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May you give the citation for the study?
The link you provided is for a stock report. Best I can tell it is an editorial or opinion piece. I would love to see the actual study. I searched for it online but could not find it. Perhaps it is not NIH approved? Do you know what country it was based out of?
Also what time frame and patient population does this high mortality rate come from? These medications are sometimes used in organ transplant patients. We want to compare apples to apples. Mortality has steadily improved from March to present day. I would suggest mortality above 35% to 40% even for critical patients is high. Only intubated patients on high dose pressors or ecomo should be above 40%. For Severe patients, in the icu or covid ward on O2 but not intubated, mortality should be in the single digits.
How many patients were ventilated?
SF Anony I agree. In the two subsets of patients, severe and critical, they are very different. We don't know how many of the patients enrolled met severe criteria verses how many met critical criteria. Not all patients enrolled are likely to have even been in the ICU. Most severe patients enrolled could just be on a covid ward with telemetryf. Here is the criteria needed to be in Severe arm of the study:
Symptoms of severe systemic illness/infection with COVID-19:
- At least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress
AND
Clinical signs indicative of severe systemic illness/infection with COVID-19, with at least 1 of the following:
- RR ≥ 30, HR ≥ 125, SaO2 <93% on room air or requires > 2L oxygen by NC in order maintain SaO2 ≥93%, PaO2/FiO2 <300
AND
- None of the following: Respiratory failure (defined by endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, or clinical diagnosis of respiratory failure in setting of resource limitations), Septic shock (defined by SBP < 90 mm Hg, or Diastolic BP < 60 mm Hg), Multiple organ dysfunction/failure.
This patient arm is similar to the moderate patient population of the prior leronlimab study of mild to moderate disease. Sicker for sure but not really much worse off than moderate patients. In that study the only patient death as in the Leronlimab arm.
While impossible to know how many patients are meeting criteria for Severe verses Critical I would think maybe a 50:50 split or close to it. Most patients in the critical group will be intubated. That patient population carries a mortality of around 35 to 40% currently. However our study excluded patients intubated on vaso pressors above a low dose. This is why I feel we have a 50:50 ratio. Also most ICUs do all they can now to prevent intubation, so that patient population may be lower in number overall leading to less Critical patient enrollment.
Overall Mortality is HIGH
If 87 died out of 390 patients mortality is about 22%. My concern is this overall mortality rate is above average. Regardless of where the deaths end up, in placebo or in Leronlimab arms, the number is just too high. From April onward the average ICU mortality for covid 19 seems to be between 12 and 15% (1). The numbers improved as time went on "Adjusted mortality from COVID-19 decreased from 25.6% in March 2020 to 7.6% in August 2020." Just look at the CDC website. Even in Lombardy, Italy during the worst moments of this pandemic mortality was only 25% for patients over 70 years of age (2). How the heck did this study average 22% and climbing? Perhaps the selection process limited us to only the sickest patients within the ICU? Not likely as we rejected patients on pressor support.
The big question I have is how can a study designed to show improvement in all cause mortality have a higher than average overall mortality and still be taken seriously? Regardless of how deaths are in either arm, we should not average worse than 12 to 15% unless our patients were all recruited earlier in the year, prior to April. Perhaps I am missing something? I know NP quotes average ICU mortality of 40% but I can not find that anywhere. If anyone has a link to such a study or data please post or link it so I may feel better.
1) https://www.cdc.gov/library/covid19/112420_covidupdate.html
2) https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2768601
I am in HGEN.
I feel the data and company leadership offer a leg up on covid 19 competition. Our study, HGENs is of a better design than CYDY. We will have full enrollment and full data read out before them and in time to make a difference before mass vaccination takes place. CYDY interm analysis will be a waste of time. Measuring mortality has changed as outcomes have improved. Their study is now under powered so an interm look will reveal little useful data. The new standard in covid studies is decreased time in the hospital, decreasing costs and freeing up hospital beds. So time to discharge is huge.
I have and continue to lighten my holding in CYDY. I do feel they have a bright future but fear their poor leadership has spent too much time and money chasing a covid 19 dream. They have no partners, no grants, no government funding, and a lack of big private investors. The most they got was a private loan at high interest. They will eventually get HIV approval, they should. Other areas like NASH and Breast Cancer look promising. My fear is when they fail at covid 19 and don't get up listed before this happens the share price will drop below 2 usd. I may buy back my shares in CYDY at that time. In my eyes, the turning point for CYDY was the lack of approval for HIV. They really screwed it up. Amazed the leadership took no blame for that and remained intact. That is like a billion dollar screw up. Yet here they are, continuing on the same path and the same people making another effort at HIV approval. For me the risk verse benefit is no longer in favor of holding the stock.
That being said, I am reinvesting my sales of CYDY into HGEN. I feel HGEN has more promise in turning out a covid 19 product. Study end points are in line with what both matters and is achievable. Synergy with remdesivir is a great path forward as well. Multiple countries on board early and interested in taking part in data collection. Any EUA or FDA approval makes future therapeutic indications all the more in reach.
I am long on HGEN and short on CYDY, well with what I have left in CYDY.
CYDY trial of mild to moderate has been completed for weeks.
This much is true.
