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***OFFICIAL CYDY/Leronlimab Thread*** (2 Viewers)

Charlie Harper said:
These are the results from Remdesivir study. THIS IS THE CURRENT STANDARD OF CARE!!! Does anything in there sound better than LL?

CYDY has proven it decreases SAEs and actually has a statistically significant NEWS2 improvement. The drug works better than Remdesivir. It just needs press and traction. 

#notselling
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This is it to me.  It is unimaginable to me that FDA doesn't allow immediate use (and require continue to phase 3).  But this is CYDY so that is what I expect.

I'll likely buy back today some of my shares that I sold off last week, was hoping for more of a pullback.

 
Charlie Harper said:
Adverse events were reported in 102 (66%) of 155 remdesivir recipients versus 50 (64%) of 78 placebo recipients. Remdesivir was stopped early because of adverse events in 18 (12%) patients versus four (5%) patients who stopped placebo early.
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:shock:   WOW :shock:  

Those seem like pretty terrible results of the study.  LL to the rescue!!!!

 
Charlie Harper said:
RESULTS
A total of 1063 patients underwent randomization. The data and safety monitoring board recommended early unblinding of the results on the basis of findings from an analysis that showed shortened time to recovery in the remdesivir group. Preliminary results from the 1059 patients (538 assigned to remdesivir and 521 to placebo) with data available after randomization indicated that those who received remdesivir had a median recovery time of 11 days (95% confidence interval [CI], 9 to 12), as compared with 15 days (95% CI, 13 to 19) in those who received placebo (rate ratio for recovery, 1.32; 95% CI, 1.12 to 1.55; P<0.001). The Kaplan-Meier estimates of mortality by 14 days were 7.1% with remdesivir and 11.9% with placebo (hazard ratio for death, 0.70; 95% CI, 0.47 to 1.04). Serious adverse events were reported for 114 of the 541 patients in the remdesivir group who underwent randomization (21.1%) and 141 of the 522 patients in the placebo group who underwent randomization (27.0%).

CONCLUSIONS
Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTT-1 ClinicalTrials.gov number, NCT04280705. opens in new tab.)
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I thought the first study I quoted was the one that got Remdesivir approved. To be fair this is actually the study that gained it approval and also had the endpoints changed. 

Remdesivir did have lower SAEs but likely not statistically significant because Rem:placebo was almost equal. 

Either way you still can't ignore the other study. 

 
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Charlie Harper said:
I thought the first study I quoted was the one that got Remdesivir approved. To be fair this is actually the study that gained it approval and also had the endpoints changed other study that had the endpoints changed. 

Remdesivir did have lower SAEs but likely not statistically significant because Rem:placebo was almost equal. 

Either way you still can't ignore the other study. 
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It is amazing when you look at the drug that is the standard of care in the US. Then that tocilzimulab (I know that’s wrong) failed to show any efficacy. I really hope the FDA moves forward because it’s scary what’s out there. The president praising a doctor touting hydroxychloronique because we bought a lot and she’s a conspiracy quack too.

Still losing a lot of real people every day. So sad.

 
Charlie Harper said:
I thought the first study I quoted was the one that got Remdesivir approved. To be fair this is actually the study that gained it approval and also had the endpoints changed other study that had the endpoints changed. 

Remdesivir did have lower SAEs but likely not statistically significant because Rem:placebo was almost equal. 

Either way you still can't ignore the other study. 
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Not only did they get approval, they stopped the trial early because it was so good!?!

 
Chaz McNulty said:
Not only did they get approval, they stopped the trial early because it was so good!?!
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Yup. How the FDA handles CYDY can confirm (again) just how deep corporations have control over government. 

Just thought it would be reassuring for people to see what type of results LL needs to get FDA approval. 

#notselling

 
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Dwayne Hoover said:
If you look at twitter, you've got all the usual suspects on the short side calling it a failure vs the same on the CYDY side saying success.  

Its going to take some outside experts who like the results to move this stock positively. Until then, I do think the shorts will largely control this narrative.  There are enough speculators in this stock that are gonna bail.

SP up a little, hope Im wrong but not sure how long this holds until we get some outside confirmation.  I'm holding strong for now.
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It's good enough for outside experts to be optimistic, but I think it'll take preliminary findings from the S/C trial to really break through to the outside in a huge way.  If the results for s/c are as safe and show efficacy, then it will gain more of an audience.

That leronlimab showed statistically significant improvements for the m/m population is quite encouraging that we'll see significant changes in the s/c population as well, with a higher patient enrollment, leading to more robust statistical results (hopefully in favor of the drug).

 
You can believe that CYDY will get held back due to Big Pharma and you can definitely doubt CYDY leadership, but the science is there. 

