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***OFFICIAL CYDY/Leronlimab Thread*** (9 Viewers)

The hospital where Chris Christie is staying is participating in the leronlimab S/C trial.
Hi Chris, we are running a clinical trial on an exciting Covid treatment. Interim analysis has shown only 45 of 195 patients have died during the trial so far.

Chris - fantastic! By the way what is the typical mortality of S/C patients? We have that information don’t we? 
Sure do Chris, 20-25%.

Chris - can you check this on your calculator?? mine seems off.

 
Hi Chris, we are running a clinical trial on an exciting Covid treatment. Interim analysis has shown only 45 of 195 patients have died during the trial so far.

Chris - fantastic! By the way what is the typical mortality of S/C patients? We have that information don’t we? 
Sure do Chris, 20-25%.

Chris - can you check this on your calculator?? mine seems off.
First, picked up some HGEN at around $10 so loving that of late. 

I've seen this a bit on Twitter and I think my only theoretical counter is that those who are going to sign up for an experimental treatment trial might be closer to the "critical" end of the spectrum and thus that 25% might be low in the 'placebo' arm. Though it will have to be pretty drastically increased to reach significance. Nothing to do but wait and see! 

 
I've seen this a bit on Twitter and I think my only theoretical counter is that those who are going to sign up for an experimental treatment trial might be closer to the "critical" end of the spectrum and thus that 25% might be low in the 'placebo' arm.
100% right

Unfair assessment from Whyatt but not surprising as he hates CYDY.   People arent going to jump through hoops to get into  this trial, they are going to take a chance when they feel their options are running out.  I definitely think the severe cases are more severe than the average population.

If there was a problem with leronlimab, the trial would have been stopped already so not worried about that.

 
First, picked up some HGEN at around $10 so loving that of late. 

I've seen this a bit on Twitter and I think my only theoretical counter is that those who are going to sign up for an experimental treatment trial might be closer to the "critical" end of the spectrum and thus that 25% might be low in the 'placebo' arm. Though it will have to be pretty drastically increased to reach significance. Nothing to do but wait and see! 
Also, leronlimab usually wasn't the first choice of treatments.  So they joined the trial after other treatments failed which would indicate that they were further along and worse off.  If 23 out of 65 passed away in the placebo arm, that would be 35%.  If 22 passed away out of 130 in the treatment arm, that would be 17%.  That seems possible.

 
First, picked up some HGEN at around $10 so loving that of late. 
:thumbup:  easy money until $20 imo. I have way more invested than I originally could have thought.

 I realize my input isn’t valued much here, but sometimes I can’t resist. 

If 22 passed away out of 130 in the treatment arm, that would be 17%.  That seems possible.
Do you think in any circumstance the trial is cut short based on this? If no, any idea if other better treatments will be available by the time Cydy’s trial is done.

I have a couple of ideas.

Good luck on this investment, as same as from day 1 I’m simply offering my opinion.

 
:thumbup:  easy money until $20 imo. I have way more invested than I originally could have thought.

 I realize my input isn’t valued much here, but sometimes I can’t resist. 

Do you think in any circumstance the trial is cut short based on this? If no, any idea if other better treatments will be available by the time Cydy’s trial is done.

I have a couple of ideas.

Good luck on this investment, as same as from day 1 I’m simply offering my opinion.
I'd hope it would be, right? Given the safety profile (would be different, to me, if it didn't have a track record of safety outside of these trials) and this efficacy it seems like a no brainer. Especially considering the alternatives. 

 
I'd hope it would be, right? Given the safety profile (would be different, to me, if it didn't have a track record of safety outside of these trials) and this efficacy it seems like a no brainer. Especially considering the alternatives. 
Assume your question is do I think a clinical trial would be stopped 1/2 complete because a p value is obtained due to the placebo group being far out of expected trend.

 I think that is highly unlikely.

 
If no, any idea if other better treatments will be available by the time Cydy’s trial is done.
I dont mind your input when you aren't taking cheap shots and looking through a really myopic lens.

You seem to be pretty sure that CYDY's treatments are going to be surpassed and I've yet to see a lot of evidence of that.  They have a very safe drug that is easy to administer, not easily surpassed once they have proven efficacy.

 
:thumbup:  easy money until $20 imo. I have way more invested than I originally could have thought.

 I realize my input isn’t valued much here, but sometimes I can’t resist. 
The people who sent hate your way are mostly gone.  Those that are still here in this thread are mostly open-minded.

Do you think in any circumstance the trial is cut short based on this? If no, any idea if other better treatments will be available by the time Cydy’s trial is done.

