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Misiu. I have missed you so much and so glad you are back on our board. You are head and shoulders over any other contributor. Your knowledge, insight, drive and commitment is beyond reproach. On behalf of the thousands of silent investors on this board who are suffering but know the value of what we have got I thank you most sincerely for your efforts.
Theguardian.com/fatty acid found in palm oil linked to spread of cancer
Folks, you should read this as it affects your health and will definitely be relevant to our/CYDY Triple-Negative Breast Cancer (mTNBC) trials. A study published in the journal Nature has made a shocking discovery linking dietary fat and the spread of cancer. The study has potentially pinpointed a popular food item, most are consuming which is significantly causing cancer to spread in the body. The study, part-funded by the UK charity Worldwide Cancer Research, found palmitic acid alters the cancer genome which in turn significantly increases the likelihood this cancer will spread. This is particularly relevant to Metastasis which is estimated to be responsible for 90% of cancer deaths.
Cytodyn should now start another leg of their Triple-Negative Breast Cancer (mTNBC) studies with patients consuming an appropriate/modified diet.
https://www.theguardian.com/society/2021/nov/10/fatty-acid-found-in-palm-oil-linked-to-spread-of-cancer
https://www.express.co.uk/life-style/health/1519631/Cancer-risk-fatty-acid-palm-oil-metastasis-mouth-skin
https://www.walesonline.co.uk/news/uk-news/everyday-food-could-causing-90-22147328
DollwrBill - I would appreciate it if you could record the event and post it please for those of us living in Europe
Andrew Marr runs a current affairs program on UK television. He was vaccinated c.4 months ago and caught Covid 2 weeks ago. He said it started with what he thought was a cold and developed in to what was a most horrible experience. He has fully recovered now but the learning point is just because you are vaccinated don’t think you are safe.
Tony Blair( former PM and now speaker for the Inst for GlobalChange) was on Bloomberg today said this virus is not going to go away and there is now a long term need to develop antivirals and thereupics in case the virus mutates out of control being less resistant or totally resistant to vaccines. WE HAVE ONE MATE!
“All truth passes through three stages. First, it is ridiculed. Second, it is violently opposed. Third, it is accepted as being self-evident.”
— Arthur Schopenhauer
The FDA, The Shorts, BP are just entering the third stage.
MHRA Customer Service Centre of The British Medicines and Healthcare products Regulatory Agency wrote to me two days ago (relating my email to them and which I posted here on the 24 March) to say “We have reviewed your enquiry and this has been passed on for consideration.”
I am now very confident that my very important letter about Lero / Cytodyn is now in the hands of the movers and shakers in the heart of the MHRA. Keep your fingers crossed that they approve and help make the world a better place by saving countless numbers of lives.
Got a simple holding reply to yesterday's email to the MHRA as follows:
Dear K,
Thank you for your email.
The MHRA are aware of this recently published information. All information presented to the MHRA is considered in our reviews.
Kind regards,
COVID Clinical Trial Helpline
I sent this to MHRA today
Dear June,
LERONLIMAB -14 Day Results
Further to my letter sent you by email on the 24 March I am writing to ensure you have received a copy of Cytodyn’s latest press release yesterday relating to completed the Phase 3 CD12 trial for the first randomized, double-blind, placebo-controlled study investigating the benefits of treating critically ill Covid patients with Leronlimab. I attach a link at the bottom of the page showing this statement.
These stunning results show 400% improvement in the 14 day mortality of these critically ill patients in the CD12 trial and forms part of the 28 day data set which represents the strongest clinical data ever achieved in any randomized controlled clinical trial around the world.
I would take the opportunity to say that whilst these results are fantastic, these day 14 results, and the 28 day trial results could have been even better. Although the FDA knew the excellent safety record of Leronlimab they “requested” that:
(a) the first dose was administered by subcutaneous infusion instead of IV.
(b) only 2 doses were given 7 days apart.
Whilst (a) would have the benefit of knowing (if the drug was subsequently proven to be effective) it could be delivered quickly at doctors surgeries or even self administered at home, there is a delay of c. 52 hours before the drug gets to the patients tissues and starts to work properly. This was demonstrated in the Leronlimab ‘Mild to Moderate’ phase 2 trial when there was a sudden improvement in patients at day 3. However this 52 hour delay in facilitating the drug to work would have caused a significant deterioration in these very sick patients making them even harder to save.
