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***OFFICIAL CYDY/Leronlimab Thread*** (3 Viewers)

chet said:
I just got out of a meeting with guys who are much more in the know than me and some agreed with you about the sample size.  My point is that statistically significant is just that regardless of whether you have 60 patients or 6000.  I think the difference in mortality between drug and placebo was so great that the FDA can't ignore it especially with nothing else working for criticals.  The FDA can give a restricted EUA and monitor is closely to ensure the new patients are getting better and if they aren't, they can pull the EUA.  The drug is safe so they don't have to worry about harming anyone.  Just my $0.02.
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The only issue I have with this is that the 60 becomes single digits when you toss out everyone 65 and older.  At that point the outcome of one person can swing results 10-20%

 
Capella said:
Analysis is now predicted to be much higher than first suggested..... what does that even mean? 
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I don’t religiously follow it over there or post, I just periodically check in, but from my understanding he does, or is part of a group who does, stock analysis.  He referring to his/his groups analysis of the stock potential.  

 
CYDY and it's community are amazing.  Getting bought up again when an approval is still a long shot.  Meanwhile HGEN languishes, no one cares about this stock at all.

 
Dwayne Hoover said:
CYDY and it's community are amazing.  Getting bought up again when an approval is still a long shot.  Meanwhile HGEN languishes, no one cares about this stock at all.
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Bought a bunch of Hgen again this morning. Not guaranteed approval but as close as you can get. Easy decision. 

 
Dwayne Hoover said:
At least it makes for some great trading opportunities on CYDY, it seems like it will have countless lives at this point.

You can have an absolute imbecile at the helm and the community doesn't care at all.  Lies don't even phase people.
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I remember saying this the day after the poor results. It was a hold for me because of how strong the community was. 

 
Dwayne Hoover said:
At least it makes for some great trading opportunities on CYDY, it seems like it will have countless lives at this point.

You can have an absolute imbecile at the helm and the community doesn't care at all.  Lies don't even phase people.
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Even though management's a complete disaster, the drug works, and it appears it works spectacularly well.  One way or another, management will get sorted and the world will benefit from LL.

 
And now hard melt down

Edit: too soon, it is doing fine. That 52 week high of $10.01 always taunts me.

 
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chet said:
Even though management's a complete disaster, the drug works, and it appears it works spectacularly well.  One way or another, management will get sorted and the world will benefit from LL.
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I'm not ready to say "spectacular" yet.  They may have found a niche for it for Covid but it needs to be proven out better.  Slicing the results for small populations, not all of them were positive.

 
Dwayne Hoover said:
I'm not ready to say "spectacular" yet.  They may have found a niche for it for Covid but it needs to be proven out better.  Slicing the results for small populations, not all of them were positive.
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If you're quoting Paulo Santos' article, then you should know he's been outed as a member of the #shortmafia.  Maybe that's ok with you, but they have no credibility with me as they have been shown to distort and lie.  They are not objective in any way. 

 
chet said:
If you're quoting Paulo Santos' article, then you should know he's been outed as a member of the #shortmafia.  Maybe that's ok with you, but they have no credibility with me as they have been shown to distort and lie.  They are not objective in any way. 
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Common sense tells you that when a football team finishes 9-7 but brags about going 5-1 in their division that they were 4-6 outside of the division.  

 
chet said:
If you're quoting Paulo Santos' article, then you should know he's been outed as a member of the #shortmafia.  Maybe that's ok with you, but they have no credibility with me as they have been shown to distort and lie.  They are not objective in any way. 
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Felt like there was still a point there, the numbers are what they are.  

 
Dwayne Hoover said:
Felt like there was still a point there, the numbers are what they are.  
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There's no attempt by him or any of the other members to be objective.  They are actively lying to you and actively trying to mislead you.  Why would you believe anything any of them say?

 
chet said:
There's no attempt by him or any of the other members to be objective.  They are actively lying to you and actively trying to mislead you.  Why would you believe anything any of them say?
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Well all that matters is what the FDA thinks and my perception of that is where Im aligning.

I'm having a hard time believing that the FDA will approve on an underpowered population of patients.  I don't disagree with you at all that the numbers for this small population look really good and I think they will be asked to prove it out in a bigger trial.  

If that does happen, this is heading back to $2.20 range (if not a lot lower) in the interim as it will take months.  Since it's what I believe right now, i  really cant justify buying it at this price.

 
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chet said:
There's no attempt by him or any of the other members to be objective.  They are actively lying to you and actively trying to mislead you.  Why would you believe anything any of them say?
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The only problem is that Cytodyn management is also trying to do the same thing (maybe not lying, but definitely misleading).  I wish they would release all the data so we can view it for ourselves.

My issue with their new data is that any company can pick a random time frame to tout their drug.  If at 3 days out their were 2 deaths in the placebo and 2 deaths in LL (on a 2-1 trial), the company can say they reduce death by 50% at the 3 day mark.

