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***OFFICIAL CYDY/Leronlimab Thread*** (1 Viewer)

Boris Johnson will look foolish if he buys a ton of leronlimab and it turns out to be a dud.  Politicians don't like taking those kinds of gambles.  It's politically safer to do nothing.
If the UK spent $10 million on LL and it didn't move the needle, few would know or care. Even $100 million. The downside is limited to the investment loss, which is insignificant. There is no safety downside. The upside is, as is said, tremendous. 

I do agree S/C is where it's at. UK may be smartly positioning itself for first customer; maybe they have seen enough to take a chance before S/C results from the trial.

 
Not looking strong into the close. But still up over 9% for the day. Green is a good color.
I’d say it held up well. Had the big pop at the start but then traded in a small range the whole way. It sure didn’t fall off a cliff like yesterday right at the end. It was basically 3.80 to 4 all day after the start and it ended right about the middle of that. 

 
If the UK spent $10 million on LL and it didn't move the needle, few would know or care. Even $100 million. The downside is limited to the investment loss, which is insignificant. There is no safety downside. The upside is, as is said, tremendous. 

I do agree S/C is where it's at. UK may be smartly positioning itself for first customer; maybe they have seen enough to take a chance before S/C results from the trial.
I could see a billionaire philanthropist taking that kind of gamble but not a government official.  A politician taking a 25% chance on a drug means he'll look bad 75% of the time.  It's the kind of visible mistake that will cause a politician to lose their next election.  Boris Johnson or any other leader is going to want to see results before buying.  And all any country cares about right now is S/C.

 
I could see a billionaire philanthropist taking that kind of gamble but not a government official.  A politician taking a 25% chance on a drug means he'll look bad 75% of the time.  It's the kind of visible mistake that will cause a politician to lose their next election.  Boris Johnson or any other leader is going to want to see results before buying.  And all any country cares about right now is S/C.
Newsflash:  the drug works. HTH

 
That belief has very little traction in the medical and scientific communities.
Have you talked to a lot of experts about this?

I agree that they dont have published data so if that's the correlation you are trying to make, I can't say you are wrong about that.  

Sounds like you really soured on this.  What was the tipping point for you?

 
Have you talked to a lot of experts about this?

I agree that they dont have published data so if that's the correlation you are trying to make, I can't say you are wrong about that.  

Sounds like you really soured on this.  What was the tipping point for you?
And it’s a bit much to expect a drug that hasn’t completed phase 3 trials for Covid, nor has been approved by the FDA (just the FFA), to be the buzz of a community that requires these things for something to be on their radar.

Most drugs at this point in development, that go on to widespread adoption, aren’t on the radar of these folks until phase three and fda approvals.

 
There has been no tipping point.  I still believe that leronlimab might be a great drug.  But I've also accepted that leronlimab might not be a great drug.  
There are indications that show it’s a good drug.  Trial results.

The indicators you cite as negatives are not indications it’s not a good drug.  They’re indications of other things unrelated to drug function, but more to do with folks awareness of the drug at this stage in the process.

 
https://www.zerohedge.com/news/2020-09-03/can-we-trust-big-pharma-find-cure-covid-19

Instead the research seems to confirm that IL-6 and more importantly CCL5 (RANTES) and the CCR5/CCL5 axis is the achilles heel of the cytokine storm.  There is only one drug to date that has demonstrated statistically significant results in clinical trials that they can quiet the cytokine storm and take dying off the table.  That drug is called leronlimab and it is a subcutaneous shot, like what diabetics take, then you feel better in about 3 days.  Trump mentioned this type of treatment in a campaign speech less than two weeks ago.  Drug maker CytoDyn is the second company after Gilead to file for an EUA in Mild to Moderate COVID-19.  It also filed the equivalent of an EUA in the United Kingdom and is expecting a response shortly. 