They might be able to ignore m/m, but IF S/C hits they can't ignore LL anymore. The interim analysis will be HUGE!

I do question why CYDY doesn't just head to the steps of the White House and hold a press conference like the demon sperm MD. It maybe beneath a big corp, but CYDY needs to stop preaching to the choir.

 
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I kinda just wish they’d get bought out at this point? At least for covid, and to get a real mouthpiece in there. 

 
Otis said:
I don't know if they're true.  Everyone seems to be assuming it.  

And I was told there'd be riches. :shrug:
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There are riches for those who bought in @$0.30.  And I did tag you but using your supremely superior judgement, you chose not to buy.  How about you play a game where you do the opposite of what you think is correct for the next week.  For this opposite game to work, it must only be for decisions where you're truly on the fence and you must devote some serious thinking to deciding what you should do.  When you've made up your mind, do the opposite and report back here.  When you see that you're better off ignoring your judgement in difficult situations, you can move to doing the opposite when you think the decision is a slam dunk.  HTH

 
Charlie Harper said:
I thought the first study I quoted was the one that got Remdesivir approved. To be fair this is actually the study that gained it approval and also had the endpoints changed. 

Remdesivir did have lower SAEs but likely not statistically significant because Rem:placebo was almost equal. 

Either way you still can't ignore the other study. 
Click to expand...
Do you know Charlie if these populations were M-M or S-C?

 
djmich said:
Do you know Charlie if these populations were M-M or S-C?
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Not sure. Here's the first population where the study was stopped early due to SAEs. We have patients in med-surg (non-ICU) with Sp 02 < 94% all the time.

Charlie Harper said:
Methods We did a randomised, double-blind, placebo-controlled, multicentre trial at ten hospitals in Hubei, China. 
Eligible patients were adults (aged ≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection, 
with an interval from symptom onset to enrolment of 12 days or less, oxygen saturation of 94% or less on room air 
or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mm Hg or less, and radiologically 
confirmed pneumonia
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Here's the population from the study where it got approved.

Charlie Harper said:
METHODS
We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement. 
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So seems like the first group maybe a bit worse off since sp02 < 94%. Doesn't mean though the second group didn't have low oxygenation levels. 

Not sure what they're using as parameters for m/m and s/c. Sorry. In my mind m/m med-surg level and s/c needs ICU, but that's as a nurse and not researcher.

 
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I think the challenge here is what is the significant differentiating factor in LL results vs this Rem study that would justify immediate approval (better than current SOC).

That p value is pretty sick.

SAE's also reduced by Rem.

 1 hour ago, Charlie Harper said:

RESULTS
A total of 1063 patients underwent randomization. The data and safety monitoring board recommended early unblinding of the results on the basis of findings from an analysis that showed shortened time to recovery in the remdesivir group. Preliminary results from the 1059 patients (538 assigned to remdesivir and 521 to placebo) with data available after randomization indicated that those who received remdesivir had a median recovery time of 11 days (95% confidence interval [CI], 9 to 12), as compared with 15 days (95% CI, 13 to 19) in those who received placebo (rate ratio for recovery, 1.32; 95% CI, 1.12 to 1.55; P<0.001). The Kaplan-Meier estimates of mortality by 14 days were 7.1% with remdesivir and 11.9% with placebo (hazard ratio for death, 0.70; 95% CI, 0.47 to 1.04). Serious adverse events were reported for 114 of the 541 patients in the remdesivir group who underwent randomization (21.1%) and 141 of the 522 patients in the placebo group who underwent randomization (27.0%).

 
Found this digging through the supplement data:

Charlie Harper said:
Severe disease 

was defined as participants meeting one or more of the following criteria: requiring invasive or 
non-invasive mechanical ventilation, requiring supplemental oxygen, an SpO2 ≤ 94% on room air, 
or tachypnea (respiratory rate ≥ 24 breaths per minute).

Mild / moderate disease was defined by a SpO2 > 94% and respiratory rate < 24 breaths per minute without supplemental oxygen requirement.

The definition of the two categories of disease severity were chosen to generally align with the two separate remdesivir studies being developed for implementation in Wuhan, China to facilitate comparability of results (NCT04252664, and NCT04257656 (1)).
Click to expand...
So using the study definition both are "severe" population. In the 2nd approval study only 120/1063 were "mild" and only 63 of mild received Remdesivir and 57 received placebo.

Looks LL used similar definition for mild to moderate.

Seeing this "loose" definition of "severe" gives me even more hope for LL if the anecdotal evidence is to believed.

 
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djmich said:
I think the challenge here is what is the significant differentiating factor in LL results vs this Rem study that would justify immediate approval (better than current SOC).

