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***OFFICIAL CYDY/Leronlimab Thread*** (5 Viewers)

Jayrok said:
I see the same thing.  And this comment you quoted is basically the only new piece of ammo that AF is using in the article.  NP promised an update.  He gave an update.  He didn't provide all efficacy detailed data.  That is coming, he said, in "10 days or so." 

So the 14 day endpoint data will be discussed in detail in the report coming in 10 days or so.  

So this was just an update and Lelazari commented because it was a surprise and they thought it noteworthy that patients on LL were showing improved symptoms in only 3 days.  

AF is confusing this update with all efficacy results in the trial and he is suggesting that NP and his staff are purposely dodging endpoints because they know the results are bad news.  It's ridiculous.  

That said, I think that NP, while giving "updates",  should stick to those that are associated with exact endpoints.  Because everything else, no matter how positive, will be used against him in a hit piece.  Absurd.  
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They are cherry picking a few endpoints.  If there were 2 placebos in a trial, each placebo would better than the other in a few endpoints.  He never says "statistical significance" or p value.  So maybe leronlimab helped a bit at Day 3.  That could be significant in the S/C trial because those are extreme cases that need immediate help.  But it's clear at this point that the M2M trial data are far from impressive.

 
Don Hutson said:
They are cherry picking a few endpoints.  If there were 2 placebos in a trial, each placebo would better than the other in a few endpoints.  He never says "statistical significance" or p value.  So maybe leronlimab helped a bit at Day 3.  That could be significant in the S/C trial because those are extreme cases that need immediate help.  But it's clear at this point that the M2M trial data are far from impressive.
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Lacking any additional context from the people that host a call to share this information with us, it is hard to not believe this.

 
Don Hutson said:
They are cherry picking a few endpoints.  If there were 2 placebos in a trial, each placebo would better than the other in a few endpoints.  He never says "statistical significance" or p value.  So maybe leronlimab helped a bit at Day 3.  That could be significant in the S/C trial because those are extreme cases that need immediate help.  But it's clear at this point that the M2M trial data are far from impressive.
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Really.  I guess we will see in a couple weeks.  

It is far from clear to me.

 
adonis said:
Makes sense. I'm just under the impression (asking for input in case it's false) that most clinicians are responding to phase 3 trials as those are the ones that guide clinical decision more often than phase 2 results.  Phase 2 results, again maybe I have this wrong, are often used to figure out safety and how effective the drug is in various areas.  That's why I think treating primary endpoints and secondary endpoints in phase 2 trials as the same as in phase 3 trials isn't necessarily fair.  

If the phase 2 trial shows promise on the primary but doesn't hit "significance" but quite a few meaningful secondary endpoints show "significance" and are beneficial for the patients, that would likely lead to a phase 3 trial focusing more on those areas in which significance was shown, with a shift in how the phase 3 primary endpoint was geared.

In the phase 2 trial we have here for m/m, it was initiated with collaboration from the FDA to highlight what they thought early on would be the most significant data points, and they included a slew of meaningful secondary endpoints as well to make sure they were capturing how effective the drug was, if at all.  If it turns out the primary endpoint wasn't a good choice, but a fair number of secondary endpoints that are relevant and important to clinical improvement for patients, the results won't be dismissed just because they didn't hit their primary endpoint.  This trial was a scattershot of endpoints to judge efficacy of leronlimab.  Its efficacy doesn't rely solely on the primary endpoint, in other words, but in the bigger picture of how the drug can help people.

If the secondary endpoints that are significant can be presented in such a way to show that clinical benefit can be offered by using the drug, it'd be foolish for anyone to dismiss the trial based on the primary endpoint missing "significance", if the secondary endpoints show statistically significant efficacy in areas that are important for patient wellbeing.

All this said, i'm not really arguing with you...just making points that are up for refutation by anyone.  Looking for feedback on these views.
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Very fair. And from a practicality standpoint, I'm not sure it's super fair to do the traditional primary/secondary endpoints for trials against a disease as ravaging and complex as COVID seems to be. I think (not 100% sure) that the primary endpoint is used to determine how useful it is in an area that is most important for that patient population but then also to determine how powered the study needs to be (enrollment) to fairly determine a thumbs up/down against that endpoint.

