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***OFFICIAL CYDY/Leronlimab Thread***


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Does anyone know if any of the treatments are finishing trials, having safety reviews, or having a mid-trial looks in the next 3-4 weeks. And will they have the data available?

It doesn't look good that Trump will be able to announce a vaccine approval in the next 3 weeks, so the next best thing for him would be a treatment.  This gives me more hope that if SS is reached, that we will be granted emergency approval.

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Yes, go ahead FC42

I closed.  Cydy operation mountain house completed.

Fear is a disease.  Get rid of it or you're doomed for failure.  Though I did hear Leronlimab cures it. This is NOT an investment.  It is a Grand Slam Home Run or a Strike Out gamble in the stock

7 minutes ago, ex-ghost said:

Ugh, NP body language again. We know how that works.

NP was proud as a peacock today. 

Having seen/heard NP on days when the news is not as good, there actually is a discernible difference in how he carries himself.   He's always irritable and short, you can tell he's not comfortable delivering bad news.

Now perhaps he was just pumped up because it was his first hit with "big media" as he calls it.  Other than that, he did seem fairly relaxed and tried to cover off on a lot of talking points quickly.  He seemed fairly confident, that's all you can say.

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7 minutes ago, Dwayne Hoover said:

NP was proud as a peacock today. 

Having seen/heard NP on days when the news is not as good, there actually is a discernible difference in how he carries himself.   He's always irritable and short, you can tell he's not comfortable delivering bad news.

Now perhaps he was just pumped up because it was his first hit with "big media" as he calls it.  Other than that, he did seem fairly relaxed and tried to cover off on a lot of talking points quickly.  He seemed fairly confident, that's all you can say.

I thought it was a home run.  The casual fox viewer will think he's a real doctor.  Interesting that he mentioned the FDA granted LL more EIND approvals than any other drug for COVID.  If this drug works, the FDA is going to have a lot of dead bodies on the hands.  I was thinking earlier today they should have killed the double blind studies due to the pandemic.  With safety already proven, they should have  piled a bunch of people into the LL study with no control group.  With 20k a day getting infected, you already had a huge control group.

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5 minutes ago, Chaz McNulty said:

Does anyone know if any of the treatments are finishing trials, having safety reviews, or having a mid-trial looks in the next 3-4 weeks. And will they have the data available?

It doesn't look good that Trump will be able to announce a vaccine approval in the next 3 weeks, so the next best thing for him would be a treatment.  This gives me more hope that if SS is reached, that we will be granted emergency approval.

RLFTF and HGEN might finish enrollment in their phase III trials before the election but they definitely won't have results.  I don't know much about Big Pharma's trials.

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41 minutes ago, Dwayne Hoover said:

NP was proud as a peacock today. 

Having seen/heard NP on days when the news is not as good, there actually is a discernible difference in how he carries himself.   He's always irritable and short, you can tell he's not comfortable delivering bad news.

Now perhaps he was just pumped up because it was his first hit with "big media" as he calls it.  Other than that, he did seem fairly relaxed and tried to cover off on a lot of talking points quickly.  He seemed fairly confident, that's all you can say.

He was definitely upbeat. However, after previously saying they submitted EUA for M/M and then after saying they just sought advice on EUA and never submitted EUA....I've learned he's a slick salesman to put it nicely.

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1 hour ago, Chaz McNulty said:

Does anyone know if any of the treatments are finishing trials, having safety reviews, or having a mid-trial looks in the next 3-4 weeks. And will they have the data available?

It doesn't look good that Trump will be able to announce a vaccine approval in the next 3 weeks, so the next best thing for him would be a treatment.  This gives me more hope that if SS is reached, that we will be granted emergency approval.

Nevermind.  Trump's already pimping Regeneron and Eli Lily.

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I wonder if CytoDyn is intentionally not filling the S/C trial and wants to just go with the interim study.  The Standard Of Care has gotten much better.  There will be far fewer deaths in the summer/fall months than when the study began.  I bet the 45 deaths that happened disproportionately happened early and CytoDyn already has that information.  Getting statistical significance now would be much more difficult than before.  So they'll pay the .005 Troll Toll to unblind the trial if an EUA isn't granted.  They'll sell abroad if the FDA won't budge.  If they have to get the study going again, they'll start pushing enrollment in winter when our hospitals get swamped and people aren't getting nearly as good of care so there will be more deaths and therefore more chance at statistical significance.