If the FDA or Operation Warp Speed fails to act in the coming days, one of the most promising treatments in the world may be shipped off to the UK leaving Americans with the highly toxic and ineffective big pharma treatment called remdesivir which was just expanded under an EUA for Mild to Moderate patients.  Big pharma clearly doesn’t have the answers and is spending money in all the wrong areas like vaccines and antivirals.  We have been brainwashed into thinking a vaccine is the panacea.  Yet common sense tells us that COVID-19 is just a more contagious and viral form of influenza and we haven’t been successful in defeating it yet.  If we are going to find a treatment that takes dying off the table it's going to come from a development stage company like CytoDyn and not from big pharma.  People have a right to try, and a drug with a strong safety profile in over 1000 patients should be approved post haste. 

 
wow...I think that article is big for CYDY.  Zerohedge has a following and it doesn't come across as an intentional CYDY pump.  This will get eyeballs.

Other than that it is spot on in terms what a joke it is that OWS has basically been giving all the money to the companies that don't need it.  #####.

 
When are the results from the trials expected?  Will they beat LL tothe finish line for the S/C peak?
Humanigen decided not to do an interim analysis.  They believe the phase 3 will be completely enrolled by the end of September.  So the interim analysis of leronlimab's S/C trial will come a few weeks before lenzilumab's completed phase 3 trial.

 
They've been on Zerohedge and Seeking Alpha plenty, and still crickets
Yah I know, I've read the SA articles and they are much more of a "balanced investment view" to my recollection.  This basically throwing down the gauntlet to the FDA/US gov't with regard to their caving to BP and the UK potentially grabbing all of the supply.

:shrug: I know one article is not gonna change the world.

 
Wow.  I read this thread just for the entertainment.  There seriously is no in between.  Either it's a dog or LL is the next coming.

I honestly wish I had 10k laying around when this thread 1st started and I'm the type that would have sold when it hit $8 or $9 and been happy to pay off my student loans.

But to watch once buyers now completely toss cydy into the garbage and the current stakeholders try to prop it up is comical.  

It's a penny stock (or at least it was) for God's sake.  Let it run. Let it fall.  Dont base your day on it.  I sincerely hope for those of you that got in early that you become gazillionaire.  And I sincerely hope none of you lose your shirt.  By the sounds of it, it sounds like most of you are level headed enough that it really wont be either.

Drug companies dont just appear out of thin air.  It takes time.  No news is bad.  Any news is good (despite the short sharks).  Let it ride, leverage yourself and dont bask in others losses just to say "I told you so".

 
They've been on Zerohedge and Seeking Alpha plenty, and still crickets
I would assume he meant more in the terms of stock price and not that a zerohedge article would have any effect on the fda. 

Zerohedge can definitely and regularly does influence stock price action in large ways. 

 
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When are the results from the trials expected?  Will they beat LL tothe finish line for the S/C peak?
No, HGEN stated today that they will not do interm analysis, and instead wait for the trial completion, which is expected to fill late September/early October then wait for outcomes. So while HGEN is currently ahead of Cytodyn in trial enrollment, Cytodyn’s 50% data will be available 5 to 6 weeks prior to HGEN’s. 

It will be interesting to see how this plays out.

 
No, HGEN stated today that they will not do interm analysis, and instead wait for the trial completion, which is expected to fill late September/early October then wait for outcomes. So while HGEN is currently ahead of Cytodyn in trial enrollment, Cytodyn’s 50% data will be available 5 to 6 weeks prior to HGEN’s. 

It will be interesting to see how this plays out.
Why would a fake company vs HGEN be interesting.  You’re cracking!  Join the dark side.

 
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Wow.  I read this thread just for the entertainment.  There seriously is no in between.  Either it's a dog or LL is the next coming.

I honestly wish I had 10k laying around when this thread 1st started and I'm the type that would have sold when it hit $8 or $9 and been happy to pay off my student loans.

But to watch once buyers now completely toss cydy into the garbage and the current stakeholders try to prop it up is comical.  

It's a penny stock (or at least it was) for God's sake.  Let it run. Let it fall.  Dont base your day on it.  I sincerely hope for those of you that got in early that you become gazillionaire.  And I sincerely hope none of you lose your shirt.  By the sounds of it, it sounds like most of you are level headed enough that it really wont be either.

Drug companies dont just appear out of thin air.  It takes time.  No news is bad.  Any news is good (despite the short sharks).  Let it ride, leverage yourself and dont bask in others losses just to say "I told you so".
Bruh. Let us be rich. 