Truly, I'm not an expert in devising clinical trials so I couldn't say for sure. I think I had posted elsewhere that I actually preferred some of their secondary endpoints as more objective anyway. It would be interesting to learn when this study was developed why they specifically chose that composite score as their primary and why they chose a 14 day interval.

 
Don Hutson said:
They are cherry picking a few endpoints.  If there were 2 placebos in a trial, each placebo would better than the other in a few endpoints.  He never says "statistical significance" or p value.  So maybe leronlimab helped a bit at Day 3.  That could be significant in the S/C trial because those are extreme cases that need immediate help.  But it's clear at this point that the M2M trial data are far from impressive.
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That's one way to see it.  Another is he is saying improvement in day 3, sooner than we expected.  He believes it indicates that they'll thus be better in day 14, but he doesn't have the exact numbers to prove it yet.  He isn't the scientist and listens to Dr. J and the others.  Jay said it was surprising to see that improvement in the M/M trial and he is anxious to look into the S/C data because this type of improvement was what they were seeing in S/C patients in the EIND group.  NP thought it was noteworthy to mention in the update.  I don't think it is clear at this point that the M/M trial data are far from impressive.  Time will tell.  

I get that his language can be interpreted in different ways.  But I don't think it's a case of just cherry picking endpoints that sound good.  Why give an update at all if the data is not looking good?  Just wrap it up, submit findings and move resources back to HIV and other trials.  

To me, it shows that these people really believe they are onto something.  Of course it isn't a magical miracle drug.  There is none.  But I believe that they truly believe it can help in the fight against covid.    

 
I don't know, however, why NP didn't just say those same patients that showed improvement in 3 days improved further in 14 days, along with other patients as well.  Or is he allowed to say that without releasing all efficacy data?  I don't know.  

 
NP's gotta feel like, at this point, no matter what he says folks like AF will distort his comments and read into not only what was said but what wasn't said.

If he says "it's a great morning", AF will release an article saying NP must expect the night to be bad because he only talked about how the morning was good and if the night also was good or expected to be good, why wouldn't he say so?  What's he hiding?  Is the future guidance on the afternoon also looking down?  

 
Dr. Lazelari said "clinical significance" a lot. I suspect that was a conscious choice, because many patients improved, but the p-value is gonna just miss.

 
Jayrok said:
That's one way to see it.  Another is he is saying improvement in day 3, sooner than we expected.  He believes it indicates that they'll thus be better in day 14, but he doesn't have the exact numbers to prove it yet.  He isn't the scientist and listens to Dr. J and the others.  Jay said it was surprising to see that improvement in the M/M trial and he is anxious to look into the S/C data because this type of improvement was what they were seeing in S/C patients in the EIND group.  NP thought it was noteworthy to mention in the update.  I don't think it is clear at this point that the M/M trial data are far from impressive.  Time will tell.  

I get that his language can be interpreted in different ways.  But I don't think it's a case of just cherry picking endpoints that sound good.  Why give an update at all if the data is not looking good?  Just wrap it up, submit findings and move resources back to HIV and other trials.  

To me, it shows that these people really believe they are onto something.  Of course it isn't a magical miracle drug.  There is none.  But I believe that they truly believe it can help in the fight against covid.    
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I think this can be the answer.  They truly believe they are on to something and some of the data they are seeing conflicts with that.  So they are releasing some that they feel comfortable enough proclaiming is good and trying to figure out how to explain the rest.  To me, that would be misrepresenting the story.  Show what you have or show none of it.

In your example it would have been so incredibly helpful to finish the sentence and say that we think from the data we see on day 3 that the results will also show improvement in day 14...but we do not have that data analyzed yet, it is next up.  Without it, sounds sneaky.  They have day 14 results for other endpoints (OH...the ones they like the results on!)

Stakes are high here, I want to cut them slack but this isnt a backyard bbq conversation....$2B company, real money.

 
adonis said:
NP's gotta feel like, at this point, no matter what he says folks like AF will distort his comments and read into not only what was said but what wasn't said.

If he says "it's a great morning", AF will release an article saying NP must expect the night to be bad because he only talked about how the morning was good and if the night also was good or expected to be good, why wouldn't he say so?  What's he hiding?  Is the future guidance on the afternoon also looking down?  
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Exactly.  AF and his ilk get paid, I presume, based on traffic and hits on the site, twitter comments/retweets, etc.  