As regards (b) some very sick patients using Leronlimab have occasionally required more than 2 doses to survive so 2 doses in the trial could have been limiting its full potential/performance. Also Leronlimab has a half-life of 7 days and the patients were only injected twice which means the active drug was only in their body for 14 days. This ultimately leaves the patient without any treatment for the second half of the 28 day study time.
I would be pleased if you could take these considerations into account in your assessment of this very special drug.
Yours sincerely
Thanks for the good feedback. I am particularly honoured to get it from you as I am your biggest fan.
I have sent this to the Chief Exec of the MHRA and the MHRA's Covid Working Group today
LERONLIMAB
In recents weeks Cytodyn has completed the CD12 Phase 3 CD12 trial for the first randomized, double-blind, placebo-controlled study investigating the benefits of treating critically ill Covid patients with Leronlimab. The results are marvellous and absolutely the best trial results so far for any medication investigating the treatment of Covid19.
Leronlimab is not a vaccine but a vaccine will not save people if they are already sick from Covid 19. Despite the roll-out of vaccines, therapeutics will continue to be needed for variants and people who catch the disease.
The drug’s target is not the virus itself, but the CCR 5 expression (Note that Leronlimab binds to CCR5 100%) The goal is to restore immune function in the sickest patients, and will work equally well with all the covid variants. Leronlimab is essentially a fully humanized Monoclonal Antibody directed against the CCR5 Receptor. It works by inhibiting the Chemokines from stimulating the Immune Cells in an uncontrolled manner. It restores the immune homeostasis in the body which then attacks and removes the virus.
The results data shows how important age is as a factor in mortality. Older people are more likely to die with Covid and inadvertently, a high proportion of older patients (by a ratio of 3:1) where enrolled in the Leronlimab arm of the study thus lowering the relative mortality in favour of the placebo. Given the very confounding factor of age and the significant difference in age subgroups in CytoDyn’s CD12 trial, it is important to stratify the groups by age to see how Leronlimab performed when accounting for various factors that may have been dissimilar at baseline. There were 33% of >65-year-old patients enrolled in the Leronlimab arm versus only 23% in the placebo arm. That is enough to make a profound difference in the trial results.
Age adjustment might have also put the CD12 trial’s placebo group’s overall mortality rate in-line with other studies. In taking this corrective action the overall mortality in the Leronlimab arm drops to 18.91% and the placebo arm rises to 25.6%.
In the overall age-adjusted population, the mortality reduces from 25.6% to 18.9%, a total reduction of 6.7% or a relative reduction of about 26%, above and beyond benefits observed from dexamethasone use.
It should be noted that peer-reviewed analysis on other drug trials for COVID-19 such as the powerful immunosuppressive steroid, Dexamethasone, utilized age adjustments to more accurately quantify their therapeutic effects.
The recent phase 3 trial data showed:
1) When Leronlimab was used in addition to “commonly used COVID-19 treatments” a clear benefit was seen in the primary endpoint of all-cause mortality at day 28 with an absolute risk reduction of death of 6.5% and a relative risk reduction of death of 28.1% (N = 309, p = .0319).
2) When Leronlimab was used in combination with dexamethasone, a clear benefit was seen in the primary endpoint of all-cause mortality at day 28 with an absolute risk reduction of death of 5.7% and a relative risk reduction of 26.2% (N=233, p=.055)
3) The mean length in hospital stay was decreased by 5.5 days in the critically ill population (p = .005)
4) Mortality status at day 28 when Leronlimab was used in addition to “commonly used COVID-19 treatments” in the critically ill population with an age < 65 showed a clear mortality benefit with an absolute risk reduction of death of 20.9% and a relative risk reduction of death of 73%.
Put more simply, for every 4.8 patients treated with leronlimab and other commonly used COVID treatments who are under 65 and on a ventilator, 1 life would be saved.
