought about by having no direct contact with people who have died from these diseases or just a general apathy for human life. I will still happily buy shares as a result of their manipulation, but I will not be joining them in Hell when karma gives them a life-threatening illness that even Leronlimab can't save them from. But I wouldn't wish that on anyone, and I know that no external factors can capsize CytoDyn's efforts with getting Leronlimab to market that this point; there is just too much growing awareness and support within the medical community, too many devout and devoted shareholders, and too great of a demand for this unique biological panacea.
The manufacturing strategy for Leronlimab in regards to HIV application and the FDA-approved rolling submission process for the BLA was encouraging to hear on the call. The non-clinical part is ready for submission, and the 4 jurisdictions (US, UK, UE, Canada) are anticipated to happen in the 2nd quarter of 2021. If they hit this timeline, and the applications are submitted properly, that would result in a PDUFA date for late 2021, which likely means Leronlimab will become the SoC in HIV treatment in the biggest markets in the world in 2022. HIV is a $30+ billion market, and it's conceivable that CytoDyn will have the safest and most effective self-administed treatment within that market. The cynics out there may still believe that Big Pharma won't let that happen, but at this point Big Pharma can't suppress Leronlimab, it can only try to buy it. The leverage that CytoDyn will have in that discussion would be like David's slingshot. Who knows if CytoDyn will submit to a buyout (or a partnership), or rather choose to grow into one of the most prominent biotech companies in the world with its 12-year patent for Leronlimab, but either scenario will reward shareholders with riches beyond imagination, especially the wise investors accumulating shares at a single-digit price in the highest volume their risk tolerance and financial appetite will allow.
If EUA for Covid happens, Nader will fly to S. Korea to negotiate the expediting manufacturing with Samsung because their deal was put in place pre-Covid and was designed for HIV manufacturing, and OWS has been in contact with CytoDyn to support if the drug gets EUA. Everyone seems to bee well aware that the demand for LL will far exceed the supply if the drug proves efficacious in reducing mortality, so it's great to hear they are already considering ways to maximize the contribution they can make to fight against Covid-19. I read this short's Tweet after the call that tried to spin this potential Samsung renegotiation as a result of not being able to pay their bill. It's utterly asinine to present it that way after how it was characterized on the call, and when shorts make such ridiculously obvious distortions, that's when we know how desperately they are reaching with their negativity, and it further confirms that nothing they say can ever be trusted or taken at face value.
It was fantastic news that other countries in need, like Brazil, Turkey, Pakistan, and Indonesia, have recently reported that they can approve LL in Covid without CD12 data, because the CD10 data is a more encouraging result for them than other drugs in that population. And the fact that CytoDyn isn't just going to turn over their limited supply upon this initial request, namely because they are so close to determining their effectiveness in saving lives in last-stage infection patients vs just preventing infections that may not proceed to that stage anyway, really speaks to the confidence in the drug in its more critical population. This also provides a hedge for a Covid application for Leronlimab. I agree with Nader that it's best to see if the US wants LL first, and not just because he feels indebted to the US for what it's done for him, but more because 1) the US is the worst off in deaths, 2) it will be able to best afford LL's true value, and 3) I like the leverage that it provides in seeking a US EUA in case the data is on the cusp of optimal p-value. It's good to hear that CytoDyn will explore these options as a possible revenue stream and application in Covid but they will reserve the right for LL to the US (and possibly the Philippines) first.
The Philippines submission is expected to be done by mid-January, so that news could be a prelude to the analysis from the unblinded CD12 data, and CytoDyn is teed up to deliver 1.2 million vials to any country that can approve marketing. So some form of revenue in Covid sounds like a foregone conclusion, but given we are so close to determine the drug's effectiveness in the most vital population, it will be the first determination, with other viable options waiting in the wings, if need be. This was a tremendous update for Covid-19 usage of LL.