I have a couple of ideas.

Good luck on this investment, as same as from day 1 I’m simply offering my opinion.
I wouldn't be invested in CYDY if I thought the trial had no chance of being stopped.  I will admit I know little about how these things work.  But I think even those that do know how trials work don't know how things work in a pandemic.  We are in uncharted waters.  FDA Commissioner Stephen Hahn said that a 35% reduction in mortality is a tremendous number.  If 20 out of 65 passed away in the placebo arm, that would be 19.2%.  If 25 passed away out of 130 in the treatment arm that would be 30.7%.  That would be a 37.5% reduction in mortality. 

 
Assume your question is do I think a clinical trial would be stopped 1/2 complete because a p value is obtained due to the placebo group being far out of expected trend.

 I think that is highly unlikely.
I think they pay the penalty to get the results.  If it's below SS then some country will approve.

 
This came from Investor's Hangout (I have no idea how accurate it is):

Using the Unequal Variance T-Test here are the P values:

LL  Plac  P value
23    22     .034
22    23     .013
21    24     .008
20    25     .003
19    26     .001

 
Assume your question is do I think a clinical trial would be stopped 1/2 complete because a p value is obtained due to the placebo group being far out of expected trend.

 I think that is highly unlikely.
Doesn't the statistical analysis already account for this in the low number of test subjects?

I believe that you can have the exact same percentages, but a higher number of participants will give you a much better p-value because they take into account possible outliers in the low number of participants.

 
Those look similar to my numbers. BTW, I've decided to let the numbers I put out stand. I don't have enough info on how they will come up with the P value and just using R without a clear info will most likely result in something I can not judge. I don't think it's off by much though. 

 
This came from Investor's Hangout (I have no idea how accurate it is):

Using the Unequal Variance T-Test here are the P values:

LL  Plac  P value
23    22     .034
22    23     .013
21    24     .008
20    25     .003
19    26     .001


Someone replied to the above post with the below post:

In cases where there are two groups each with a yes or not outcome (as in success or failure, or live and death) it is commonly to use the binomial distribution as opposed to a continuous distribution.

The good news is that, if we use this test between two binomials (one for LL and the other for placebo), the p-values are significantly lower than the T-Test with unequal variance .

Without starting a rabbit-hole discussion on mathematics and statistical methods, suffice to say that the p-value for 22-23 deaths LL/Placebo is very good for trial stoppage (I get 0.00482 for a 2-tailed test).

So we are all good with 22/23  Please note that this is a very high bar (16.9% deaths in LL and 35.4% deaths in SOC).

 
Someone replied to the above post with the below post:
The 2nd method looks much better, but either way I think the trial stops on a 22-23 deaths of LL vs Placebo.

If we are to believe any of the anectodal evidence that came in, this does not seem like it would be out of the realm of possibilities.

But I could see the FDA delaying their decision for 4 to 6 weeks.  I am one of those tin hat fellows that believes we have forces working against us.

 
Thanks @Don Hutson, I didn't see that. I did find out that the old Excel Analysis tool pack T.Test which I used has dependencies between the samples even if you use the two samples (vs paired samples) so my results were off. It wasn't apparent until you start changing the samples and get different results even for the same amount of deaths in each. So I changed over to the newer functions which do not have this issue. The result was a betterment of 1 for each. I'm going to post this over in IH 

 
Below is an abbreviated version of Dave's revised p value chart.  Get his whole chart here.  Dr Yo was definitely assuming a 1:1 treatment to placebo ratio when he made the 30% statement today.  If there were equal numbers of patients in each arm, then 70% deaths in the placebo and 30% of deaths in the treatment arm would be possible.  It's not realistic with a 2:1 treatment to placebo ratio.

Deaths

LL    PL      p value

25    20        .072

24    21        .030

23    22        .019

22    23        .008

21    24        .003

20    25        .001

 
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If 23 out of 65 passed away in the placebo arm, that would be 35%.  If 22 passed away out of 130 in the treatment arm, that would be 17%.  That seems possible.
To be honest, It’s probably true I hate Cydy, because I think they screw all their stakeholders. The CEO made $9 million last year?

Linked below are mortality rates of the worst patients early in the pandemic. Do you really want to count on a 35% mortality rate in the placebo arm?

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7255393/#__sec13title

If Hgen shared those numbers with me I would be running for the door.

 
To be honest, It’s probably true I hate Cydy, because I think they screw all their stakeholders. The CEO made $9 million last year?