They missed on all primary end points in their study per the CEOs admission. In fact my understanding is the only patient death was among a patient who was given leronlimab. The study was a 2:1 ratio of Leronlimab to placebo. Not a good study, not well powered, and not designed to move leronlimab to FDA approval. This was a true phase 2 study.
They did not publish a peer review of their results. They actually have not fully published any results or even given out the data. They have only mentioned, in a conference call to my knowledge (I am a CYDY shareholder) that they achieved significant statistical difference in one secondary measure, the news2 score. However they failed to mention what difference and also did not release the data. My guess is, honestly, they achieved a lower temperature (fever) upon ICU admission. Without a full release of data it is all a guess. Not sure why they are applying for EUA for covid 19. The study was a small phase 2 study, designed to help them focus on a future phase 3 study. If the data is so great why not publish it?
NEWS 2 measures the following:
respiration rate
oxygen saturation
systolic blood pressure
pulse rate
level of consciousness or new confusion*
temperature.
Primary end points measured 02 Sat, and oxygen use and they failed to show a statistical difference in those. So I feel resp rate and Oxygen saturation really couldn't have been that much different to placebo even in the news2 score. Level of consciousness in covid 19 is directly linked to 02 sat, again (02 Sat) a failed in the primary end point That leaves heart rate, blood pressure and temperature. The first two are highly variable upon ICU admissions. Most covid 19 admissions are for low 02 sats or they wouldn't be going there, they would stay on the floor. Some are for hypotension, though not many compared to resp failure, and low blood pressure is linked to increased HR. So my money is on fever reduction. Again without a full release of the data, who knows? If anyone has all the data, peer reviewed, I would love a link. Perhaps I am wrong? Perhaps CYDY just forgot to release the data?
I do feel CYDY will get HIV approval, if not in the USA then in the UK. That will be big news for them. However, HIV patients self injecting at home may be an issue in many countries as what will they do with the dirty needles? I do not see the UK funding CYDY to promote treatment of Covid 19. Warp Speed rejected them. They haven't released the data yet, just some strange words of support from the CEO about meeting a secondary end points and focusing on they drug being safe though not effective. Also the CEO touts many times that leronlimab stays in the system for weeks if not months, per his HIV data review video. If this is true why was there no significant statistical data shown progression to ICU or mechanical ventilation in then mild to moderate study. Leronlimab was no better than placebo. I do not see the data from the Severe to Critical study having a good read out for CYDY. With all that in mind covid 19 is not for CYDY.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “We are very motivated to provide leronlimab to patients throughout the world who are suffering from COVID-19. We believe the statistically significant data of NEWS2 findings, along with impressive safety results (less SAEs or AEs with leronlimab vs. placebo), from our Phase 2 trial set forth in the Top-line Report provides compelling data in support of leronlimab’s use to fight COVID-19. We are in discussions with several regulatory agencies in other countries and hope to obtain emergency approval for its use. We are in a very exciting period for CytoDyn in regards to the potential role of leronlimab in three different COVID-19 populations, mild-to-moderate, severe-to-critical, and long-haulers.”
Here is the link to their "data," Would love a better one, or a full release of the numbers and findings.
https://www.cytodyn.com/newsroom/press-releases/detail/460/cytodyn-submits-its-top-line-report-from-its-phase-2
I have watched this video,
the EIND data mentioned in this video has not been released. About 3 months behind for some reason.
What was improved at 3 days was my question? NEWS2 is stuff like fever, HR, Blood Pressure, and level of consciousness as well as Oxygen saturation which later in the call they admitted did not have much difference 84% placebo verses 79% leronlimab, in terms of needing supplemental O2. In fact during the call they seemed to feel the biggest NEW2 difference was fever and respiratory rate. Is that was was improved at day 3? I just am wondering how they can claim no statistical significance in primary end points but according to them "they could have asked for better results"? I feel I must be missing something? Happy patients had a lower temperature and lower resting respiratory rate as well as cough. I would have preferred a decrease in hospitalization and oxygen demand.
May I ask,
What was improved by day three? Both arms placebo and leronlimab required Oxygen (84% placebo and 79% leronlimab). They had equal number of intubations as well. Was outcome changed at all?
Also primary end points did not achieve statistical significance so what are the secondary end points that did? Does anyone feel a phase 3 with adjusted endpoints will not be required? If so why? Not bashing just trying to figure out why they were so excited in the call.
I think the placebo group still gets standard of care therapy. So they get decadron (dexamethasone) and remdesivir possibly convalescent plasma if they can find any (in short supply where I am).
I feel the compartative death rates in CD12 likely are not significant enough to stop the trial. Most ICU docs would agree the best way to treat ARDS is via a set of protocols to prevent ARDS. Anesthesia has ARDS prevention protocols when ever a high risk patient is vented. This ARDS in covid 19 is different, but still, giving the drug early and a focus on prevention of ARDS is the key in my mind. This is where HGEN got a better start on us with a simple but effective study focused on prevention of ARDS.
The fate of this stock is in the hands of the M2M study. I believe the data here will show early treatment with leronlimab yields shorter hospital stays, decreased symptoms, decreased FIO2 requirements and prevents or decreases progression to ARDS. The problem here is the study is a phase 2 of only 86 patients. Many patients are truely mild and ratio is 1:2. I see the FDA possibly asking for a phase 3 study.