 
Dwayne Hoover said:
Well all that matters is what the FDA thinks and my perception of that is where Im aligning.

I'm having a hard time believing that the FDA will approve on an underpowered population of patients.  I don't disagree with you at all that the numbers for this small population look really good and I think they will be asked to prove it out in a bigger trial.  

If that does happen, this is heading back to $2.20 range in the interim as it will take months.  Since it's what I believe right now, i  really cant justify buying it at this price.
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This is a well thought out argument.  I don't agree with some/most of it but I cannot say it won't happen.  

 
Chaz McNulty said:
The only problem is that Cytodyn management is also trying to do the same thing (maybe not lying, but definitely misleading).  I wish they would release all the data so we can view it for ourselves.

My issue with their new data is that any company can pick a random time frame to tout their drug.  If at 3 days out their were 2 deaths in the placebo and 2 deaths in LL (on a 2-1 trial), the company can say they reduce death by 50% at the 3 day mark.
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Yes, management's credibility is an issue.  However, what happened in this case is perfectly clear to me and the results make perfect sense.  

 
Chaz McNulty said:
The only problem is that Cytodyn management is also trying to do the same thing (maybe not lying, but definitely misleading).  I wish they would release all the data so we can view it for ourselves.

My issue with their new data is that any company can pick a random time frame to tout their drug.  If at 3 days out their were 2 deaths in the placebo and 2 deaths in LL (on a 2-1 trial), the company can say they reduce death by 50% at the 3 day mark.
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14-day mortality was a secondary endpoint so it’s not random. What we have here is a poorly designed trial. Poorly designed because of incompetent management and also because so little was known back in March / April. 

I am confident that this trial would be overwhelmingly successful with the benefit of hindsight and competent design. That tells me the drug works. Should the FDA deprive the country and the world of something that works because a couple of clowns don’t know what they’re doing?  
 

 
chet said:
14-day mortality was a secondary endpoint so it’s not random. What we have here is a poorly designed trial. Poorly designed because of incompetent management and also because so little was known back in March / April. 

I am confident that this trial would be overwhelmingly successful with the benefit of hindsight and competent design. That tells me the drug works. Should the FDA deprive the country and the world of something that works because a couple of clowns don’t know what they’re doing?  
 
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The 14 day endpoint was a secondary endpoint for the entire trial (not just the 62 in critical).

I agree that this is probably better than anything out there for critical.  And with no side effects.  But until they can properly set up a trial, it will be tough to get an EUA.  In their 2 Covid trials they have done so far, have they met any endpoint (primary or secondary)?

I just look at the FDA and wonder why they would grant an EUA for Leronlimab.  They don't take anything on faith, and saying "it works" is not a good enough standard to them.

 
Chaz McNulty said:
The 14 day endpoint was a secondary endpoint for the entire trial (not just the 62 in critical).

I agree that this is probably better than anything out there for critical.  And with no side effects.  But until they can properly set up a trial, it will be tough to get an EUA.  In their 2 Covid trials they have done so far, have they met any endpoint (primary or secondary)?

I just look at the FDA and wonder why they would grant an EUA for Leronlimab.  They don't take anything on faith, and saying "it works" is not a good enough standard to them.
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Because it’s a global pandemic unlike anything we’ve ever seen, we know the drug is safe, and it might work, or at least works as well as the garbage they approved last year. 

 
Capella said:
Because it’s a global pandemic unlike anything we’ve ever seen, we know the drug is safe, and it might work, or at least works as well as the garbage they approved last year. 
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They have probably known this for 6 months.  Do you think their position with the FDA is better now or before the last trial ended?

From what NP has said, it sounds like the FDA directed them to do another trial (and not to submit for an EUA).  I'm happy that they decided to submit for an EUA anyways, but I still think it's unlikely for the FDA to approve.  Even if the FDA is proven wrong on this, they can point to the trial and say we have never granted an EUA when all the endpoints have been missed.

I am invested in this stock, but I believe we are waiting for the completion of one more trial before we hear good news.

 
Chaz McNulty said:
The 14 day endpoint was a secondary endpoint for the entire trial (not just the 62 in critical).

I agree that this is probably better than anything out there for critical.  And with no side effects.  But until they can properly set up a trial, it will be tough to get an EUA.  In their 2 Covid trials they have done so far, have they met any endpoint (primary or secondary)?

I just look at the FDA and wonder why they would grant an EUA for Leronlimab.  They don't take anything on faith, and saying "it works" is not a good enough standard to them.
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Ummm... critical under the age of 65 which is typically less than 20% of the population. I don’t know that to be the case here, but you could be talking n=12. Which would mean 8 getting LL and 4 getting placebo. Cydy also indicated they got the short end of the stick on the under 65 so it could be 6 and 6. How does the fda approved based on a positive results for a 12 person study where only 6 received the drug?