That said, perhaps NP should just stop giving updates and interviews.  Just release the data to the FDA and go from there.  No PR unless/until they get approval.  

 
kevzilla said:
Dr. Lazelari said "clinical significance" a lot. I suspect that was a conscious choice, because many patients improved, but the p-value is gonna just miss.
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So, if the results are not quite clinically significant, but are better than the results of the standard of care therapuetic being used now, I wonder if Leronlimab will get any play.

 
adonis said:
NP's gotta feel like, at this point, no matter what he says folks like AF will distort his comments and read into not only what was said but what wasn't said.

If he says "it's a great morning", AF will release an article saying NP must expect the night to be bad because he only talked about how the morning was good and if the night also was good or expected to be good, why wouldn't he say so?  What's he hiding?  Is the future guidance on the afternoon also looking down?  
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And thats his mistake, blaming other people for the traps he sets for himself.  If he believes this, then no wonder he doesn't find a way to fix it.

 
djmich said:
And thats his mistake, blaming other people for the traps he sets for himself.  If he believes this, then no wonder he doesn't find a way to fix it.
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It's not just a trap he sets for himself, it's a trap others are exploiting for their personal gain.

NP has been doing just what he's doing for years now.  Only since the share price has risen significantly and can be manipulated profitably by AF and other folks, has his weaknesses been exploited.

I agree though, he needs to close those exploits, but it's tough to turn your back on things that got you where you are today, which is to a 2 billion dollar company (some of that is luck of Covid too though, for the company).  His personality is one of selling and embellishing.  It's in what he says, how he says it, and how he just can't help himself.  Any deviation from this embellishment process at this point, substituting a "just let the records speak for themselves" could be seen as a negative by AF types as well.  AF: "All of a sudden NP has gone quiet.  Never one to shy away from even the slightest hint of success, CYDY has gone radio silent.  Could the cause of that be major behind the scenes disappointment with the results and a lack of desire to get in front of the shareholders with bad results for fear he may slip up and reveal how bad things are going?"

It's NP's fault, but you also gotta lay some responsibility at the feet of folks who will literally capitalize on anything that's done or said here.  The benefit up front is big for them, and the price they have to pay is minimal if they're wrong.  

 
Jayrok said:
Exactly.  AF and his ilk get paid, I presume, based on traffic and hits on the site, twitter comments/retweets, etc.  

That said, perhaps NP should just stop giving updates and interviews.  Just release the data to the FDA and go from there.  No PR unless/until they get approval.  
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I can see the argument both ways. I don't think his conference calls help much but they probably don't hurt any more than if there is no news for weeks.  No news seems just as bad for doubt to creep in and the stock price is likely negatively affected just the same.  

NP has made it his MO to have regular calls.  Keeps people talking about CYDY.  Good or bad.  Seems like a lot of the longs, at least the yahoos on the CYDY board, eat those conference calls up.  He's playing to the crowd there.

To put things more into perspective and I'm not an NP fan, for a company that has not proven they can get an approval yet, they have done a pretty job of raising the share price.

 
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Folks bearish about CYDY, answer this:

If there was a simple change to the primary endpoint where it was measuring SAE's in the leronlimab arm vs placebo, how would the results be looking now?

 
adonis said:
It's not just a trap he sets for himself, it's a trap others are exploiting for their personal gain.

NP has been doing just what he's doing for years now.  Only since the share price has risen significantly and can be manipulated profitably by AF and other folks, has his weaknesses been exploited.

I agree though, he needs to close those exploits, but it's tough to turn your back on things that got you where you are today, which is to a 2 billion dollar company (some of that is luck of Covid too though, for the company).  His personality is one of selling and embellishing.  It's in what he says, how he says it, and how he just can't help himself.  Any deviation from this embellishment process at this point, substituting a "just let the records speak for themselves" could be seen as a negative by AF types as well.  AF: "All of a sudden NP has gone quiet.  Never one to shy away from even the slightest hint of success, CYDY has gone radio silent.  Could the cause of that be major behind the scenes disappointment with the results and a lack of desire to get in front of the shareholders with bad results for fear he may slip up and reveal how bad things are going?"