The problem with CYDY is the management. If they are serious about treating covid 19 they need to launch a follow up study to the M2M phase 2 study now. Don't wait for the FDA to ask for it. Show them you are serious and launch it now. Probably a experienced covid 19 physician rather than a pathologist should have designed the studies for leronlimab in regards to covid 19 therapy.
Fauci Supports Monoclonal Antibodies on video
Who is Ready for Fauci basically talking about MABS on a National Podium!!!
11 minutes in!!!
monoclonal antibodies!!!!
https://www.facebook.com/ABCNewsLive/videos/571965866820082/?
Lets hope is talking about CYDY, he does mention Sub Q injection.
Scooter,
You posted a link to a review on compassionate use of remdesivir, not a study. This dates back to Jan, Feb Mar and maybe April before FDA approval for Remdesivir on May 1 for emergent use. Look if remdesivir upsets you so much lets not write about. The study at the university of Chicago is not linked in the article. The university website states the study is still on going. Perhaps I am confusing studies. If so I am sorry.
Either way do you really feel we should not go after the other 98% of covid 19 patients? My initial argument with you was "lets not worry about the 1-2% of severe patients." I prefer we focus on the other 98%. We should have data from our Mild to Moderate study soon. Lets not wait for the Severe study and hope the news is good on Leronlimab as a treatment for Mild to Moderate and expand upon our phase 2 study with a follow up phase 3 study. We should target out patient therapy as well.
Dear Dieselpro,
Vyrologix is Leronlimab by another name. Sorry for your confusion.
In medicine we have both a generic name, Lorenlimab, and a proprietary, Vyroligix.
CytoDyn Announces Vyrologix as Proprietary Name for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients in the United States
Here is a better explanation:
https://www.cytodyn.com/investors/news-events/press-releases/detail/422/cytodyn-announces-vyrologix-as-proprietary-name-for
Dear Scooter New reports aren't medical journal worthy studies, they are just something to read for the general public. Nor does anyone including the FDA use them in medical decision making.
I am asking for data not Sun news or financial times reports, Reutors or Barrons or Alpha Stocks. Please provide me with the drug studies not news reports. I am asking you for the same courtesy I extended you. You cited a study on remdesivir out of Chicago. As far as I can tell the University of Chicago study is ongoing. Are you referring to this:
https://chicago.suntimes.com/coronavirus/2020/4/16/21224436/covid-19-remdesivir-patients-university-chicago-trial-coronvirus-uchicago-medicine-covid-19
The FDA does not use news media as guidance. I await the results from University of Chicago. Even so, the news media seems to like Remdesivir and supports my claim that we, Leronlimab should increase our treatment population to include Mild to Moderate not just Severe. The Mild to Moderate Leronlimab study of 86 patients will require a follow up study.
You do know others can read our posts? They can see you are not providing the material you are quoting. I am glad you have a strong opinion of Leronlimab but lets post factual information so as not to mislead one another, or others on this site.
My questions remains, what should CYDY study next? Follow up covid 19 study or move on?
Dear Sir,
I did post the research, did you take time to read it?
"Remdesivir and Leronlimab where tested in rigorous double blind critical,moderate,mild or whatever it would not be close listen to what Dr.Patterson says about the drugs our drug calms the cytokines storm reduces viral load and kills the virus while Remdesivir does none of that go and research something before it’s posted to be sure it has credibility" Per your statement.
May you please provide a link to support this above statement? Actual study results to my knowledge are not available to anyone else but you regarding leronlimab Severe study data.
Either way, CYDY is a company with a 2.5 Billion dollar market cap. They have only one future product, Leronlimab. They are marketing it for covid 19 per forward looking statements. One study is completed and one is on going for Covid 19. They have another in Mexico of 25 patients not yet started. I strongly feel it is the best interest of share holders to not wait around for results. Another study should be designed and started for Covid 19 therapy. Only about 1-2% of all covid 19 will be of severe status. I am amiss as to why share holders don't want to go after the other 98%. A simple out patient study, (they are cheaper), to assess effectiveness and cost savings for Leronlimab Vs Placebo in Sub Q injections as out patients. Primary out come measures time to reduction in symptoms and recovery. Secondary measures decreased medical costs through a reduction in hospital admissions and decreased transmittance of covid 19 among house hold members. A phase 2 study of 75 (now 86) mild to moderate covid 19 patients would require a follow up study, even if approval by the FDA is reached.
Even if you don't not support my future studies of Covid 19 and only want to focus on Severe patients with covid 19 do you not feel we should start some other studies. After all 2.5 billion market cap with only one possible product, you want to get the most return on that product.
If you would like to read the data I am referring to in regards to remdesivir here is the link:
https://www.gilead.com/news-and-press/press-room/press-releases/2020/7/gilead-presents-additional-data-on-investigational-antiviral-remdesivir-for-the-treatment-of-covid-19
Please link me to the study you refer to? Please cite your references. Hard to make reasonable point if you can't back it up with the study. I am open to learning something I may have missed, but need the data, not just someone telling me I am wrong and they know better than the current standard of care.