 
BassNBrew said:
Ummm... critical under the age of 65 which is typically less than 20% of the population. I don’t know that to be the case here, but you could be talking n=12. Which would mean 8 getting LL and 4 getting placebo. Cydy also indicated they got the short end of the stick on the under 65 so it could be 6 and 6. How does the fda approved based on a positive results for a 12 person study where only 6 received the drug?
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Umm no.  There were 62 people in the group that showed 82% less mortality and a p-value of .0233.

 
BassNBrew said:
Ummm... critical under the age of 65 which is typically less than 20% of the population. I don’t know that to be the case here, but you could be talking n=12. Which would mean 8 getting LL and 4 getting placebo. Cydy also indicated they got the short end of the stick on the under 65 so it could be 6 and 6. How does the fda approved based on a positive results for a 12 person study where only 6 received the drug?
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They had an N=62 value for this.

 
chet said:
If you really believe this, then you need to re-read the PR.
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The PR was good news, does it get them over the hump for approval in a month or so, that's where we all disagree.

If you dont think it does, then the sharp move upward yesterday (which is already coming back) would seem like fool's gold.

On the other hand, if approval comes soon, those of us on the sidelines are gonna wish we bought today in the $2.60 range.

My number right now is the $1.60 range so will see if we get there or not but not in a hurry to buy at this point.  Cautiously skeptical

 
Capella said:
I’ve said this before but this stock isn’t going to 1.60. The cult is too strong. 
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Intraday on November 10th it got into the $1.60 range so certainly possible.

It may take a bit, but a couple of months of going nowhere, people get impatient.  If the HIV BLA was close to being done, then maybe not, but that thing still languishing and Covid potentially not being close, I think it gets there.

 
chet said:
Umm no.  There were 62 people in the group that showed 82% less mortality and a p-value of .0233.
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Length in hospital stay decreased by 5.5 days in the critically ill population (N=62, p=.005).

A clear trend toward mortality benefit at day 28 with an absolute risk reduction of death of 20.9% and a relative risk reduction of death of 73% when leronlimab was used in addition to “commonly used COVID-19 treatments”

in the critically ill population with an age ≤ 65 years old.
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A clear trend toward mortality benefit at day 28 with an absolute risk reduction of death of 16.3% and a relative risk reduction of death of 73.5% when leronlimab was used in addition to dexamethasone in the critically ill population ≤ 65 years old. 
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Looks like you are correct on the day 14 number.  Something doesn't add up.  LL must for great for 14 days then kill off older people in droves between 14-28 days.  Makes sense if they discontinued use....but who discontinues use of something that is working?

 
BassNBrew said:
Looks like you are correct on the day 14 number.  Something doesn't add up.  LL must for great for 14 days then kill off older people in droves between 14-28 days.  Makes sense if they discontinued use....but who discontinues use of something that is working?
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They did continue use at day 7 and apparently, the FDA denied their request to inject patients at days 14 and 21.

 
It adds up if you consider a drug half-life of 10 days and only 2 doses given. Imagine what could have happened if they were able to provide more at 14 and 21 days. Then consider what an initial dose given via IV would have done. The one thing it does almost conclusively prove is that LL works for Covid. For those of us hanging on to our shares I think it might be the one thing that convinces the FDA to change their direction from further trials to EUA. Also from what I've read and heard it was the FDA that decided not to have additional dosings. Next couple of weeks should be interesting.

 
chet said:
There's no attempt by him or any of the other members to be objective.  They are actively lying to you and actively trying to mislead you.  Why would you believe anything any of them say?
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You don't need to read #shortmafia to interpret the data that CYDY has cherry picked to give us. Bass, DH, and others can simply look at the fact that CYDY FAILED it's primary endpoint in a 300+ person trial. 

THIS IS A FACT.

Don't need short mafia to convince us. 

I'll take the results of a randomized 300+ sample vs the results of a cherry picked data set from CYDY. 

I get it you believe in CYDY, but it is annoying that you assume everyone who disagrees with the trial data is just listening to "short mafia" and isn't smart enough to interpret the factual data on their own.

 
Capella said:
Lol their headlines are just the entire press release now 
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I'm always wary about other countries that get mentioned but if Brazil is in the mix, it could help to speed up enrollment

"The Company will initiate patient enrollment in multiple countries, including Brazil, where there are over 20,000 COVID-19 patients in ICU."

Unfortunately since Nader can't be trusted, who knows how much it will scale in Brazil

 
Dwayne Hoover said:
I'm always wary about other countries that get mentioned but if Brazil is in the mix, it could help to speed up enrollment

"The Company will initiate patient enrollment in multiple countries, including Brazil, where there are over 20,000 COVID-19 patients in ICU."

Unfortunately since Nader can't be trusted, who knows how much it will scale in Brazil
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Again any other company I’d be like wow this is great news, but with Nader who knows where the truth is. Hopeful they’re turning a corner though. 

 
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