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32 minutes ago, Don Hutson said:

I wonder if CytoDyn is intentionally not filling the S/C trial and wants to just go with the interim study.  The Standard Of Care has gotten much better.  There will be far fewer deaths in the summer/fall months than when the study began.  I bet the 45 deaths that happened disproportionately happened early and CytoDyn already has that information.  Getting statistical significance now would be much more difficult than before.  So they'll pay the .005 Troll Toll to unblind the trial if an EUA isn't granted.  They'll sell abroad if the FDA won't budge.  If they have to get the study going again, they'll start pushing enrollment in winter when our hospitals get swamped and people aren't getting nearly as good of care so there will be more deaths and therefore more chance at statistical significance.

I think he wouldn't have given the 'late next week' timeline for the reveal if that was the case.

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So with Regeneron requesting EUA with only a little over 275 patients enrolled so far, have to think this at least opens up the door that Cytodyn may get approved at the interim.

Not that anything has been granted yet for Regeneron but if they are going to consider low enrollment for them, Cytodyn definitely should receive that same consideration.

All I'm trying to say is that the low number in the trial may not be a barrier anymore, we will see how this plays out.

Disagree with the @Whyattassessment, what did he say chance are .01?

Edited by Dwayne Hoover
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Are we going to get the normal Friday late afternoon rise?  I'm thinking it could rise every day in the last half hour of trading since people will want to own it overnight in case good news comes out afterhours.  The flipside of that is it could fall every morning.

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1 minute ago, Don Hutson said:

Are we going to get the normal Friday late afternoon rise?  I'm thinking it could rise every day in the last half hour of trading since people will want to own it overnight in case good news comes out afterhours.  The flipside of that is it could fall every morning.

Friday afternoon has been pretty consistent.  

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6 hours ago, Dave RL said:

Just ran the numbers for 35 deaths for the CD12 interim since there was some discussion that it may not be 45 after all. FYI

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I read that guy's reasoning why it could be 35 or 40 deaths and it made no sense to me.  The slide in the shareholder meeting said "Interim after 195 (total death ~45)".  And then Nader said that it was 50 deaths now which makes sense since the trial was then at 220 patients.  Maybe it'll be 43 or 44 deaths because Nader did use the ~ sign and Nader can't help himself from lying/exaggerating a little bit about everything.  But it's definitely not 35 deaths.

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What it proved to me is for 35 the same ratio of LL to PL deaths gives almost the same p value (meaning we don't lose too much statistical significance with 10 less deaths). It really comes down to what that ratio is between LL and PL. We can guess and infer based on known PL mortality rate of other studies and trials but in the end it will all be clear if we were close or way off. 

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38 minutes ago, Dave RL said:

What it proved to me is for 35 the same ratio of LL to PL deaths gives almost the same p value (meaning we don't lose too much statistical significance with 10 less deaths). It really comes down to what that ratio is between LL and PL. We can guess and infer based on known PL mortality rate of other studies and trials but in the end it will all be clear if we were close or way off. 

And people seemed obsessed with achieving a p value of .05 or less but that might not matter.  We are in a pandemic.  We are entering a crazy period without any good S/C drugs.  If there are 20 deaths in the placebo or 30% and 25 deaths in the treatment arm or 19%, it'll be hard for them not to give the green light to leronlimab.  It does not achieve statistical significance but beggars can't be choosers.  Remdesivir was accepted on less.  The DMSC/FDA rejecting that will know that people will die because of their rejection.  And they will know that people will find out what they did.

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2 hours ago, Don Hutson said:

And people seemed obsessed with achieving a p value of .05 or less but that might not matter.  We are in a pandemic.  We are entering a crazy period without any good S/C drugs.  If there are 20 deaths in the placebo or 30% and 25 deaths in the treatment arm or 19%, it'll be hard for them not to give the green light to leronlimab.  It does not achieve statistical significance but beggars can't be choosers.  Remdesivir was accepted on less.  The DMSC/FDA rejecting that will know that people will die because of their rejection.  And they will know that people will find out what they did.

You have more faith in regulating organizations than me.

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8 minutes ago, Charlie Harper said:

You have more faith in regulating organizations than me.

I'm not a conspiracy theorist but I do understand that Big Pharma has advantages.  And Trump promotes those advantages.  But we are are in unique times.  It is a pandemic.  I am not so cynical to think that all forces are against leronlimab.  If I thought that, I would not be invested.

Edited by Don Hutson
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On 10/8/2020 at 7:34 AM, unckeyherb said:

two weeks.

 

On 10/8/2020 at 7:36 AM, arrow1 said:

melting green

 

On 10/8/2020 at 1:33 PM, dkp993 said:

Short attack!  😉

 

Maybe this thing goes back to $0.29 and we all either lose all our profits or lose money depending on when you got in, but you can't put a price on laughter and the bond we've all made along the way.  When I use terms like these quoted here in real life I just get blank stares.  But you guys.  You guys get it.