Read the latest studies on Remdesivir. Things have changed since the original lorenlimab studies were started. The study you are referring to was in April and the study took place in China. New data shows:
"The data are being presented at the Virtual COVID-19 Conference as part of the 23rd International AIDS Conference (AIDS 2020: Virtual) and include a comparative analysis of the Phase 3 SIMPLE-Severe trial and a real-world retrospective cohort of patients with severe COVID-19. In this analysis, remdesivir was associated with an improvement in clinical recovery and a 62 percent reduction in the risk of mortality compared with standard of care – an important finding that requires confirmation in prospective clinical trials."
If you want to stay focused on the past I fear what the future will hold.
May I ask what you feel lorenlimab should be targeting for therapy?
https://www.gilead.com/news-and-press/press-room/press-releases/2020/7/gilead-presents-additional-data-on-investigational-antiviral-remdesivir-for-the-treatment-of-covid-19
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31022-9/fulltext
Focus should be on Mild to Moderate covid 19 patient study.
Lets all be honest. The market has changed a bit since to original two studies for Leronlimab began. Remdesivir has good data on treating the Severe covid 19 patient population. That being said I feel we should be doubling down on the mild to moderate patient population. So why are we doing nothing? I don't want to wait and release the datq from the Mild to Moderate on the same day as the Severe patient safety data. We have plenty of safety data from the HIV studies. Why waste time?
Our mild to moderate patient population study is complete. We are just organizing the data for release. We should in the mean time be starting another study. Why not continue with a phase 3 study? How about "out patient therapy with leronlimab?" I mean drive through Sub Q injection is pretty dam easy. Roll up your shirt (shoulder), lift up your shirt (abdomen), or pull down the back side of your pants (thigh or buttocks). If our mild to moderate study shows a decrease in symptoms like cough, sneezing and shorter duration of infection, I feel out patient sub Q treatment is indicated. We only need a phase three to prove it effective and benificial. We don't have to reinvent the wheel here. If you cough and sneeze less and have fewer days of being sick, then the treatment of lorenlimab sub Q will decrease the rate of transmission. That would be huge, that is what we all want and need. Done as an out patients costs little just follow up phone calls. Check in daily or every 24 hours with a blood test after a set number of days to measure viral load. This is the direction we should be going. Why stand around and wait? Why spend so much time competing with Remdesivir when we could be complementing it by targeting a different, not yet served patient population.
Thank You for the well written update.
Millstone, that was a great summary of events and a good description of the process. Finally a post that is free of pumping or jealousy or anger from CYDY investors.
I am hopeful the up listing is complete before September and release of interim data is early next month or late this month. Also we are lucky we are targeting mild to moderate patients. Remdesivir seems to have good data on treating the Severe covid 19 patient population.
Lets all keep an eye out for EUA for B cell Lymphoma. Lets all hope good news is one the way.
Storage life verses shelf life are very different
I feel NP confused the two. Yes, at -80 C in liquid nitrogen (although the website I am looking at says -20 C), you can store monoclonal antibodies for a long time. Usually you can thaw them once. This is called storage life. You are storing the monoclonal antibodies for long term. The are not usually stored in small individual vials like you see when they arrive at the hospital but a more sturdy long term container.
Shelf life (what I would also call short term storage) is basically how long a hospital can keep it in refrigerated in a hospital pharmacy a 4 C. Typically for monoclonal antibodies that is about 90 days, by my understanding. That may very on light exposure and the compound it is preserved in.
https://www.pacificimmunology.com/resources/antibody-characterization/antibody-storage/
Help me with interim data release on Severe study.
I understand they are going to release data from both studies on the same day. The mild to moderate patient data study will have full release of data by the end of the month.
On that same day, NP said interim data from the Severe study will also be released. Then he later corrected saying they don't have 50% of patients and it will not be a real or full interim data release. That it will instead be a release of safety based data for the severe trail? ALso this release of data will have nothing to do with the FDA or the real interim data release which will be later.
So, my take away is we are only really getting a data release on the mild to moderate trial this month. Does everyone agree or am I not understanding? Honestly I could not put together the message he was trying to convey.
If no Severe study interim data release this month, does anyone have an estimate on when?
8-k before listing or within 4 business days of application process.
You guys are killing me here.
https://www.sec.gov/fast-answers/answersform8khtm.html
Item 3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard or Transfer of Listing
Here is the process of NASDAQ up listing.
This is direct from them, NASDAQ. Yes there is a paper trail. Yes they usually file a 8-k (week one in the process of the application). No, it does not magically happen, at least I have not ever seen that.
https://listingcenter.nasdaq.com/assets/initialguide.pdf
I am not a business major, nor has it been my area of study. I have only been an investor a few year. Several times a stock I owned has moved from one market to another and this process has been followed. That being said some circumstances may lead to unusual events. I would not be upset if we magically up listed without any paper work being filed.
8-K must be filed before the application process to NASDAQ can begin. I am certain of this. Other stocks I have owned have done it this way. After the 8-k, usually 4 to 6 week till up listings. Pretty sure the SEC and NASDAQ management would agree. That being said, if you are refering to when the SEC posts or we get a press release about the 8-k, then yes, the process started before we heard about it, yes. However the date on the 8-k reflects the starting date of the process no matter when we hear about.
My thoughts on why special share holder meeting is being called. They are requiring us to vote on something.