Linked below are mortality rates of the worst patients early in the pandemic. Do you really want to count on a 35% mortality rate in the placebo arm?

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7255393/#__sec13title

If Hgen shared those numbers with me I would be running for the door.
Probably the first time you've been honest in this thread

 
Do you really want to count on a 35% mortality rate in the placebo arm?
The interim analysis probably doesn't need a mortality rate of 35% for the trial be stopped and an EUA granted.  And I'm not counting on the trial being stopped.  I know it's a longshot.  I'm hoping that leronlimab has a 10% chance of getting an EUA from the interim analysis results.  The stock price will skyrocket if an EUA is granted.  The stock price could go up 10-fold.  I might lose 10% if an EUA isn't granted since I will get out as quickly as humanly possible.  So a 10% chance at a 1,000% stock price increase with only a 10% stock price decline at risk if it fails.  I like those odds.

I'd like to hear your answer to Cav's question:  what do you think the odds are of an EUA from the interim analysis?

 
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30% (PL M Rate) puts us just below p < .07

31% p < .03

37% p < .003

40% p < .00003

That's a range of 6 deaths

I say the real indicator to which side of the 30% to 40% range we are at is the demographics around the hospitals where the trials were run. Lower income working class and we will be nearer to 40% ( Sad to say but that's the reality)

Also as pointed out, my p values may be a bit conservative due to the method I used ( t-test vs binomial method )

Here's my prediction: if we hit 22/23 and can say we have reduced mortality by over 50% we get EUA and I give that a 30% chance.

 
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Dave RL said:
30% (PL M Rate) puts us just below p < .07
I hope that they would consider giving a EUA in this scenario.  We're in a freaking pandemic without great treatment options for the S/C patients.  30% deaths in placebo with 19% deaths in treatment won't technically provide statistical significance but it comes close and it would be a 37% reduction in mortality which the FDA's Hahn has already said would be tremendous.  It could be said that this scenario would be trending toward statistical significance i.e. it'd have statistical significance if the second half of the trial produced equal numbers.  Fauci used the "trending toward statistical significance" when justifying remdesivir's EUA.

 
When the market opens,  adjusted for the stock split,  HGEN will be higher priced than CYDY. It was not to long ago that CYDY was almost twice as high.   

CYDY volume used to be 8 to 10 higher per day.  Now, adjusted for the split, HGEN is 8 to 10 times higher per day than CYDY.  A lot of it due to being on NASDAQ. 

 
I hope that they would consider giving a EUA in this scenario.  We're in a freaking pandemic without great treatment options for the S/C patients.  30% deaths in placebo with 19% deaths in treatment won't technically provide statistical significance but it comes close and it would be a 37% reduction in mortality which the FDA's Hahn has already said would be tremendous.  It could be said that this scenario would be trending toward statistical significance i.e. it'd have statistical significance if the second half of the trial produced equal numbers.  Fauci used the "trending toward statistical significance" when justifying remdesivir's EUA.
The part that is gonna piss me off is when our government magically announces which one of these is approved for treatment about a week before the election.  And I mean which one of these therapeutics: whether it's leronlimab, HGEN, RLF-100 - whatever. I really don't care which one it is - our country needs a solution to this pandemic and we need it sooner rather than later.

And if these are being held back right now for political gain in two weeks.....man........I don't know what else to say about our country. 

(and I'm not trying to start a political debate here - I hate politics and all the arguing that goes with it.)

I just want people to feel better and feel comfortable that Covid can be beaten back so we can all have some positive ju-ju going into 2021.

 
Let us be together on this regardless of political beliefs... so we can get back to discussing the statistical significance of tight ends rather than people's lives.

 
Let us be together on this regardless of political beliefs... so we can get back to discussing the statistical significance of tight ends rather than people's lives.
Point taken. I could have used a Huffington Post example. Let's not turn stock threads into echo chambers. That is what has happened here, IMHO. 

 
Point taken. I could have used a Huffington Post example. Let's not turn stock threads into echo chambers. That is what has happened here, IMHO. 
I don't think you are paying close attention if you haven't seen a lot of criticism about cytodyn in this thread.

Have no issue  myself with any counterpoints but if you are going to be making blanket statements, like Cytodyn is going to get surpassed or not approved  for HIV or Covid, hopefully the person that says these things can back up why they think that's going to be the  case, rather than just throwing out a statement.

Also yesterday Whyatt clearly took a cheap shot in regards to the trial and number of deaths, almost insinuating that leronlimab may be driving that.  If you are going to be throwing gas on a fire with a controversial statement, even if joking, you can expect a response. The number of deaths probably helps Cytodyn here not hurts.