 
I meant in terms of stock price. Nothing's influenced it upwards previously, not sure why another ZH now would change that.
Were there other ZH articles that were that bullish? I am part of a day trading group and one of the things we have alerts on are zerohedge tweets/articles as they often move a stock pretty hard in the short term. 

Of course those are during market hours. 

 
I’d love to listen in to the CYDY PR Team brainstorm session where someone was like “hey when should we release all this good news and get the good folks at zzzzzomgzerohedge all wound up and excited about with a great article?” and the intern responds “hm, how about the night before Labor Day Weekend, surely lots of folks will be sitting around looking at their portfolios then?”, and then everyone else just nods along in agreement. 

 
I’d love to listen in to the CYDY PR Team brainstorm session where someone was like “hey when should we release all this good news and get the good folks at zzzzzomgzerohedge all wound up and excited about with a great article?” and the intern responds “hm, how about the night before Labor Day Weekend, surely lots of folks will be sitting around looking at their portfolios then?”, and then everyone else just nods along in agreement. 
Probably a lot like the meeting where Joe B declared that the board would allow imbedded pictures, I’m sure Chase said “yeah, what could go wrong”

 
That belief has very little traction in the medical and scientific communities.
Not with experts who have had direct interaction:  Drs. Patterson, Yang and Seethamraju to start.  The naysayers, like yourself and Adam Feuerstein are basing their opinions on NP which confuses drug efficacy with management capability.  The drug works.

 
Not with experts who have had direct interaction:  Drs. Patterson, Yang and Seethamraju to start.  The naysayers, like yourself and Adam Feuerstein are basing their opinions on NP which confuses drug efficacy with management capability.  The drug works.
Patterson is a stockholder.  Yang and Seethamraju haven't said much lately.  When was the last time a reputable scientist or doctor supported leronlimab?  It's been months without any traction in the scientific community.  A lot of you decided that leronlimab was a miracle drug for Covid before any results were released.   The M2M trial results are mediocre.  That has nothing to do with NP.

 
Patterson is a stockholder.  Yang and Seethamraju haven't said much lately.  When was the last time a reputable scientist or doctor supported leronlimab?  It's been months without any traction in the scientific community.  A lot of you decided that leronlimab was a miracle drug for Covid before any results were released.   The M2M trial results are mediocre.  That has nothing to do with NP.
I thought the results were good (better than anything currently out there for m/m), but whoever set the primary endpoint was dumb.  When 70% of the population heals on their own at 14 days, it doesn't take a rocket scientist to figure out that the primary endpoint was going to be almost impossible to meet with such a small trial.  

They definitely showed their inexperience on that one.

 
I thought the results were good (better than anything currently out there for m/m), but whoever set the primary endpoint was dumb.  When 70% of the population heals on their own at 14 days, it doesn't take a rocket scientist to figure out that the primary endpoint was going to be almost impossible to meet with such a small trial.  

They definitely showed their inexperience on that one.
They had a ton of endpoints and only did well on NEWS2 at 3 days.  With the number of endpoints in the trial, they were bound to get lucky on a few.  So they cherry pick the few good results they have and ignore all of the bad data. No one in the scientific community has said anything positive about the M2M results.

 
They had a ton of endpoints and only did well on NEWS2 at 3 days.  With the number of endpoints in the trial, they were bound to get lucky on a few.  So they cherry pick the few good results they have and ignore all of the bad data. No one in the scientific community has said anything positive about the M2M results.
That's incorrect.

National Early Warning Score 2 (NEWS2), an objective scale which identifies patients at risk for rapid clinical deterioration requiring critical care intervention was reported. It showed that 50% of patients in the LERONLIMAB arm compared to 20% in the Placebo arm, experienced beneficial improvement at End of Treatment or Day 14; a 2.5 ratio in favor of LERONLIMAB over Placebo. In addition, similar NEWS2 results were observed at Day 3 and Day 14.

All NEWS2 outcomes for this trial achieved Statistical Significance. Statistical Significance levels were p<0.03, p<0.02, and p=0.0223 for Day 3, Day 14, and End of Treatment or Day 14, respectively.

 
That's incorrect.