Let me first disclose:
I am not a businessman nor do I have formal training in that field. I am only a investor with several years of experience.
This is not our annual share holder meeting.
I have heard of no plans to expand our board of directors.
I am not aware of any vacancies on the board needing filled.
Does anyone think this is due to issuance of more shares to raise capital?
Thanks,
You efforts are grand. I hope we are not delisting but up listing.
Here is what the process should look like:
Listing Timeline
While it generally takes four to six weeks to process a listing application, this time frame is variable and may
be shortened considerably, if the application raises no issues and the company responds quickly to Staff
comments.
Week 1. Company submits application for listing and Nasdaq Listing Qualifications Staff begins its review.
Weeks 2-3. Staff completes its preliminary review and prepares comment letter.
Weeks 3-4. Company addresses any issues raised by Staff.
Weeks 5-6. Staff completes their review and company is approved for listing.
So, week one involves submitting and application both with Nasdaq (or NYSE) and the SEC (this form is called a 8-k). Nothing can move forward until this process happens first. I am asking if anyone has any firm paper, emails, press release or general proof that we have submitted the application or 8-K?
Getting mixed messages on up listing.
If CYDY is in process of up listing we should have some sort of paper trail with the SEC. Does anyone have a copy of the paper or a link to the filings? These are supposed to be made public. I just want to know for sure we are up listing, I think a lot of people want to know. If we haven't started the process that is okay.... Next question, when do we plan on starting the process? Just saying we are going to do it doesn't make it happen.
Hey Bobby,
On the sec.gov website I don't see the filing of the 8-k form for up listing. The last 8-k form I see is NP paying himself more money in stock. May you please link or refer me to the 8-k up listing form for cydy? The up listing process doesn't start until that is filed so if that has been filed it is a big deal.
Up listing would be super helpful at limiting short sellers and attracting institutional investors .
Up Listing?
Does anyone know why we have not started the process of up listing? I feel these wild swings in price and crazy attacks from short sellers would be greatly limited with an up listing? Also seems NP mentioned this process of up listing over a month ago. So far it would appear the process has not started yet? Anyone know what is going on with up listing? Was hoping we would up list before the data reveal but that seems less likely now.
Hey Away,
Honestly I have no idea. That may be a better question for the HGEN board.
Remdesivir works by a different mechanism than either Leronlimab or Lenzilumab. At one time I thought Leronlimab was going for a synergy study with Remdesivir and I was excited about that. Then suddenly it all vanished and the focus became Leronlimab as a stand alone.
I feel Remdesivir a antiviral, plus cytokine storm prevention is a winning combination. Currently being done with dexamethasone. That being said dexamethasone worries me, given at the wrong time it may worsen outcomes. You don't like to give steroids to a patient with a bacterial or viral infection. On top of that, long term use may lead to adrenal suppression.
With my above thoughts in mind, Gilead would benefit from partnering with someone who can add cytokine storm prevention (none steroidal) to the mix of therapies currently on hand. A study of Lorenlimab and Remdesivir makes a lot sense. If not Lorenlimab then Lenzilumab. No doubt HGEN and Gilead work closely together, that doesn't mean CYDY can work with Gilead as well.
Silver,
You crack me up. I am willing to go for 97.95 USD per share.
Lets hope the trails yield success and the government funds production and delivery. Also lets hope they purchase all 1.2 million doses we have available.
Here are the NIH studies for those who feel I am not honest. Please read and determine your own findings if you don't like mine.
hgen study
https://clinicaltrials.gov/ct2/show/NCT04351152
cydy severe study
https://clinicaltrials.gov/ct2/show/NCT04347239
cydy mild to moderate study
https://clinicaltrials.gov/ct2/show/NCT04343651
Again I feel both companies can have success as they are targeting different patient populations and different end points.
Up listing process has not started yet!
You will know when the process starts as NP will file an 8-k form with the SEC. Usually about 6 or 8 week process I think. Until the file is submitted then up listing is only talk with no action having been taken place.
Both CYDY and HGEN can get along. I own both though I currently own more HGEN.
The study by HGEN has a primary end point of preventing ARDS and Mechanical Ventilation. That is why patients with ARDS and who are intubated must be excluded. If you are already on a ventilator or have ARDS, how can it be prevented?
Both companies are studying covid 19 positive patients.
HGEN is targeting hospitalized patients that do not require Mechanical ventilation or have ARDS at time of arrival. That is about 20% of all covid 19 patients. Their drug is being measured to prevent ARDS and Mechanical ventilation.
CYDY is targeting Severe patients, patients in the critical care setting, with or without ARDS. Low PaO2 and low O2 sats. This represents the sickest 2% of all covid 19 patients. Their drug is measured by All-cause mortality at Day 28. Not sure why they designed the study this way. If you recover from Covid 19 go home and get hit by a car and die, then you count as dead in all cause mortality. Lets hope this doesn't happen.
Here you have it simply explained. The two companies are targeting two different patient populations with different primary end points. Room for both.
CYDY also has a phase two study of 86 patients. Pts are mild to moderate. Primary end point measures decreased symptoms of covid 19. This is very subjective. Pts are asked if they saw improvement in cough, body aches, shortness of breath, and fever.