5) Mortality status at day 28 when Leronlimab was used in addition to Dexamethasone in the critically ill population showed a clear mortality benefit with an absolute risk reduction of death of 6.5% and a relative risk reduction of death of 23.5%.
6) Length of hospital stay in critically ill patients < 65-years-old showed a clear benefit with a reduction of 6.8 days (N=44, p=.006)
In addition, there were no safety signals seen in the Leronlimab group versus placebo. Indeed the drug has a wonderful safety profile treating over 1000 people over many years of continuous use.
So what do all these statistics mean in practise. For example take the 1000 Americans who continue to die each day from covid-19, all in critical condition at the time of death. Leronlimab can save about 300 of these folks and if these people took the drug in mild to moderate stage of the disease then over 90% would live. Even though the FDA knows the drug is safe and effective they prevaricate over giving Emergency Use Authorization and ask for yet more trials to be done.
In addition I would make the following comments:
CCR5 is a major player in over 70 diseases (Long Covid, HIV , cancer, NASH, Sepsis to mention but a few) and Leronlimab could be a major medicine in the future treatment of all those diseases.
If the MHRA were to give EUA for Leronlimab, the country would be given some priority over the immediate deployment of the limited supply of this drug to save British lives.
There are major dark forces in play at present trying to cause Cytodyn to fail. An approval would allow CytoDyn to sell Leronlimab meaning CytoDyn will be open for business. Note most developing countries will not use Leronlimab without a major approval from such an eminent institution such as yourselves. If this life saving therapeutic doesn't get emergency use authorization (EUA) soon it will be a crime against humanity IMO.
The CD12 trial results are very compelling and Leronlimab may be the only safe medication to help critically ill patients.
Dr Jay Lalezari is an eminent consulting physician operating on the west coast of America. He has written a letter to Dr Janet Woodcock at the FDA about the strategic importance of the Leronlimab CD12 results. I attach a copy of this letter for you to review.
I also attach two articles from “Insider Financial” , the medical parts of which are written in a way that the scientists at MHRA will appreciate.
During this pandemic the MHRA has shown immense creative and leadership skills. I would beg you not to wait for the FDA to approve this drug (which may not be forthcoming owing to political and wider commercial reasons and gross conflicts of interest in America) but to independently review the merits of this safe drug and act accordingly for the benefit of the British people and indeed the whole world.
I understand you have asked Cytodyn to apply for an
accelerated rolling review. Leronlimab is by far, the best therapeutic available today and I submit to you that you have enough data today to approve this drug immediately. However if you insist on getting further data about the drugs efficacy, I would ask that you give conditional emergency use authorization whilst this additional information is collected. Countless lives will immediately be saved.
Yours Sincerely
Today I sent this to the Chief Executive of the MHRA and the MHRA's Covid Working Group
Dear June,
In recents weeks Cytodyn has completed the CD12 Phase 3 CD12 trial for the first randomized, double-blind, placebo-controlled study investigating the benefits of treating critically ill Covid patients with Leronlimab. The results are marvellous and absolutely the best trial results so far for any medication investigating the treatment of Covid19.
Leronlimab is not a vaccine but a vaccine will not save people if they are already sick from Covid 19. Despite the roll-out of vaccines, therapeutics will continue to be needed for variants and people who catch the disease.
The drug’s target is not the virus itself, but the CCR 5 expression (Note that Leronlimab binds to CCR5 100%) The goal is to restore immune function in the sickest patients, and will work equally well with all the covid variants. Leronlimab is essentially a fully humanized Monoclonal Antibody directed against the CCR5 Receptor. It works by inhibiting the Chemokines from stimulating the Immune Cells in an uncontrolled manner. It restores the immune homeostasis in the body which then attacks and removes the virus.
The results data shows how important age is as a factor in mortality. Older people are more likely to die with Covid and inadvertently, a high proportion of older patients (by a ratio of 3:1) where enrolled in the Leronlimab arm of the study thus lowering the relative mortality in favour of the placebo. Given the very confounding factor of age and the significant difference in age subgroups in CytoDyn’s CD12 trial, it is important to stratify the groups by age to see how Leronlimab performed when accounting for various factors that may have been dissimilar at baseline. There were 33% of >65-year-old patients enrolled in the Leronlimab arm versus only 23% in the placebo arm. That is enough to make a profound difference in the trial results.
