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Call for Humanity........
Call For Humanity......
Call For Humanity.....
This is a great Mantra/Mascot/Global Cry for Cytodyn/Leronlimab to adapt, to post everywhere on forums and to try to get some MOMENTUM to make the planet aware! Yes, Leronlimab saves lives, has saved many, can save many in the future. But imagine how manu lives would have been saved if the world had heard/responded to Dr Patterson's speech 2 years ago come April, and considering Leronlimabs 75 eIND results, saving the criticals.....etc., etc., etc.
Boom Boom Boom, Dr Homer Lim near minute 35 states this".....the biggest thing that really helped him......that shifted him to become really better was actually leronlimab ..... with just 2 injection of 700 mg, then you could see in 36 to 42 hours, then suddenly became better, and that is what happened....very consistent with everyone who was given leronlimab......it has saved so many lived......will improve survival of your patients".
The FDA maybe have actually been messing with the wrong dog here.
1) Because Leronlimab is such a "disruptive miraculous drug", it has attracted sophisticated investors, some investors that have a lot of money, doctors, business owners, seasoned market players. And these guys, many, have broken their personal rules for investing, by placing higher percentages of their portfolios into CYDY, than they've ever allowed themselves to do. Energy is building as forums (and discussions in homes) bring out facts and memories of attacks and as folks come out of denial as to their losses and months of anxiety and expectations.
2) the blatant corrupt action of the FDA today (bold lies) has not only shifted millions of dollars of wealth, some on paper, some actual cash, but also has created enormous action-provoking anger, folks are furious and determined for revenge and retribution. Some of our more sophisticated, educated, financially established investors besides being furious, have huge egos, many are determined to expose the FDA and are determined more than ever, to turn Cytodyn's one drug into a global disruptive grand success.
3) the blatant corrupt action of the FDA today brought many investors angrily over to the other side of the fence, now convinced beyond doubt, that the FDA has been involved in the plots to prevent Leronlimab's success. We want our investment money BACK.
4) It appears that American corporate and bureaucratic corruption by threats and pressure, have forced the FDA to cross a line into flagrant very risky recklessness such that all of this is very likely to be exposed resulting in possibly one of the biggest scandals in American history, because huge numbers of deaths will be considered as possilby having been avoidable.
5) another reason the FDA will probably not get away with this, is because they took the biggest swing at Leronlimab a little bit too late considering activities with Brazil, India and the Phiippines. These desperate countries need and want leronlimab, and they have no therapuetic for suffering, dying criticals. Even IV administered in-patient HGEN if approved, will help only moderate to severe, no criticals, who are the ones who die.
FACTUAL TRUTH:
CD10 displayed "Clinical Signficance" for its Primary Endpoint, and "Statistical Significance" for the Secondary Endpoint NEWS2.
FDA ARTICLE TODAY: (the opposite, why?)
In the smaller study that CytoDyn conducted in patients with mild-to-moderate COVID-19 disease (CD10), there was no observed effect of the drug on the study’s primary endpoint or on any of the secondary endpoints.
All CYDY discussion forums.....consensus mostly seems to be that this sp attack is the FDA's response to Leronlimab's disruptive potential as the miraculous new drug of the century, next to penicillin.
IMO most substantial things for this week for Leronlimab:
(I think any EUA anywhere, is on the back burner temporarily)
1) does the statement below imply that Mcleod may be able to get us some Compassionate Use Leronlimab into India soon & very soon?
Vijay Agarwal, tge Business Development Director at Macleods, commented, “We are thrilled with our recently executed exclusive supply and distribution agreement with CytoDyn. We believe there is an immediate need for leronlimab in our country, to save COVID-19 infected patients who are on ventilators. We need to bring this product to market ASAP for them!”
2) Nader did not say he would tell anyone right away, when our 1st order was received. In fact, he responded saying we can read about it in the next 10E or 8K or whatever that report filing is. Thus, an order may have already been received.
3) Where are results for shipments of Compassionate Use LL for 28 + 100 Criticals in the Philippines? Overdue? Not sure. Nader said they are waiting until all the 28 have been fully treated and evaluated. (and recovered & release from the hospital)
4) The green light for the Philippines, any hospital now can order LL for up to 100 patients, up to 400 vials per hospital. I'd say that tells us they must have seen some strong Compassionate Use responses. Nader said what he had heard so far about the Philippine 28 criticals is "very very strong" (not just very strong)
5) Brazil is so desperate, after they evaluate all the data we sent them, some folks expect an order from Brazil for Compassionate Use of leronlimab.