This study is probably not as helpful as you think. A subjective end point like this is hard to measure and usually requires a large patient population to be accurate. 86 patients is way under powered. Patients are often out patients and self report. This will almost certainly require a follow up study with a larger number of patients.
Hope this helps.
I am for both companies and both have a place in covid 19 therapies.
Please enlighten me as to why Pfizer would buy Leronlimab? They already own a CCR5 blocker and it was FDA approved back in 2007. Maraviroc is the name of the drug. Why would they compete with themselves by purchasing CYDY. Just of note, Pfizer never made any money on Maraviroc as an HIV medicine. Pfizer's drug is far from perfect having liver issues and strong side effect profile. However, I do not see them purchasing a second CCR5 inbibitor at least not one so similar to the one they already own.
Here is a simple description of all the CCR5 inhibitors. Too my knowledge only one, Maraviroc has FDA approval.
https://en.wikipedia.org/wiki/CCR5_receptor_antagonist#Aplaviroc_2
Assume you are all talking about FDA approval for HIV. To be totally honest I am unsure how successful Leronlimab will be at at earning money treating HIV. Yes the drug is effective at treating HIV, sub type of HIV and requires special testing before the drug can be used. The drug is also only available as a Sub Q injection for HIV. To make matters worse we are not first to market. Maraviroc has been around since 2007 by Pfizer. Maraviroc is a similar CCR5 that is more potent and has better bioavailability. The drug has not turned a profit for them. Actually the drug is too expensive, however we are in a worse situation being we can not market our drug in a solid or oral form making costs even higher for production, storage and administration. Also what kids want to get a shot every week? What will patients in Africa do with all the dirty needles?. That being said at least we are safe for the liver. We should have the NASH therapy market covered but hope studies start ASAP. Also hoping for Covid 19 therapy but not banking on it. The idea of Sub Q shot in the ER or before discharge home and being effective for a week sounds like a great way to increase compliance in America.
Many people on here think we are going to charge 2000 usd a dose for Leronlimab, but I just don't see it. Even for covid 19 we would be competing against Maraviroc in off label use. When Maraviroc came out a daily dose went for 29 USD.. So 10 days would be 290 usd. Easier to store and easier to admin, orally. The compliance issue is in our favor (for covid 19) and would be my idea of standard of care (one or two time sub Q injection) but we would have to price it correctly.
Maraviroc is produced in 150mg and 300mg tablets. US price is approximately USD $900 per month ($29/day), for either 150mg or 300mg BID dose. Patients using maraviroc with efavirenz need to use 600mg BID and will have to pay the double cost.
North American pharma company CytoDyn has announced that its primary product leronlimab exceeded expectations as a monotherapy for human immunodeficiency virus (HIV).
The company has published new data that shows a weekly 525mg and 700mg dose of leronlimab led to a 90% response rate in HIV-infected patients who made it through ten weeks of monotherapy without virologic failure. Approximately 30% of the 525mg group and 17% of the 700mg group failed the first ten weeks of monotherapy.
Those patients taking 525mg dose who reached the ten week mark without virologic failure have reached an average of 32 weeks with sustained viral load suppression.
The only currently approved tropism test is the Trofile test manufactured by Monogram and costs approximately £900. Samples to be shipped to the US. Viral load needs to be >1,000 copies/mL for the test to work, and sensitivity drops from 100% at 10% dual/mixed tropism to around 80% when only 5% virus is X4.
Here are the links
https://www.pharmaceutical-technology.com/news/cytodyn-leronlimab-monotherapy-hiv/
https://www.forbes.com/sites/matthewherper/2012/07/11/immune-reversal-unsuccessful-pfizer-aids-drug-might-help-transplant-patients/#7c4d24e4e0b7
http://i-base.info/htb/2172
Scooter,
I do enjoy our back and fourth support of CYDY as well as HGEN and share what I hope is mutual respect for one another. We have both similar and differing opinions at times. That being said you probably have more business and investment knowledge than I. However, I do feel my pharmacology and medical knowledge is strong.
Let me try to address our differing opinions first:
1) This actually doesn't address anything regarding the exclusions criteria HGEN opted for in it's study.
I do feel I addressed how the studies vary. Clearly HGEN is opting for early therapy is better than late. The study reflects this. The studies are different but that doesn't mean they are designed to cheat out the competition. Even CYDY's NP agrees in his video interview that early treatment is better. Each company designs their own study, own end points, number of patients, and dosing of drugs on trail. This was never designed to be a competition between the two though it is shaping up to be. I do feel HGEN's study is a better one.
2) The fact remains HGEN's study left out the most vulnerable and those most in need of treatment from COVID. With the target audience for COVID treatment excluded how could any physician take it seriously? More importantly what physician can have confidence in the drug if they don't know if it will actually work?
Are you a physician? Let me answer this with how I view the study. A physician can best utilize Lenzilumab by getting it to patients early, before ARDS and before mechanical ventilation. They choose to focus on this in the study. Similar to the goals and exclusions set in CYDY's mild to moderate study. I feel that is a better study than CYDY's severe study. After watching Bean's interview with NP, I feel NP would agree with me. Problem with CYDY is they are trying to go after to many things at once. Targeting multiple diseases with studies and end points hoping they get a direct hit on something. The mild to moderate covid 19study by CYDY is a good study, however a phase 2 with only 75 patients it is under powered and will likely require an additional follow up study. The severe study will take a while, results for the intermim data will likely be released after July. The study is to broad and not focused. The end points are measured over too long a period.