Age adjustment might have also put the CD12 trial’s placebo group’s overall mortality rate in-line with other studies. In taking this corrective action the overall mortality in the Leronlimab arm drops to 18.91% and the placebo arm rises to 25.6%.
In the overall age-adjusted population, the mortality reduces from 25.6% to 18.9%, a total reduction of 6.7% or a relative reduction of about 26%, above and beyond benefits observed from dexamethasone use.
It should be noted that peer-reviewed analysis on other drug trials for COVID-19 such as the powerful immunosuppressive steroid, Dexamethasone, utilized age adjustments to more accurately quantify their therapeutic effects.
The recent phase 3 trial data showed:
1) When Leronlimab was used in addition to “commonly used COVID-19 treatments” a clear benefit was seen in the primary endpoint of all-cause mortality at day 28 with an absolute risk reduction of death of 6.5% and a relative risk reduction of death of 28.1% (N = 309, p = .0319).
2) When Leronlimab was used in combination with dexamethasone, a clear benefit was seen in the primary endpoint of all-cause mortality at day 28 with an absolute risk reduction of death of 5.7% and a relative risk reduction of 26.2% (N=233, p=.055)
3) The mean length in hospital stay was decreased by 5.5 days in the critically ill population (p = .005)
4) Mortality status at day 28 when Leronlimab was used in addition to “commonly used COVID-19 treatments” in the critically ill population with an age < 65 showed a clear mortality benefit with an absolute risk reduction of death of 20.9% and a relative risk reduction of death of 73%.
Put more simply, for every 4.8 patients treated with leronlimab and other commonly used COVID treatments who are under 65 and on a ventilator, 1 life would be saved.
5) Mortality status at day 28 when Leronlimab was used in addition to Dexamethasone in the critically ill population showed a clear mortality benefit with an absolute risk reduction of death of 6.5% and a relative risk reduction of death of 23.5%.
6) Length of hospital stay in critically ill patients < 65-years-old showed a clear benefit with a reduction of 6.8 days (N=44, p=.006)
In addition, there were no safety signals seen in the Leronlimab group versus placebo. Indeed the drug has a wonderful safety profile treating over 1000 people over many years of continuous use.
So what do all these statistics mean in practise. For example take the 1000 Americans who continue to die each day from covid-19, all in critical condition at the time of death. Leronlimab can save about 300 of these folks and if these people took the drug in mild to moderate stage of the disease then over 90% would live. Even though the FDA knows the drug is safe and effective they prevaricate over giving Emergency Use Authorization and ask for yet more trials to be done.
In addition I would make the following comments:
CCR5 is a major player in over 70 diseases (Long Covid, HIV , cancer, NASH, Sepsis to mention but a few) and Leronlimab could be a major medicine in the future treatment of all those diseases.
If the MHRA were to give EUA for Leronlimab, the country would be given some priority over the immediate deployment of the limited supply of this drug to save British lives.
There are major dark forces in play at present trying to cause Cytodyn to fail. An approval would allow CytoDyn to sell Leronlimab meaning CytoDyn will be open for business. Note most developing countries will not use Leronlimab without a major approval from such an eminent institution such as yourselves. If this life saving therapeutic doesn't get emergency use authorization (EUA) soon it will be a crime against humanity IMO.
The CD12 trial results are very compelling and Leronlimab may be the only safe medication to help critically ill patients.
Dr Jay Lalezari is an eminent consulting physician operating on the west coast of America. He has written a letter to Dr Janet Woodcock at the FDA about the strategic importance of the Leronlimab CD12 results. I attach a copy of this letter for you to review.
I also attach two articles from “Insider Financial” , the medical parts of which are written in a way that the scientists at MHRA will appreciate.
During this pandemic the MHRA has shown immense creative and leadership skills. I would beg you not to wait for the FDA to approve this drug (which may not be forthcoming owing to political and wider commercial reasons and gross conflicts of interest in America) but to independently review the merits of this safe drug and act accordingly for the benefit of the British people and indeed the whole world.