That p value is pretty sick.

SAE's also reduced by Rem.
Click to expand...
The p-value is good. 

LL could potentially get people out sooner if patients show improvement by Day 3, but we don't have full recovery time data to see if it beats Rems LL days. However, judging from how CYDY dealt with info release it's probably same, worse, or not statically significant. 

Remdisivir did decrease SAEs but I don't think it's statically significant because the population groups were practically 1:1. In the study that was stopped early due to SAE, Rem was given in 2:1 vs placebo. LL showed DECREASED SAEs in 2:1 vs placebo. So Remdisvir at BEST is safe, at WORST unsafe. LL at BEST decrease SAE, at WORST safe.

 
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Remdesivir has EUA for what is considered the severe population

from the FDA https://www.fda.gov/media/137574/download

Q. What does this EUA allow?

A. The EUA allows remdesivir, manufactured by Gilead, to be distributed and used by licensed health care providers to treat adults and children hospitalized with severe COVID-19. Severe COVID-19 is defined as patients with an oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO), a heart-lung bypass machine.

 
Dr. Yo touting Aviptadil (RLTFT) today.  Somewhat interesting, Dr. Drew (with 2.7M followers), chose to retweet Dr. Yo's tweet regarding RLTFT with "This is great news!".  

Went back and did not see anything on Dr. Drew regarding Leronlimab.  

 
Capella said:
“The problem we have is the investors don’t understand the great results” 

THAT IS YOUR GOD #### JOB TO MAKE THEM UNDERSTAND 
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Disagree. His job is to get the FDA to understand. If he can do that then he’s done his job and the stock price will follow. Feels like they’ve spent way too much time worried about shorts and stock price. Stock price only matters if it’s not high enough to uplist.

 
Charlie Harper said:
Found this digging through the supplement data:

So using the study definition both are "severe" population. In the 2nd approval study only 120/1063 were "mild" and only 63 of mild received Remdesivir and 57 received placebo.

Looks LL used similar definition for mild to moderate.

Seeing this "loose" definition of "severe" gives me even more hope for LL if the anecdotal evidence is to believed.
Click to expand...
Agree, thanks.

 
Hope I'm not chasing right now but just added more shares.  Definitely will unload some of what I have with a modest increase but planning to keep majority at least through the results of the severe critical trial.

I believe the worm will turn in our favor

 
"We are filing with UK, EU, Mexico and Israel.  They wanted to see the data and we are going to go forward with all of it."  

First time Israel has been talked about and nice to see that Mexico wants to see data.  

 
stbugs said:
Disagree. His job is to get the FDA to understand. If he can do that then he’s done his job and the stock price will follow. Feels like they’ve spent way too much time worried about shorts and stock price. Stock price only matters if it’s not high enough to uplist.
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You don’t think part of the CEO’s job is making sure the press release is easy to digest for the common investor? 
 

I mean, a competent CEO could do both. 

 
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DISSECTING CLINICALLY SIGNIFICANT DATA

Lerononlimab did not meet its primary endpoint but appeared to get really close, close enough for them to call it clinically significant. So the question that should be asked is “why did that happen?”  It really boils down to the definition of the endpoint.  They were measuring the clinical symptom score which includes fever, myalgia, dyspnea and cough.  Many people in the trial just weren’t that sick which is why their press release stated

“The subgroup analysis indicates that among patients with more symptoms at baseline, those who received leronlimab had a greater treatment effect than patients who received the placebo.”                          

What this means is that leronlimab only seems to work on sicker patients experiencing the cytokine storm.  This is completely in line of the mechanism of action that CCR5 inhibition stops the trafficking of macrophages and their release of cytokines.   
Click to expand...


This drug isn’t a one trick pony and the NEWS2 endpoint was developed by the Royal College of Physicians in England.  So the likelihood of approval in England is quite high because this is the first trial to have statistically significant efficacy data and uses their own scoring system.  It is important to note that no other trial in mild to moderate COVID-19 patients anywhere in the world has reported any efficacy. 
Click to expand...
:shrug:

 
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Jayrok said:
DISSECTING CLINICALLY SIGNIFICANT DATA

Lerononlimab did not meet its primary endpoint but appeared to get really close, close enough for them to call it clinically significant. So the question that should be asked is “why did that happen?”  It really boils down to the definition of the endpoint.  They were measuring the clinical symptom score which includes fever, myalgia, dyspnea and cough.  Many people in the trial just weren’t that sick which is why their press release stated

“The subgroup analysis indicates that among patients with more symptoms at baseline, those who received leronlimab had a greater treatment effect than patients who received the placebo.”                          