3) As I stated over a month ago this drug could work but it actually needs to be tested. We already saw what happened with Remdsivir and it's goal post moving. While first to market everyone is racing to come up with something better.
So first to market doesn't mean that's the winner.
I honestly don't think you believe timing to the market during a pandemic has no effect on a drugs usage, profits and overall effectiveness in a population. You even admit being first to market helped remdesivir. Not sure what point you are trying to make with that. You do know that lernolimab can never be first to the market? Other CCR5 inhibitors exist and they have FDA approval already. That being said, no one is using them for Covid 19. They are made by big pharama like Pfizer (Maraviroc), the most common among them and used for HIV. The drug is available orally, unlike Lernolimab. If the mild to moderate study of Lernolimab is a success, I kind of only see it promoting the use of Maraviroc in the outpatient setting. After all, taking a pill is much easier for a patient than coming in for an IV infusion or an injection if they are at home awaiting covid 19 testing results. Currently no GM-CSF is available as non are FDA approved. HGEN will be first to market within this class of drugs.
4) I see Leronlimab as a major drug because it's backed by an actual study aimed at helping the most vulnerable.
We agree on this. Leronlimab is targeting sicker patients in the Severe study. Problem is this, while Lernolimab is not a direct IL6 blocker that is the mechanism of action used to treat cytokine storm in its pathway. Studies on this drug class have not been successful thus far. Perhaps Lernolimab will be different. I truly hope so and think so.
May I ask if you have any shares in HGEN? I will admit to you I am not the worlds best investor. I have faults and I am imperfect. Currently I am 60:40 heavier in HGEN. I await the data on both drugs (I am invested in both as state) and feel the most effective and appropriate drug should be used in patients yielding the best results regardless of my investments.
I invested in CYDY for NASH therapy. I invested in HGEN for B Cell Lymphoma but mostly for Covid 19 therapy.
Here was my reply to Scooter,
Sad to say it was not published on CYDY board.
May I ask why you are so upset they have a better designed study? Remember the study is more than impartial. This is a true double blinded 1:1 randomized study, the HGEN study. Not a 2:1 study like we have, the CYDY study. Exclusion applies to both the placebo group and the test group in equal numbers or 1:1 for HGEN. In our study the exclusions favor the test group 2:1. I get the feeling you have never been involved in a NIH study.
Every study has set exclusion criteria to ensure safety and a proper measure of what the drug can do per the design by measured outcomes. You almost sound jealous of HGEN. If you feel the studies are not a proper measure of what both is capable of, then you as a prescribing physician can determine which drug best fits your patients needs based upon FDA approval and the data you analyze in the studies.
I feel like most new drug that which come to market, the one who gets there first gets the most recognition. Like Viagra, or Lipitor. Better drugs in each class exist, but when you think of those classes, those particular meds come to mind. Problem is, Lorenlimab is not first among the class of CD5 blockers. Further more it is not as potent nor does it have good bio availability. When a prescribing physician has an option to order an HIV medication that is given IV or sub Q, verses P.O. (oral) they will choose oral 99% of the time. Maraviroc will win out and they already have FDA approved. Now, on our side, after all I am an investor in CYDY, a sub Q injection of one or two doses at the clinic or in the ER or upon admission or before discharge will dramatically improve compliance. Not to mention IV admin will bipass the liver, the first pass effect, decreasing side effects and bringing the drug to level in the body faster. Both will help us with covid 19 therapy. All this being said I own shares in both HGEN and CYDY. My thoughts are whom ever comes to market first wins. Lorenlimab has better therapies than covid 19, like NASH, breast cancer, colon cancer and others. Covid 19 is a flash in the pan. Granted it has driven the price up and I love that, but I am not banking upon it.
May I ask why you are so upset they have a better designed study? Remember the study is more than impartial. This is a true double blinded 1:1 randomized study, the HGEN study. Not a 2:1 study like we have, the CYDY study. Exclusion applies to both the placebo group and the test group in equal numbers or 1:1 for HGEN. In our study the exclusions favor the test group 2:1. I get the feeling you have never been involved in a NIH study.
Every study has set exclusion criteria to ensure safety and a proper measure of what the drug can do per the design by measured outcomes. You almost sound jealous of HGEN. If you feel the studies are not a proper measure of what both is capable of, then you as a prescribing physician can determine which drug best fits your patients needs based upon FDA approval and the data you analyze in the studies.
I feel like most new drug that which come to market, the one who gets there first gets the most recognition. Like Viagra, or Lipitor. Better drugs in each class exist, but when you think of those classes, those particular meds come to mind. Problem is, Lorenlimab is not first among the class of CD5 blockers. Further more it is not as potent nor does it have good bio availability. When a prescribing physician has an option to order an HIV medication that is given IV or sub Q, verses P.O. (oral) they will choose oral 99% of the time. Maraviroc will win out and they already have FDA approved. Now, on our side, after all I am an investor in CYDY, a sub Q injection of one or two doses at the clinic or in the ER or upon admission or before discharge will dramatically improve compliance. Not to mention IV admin will bipass the liver, the first pass effect, decreasing side effects and bringing the drug to level in the body faster. Both will help us with covid 19 therapy. All this being said I own shares in both HGEN and CYDY. My thoughts are whom ever comes to market first wins. Lorenlimab has better therapies than covid 19, like NASH, breast cancer, colon cancer and others. Covid 19 is a flash in the pan. Granted it has driven the price up and I love that, but I am not banking upon it.