I understand you have asked Cytodyn to apply for an
accelerated rolling review. Leronlimab is by far, the best therapeutic available today and I submit to you that you have enough data today to approve this drug immediately. However if you insist on getting further data about the drugs efficacy, I would ask that you give conditional emergency use authorization whilst this additional information is collected. Countless lives will immediately be saved.
Yours Sincerely
(Killery)
Attachments:
1. See Dr. Lalezari’s letter to Janet Woodcock, FDA
Lalezari draft manuscript: https://drive.google.com/file/d/1vdo5RhM3qdcBJY25rzLUTAsioPYUmYkz/view
2. https://insiderfinancial.com/cytodyns-smoking-gun-for-an-immediate-eua/181182/
3. https://insiderfinancial.com/cytodyn-saves-lives-reduces-covid-19-hospital-duration/181154/
Misiu, Maverick, It is important to stress that Maraviroc can cause serious, life-threatening side effects. These include liver problems, heart problems (including heart attack), skin reactions, and allergic reactions. An allergic reaction may happen before liver problems occur.
I have not got that but I was pleased that 1. They found the report interesting, 2. I flagged some of the merits and raised the profile of Lero at the heart of the MHRA 3. There is an ongoing trial with Lero
After sending Rock's post to the MHRA this afternoon, I have had a very encouraging, astonishingly quick, response already as follows (pity the FDA doesn't work as fast as us Brits haha):
Dear Killery,
Thank you for the interesting information for leronlimab.
The MHRA regulatory centre of the Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. While the Agency plays a leading global role in protecting and improving public health and supports innovation through scientific research and development, its remit does not include carrying out clinical trials itself. Therefore MHRA is not involved in determining which products are included in clinical trials, which is the remit of the individual trial sponsor.
The WHO Solidarity trial is not ongoing in the UK, however, there is an ongoing leronlimab clinical trial in the UK: Clinical Trials Register
Kind regards,
COVID Clinical Trial Helpline
Rock, Thank you so much for writing this. I have forwarded it to the head of the MHRA and the MHRA's Covid Action Group for their information and ask for their help to get it included in the The WHO's Solidarity Therapeutics Trial.
Gas, we in the UK are not allowed to see this interview so if they show any more I would appreciate a brief summary or the three main bullet points. CYTODYN please get interviewed by companies which can be seen in Europe.
Rock. Learning53 -Because Of Bruce Pattison, Maraviroc is getting a lot of publicity at present as a CCR5 blocker but this med can cause serious, life-threatening side effects. These include liver problems, heart problems (including heart attack), skin reactions, and allergic reactions. An allergic reaction may happen before liver problems occur. On the other hand we know from years of trials that Lero has not shown any serious side effects. Whilst Maraviroc is cheap, it has not proved itself in a Phase 3 trial against Covid. If I had the money or health insurance, I know which one I would go for.
This was published in yesterdays Telegraph but no mention of Lero/CYDY. We have known how good Lero is for years so how come nearly all doctors and the world's press do not yet know about Lero. This feels very sinister to me.
Arsenal of drugs in the works in the war against Covid
http://digitaleditions.telegraph.co.uk/data/508/reader/reader.html?social#!preferred/0/package/508/pub/508/page/26/article/141482
I sent this to my doctor last week and you may find it interesting.
The presentation also includes a paper by Bruce Patterson on Leronlimab and you may find that interesting also:
DOXAZOSIN
Johns Hopkins Medical University did a presentation last week at Precision World Medicine Conference and here is a link for you to view:
https://fb.watch/3gvWTXYKMp/
Their research has found that Alpha Blockers improve the outcomes of Covid 19 patients by preventing the super inflammatory cytokine storms.
They have shown that use of these drugs in animal studies prevents death from Covid19. They have also shown by looking at a large number of retrospective cohorts of patients suffering from pneumonia, respiratory diseases, and Covid 19 patients, the use of these drugs gives a markedly reduced mortality.
Now there are three types of Alpha-1 receptors. Tamsulosin blocks one type of Alpha 1 receptor and two other drugs including Doxazosin block all three types of Alpha-1 receptors. In their studies they found that patients using Doxazosin have much better outcomes than Tamsulosin.