Vijay Agarwal, Business Development Director at Macleods, commented, “We are thrilled with our recently executed exclusive supply and distribution agreement with CytoDyn ( CYDY ). We believe there is an immediate need for leronlimab in our country, to save COVID-19 infected patients who are on ventilators. We need to bring this product to market ASAP for them!”
Brazil, India, Philippines, yes any of these countries may/will require a trial for approval, probably not the PHilippines, but that is not our immediate expectation for the next catalyts.
The next catalyst IMO, that we are looking for are any or all of these: 1) results on the Philippine 28 criticals Compassionate Use
2) an order from the Philippines for more Compassionate Use from any othe the 1000 Plus hospitals there that have been cleared to order enough Compassionate Use Leronlimab for 100 patients per hospital
3) Notice that Mcleaod has worked out Compassionate Use OK for India.
Is a Bounce Coming for CytoDyn Inc (OTCMKTS:CYDY)?
CYDY is trading below its 50-day and 200-day moving average price of $2.85 and $3.70 respectively. Watch for reversals at the following areas 2.84, 3.06, and 3.39 above and 2.51, 2.40, and 2.07 below.
Vijay Agarwal, Business Development Director at Macleods, commented, “We are thrilled with our recently executed exclusive supply and distribution agreement with CytoDyn. We believe there is an immediate need for leronlimab in our country, to save COVID-19 infected patients who are on ventilators. We need to bring this product to market ASAP for them!”
The stock needs to break past 3.00 to rally.
https://drpgazette.com/2021/05/15/is-a-bounce-coming-for-cytodyn-inc-otcmktscydy/
The immediate catalyst for Cytodyn's leronlimab will be Compassionate Use "RESULTS". All EUAs are on the back burner IMO, for later. Leronlimab has Compassionate Use granted for the Philippines and Leronlimab has been shipped free, enough for 128 critical patients there, 4 shots each. Further, road cleared for enough LL for 100 patients per every hospital in the country for Compassionate Use. Future Compassionate Use vials of Leronlimab for the Philippines will be sold. There have been questions about Cytodyn charging money for Compassionate Use vials, and Nader made it clear, yes, they cannot "market", "promote", nor "advertize" product without an EUA, but they can charge for the drug. So, Philippines is already rolling and we expect India to be receiving Compassionate Use Leronlimab very very soon, may be free, may be sold, don't know that yet. Either way, things are looking bright for Cytodyn.
No order yet "THIS WEEK" as Nader stated? We're not sure! He said we would not be told about it, that we could read about the order in the next 8E or 10A or whatever that report is.
Notice to non-believers, note that no reference is made in my comments above, about efficacy, recent trial results nor safety so please don't respond with claiming Leronlimab is not efficacious, please respond to topics in my comments.
Incredible. Unbelievable. Extreme. Obvious. Consistent. Predicable.
Leronlimab is actually just distilled water with a Multi-Vitamin Pill dissolved in it, right?
Interesting HGEN in their Primary Endpoint, they did not include any patients on ventilation or ECMO. They didn't think it would help them? Clever to design an easy to obtain PE. Truly the planet needs HGEN's drug and leronlimab and RLFTF if all are safe.
I thought that CSP Compassionate Use drugs yes, they cannot be marketed, meaning "marketing" eg promoted, advertised etc., but they can be sold for revenue.
Great new video Dr Jay Seeth...& Dr Lelezari..Leronlimab
So what will be the reaction be from "some" of our posters here?
These guys are not real doctors, they are hackers for hire?
These guys are drinking buddies, I saw them drunk at Hooters Monday?
These guys are paid pumpers, paid by Cytodyn?
These guys are loosers, they both been sued malpractive 10 times?
These guys are cherry picking data because they own CYDY stock?
These guys escaped from a mental institution, they were roommates?
https://www.questclinical.com/video-hope-for-critically-ill-covid-19
Snatched this off of reddit/CYDY: (is there going to be a trial in India?)