Something I think is important to acknowledge is that the CD12 trial reached completion, and did so with no modifications to the trial parameters and protocol, nor any safety concerns. Reaching trail completion in this fashion is rare, and it bodes very well for the trial's prospects of showing favorable results. And trials with large molecules, like Leronlimab, are statistically more successful in moving to the application phase than smaller molecules, with an average approval success rate of 74%. Additionally, studies have shown that large molecules like recombinant proteins failed more often than monoclonal antibodies in transition from Phase 3 testing to regulatory review, with a success rate of 83% for MABs and only 66% for recombinant proteins. So, the fact LL made it this far in the trial historically bodes well for efficacy results. We have no way of knowing yet how the 87+ deaths will be broken down within the two arms of the trial, but I've already seen charted speculation online. I saw short claiming it's impossible to reach p-value, and then he presented some charts that looked like he drew it up himself on his computer and just inserted data that serves his agenda, assuming no one will do the legwork to disprove the credibility of "studies" he is drawing the data from. It was a laughable attempt to discredit the trial efficacy. Did Nader sound concerned by that number in regards to how it could play out in the data for the LL arm? Not one wink. In fact, he remained bullish on CD12 for the US, while making sure we know there is other countries eager to get LL, since CytoDyn can't control or predict the FDA's decision. CD12 was just one aspect of the holistic nature of the call, and it was clear to me that this call was new year's scheduled to cover a broad array of updates and topics, as indicated by the litany of items listed on the agenda in the PR. If anyone was expecting it to be more Covid-centric, then I simply think you didn't read the PR carefully enough to realize it was a big agenda with a limited time to cover it all.
I listened to the call while a small FB Messenger group of CYDY investors did live commentary during it. It quickly became apparent to me that some shareholders only care about Covid data and Nasdaq uplisting right now. They didn't seem to care about the patient updates and testimonials, or the updates on cancer, HIV, NASH, etc. I think that 2020 was just so engrossed in ongoing Covid trials and delays, and now we are at the cusp of completed Phase 3 trial, that there's just some anxiety about an immediate result, for both financial and humanitarian reasons. And that's all understandable. I just needed to check out from that group because I work hard to remain focused on the entire picture with this investment and I don't want to devalue favorable updates because they aren't geared enough toward the more immediate payoffs. I can appreciate many longs were financially triggered when Covid popped their portfolios but not enough to cash them out yet, and now all that patience they once had has been diluted by volatile stock price that makes or loses them tens of thousands of dollars a day. But I would like to point out that anyone who was in this stock in Dec 2019 or earlier will never see a loss on this investment - how many investments in a pre-revenue company can have shareholders say that? I think never growing impatient is a healthy approach to an investment like this, otherwise the emotional toll can just be too stressful and disappointing, and there was literally nothing to be disappointed about from that call, despite what will surely happen to the stock price at open when shorts and weak-hands control the trading activity (and incidentally provide another potential buying opportunity for those who still want more shares). I had already ear-marked end of 2021 for a PDUFA date based on the expectations that were being slow-rolled by the company toward the end of last year, and I always considered Nasdaq most likely won't happen till revenue is guaranteed, so it was encouraging to hear the company is still so dedicated to meeting the criteria before that.
With three published papers on LL, two more pending, 60 eIND Covid patients that resulted in FDA fast-track designation for Covid trials, eIND re-instatement now that trials have been filled, OLE use beyond eIND, an insurance code for Vyrologix going into effect on 1/21, one week away from completion of a Phase 2b/3 trial that passed 2 DSMC interim checks for safety & efficacy and no modifications to the trial, and an expedited Long-Hauler trial in what will be the largest Covid-affected population and has more volunteers than the trial can support, do you see why the shorts are ramping up the chatter surrounding Covid right now. They will post fabricated charts trying to disspell the possibility that LL can reach its p-value with 87 deaths in the CD12 trial, they will throw shade on the CD10 Phase 2 trial not ending up in EUA,. when CytoDyn didn't even apply given it didn't hit its primary endpoint (Phase 2 is designed to determine how to best determine Phase 3 endpoint assignments) and thus the FDA recommended a Phase 3 with 60 moderate patients with NEWS2 as the endpoint but couldn't offer EUA off a 84-patient Phase 2 trial in a non-critical population for a drug with limited supply and is currently in a Phase 3 trial for a more vital population (and seeing Relief Therapeutics get rejected EUA for their Phase 2 trial just goes to show that Phase 2 isn't going to cut it for an emergency authorization), and shorts will continue to exploit the naivete surrounding shareholder knowledge for SEC filing, debt repayment, stock dilution, irrelevant employee history, frivolous lawsuits, etc. It's just another day at the office for them, and these are their tactics performed behind anonymous accounts.