They are about to commence a large clinical study using Doxazosin against Covid19 in the coming months.
The Covid19 vaccines are far from 100% efficacious and may not be able to treat mutant strains of the virus which are developing monthly.
Like many older men I take Tamsulosin to help me urinate owing to enlarged prostate problems so I enquired whether my doctor would consider prescribing Doxazosin for me instead to give additional cover against Covid 19.
She told me that Tamsulosin was very widely used and had good safety record. On the other hand she said Doxazosin had a very long list of side effects and until the study is complete would have ill-defined benefits. We agreed I should keep taking the Tamsulosin.
Rock, Misiu, - A cartoon in the Sunday Times newspaper showed a man getting his first vaccination jab, and the nurse saying, "One of the side effects is a feeling of smugness." Well I definitely feel smug today haha and hope to be allowed out to meet friends outdoors soon.
Although they are trying to control it, the South African strain is spreading in the UK. I have had the AstraZeneca vaccine today and Oxford have not yet determined its efficacy against this strain. Do you think people need to continue taking precautions (taking zinc, quercetin, CoQ10 etc ) if they have had the vaccine?
Misiu, Welcome back from Liverpool ,Eng. I missed you.
I agree , you rock Rock and we will have the other star back on Tuesday. WELCOME BACK MISIU
Preliminary data from South Africa suggests that the novel variant 501.V2 wasn't recognised by antibodies in 21/44 serum samples collected from people infected in the first wave - worth watching today's presentation for more info & caveats
I hope they don’t and 1. The country rises up against them and 2. The MHRA uk takes the med instead. I know you at the MHRA are looking so just do it and get ahead of the crowd.
CJ comments on Yahoo Board as follows:
I work in academic clinical research having experience in with clinical coordinating, regulatory, finance, contracts, IND, you name it. I know that people are expecting results "any day now."Let me tell you, Amarex has its hands full. Trust me, they are rushing mad as hell and pushing sites to complete their data entry (imagine all of the data collected for the study on all the subject) and then to source validate the data. They just don't take the doctor's or coordinators word for it. Every blood test measured is reviewed, every lab needed for study is reviewed, this means access to the medical record for every subject.Once all "queries" are resolved they will "lock" the database. Typically, data analysis only occurs after the data lock. This ensures that late data isn't entered or changed as it would have been vetted and then locked. Only under very specific and serious situations would a dataset be changed after a lock (and this would not be by the company but by 1 or 2 authorized at Amarex--if even that). This is serious stuff. The FDA has the authority to review and you don't want to run afoul of the process. (Drugs that are nearing approval WILL have an FDA audit of top enrolling sites. EUA is different but assume it could come post EUA). So you can't cut corners and rushing will #$%$ big time.So Amarex has a herculean task. Access to the EMR is difficult due to the pandemic. Typically this is done physically on site. Many hospital/healthcare sites have set up systems for remote access but this is often limited and highly monitored and can slow down the process. I know at my site, quarantine is required (or a recent negative covid test) before allowing access to offices/staff to validate data. I say this to illustrate that it won't be days for results. Expect weeks. Now we may get PR's on mortality but honestly, if a company is this close to an approvable treatment they will make sure not only the data is solid but that the analysis is absolutely complete and accurate. Get comfortable with waiting. CD12 has 5x the number of patients than CD10 and much sicker patients. It took 4 weeks to get news on CD10. So expect CD12 to take at least as long.GLTA
CT Medic, I am not sure of their Mode of Action but they will be used world now as people have confidence in our Regulator doing a great job.
Tocilizumab (made by Hoffman-La Roch) and Sarilumab (made by Regeneron & Sonofi) were approved today for immediate use in hospitals by the UK Regulator for use on critical Covid patients. Used with Dexi they will save an additional one in twelve patients lives and cut recoverty times in ICU hopitals. I think they are IL 6 inhibitors (onlY ??) so will do a great job until Lero is available.