It's NP's fault, but you also gotta lay some responsibility at the feet of folks who will literally capitalize on anything that's done or said here.  The benefit up front is big for them, and the price they have to pay is minimal if they're wrong.  
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Yes.  AF is a dooshnozzle.  But like I said this is big leagues.  If Nader thinks he's the only CEO that has to deal with skeptics and people looking to make money by shorting his company based on the exploits he leaves them then he's flat out wrong and its actually silly that he spends time addressing it.  AF is winning that fight.

If it was a one time thing, ok.  Its repeated.  Nader has to address it.  He has started by bringing the team on the calls, he needs to turn more over to them.  But...that presumes this is all just an unintentional miscommunication.  Jury is out.

 
adonis said:
So, if the results are not quite clinically significant, but are better than the results of the standard of care therapuetic being used now, I wonder if Leronlimab will get any play.
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I'm saying "clinical significance" is not a thing. It's what you say when you can't say statistical significance. Still hopeful for a p-value that just gets across the line on the S/C trial.

 
adonis said:
Folks bearish about CYDY, answer this:

If there was a simple change to the primary endpoint where it was measuring SAE's in the leronlimab arm vs placebo, how would the results be looking now?
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I wouldn't call myself bearish.  Confused, puzzled, skeptical, optomistic.

If that was the endpoint and it achieved a p value that "hit the mark" I would accept that...actually would be great.  However, that would be dependent on scientists first identifying that was an appropriate endpoint for this trial.  They did not do that at the start, I assume there was a reason why.  I would be open to someone other than Nader and cydy making that case though.

 
Don't most Mild/Moderates recover on their own after 14 days?  If so what LL does between (on day 3 for instance) would seem most important to me anyways.  I mean if it took on average 10 days to get over a common cold and I could take a new drug Shaqlimab and get over it in 3 days that's incredible.  Sure in compared to the placebo group - both groups would have high recovery rates after 10 days, but improvement after 3 days would be a game changer.

 
adonis said:
NP embellishes.  He's not in control of his public messaging.  He's an effective excitement machine, but his promises have fallen through repeatedly, and you can't count on his word in terms of deadlines or the precision of facts he's saying he's stating.  It's a risk you run believing him.

There is also the other set of interests involved, which are the folks like AF, who truly can make money by capitalizing on the lack of delivery from NP, and the lack of precision in his comments, and the lack of released data.  So it's not just NP's poor communication and embellishments, but there's an active counter-party out there seeking to profit literally from this vagueness and lack of concrete data.  

It's a balancing act that they both benefit from in ways, and suffer from.  NP benefits because the stock price has been driven by excitement and potential based off anecdotes, preliminary data, BP and others support, but at the same time it opens him to attacks from AF and others who can capitalize on his lack of precision and tendency to exaggerate or make promises he doesn't deliver on.  NP benefits from this part of his nature, but he also suffers as shorters and decreased stock price and folks not taking him at his word have the opposite effects on the stock than he'd expect.
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Nice review.

During my time following CYDY NP has delivered on distribution agreement, co-vid trial (results forthcoming though safety is good), application for uplisting filed, BLA submitted (in process), bank financing, manufacturing capacity (though now some backtracking on the number available), solid advisory board recently formed.

BLA-HIV hit roadblock meeting with FDA in process. Regarding the BLA I read that there were years of frustration/waiting for the company to do trials and get to that point. The company seems to be moving much faster now than it did in the past.

Hype regarding UK, Mexico has gone nowhere.

Almost every timeline mentioned takes longer to meet than first discussed.

CCs are frustrating due to communication style. There is a lot of embellishing that detracts from clarity. It didn't sound like there would be a PR coming until all results were available which contributes to the confusion as a PR can be studied and should set forth the results in an orderly fashion. 

The consensus before the CC was that we were going to get a peak at the results and that's what we got.

When the safety group meets Monday it will be telling if they advise that the placebo group be immediately given LL. That would be a really good sign I think.

 
Jayrok said:
Oh no... Video

:doh:  

Refuting stat report.
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AF is living rent free in Nader's head.  This is legit turning into Tiger King

Didn't really clear much up on the data other than confirming they don't have the p value yet for data referenced yesterday.  I'm actually glad he said that, facts, even if not "exciting" help.

Edited:  I listened to him again and on the p value he said "we haven't talked about it but hopefully we give that very significant p value very soon".  Will leave to everyones imagination what that means.