My biggest problem with Whyatt in particular is that he has quoted Adam Feuerstein in the past and that's someone I have no respect at all for.  The Night King lies so if you are going to quote him, Im gonna call that out.  The jury is still out if Whyatt is actually the Night King in disguise, he definitely likes AF quite a bit.

Bottom line @whyatt is an adult and I'm sure  he can handle  it.  He's  not afraid  to make some very bold statements, and that's going to get a response if people don't agree with it.  I'm sure he knows exactly what he says that is going to ignite a little fire.

 
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I don't disagree that in general there has been an bit of an "echo chamber" dynamic in this thread and the original stock thread about CYDY.   Hell--for some of us--there were moments where this stock was an exciting run.   With that said--a lot of people know that I sold my position a while ago.  I still think the drug itself has potential--I sold completely out of a lack of respect and trust for the companies management.   Looking back at my investment in this stock (which I ended up making slight profits on)--I did fall into the trap of skewing in my mind the difference between "wanting a stock to go up" vs "thinking a stock will go up".  Anytime I owned this stock--i wanted it to go up because of knowing that I owned some and other members in this community owned some.  When I got out of the stock--my belief system effectively morphed into "I don't think the stock will go up under that management.".    I absolutey believe that ownership of the stock and the "echo chamber" dynamic in here might play a part in some people's judgement about the stock as well.  Just ask yourselves--how many of you guys would proactively invest in a stock with a completely inept CEO and management at this very point in time?   My guess is that the vast majority would say "no".  However--people that are already invested in the stock are less likely to take a step back and ask that same objective question of themselves--and at that point--"they want the stock to go up more than than really think it will".    

Keep in mind--I'm not saying that this stock has no chance of going up in value--nor am I hating on it.  I'm just elaborating on my experience owning the stock and what led to my decision to move on past it.   Regardless of if you guys choose to hold, sell or buy--the only advice I'm giving is to try to be as objective as possible before you come to the decision you do.  

 
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What lies has Adam Foreskin made about CYDY?
He has twisted Nader's words around during conference calls to make statements that are very misleading.   One thing I recall in particular is when he posted  that CYDY admitted on a call that they weren't qualified to uplist to Nasdaq.  What he said didn't happen.

He's also incredibly disingenuous.   15 minutes after Cytodyn had posted a more than 300 page financial statement to the SEC, Feuerstein acted like he had already ingested and read the whole thing.  Was negative about it without quoting one thing specific.

He did the same thing after Cytodyn posted the early safety data on the M/M trial.  He was already calling the trial a failure based on Cytydyn's press release.  This was before we knew anything about the efficacy portion and the secondary endpoints that they hit.

Aside from all this, he posts immature images like the BS call image during their conference.  His bias against the company is clown like at this point.  A reporter in the industry shouldn't be carrying on so immaturely, hard to respect the guy at all.

 
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He has twisted Nader's words around during conference calls to make statements that are very misleading.   One thing I recall in particular is when he posted  that CYDY admitted on a call that they weren't qualified to uplist to Nasdaq.  What he said didn't happen.

He's also incredibly disingenuous.   15 minutes after Cytodyn had posted a more than 300 page financial statement to the SEC, Feuerstein acted like he had already ingested and read the whole thing.  Was negative about it without quoting one thing specific.

He did the same thing after Cytodyn posted the early safety data on the M/M trial.  He was already calling the trial a failure based on Cytydyn's press release.  This was before we knew anything about the secondary endpoints that they hit.

Aside from all this, he posts immature images like the BS call image during their conference.  His bias against the company is clown like at this point.  A reporter in the industry shouldn't be carrying on so immaturely, hard to respect the guy at all.
Sounds to me like everything that he speculated about has turned out to be 100% true, eh?

 
Sounds to me like everything that he speculated about has turned out to be 100% true, eh?
I'm not going to go that far.  He's posting  misleading things before they happen.  He is bound to get burned on this.  You can't carry on this cavalier without eventually stepping in it.

If you think Feuerstein is spot on, then you definitely shouldn't be invested in this company.  Why take a chance on a fraudulent product?

Seriously, you think AF is being sincere in what he posts?  

 
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Aside from all this, he posts immature images like the BS call image during their conference.  His bias against the company is clown like at this point.  A reporter in the industry shouldn't be carrying on so immaturely, hard to respect the guy at all.
Goes both ways.  One of the biggest Cytodyn supporters (Dr Yo) tweets bizarre gifs 30x's a day and sells clothing with weird cytodyn related phrases.