Rock, this new strain is something else and is spreading like wildfire. After 9 months of hardship we are back where we started and the country has been closed down for a further 2 months. However doing it a day or two late has meant that huge numbers of people now have the virus and hospitals cant cope. 1 in 30 people in London and 1 in 100 nationally have it. 1060 people died today and it is only just starting. USA should act (closedown) early or approve Lero to avoid a castastrophe coming your way. GET PREPARED.
Ombowstring, be careful . I am with one of the biggest brokers in the UK and they will not allow me to use the money from the sale for 2 or 3 days until it the money is cleared.( they use Covid as an excuse for their inefficiency). Therefore in my case I would need to come up additional funds for my ISA if I effectively wanted to transfer the shares without any delays. This is a real pain!
Mountainman, UK Rugulator. It was relayed to me months ago from someone who sits on the MHRC ,the UK’ s regulating committee that they are aware of Leronlimab and are waiting for the CD12 results to be revealed. I separately wrote to the MHRC and their sub group dealing solely with the Covid issues and got a long letter back this week with lots of legal speak basically saying they can’t say anything but I am happy I know my letter went to the key people.
Thank you CYTODYN. Many people here say we get too much info from the company and yes some info has been inaccurate, premature, misleading, and over optimistic. However I thank Cytodyn for their good communications and great efforts in this regard. In contrast as an example I am also a shareholder in Synergen and their shareholders are told absolutely nothing and are totally frustrated about what is happening and what progress is being made. We are so lucky.
Misiu143,Rock,many thanks for your responses. If anyone on this board had access to a medical lab they could do this investigation themselves. Then they could buy Butyrate from a food health shop and do the investigation again. My gut instinct ( haha) would be that this would reveal some interesting anecdotal data which could inspire some proper and important research
WOW that sounds like a disaster and must put you under incredible pressure. Our thoughts are with you and your staff. Thank you all for your efforts.
Thanks Rock, It would be great if somebody investigated how the 1.25D values varied on one patient ( or more) with various D3 doses for eg 1000IU, 2500 IU, 5000IU to see if the conversion was limited or proportional.
Rock, Misui New Vitamin D Info
Extracts in inverted commas taken from following:
From https://medicalxpress.com/news/2020-11-reveals-gut-bacteria-vitamin-d.html
Ref. Vitamin D metabolites and the gut microbiome in older men
https://www.nature.com/articles/s41467-020-19793-8
Study published in recent weeks reveals connection between gut bacteria and vitamin D levels
by Heather Buschman, PhD, University of California - San Diego
SOME GREAT FINDINGS HERE
“The team analysed stool and blood samples contributed by 567 men participating in six cities around the United States, their mean age was 84.
Our gut microbiomes—the many bacteria, viruses and other microbes living in our digestive tracts—play important roles in our health and risk for disease in ways that are only beginning to be recognized.
Vitamin D can take several different forms, but standard blood tests detect only one, an inactive precursor that can be stored by the body. To use vitamin D, the body must metabolize the precursor into an active form.
The variety of bacteria types in a person's gut—was closely associated with active vitamin D, but not the precursor form.
In addition to discovering a link between active vitamin D and overall microbiome diversity, the researchers also noted that 12 particular types of bacteria appeared more often in the gut microbiomes of men with lots of active vitamin D. Most of those 12 bacteria produce butyrate, a beneficial fatty acid that helps maintain gut lining health.
The team unexpectedly found no correlations between where men lived (and thus exposure to sunlight) and their levels of active vitamin D hormone.”
"It seems like it doesn't matter how much vitamin D you get through sunlight or supplementation, nor how much your body can store," Kado said. "It matters how well your body is able to metabolize that into active vitamin D, and maybe that's what clinical trials need to measure in order to get a more accurate picture of the vitamin's role in health."
Rock, Misiu, when you advocate extremely large doses of Vitamin D, do we know how much becomes active vitamin D?
I emailed this to the British Medicines and Healthcare products Regulatory Agency (MHRA) today, and the COVID-19 Team within the Clinical Trials Unit at the MHRA has acknowledged receipt.
Dear June Raine
Chief Executive
MHRA
Dear June,
LERONLIMAB
Just how many more lives are going to be sacrificed before it is realized how many lives could be saved if CYTODYN'S LERONLIMAB Drug were made available for Emergency Use (EUA). It would be THOUSANDS UPON THOUSANDS UPON THOUSANDS.