National Early Warning Score 2 (NEWS2), an objective scale which identifies patients at risk for rapid clinical deterioration requiring critical care intervention was reported. It showed that 50% of patients in the LERONLIMAB arm compared to 20% in the Placebo arm, experienced beneficial improvement at End of Treatment or Day 14; a 2.5 ratio in favor of LERONLIMAB over Placebo. In addition, similar NEWS2 results were observed at Day 3 and Day 14.

All NEWS2 outcomes for this trial achieved Statistical Significance. Statistical Significance levels were p<0.03, p<0.02, and p=0.0223 for Day 3, Day 14, and End of Treatment or Day 14, respectively.
Cherry-picked data.  Why aren't they releasing the results?  When they say beneficial improvement, how much improvement?  Is it a tiny amount of improvement with which they are showing statistical significance?  Adam Feuerstein predicted that CytoDyn would only release cherry-picked data and not release the bad data.  His prediction has turned out accurate.

 
From IHub:

CYDY trial of mild to moderate has been completed for weeks.

This much is true.

They missed on all primary end points in their study per the CEOs admission. In fact my understanding is the only patient death was among a patient who was given leronlimab. The study was a 2:1 ratio of Leronlimab to placebo. Not a good study, not well powered, and not designed to move leronlimab to FDA approval. This was a true phase 2 study.
They did not publish a peer review of their results. They actually have not fully published any results or even given out the data. They have only mentioned, in a conference call to my knowledge (I am a CYDY shareholder) that they achieved significant statistical difference in one secondary measure, the news2 score. However they failed to mention what difference and also did not release the data. My guess is, honestly, they achieved a lower temperature (fever) upon ICU admission. Without a full release of data it is all a guess. Not sure why they are applying for EUA for covid 19. The study was a small phase 2 study, designed to help them focus on a future phase 3 study. If the data is so great why not publish it?

NEWS 2 measures the following:

respiration rate
oxygen saturation
systolic blood pressure
pulse rate
level of consciousness or new confusion*
temperature.

Primary end points measured 02 Sat, and oxygen use and they failed to show a statistical difference in those. So I feel resp rate and Oxygen saturation really couldn't have been that much different to placebo even in the news2 score. Level of consciousness in covid 19 is directly linked to 02 sat, again (02 Sat) a failed in the primary end point That leaves heart rate, blood pressure and temperature. The first two are highly variable upon ICU admissions. Most covid 19 admissions are for low 02 sats or they wouldn't be going there, they would stay on the floor. Some are for hypotension, though not many compared to resp failure, and low blood pressure is linked to increased HR. So my money is on fever reduction. Again without a full release of the data, who knows? If anyone has all the data, peer reviewed, I would love a link. Perhaps I am wrong? Perhaps CYDY just forgot to release the data?
I do feel CYDY will get HIV approval, if not in the USA then in the UK. That will be big news for them. However, HIV patients self injecting at home may be an issue in many countries as what will they do with the dirty needles? I do not see the UK funding CYDY to promote treatment of Covid 19. Warp Speed rejected them. They haven't released the data yet, just some strange words of support from the CEO about meeting a secondary end points and focusing on they drug being safe though not effective. Also the CEO touts many times that leronlimab stays in the system for weeks if not months, per his HIV data review video. If this is true why was there no significant statistical data shown progression to ICU or mechanical ventilation in then mild to moderate study. Leronlimab was no better than placebo. I do not see the data from the Severe to Critical study having a good read out for CYDY. With all that in mind covid 19 is not for CYDY.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “We are very motivated to provide leronlimab to patients throughout the world who are suffering from COVID-19. We believe the statistically significant data of NEWS2 findings, along with impressive safety results (less SAEs or AEs with leronlimab vs. placebo), from our Phase 2 trial set forth in the Top-line Report provides compelling data in support of leronlimab’s use to fight COVID-19. We are in discussions with several regulatory agencies in other countries and hope to obtain emergency approval for its use. We are in a very exciting period for CytoDyn in regards to the potential role of leronlimab in three different COVID-19 populations, mild-to-moderate, severe-to-critical, and long-haulers.”

Here is the link to their "data," Would love a better one, or a full release of the numbers and findings.

https://www.cytodyn.com/newsroom/press-releases/detail/460/cytodyn-submits-its-top-line-report-from-its-phase-2

 
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