Nadar Says Macleods to Submit for EUA and Compassionate Use Authorization Immediately with India's CDSCO (their FDA)
Summary of Todays Proactive video on youtube:
Macleods reached out to Cytodyn
Cytodyn and Macleods closed a deal in 10 days (they had a WhatsApp group text!)
Macleods will take Cytodyn's Leronlimab data and submit to CDSCO for EUA and Compassionate Use Authorization Immediately
Cytodyn is requesting the EUA (through Macleods) concurrently while they begin a patient trial in India:
the CDSCO granted this for Tocilizumab while they ran a 30 patient trial
Cytodyn is doing the above (request an EUA while conducting a trial) with every country that is in covid trouble
Dr Kelly feels for the first time they have a supportive Board of Directors...
Best financial position they've ever been in
We have a global distribution network
We have the crucial regulatory piece
Not only are physicians embracing Leronlimab, but international pharmaceutical companies are embracing Cytodyn
Companies in the Philippines, Brazil, India, the U.K. and now Europe, are looking at our data, our safety, our manufacturing and they're understanding the pipeline of opportunities ahead of us...
Leronlimab works at the CCR5 receptor, so it won't be affected by any mutations in the spike protein.
As more covid variants continue to emerge this will put us in a unique position
Macleod can not distribute LL to all hospitals in India, but all over the world (140 different countries)
Nader and Kelly both feel they now have a perfect team in place
They are working to start a HIV Prep trial in Brazil
Leronlimab - The Little Drug That Could
I know, maybe you've seen this, but it is an important video and just only about 2 weeks old. Should be a permanent post at the top.
https://www.bing.com/videos/search?q=video+Breen+Leronlimab+the+little+drug+that+could&docid=607992138852016069&mid=9E8BDE57963A639BEFDB9E8BDE57963A639BEFDB&view=detail&FORM=VIRE
Nader is brilliant and has brought us this far from nothing and 50 cents per share. Nader is passionate yes about Leronlimab, that's good. He is aware of every detail about progress in each of the indications and in each of the past, present and upcoming trials. His timing interior clock is off, partially clouded by his enthusiasm and optimism. but I say let's keep him as Cytodyn shall be distributed across the planet giving relief and hope to suffering families, that is the most important thing, cure criticals, prevent death, why argue against a drug that has absolutely been proven to be the best drug to prevent death among critical covid patients?
Yes, Macleoads Came To Cytodyn, Pursued Us!
"We are thrilled with our recently executed exclusive supply and distribution agreement with CytoDyn. We believe there is an immediate need for leronlimab in our country, to save COVID-19 infected patients who are on ventilators. We need to bring this product to market ASAP for them!”
Todays news is a boom for all investors. CYDY deal with Macleods going to be a huge soon. WHO works with MCLEODS a lot in Mumbai, India. WHO already dealing with 60 prequalified drugs with MaCLEODS. CYDY will grow as a Big Pharma soon with India Deal. Stock might explode soon with this deal and upcoming approvals (CSP). This company located in Mumbai where COVID crisis going crazy right now (Maharashtra), CSP Approval on the corner for Leronlimab use.
India is another burner lit up on the stove top, not a Bait & Switch. Another burner with the greatest potential on earth for LL.
This is still "revenue week", the week has about 35% of the week remaining, plenty of time to announce revenue. Possibly revenue comes in this week, but we don't hear about right away. There is a lot going on with Cytodyn and Leronlimab. India PR is big news IMO and per the share price, the market seems to agree.
Compassionate Use In India could be immediate, and result in substantial shipments. India is beyond desperate. Let's pray LL gives give them relief and hope.
They approached us, not Cytodyn approaching them. A rather hugely significant detail.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn ( CYDY ), stated, “We are delighted Macleods Pharmaceuticals reached out to CytoDyn ( CYDY ) and equally excited to reach this agreement with their team so quickly. From the time they first contacted us about our drug, we were able to conclude this agreement within a few days. It is an honor to work with an organization so motivated to bring leronlimab to COVID-19 patients in India. Currently India has zero product approved for critically ill Covid-19 patients and we are delighted to be working toward being the first approved drug for this population.”