Hi Ho Silver,
Love your positions. I have a similar position. At one time I was heavy in CYDY. I lightened my position and now am split 60:40 in favor of HGEN. I am ICU and anesthesia OR based.
Both medications will likely make it to market. HGEN is my favorite as they will be the first GM-CSF medication to be FDA approved. CYDY will be one of several CCR5 blockers to be approved and has little bio availability, IV or Sub Q only. Several other CCR5 blockers are already on the market, big pharma products and come in oral form. This means the CYDY drug is IV or sub Q only not a great idea for HIV patients or patients needing to take the medication longer term. A good thing if you plan on administering a medication before discharge home from the hospital or in the ER. This improves compliance. Also IV admin will bipass the liver, the first pass effect, decreasing side effects and bringing the drug to level in the body faster. A great thing for Covid 19 patients. Problems here are they are not first to market, and being first is big. Also they compete against several big players with similar drugs. To make matters worse, IL6 blockers exist. CCR5 use in covid 19 is measured by how well it blocks IL6. Studies on IL6 blockers used to treat covid 19 are so bad they discontinued some of them. Some good things about CYDY, they have plenty of product. 500000 doses that expire in less than 90 days. They are eager to move them. Mexico seems interested in having them, for the right price. They have a distributor in place. They will at some point get approval for HIV. They are working on NASH and Breast Cancer.
HGEN has more going for it. EU approval for B Cell Lymphoma will likely happen at some point. They interim revel N50% of covid study like in 10 to 12 days. They have a well designed study in place for covid 19 and better data points to be measured on outcome. They have big pharma partners and a long term plan. They have cash available. No one else has a similar product within 3 to 6 months of approval. Down sides, how much product is readily available? What cut will Gilead want for distribution if that is the plan? They don't pump the stock as much as the CEO of CYDY, maybe good, maybe bad?
I feel better with HGEN for covid 19. I await the data to determine which one I will use in covid 19 patients and if approved by the FDA. In the ICU I will use IV infusions acutely with sub Q before discharge when appropriate. If out patient therapy, oral all the way if CCR5 works, sorry lorenlimab, you are in some ways promoting Maraviroc (oral form of CCR5 blocker) with your study. If CCR5 does not pan out, then GM-CSF all the way and everyday we get a ICU covid 19 player.
Any patient on the ventilator gets decardron until proven otherwise. Remdesivir is standard of care until proven otherwise. We combine the two presently in ICU with vented patients.
Bob,
The data one the mild to moderate will be ready in the second half of the month, at least that is what I think. I doubt the severe data will be available this month at all. Even if it is ready IL6 blockers have already been studied in severe covid 19 patients and they did not work.
The Mild to Moderate date is only 75 to 80 patients strong and a phase 2/3 study. I am hoping that data looks great. Likely additional study will have to follow.
The Severe study has 50 patients in the interim data, or N12.5% out of 390 to 400 patients. That data is worthless, even if it shows promise. I hope they delay until they have at least 100 patients if not N50% as is typical.
This is what I read:
Six severely ill patients received the CCR5 inhibitor leronlimab (PRO 140, CytoDyn) on a compassionate-use basis, and 2 received the interleukin-6 receptor antagonist tocilizumab. Interleukin-6 levels were very elevated (range, 83 to 8175 pg per milliliter) when leronlimab was initiated (on day 0) in the 5 patients with elevated interleukin-6 levels; these levels decreased markedly 3 days later (range, 37 to 2022 pg per milliliter) (see Table S2 in the Supplementary Appendix). However, only the 1 patient who had the lowest interleukin-6 level (at 83 pg per milliliter) remained in stable condition without intubation.
The one patient who was not intubated later died at home. See the attached appendix.
This is how I get 5 out of 6.
https://www.nejm.org/doi/suppl/10.1056/NEJMc2011117/suppl_file/nejmc2011117_appendix.pdf
You are correct, poor choice or words. The data results I linked in the post are very telling. I make my investments in the biotech and pharma fields based on medical data and evidence based studies. In this regard, as I stated, HGEN has better data than CYDY with the covid 19 studies. "In the bag" was a poor choice of words to reflect this.
Anyone can look at the data and review form themselves. Just look at my previous posting.
HGEN is more data based when it comes to covid 19.
CYDY is more youtube video and teary testimonial based.
I am unsure what you are trying to say in your post. Nothing about stocks and no data to review from medical data.
Is your point, data doesn't matter and that the media drives the stock price through manipulation? That may be true but I invest based on reliable research and facts, not fictional youtube stories and testimonials.
I still hold some shares in CYDY but lessened my holdings. NASH, HIV and Breast Cancer are the path forward for CYDY.
Breast Cancer alone is a 30 Billion plus yearly area of medicine.