What this means is that leronlimab only seems to work on sicker patients experiencing the cytokine storm.  This is completely in line of the mechanism of action that CCR5 inhibition stops the trafficking of macrophages and their release of cytokines.   
Click to expand...


This drug isn’t a one trick pony and the NEWS2 endpoint was developed by the Royal College of Physicians in England.  So the likelihood of approval in England is quite high because this is the first trial to have statistically significant efficacy data and uses their own scoring system.  It is important to note that no other trial in mild to moderate COVID-19 patients anywhere in the world has reported any efficacy. 
Click to expand...
Click to expand...
This is where I am sitting with the data.

Before, the drug was just potential.  Now, they're sitting on best-in-world results, but are a no-name company, in an OTC market, with 10 people, and a host of online trolls calling them frauds.  But the data is there, and if they're not committing gross fraud by misrepresenting the results, the above analysis is spot on. 

It leaves out, however, that the small sample size of the study left the ability to achieve statistical significance for the primary endpoint a very very high mark...but even then, they achieved "clinical significance" which implies that in a further study with more patients who more closely fit the folks most likely to be helped (moderate to critical patients), then you'd achieve statistical significance.

 
INVESTMENT SUMMARY

Investors need to wake up and recognize the STAT is selling a message of Fear Uncertainty and Doubt (FUD).  STAT is the epitome of fake news reporting.  They lied and said CytoDyn failed the phase 2 trial yet CytoDyn presented statistical significance in their secondary endpoint of NEWS2.  Perhaps STAT should think about doing more than 8 minutes of due diligence before they comment in the future, but investors need to do their part and stop reacting to it.  This pounding the stock has taken for being the first in COVID-19 to hit their endpoint has completely derisked the stock.  There is little to no downside left, and much upside on what amounts to an approval that is probable.  The stock should currently be at new heights but wont get there until investors digest that they have been conned by Feuerstein.  

The company is planning a conference call after the bell that may reveal more of its plan for uplisting which could be a major catalyst by bringing in institutional holders.  The CD12 severe to critical trial is also fast approaching their interim recruitment level of 195 patients, but the truth unfolding is the data is so good on the CD10 mild to moderate trial that the drug may be approved before the readout is done.  The political threat of foreign approval to the Trump administration and pressure to find something in the USA that works may finally work its way to the oval office or national news.  When the foreign countries like the United Kingdom look at approving the drug they first look at safety and then would be looking at clearly defined efficacy in the endpoint that they developed with a (p < .02).  Investors duped into believing this was a failed trial may be waking up in the near future to a UK approval and wonder what happened. 
Click to expand...

 
chet said:
Is it a real article?  I think it was written by someone who's long and if so, doesn't have much credibility IMO.
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:shrug: Chris Sandburg.  He probably is long.  The editor of the site has a disclaimer at the bottom that they have no position in stocks they report on.  

I'm sure the office of Dr. Fauci isn't going to see/read it or the white house.  But either way, the contents are encouraging to me and do not seem "made up" just to try and pump the SP.  

 
adonis said:
The author has more than 1 article, although several seem approving of Cytodyn.  I don't think it can be dismissed as the analysis (minus the trump stuff) seems reasonable.

https://insiderfinancial.com/author/chris-sandburg/
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Jayrok said:
:shrug: Chris Sandburg.  He probably is long.  The editor of the site has a disclaimer at the bottom that they have no position in stocks they report on.  

I'm sure the office of Dr. Fauci isn't going to see/read it or the white house.  But either way, the contents are encouraging to me and do not seem "made up" just to try and pump the SP.  
Click to expand...
My bad.  I stand corrected.

 
In the video he is asking callers to be prepared to ask questions that involve the press release that was put out so they can spend the time explaining the contents specifically.

Might be why the video was released this afternoon right before the call.  While it's nice to hear about uncles/siblings who would like to be involved in future trials, etc., they seem to want to limit the questions specifically to current pressing company activities.  Uplisting, trials, etc.  

 
Jayrok said:
:shrug: Chris Sandburg.  He probably is long.  The editor of the site has a disclaimer at the bottom that they have no position in stocks they report on.  

I'm sure the office of Dr. Fauci isn't going to see/read it or the white house.  But either way, the contents are encouraging to me and do not seem "made up" just to try and pump the SP.  
Click to expand...
The company doesn't have positions, but it said the individual author may have a long or short position.

Disclosure: Insider Financial and its owners do not have a position in the stocks posted and have posted this article for free without editorial input. This article was written by a guest contributor and solely reflects his opinions. The author may hold either long or short positions in the securities discussed.
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Chet is right to be skeptical, and to carefully vet his claims because he's likely long (considering about half of his articles over the year have been glowing about Cytodyn) but that doesn't mean his analyses are wrong.

 
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