Midnight Rider wrote:
600 applications held up since 2014 ? Looks like those will benefit from anti red tape long before we do In Philippines
response:
the article said many of the 600 are merely "renewels" which can be quickly renewed.
the article said many of the 600 are old dating back to 2014 and can merely be thrown out, apps actually expired or drug no longer exists.
the article said there is now a type of "green" fast track for quicker approval of pandemic drugs.
wsbull wrote:
The relevance would be whether increased dosing would have continued the 14-day trend. Obviously it couldn't be used to justify an EUA yet because 28-day endpoints failed. The increased dosing theory requires a new trial of course
my response:
Ok, more data, another trial, but "may be effective and known to be safe" and m/m trial data and s/c trial data and antectodals and eIND data and massive pandemic death "do justify an EUA" and ok, get more data, but the trials should be Phase IV (no placebo).
Leronlimab eIND cases (and trials) provided compelling datathat LL brings recovery to criticals, and Dr Bruce Patterson said yes, they were giving third and some fourth doses to the criticals for eIND patients.
Good News from the Philippines....
FDA orders quick resolution of pending drug applications
(The Philippine Star ) - May 13, 2021 - 12:00am
MANILA, Philippines — The Food and Drug Administration (FDA) yesterday ordered the quick resolution of all pending applications filed by various pharmaceutical companies.
They created some type of "fast green lane" for quicker approval of pandemic drugs.
https://www.philstar.com/headlines/2021/05/13/2097942/fda-orders-quick-resolution-pending-drug-applications
Save the dying. Singular logic says save folks by preventing them from getting the virus, thus, vaccines, that is the logic nations are using, more vaccinations.
The smarter, more logical, informed strategy is a dual strategy to reduce deaths, prevent infections and "TREAT THOSE WHO ARE INFECTED WITH LERONLIMAB" It gets criticals off ECMO, off ventilation, prevents death.
JLA Ins wrote:
Short interest holding steady at 37 million and it comes at 13 days to cover... Days to cover have more than doubled now.
my response:
I don't understand. 37 million share are being held as Short.
And 13 days to cover, but all the Shorts did not come in short at the same time, so do you mean that each person who shorts, has 13 from their date when they shorted, to cover? Was there a recent change to how many days shorts have to cover? Or does it vary from time to time?
Order from the Philippines? Could it be in Cytodyn's hands presently?
Will Nader, must Nader put out a PR when order is received, "material info"?
EUA filed in the Philippines? Could it have already been filed....on Monday?
PR being prepared? To include data on the Manila28Criticals in Philippines?
Have talks with India progressed this week?
I suppose I'll send an email to Dr Kelly today?
Is it possible EUA does get filed this week, an order is received this week, and we anxious investors are not told this week about either one. No PR, no ProAcive Video, no youtube interview, no youtube video from Dr Nickolas of Philippines?
I watched live News TV on youtube, from the Philippines. Lots of news of the virus and vaccines, nothing about any treatments. I think they are getting a vaccine from China? Small % (10%?) of their citizens have been vaccinated.
The Hippocratic Oath begins, "First. . .do no harm."
The FDA has approved Covid-19 therapeutics that DO have harmful side effects.
The FDA is slow walking Leronlimab approval even though there is ZERO evidence of any harmful side effects.
Dear Mrs Covid Widow
Your husband who died of covid19, would have had approx an 80% chance of living, if he could have had access to a therapeutic called Leronlimab, by Cytodyn. The FDA asserts that a drug if proven safe, can obtain emergency use approval, if it "may be effective". There is no doubt according to formal clinical trials, and very limited compassionate and investigational use, that Leronlimab saves lives of critically ill covid19 patients, yet the FDA refuses to approve Leronlimab for general use and easy access, such as for you late husband. We are so sorry for your loss, which probably could have been prevented.
Nader yes, 2 felonies, can't confirm that he was "convicted". He unknowingly (maybe) sold some type of precious Indian jewelry. Also, the other involved a $100 check. Sorry.....no attempted murders nor armed bank robberies.