This medicine is not a vaccine but a vaccine will not save people if they are already sick from Covid 19. Leronlimab has been shown to work in Covid and saved many lives. In HIV and Covid trials it has been shown to be perfectly safe over many years of use.
In Mild/Moderate Phase3 trials patients it was statistically significant in the more important secondary endpoints, NEWS2 , clinically significant for the less important primary endpoints, and performed much better than any other drug has done. When used as Emergency Investigational New Drug (EIND) many of the most critical patients lives were saved.
Yet you have made the antiviral Remdesivir your standard of care and this is not even reducing viral load, it has very poor results in Severe/Critical patients , but even worse in M/M , and they have full approval for all COVID patients. Even the WHO have expressed that it doesn't work and is not an effective treatment for Covid.
It is great that your other standard of care medicine, Dexamethasone, saves a small proportion of the S/C patient’s lives but this is a very dangerous drug. This steroid is an immune suppressive which shuts down the functions of the immune system that is trying to control the virus. This leaves patients vulnerable to other diseases and if they become Long Haulers could make their symptoms worse.
In the meantime, the FDA gives EUA daily to other drugs showing much less efficacy than Leronlimab, and much more side effects. Getting approval in the USA is a lot more complicated when big pharma is involved submitting competing drugs.
I would like to think MHRA has a much more objective and independent view of results aimed at better serving the interests of the great British public.
Two weeks ago Cytodyn announced it had reached enrolment of 293 patients in its Phase 3 trial for COVID-19 patients with severe-to-critical symptoms, thereby meeting the requested criteria for a second interim efficacy analysis (in two weeks) by the Data Safety Monitoring Committee (DSMC) within the FDA. Can I ask that you request a copy of Leronlimab’s results to review in confidence.
It is my understanding Cytodyne will be submitting its Biologics License Application (BLA) for Leronlimab as a combination therapy for multi-drug resistance HIV patients in the UK in the coming weeks.
I humbly beg, in the interests of the whole world, that you give CYTODYN’s Leronlimab drug EUA approval immediately.
Yours sincerely
Rock, Vitamin D consumption. I mentioned your prophylaxis comments about Vit D to a dietician friend. She commented on the huge dose of Vitamin D3 you recommend. The normal RDA for Vitamin D3 is 400i.u. daily.
She stated that this is a fat -soluble vitamin and so any excess that is not utilised by the body is deposited in the body and not excreted by the kidneys as are water-soluble vitamins. The result of overdosing on this vitamin is that you can develop renal stones because it enhances the absorption of any Calcium in your dietary intake.
She stated an increase possibly to 500iu per day would be a safe amount but no more.
Many thanks for all the great contributions you make on this board.
CORRUPTION - Here is an extract (in quotation marks) from the article Covid-19: politicisation, “corruption,” and suppression of science published in the Brit Med Journal on the 13 Nov ’20 Ref https://doi.org/10.1136/bmj.m4425
“Politicians and governments are suppressing science. They do so in the public interest, they say, to accelerate availability of diagnostics and treatments. They do so to support innovation, to bring products to market at unprecedented speed. Both of these reasons are partly plausible; the greatest deceptions are founded in a grain of truth. But the underlying behaviour is troubling.
Science is being suppressed for political and financial gain. Covid-19 has unleashed state corruption on a grand scale, and it is harmful to public health. Politicians and industry are responsible for this opportunistic embezzlement. So too are scientists and health experts. The pandemic has revealed how the medical-political complex can be manipulated in an emergency—a time when it is even more important to safeguard science.”
“Politicisation of science was enthusiastically deployed by some of history’s worst autocrats and dictators, and it is now regrettably commonplace in democracies. The medical-political complex tends towards suppression of science to aggrandise and enrich those in power. And, as the powerful become more successful, richer, and further intoxicated with power, the inconvenient truths of science are suppressed. When good science is suppressed, people die.”
Surely there must be some independent investigatory journalists out there who can expose these greedy murderous B’s. Come on BBC , we pay your wages so protect us! Start with something beginning with R, and use Leronlimab as an aggrieved party to support your case.