 
I'm not going to go that far.  He's posting things misleading things before they happen.  He is bound to get burned on this.  You can't carry on this cavalier without eventually stepping in it.

If you think Feuerstein is spot on, then you definitely shouldn't be invested in this company.  Why take a chance on a fraudulent product?
AF hasn't attacked leronlimab aside from saying the M2M trial was likely a failure.  It was a failure.  The primary endpoints weren't met.  That is why they gave us safety data instead of the topline efficacy data.  It took them forever to give us any efficacy data.  And we're still waiting for the complete results so we're just working on the assumption that what they have told us is true.  Golf Guy's daughter, who does trials in the pharma industry for a living, confirmed that the trial was likely a failure when they gave safety data instead of topline efficacy data.   

AF might be a jerk without any regards for your or Nader's feelings, but he is really smart and has been covering the biotech arena for 20 years.  He can understand things quickly and read between the lines.  Everything he has speculated about has turned out to be true.  You are like a person in their first year of fantasy football who drafts a kicker in the first round and is really confident about it and gets mad when more experienced owners tell him it was a bad pick.  

 
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I don't think you are paying close attention if you haven't seen a lot of criticism about cytodyn in this thread.

Have no issue  myself with any counterpoints but if you are going to be making blanket statements, like Cytodyn is going to get surpassed or not approved  for HIV or Covid, hopefully the person that says these things can back up why they think that's going to be the  case, rather than just throwing out a statement.

Also yesterday Whyatt clearly took a cheap shot in regards to the trial and number of deaths, almost insinuating that leronlimab may be driving that.  If you are going to be throwing gas on a fire with a controversial statement, even if joking, you can expect a response. The number of deaths probably helps Cytodyn here not hurts.

My biggest problem with Whyatt in particular is that he has quoted Adam Feuerstein in the past and that's someone I have no respect at all for.  The Night King lies so if you are going to quote him, Im gonna call that out.  The jury is still out if Whyatt is actually the Night King in disguise, he definitely likes AF quite a bit.

Bottom line @whyatt is an adult and I'm sure  he can handle  it.  He's  not afraid  to make some very bold statements, and that's going to get a response if people don't agree with it.  I'm sure he knows exactly what he says that is going to ignite a little fire.
I'm sorry  but I don't believe this statement after reading the thread. 

 
I think we can all agree that AF's war with CYDY goes beyond twitter.  When he wrote that email to the patient in Scotland, that just showed how despicable he was.  For someone to go that far shows me that he's a paid shill trying to prevent this company from having any success.  Whether he believes it or not is probably irrelevant to him.  The guy is trashy.

 
I think we can all agree that AF's war with CYDY goes beyond twitter.  When he wrote that email to the patient in Scotland, that just showed how despicable he was.  For someone to go that far shows me that he's a paid shill trying to prevent this company from having any success.  Whether he believes it or not is probably irrelevant to him.  The guy is trashy.
No argument from me at all on him. Seems scummy. 

 
I think we can all agree that AF's war with CYDY goes beyond twitter.  When he wrote that email to the patient in Scotland, that just showed how despicable he was.  For someone to go that far shows me that he's a paid shill trying to prevent this company from having any success.  Whether he believes it or not is probably irrelevant to him.  The guy is trashy.
What if you felt that people with terminal illnesses were being misled by a company and the company did this to increase their stock price?  Would you reach out to those people or would you stand by silently and let them be victimized?  CYDY is trashy.

 
AF hasn't attacked leronlimab aside from saying the M2M trial was likely a failure.  It was a failure.  The primary endpoints weren't met.  That is why they gave us safety data instead of the topline efficacy data.  It took them forever to give us any efficacy data.  And we're still waiting for the complete results so we're just working on the assumption that what they have told us is true.  Golf Guy's daughter, who does trials in the pharma industry for a living, confirmed that the trial was likely a failure when they gave safety data instead of topline efficacy data.   

AF might be a jerk without any regards for your or Nader's feelings, but he is really smart and has been covering the biotech arena for 20 years.  He can understand things quickly and read between the lines.  Everything he has speculated about has turned out to be true.  You are like a person in their first year of fantasy football who drafts a kicker in the first round and is really confident about it and gets mad when more experienced owners tell him it was a bad pick.  
I don't like people that I don't think are being genuine and that's what I think of Feuerstein.  He's got a very biased agenda and he will get burned at some point soon and I'm going to take a lot of joy when that  happens.

 

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