 
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djmich said:
AF is living rent free in Nader's head.  This is legit turning into Tiger King

Didn't really clear much up on the data other than confirming they don't have the p value yet for data referenced yesterday.  I'm actually glad he said that, facts, even if not "exciting" help.
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Yeah I actually think he did okay once he got past the AF stuff and talked about NEWS2.  Interesting that he said phase 2 endpoints are not "hit or miss."  Phase 3 is where it's "do or die" with regards to hitting endpoints.  "Phase 2 you're trying to find anything that works for this disease.  That's why you have 16+ secondary endpoints."

Monday they're looking at the mortality rate. He believes FDA will, worst case, call for phase 3 trial for M/M as opposed to denying approval.  They hope to get approval for both phase 2 and 3 trial data.  But it appears they think the best bet is in the S/C trial because they believe it is saving lives.  

 
siffoin said:
Don't most Mild/Moderates recover on their own after 14 days?  If so what LL does between (on day 3 for instance) would seem most important to me anyways.  I mean if it took on average 10 days to get over a common cold and I could take a new drug Shaqlimab and get over it in 3 days that's incredible.  Sure in compared to the placebo group - both groups would have high recovery rates after 10 days, but improvement after 3 days would be a game changer.  
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This is what I’ve asked our few bears here and nobody seems to have an answer. If it improves on day 3, then day 14 should be significantly less relevant. Seems obvious to my stupid brain. 

 
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Jayrok said:
Well, it was tongue in cheek I'm sure.  Basically, he 'd like AF to talk about his issues in public so everyone can hear sides and make up their own mind.  
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He shouldn’t even address him. He’s the ceo of a 2.5B market cap company that may have a corona answer. AF is some dork on the internet with some stupid nickname taken from a show featuring dragons and zombies. 

 
siffoin said:
Don't most Mild/Moderates recover on their own after 14 days?  If so what LL does between (on day 3 for instance) would seem most important to me anyways.  I mean if it took on average 10 days to get over a common cold and I could take a new drug Shaqlimab and get over it in 3 days that's incredible.  Sure in compared to the placebo group - both groups would have high recovery rates after 10 days, but improvement after 3 days would be a game changer.
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I think you are right.  For me, and I think most of the skeptics here its less that there are no positive datapoints or that the positive datapoint would not be really beneficial.

It's that they are only sharing the positive data (with no statistical evidence yet...p value) in a checkerboard type of way that leads one to believe they are not showing all the pieces on the board...and it's not just because they haven't gotten to those other pieces yet.

 
Capella said:
He shouldn’t even address him. He’s the ceo of a 2.5B market cap company that may have a corona answer. AF is some dork on the internet with some stupid nickname taken from a show featuring dragons and zombies. 
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Let's not forget that he took the nickname of what turned out to be a really insignificant character.  The Night King was extremely weak.

 
Capella said:
This is what I’ve asked our few bears here and nobody seems to have an answer. If it improves on day 3, then day 14 should be significantly less relevant. Seems obvious to my stupid brain. 
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This seems right and better what Remdesivir could do but all bets are off.  I don't know if being better than Remdesivir is good enough or not, the whole thing seems extremely political and that Cytodyn is going to be held to the very highest standard to get through.

 
If they keep having problems getting any traction from the FDA, perhaps a buy out with a big Pharma would help.  There is always that hope.  With the kind of lobbying and political capital necessary, I have less doubt this would already be in use if BP was behind it.

 
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Dwayne Hoover said:
If they keep can't get any traction from the FDA, perhaps a buy out with a big Pharma would help.  That's always that hope.  With the kind of lobbying and political capital necessary, I have less doubt this would already be in use if BP was behind it.
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Yea I would imagine they would go for the buyout if they can’t penetrate the federal ways. Would be disappointing but still a money maker I’d think. 

 
djmich said:
I think you are right.  For me, and I think most of the skeptics here its less that there are no positive datapoints or that the positive datapoint would not be really beneficial.

It's that they are only sharing the positive data (with no statistical evidence yet...p value) in a checkerboard type of way that leads one to believe they are not showing all the pieces on the board...and it's not just because they haven't gotten to those other pieces yet.
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There are like 70-80 endpoints.  I'm sure a few of them look good.  The placebo might have some that look good, too.  A p value of .05 means that is has a 1 in 20 chance of being due to randomness.  So having 3 or 4 endpoints with a p value of .05 means nothing.

 
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