Other call news reported that CytoDyn is ahead of schedule in their NASH trial, with the first patient already reaching their 2nd injection, 25 patients in screening, 20 patients scheduled for MRIs, and multiple sites being activated for the trial, all done during a global pandemic.
They are having breakthrough designation discussions with FDA regarding cancer this month. They have 9 patients enrolled. Nader is really pumped about the LL prospects for cancer this year.
GvHD trial had good results in animal models but had difficulty enrolling in human trials due it needing to be placebo controlled. It could take over 3 years to fill this trial, so it is not the focus and will be put on hold for now, especially given there are already approved drugs treating GvHD. Shorts will just say this trial failed, when it's an entirely logical and strategic decision when it comes to best managing time and resources across the indication prioritizes and practicalities for success. So when shorts bring up GvHD, you know they are grasping at straws and just trying to sow doubt in any possible way they can, even the areas that the company has transparently admitted their reasons for not currently moving forward.
Stroke, MS, and Alzheimer will all start trials this year!
NASDAQ has seven quantitative listing criteria in their initial listing guide, only one of which is stock price above $4. The biggest hurdle for CytoDyn is achieving positive shareholder equity of $5 million. It was at positive $2.7 million at the end of August, and the next quarter will be reported by next week. The plan is to cure the shortfall in equity soon, but the decision is still under the discretion of NASDAQ at the end of the day. Mike spoke to them a couple days ago, the prospects remain optimistic, the company is committed to handling the shareholder equity concern, as well as any other quantitative needs that may be report back by NASDAQ, so CytoDyn remains committed to the uplist process, and it just remains an ongoing process given the company has to proactively meet all the necessary criteria, which isn't all that easy at this stage in their growth.
The explanation about the insider stock sales that precluded the Q&A was precisely what has been discussed by informed investors on various boards. It was deemed legitimate and common action by company employees exercising premeditated stock sales, they were filed legally and publicly, they were in no way a result of insider trading, and these kinds of filings are predictable cannon fodder for shorts to exploit since they assume most people don't understand what's going on when employees sell stock. It's just another example of shorts lying in order to spread doubt amount shareholders so they can more effectively short the stock.
The Q&A was packed with information about the CD12 trial, but it all comes down to the analysis of the unblinded data which will initiate on Jan 13 and CytoDyn will issue a report as quickly as possible.
The eIND requests have been very high and doctors are working with the FDA to treat as many patient as possible.
LL's target in the virus is CCR5 and not the spike protein so the drug will remain effective in new strains. No one is sure yet if the new strain will adversely affect the vaccines. The S. African strain is the most concerning for the vaccine effectiveness right now.
They have only one item left on the Philippines' EUA requested list which will be done in the next 9-10 days. If anything changes, shareholders will be updated. Expectation is to submit for EUA there in 10-15 days from now.
There are 2.5 million vials of LL secured for 2021, and 2.5 millions for 2022, and those numbers could be increased if need be.
Repaying capital requires giving warrants. CytoDyn was trusted with 100 million shares in the shareholder vote last year. They will be repaying loans by exercising warrants when money needs to be repaid which, at the current stock price, is 2.5 million shares per month. This is the most minimal dilution that can occur when it comes to maintaining ongoing company operations. This is transparent standard practice under the financial circumstances of the company, and this arithmetic can be done by anyone. It's reasonable and necessary to continue to fund the company in this manner until it starts to generate revenue.
The correction in PR earlier this week was merely to correct a typo. Shorts tried to say it was the company hiding bad news about the eIND protocol. Another weak attempt of them, which makes the shorts look uninformed and desperate.
2021 has even greater potential for the company and its shareholders than 2020 did. The train is moving full steam ahead. It may not always be at the speed of some people's portfolio expectations but all indications point to forward progress with the company and upward progress with the stock.
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