Will Cytodyn get an order from the Philippines this week and apply for EUA from the Philippines this week? Yes IMO, both this week. If not, that would be double extreme mistake by Nader, extreme error in judgement to have told us both would occur this week. And he was very specific: apply for the EUA today Monday and an order this week. Extremely risky if he was not 99% sure both would occur. The first order may be small, that's fine, but I do hope that he won't back-track on the EUA app and claim he meant that they would begin preparing the EUA today, that won't fly so well. I predict both fly, this week, long CYDY, let's get this thing going.
i don't think we need Philippine EUA to ship them a lot of Leronlimab. The green light to stock each hospital in the country (over 1000 of them) with enough leronlimab for 100 patients, was based upon Compassionate Use, thus no EUA needed. The 200,000 vials being held for the Philippines may be awaiting an EUA.
Lift Shirt - Jab Belly - Cured
Cytodyn To Apply for EUA in the Philippines
https://www.thechestnutpost.com/news/cytodyn-to-apply-eua-for-leronlimab-as-treatment-for-covid-19/
Institutional Compassionate Use Permit (ICUP) in the Philippines, yes.
So doctors do not have to apply for permission for each patient to get LL under their Compassionate Use program.
The entire hospital has permission to give leronlimab to patients.
Each hospital will eventually have LL in stock enough for 100 patients.
This is virtually about equal to an EUA.
EUA is given to all doctors and hospitals in the entire country.
Once all the hospitals have ICUP, basically the entire nation can use LL, like an EUA
My understanding was that one of the trials would be criticals only.
However, IMO, waiting until August or October for the Brazil results don't seem to be where our focus should be right now. Our focus should be on the Philippines who are presently treating critical patients with leronlimab and there is nearly no wait for results. We will probably hear a lot about results Sunday on Philippines broadcast.
Hey Grip it and Sip It....
Guessing you have missed some of the"recent info" where Dr Nickolas of the Philippines recently stated that responses from critical patients in the Philippines who have been given leronlimab, have been "dramatic" (his exact words). He said it's more than 28 criticals.
And CEO Nader also said on the recent Conf Call that that these Philippine results are "very very strong" (his exact words).
Glad to help with your keeping up with the latest.
Also, don't miss the Philippine interview this Sunday, it will help you to gain an accurate perspective on leronlimab's progress & future.
Very sorry DonDonDonDon. But "a lie"? Isn't that kind of harsh?
I stated this stat incorrectly.
Leronlimab reduced deaths 82% at 14 days, vs SOC death reduction.
That's quite a powerful stat, correct, surely you do agree?
And this was very important information, it told us that critical patients need a 3rd and probably a 4th dose, so the CD16 trial protocol can be designed better than the CD12 trial, correct?
What will be the response of our FDA after the Sunday Philippine TV Station's broadcast touting leronlimab (webcast I suppose)?
What will be the response of our FDA after the Philippines tells the world that a wonderful drug, Leronlimab, is saving the lives of 82% of their critical cv19 patients, JUST LIKE AT DAY 14 IN Cytodyn's S/C Trial?
Dr Nader P says the FDA is fabulous, cooperative, helpful, correct in all their decisions. Some folks say the FDA is corrupt.... IMO, it's one of these options, and there ain't no other options....
the FDA is
Corrupt / Corruptible or
Greatly influenced by BigPharma or
Extremely Incompetent & Cowardice
Let's imagine a gathering of 100 families who lost a father or a mother to covid-19. After giving them a thorough education about Leronlimab's history, starting with Dr Patterson's Ted Talk and our early 2020 eIND compelling results, the m/m trial data and s/c trial data, all antecdotal data, then ask them what they think about our FDA, the Global Gold Standard of Drug Approval Agencies?
The TV5 Interview will be very bullish indeed. Overdue!
So what is going to happen when great results come out on the 28 criticals in the Philippines? Nader said that so far, the results are "very very strong" (his exact words). He said they will report on the 28 criticals when they have data on all of them.
The topic of the 28 criticals will surely come up on the TV interview with Nader & Dr Nickolas this Saturday.
Dr Nickolas of the Philippines stated about 10 days ago that the results with Leronlimab in the Philippines have been "dramatic" (his exact wording). Hey non believers, will you claim he is lying?
Dr NIckolas should/will have even more to add on Saturday on these 28. So is our FDA just going to sit quietly in their dark hollow office, as the Philippines describes how wonderful Leronlimab is, and how it is saving lives in the Philippines, getting criticals off ventilators, opening up urgently needed beds in hospitals???
Would it shock us if the interview was mysteriously cancelled......... permanently?