We may go broke, but we'll always be CYDY bros.  Dare I say, #cydykes.  And that is something we will never forget.

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2 minutes ago, FreeBaGeL said:

Maybe this thing goes back to $0.29 and we all either lose all our profits or lose money depending on when you got in, but you can't put a price on laughter and the bond we've all made along the way.  When I use terms like these quoted here in real life I just get blank stares.  But you guys.  You guys get it.

We may go broke, but we'll always be CYDY bros.  Dare I say, #cydykes.  And that is something we will never forget.

FreeBaGel, you are an awesome dude.  And I feel a kinship with FBGs.  But this is an investment.  Nothing more.  Nothing less.  I pray it doesn't go back to .29.  Maybe in 10 years, I'll be able to feel nostalgia.

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12 minutes ago, Don Hutson said:

FreeBaGel, you are an awesome dude.  And I feel a kinship with FBGs.  But this is an investment.  Nothing more.  Nothing less.  I pray it doesn't go back to .29.  Maybe in 10 years, I'll be able to feel nostalgia.

With Chet silent and all the crap NP has pulled, I take comfort that someone as critical of CYDY and focused on your investment still thinks this has a chance.

Edited by Charlie Harper
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3 hours ago, Charlie Harper said:

With Chet silent and all the crap NP has pulled, I take comfort that someone as critical of CYDY and focused on your investment still thinks this has a chance.

Thanks, but I'll be out within a week.  It's one last dalliance with an ex-girlfriend. I'm lying.  I'm prolly going to be in and out of this stock for years to come.  But mostly out.

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FDA Commissioner Hahn said this in an interview yesterday with Eric Topol:

Quote

 

https://webcache.googleusercontent.com/search?q=cache:HdWQOutol5UJ:https://www.medscape.com/viewarticle/938705_slide+&cd=1&hl=en&ct=clnk&gl=us#vp_5

if there are data available on any therapeutic that look like it could save a life during a pandemic, and it is safe and it fulfills the criteria of "may be effective," and the risk-benefit ratio is in the right direction, then we should go forward with it. But we intend to be transparent about the rationale behind an EUA, when and if it occurs, for therapeutics. We're going to have to encourage the sponsors to be transparent about the information we provide them, because we are restricted by law from releasing confidential commercial information. But we will, to the extent allowed, be very transparent about it.

But Eric, it is no different from vaccines with respect to needing to see data to make a decision about the criteria for an EUA. The decision is different. As you point out, because if this is for someone who's sick with COVID-19, that's different from someone who's healthy and doesn't have COVID-19.

 

 

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2 hours ago, Don Hutson said:

FDA Commissioner Hahn said this in an interview yesterday with Eric Topol:

 

So do we read into this then that leronlimab likely doesn’t clear these thresholds otherwise it would have gone through already?

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1 minute ago, dkp993 said:

So do we read into this then that leronlimab likely doesn’t clear these thresholds otherwise it would have gone through already?

The results from interim analysis of the S/C trial  weren't expected until this upcoming week.  It takes time for participating hospitals to turn in their materials and then the results are locked.  Once results are locked, it takes some more time for the DMSB to review the data.

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2 hours ago, Don Hutson said:

FDA Commissioner Hahn said this in an interview yesterday with Eric Topol:

if there are data available on any therapeutic that look like it could save a life during a pandemic, and it is safe and it fulfills the criteria of "may be effective," and the risk-benefit ratio is in the right direction, then we should go forward with it. But we intend to be transparent about the rationale behind an EUA, when and if it occurs, for therapeutics. We're going to have to encourage the sponsors to be transparent about the information we provide them, because we are restricted by law from releasing confidential commercial information. But we will, to the extent allowed, be very transparent about it.

But Eric, it is no different from vaccines with respect to needing to see data to make a decision about the criteria for an EUA. The decision is different. As you point out, because if this is for someone who's sick with COVID-19, that's different from someone who's healthy and doesn't have COVID-19.

 

In my opinion once you realize that you have a global pandemic and the economy is going to hell that you do loosen the reins to allow the use of therapeutics that are deemed safe and may be effective and record the results to determine which are actually effective. So this approach makes sense to me.

 

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14 hours ago, Moonlight said:

In my opinion once you realize that you have a global pandemic and the economy is going to hell that you do loosen the reins to allow the use of therapeutics that are deemed safe and may be effective and record the results to determine which are actually effective. So this approach makes sense to me.

 

It seems like this interim analysis is coming at a very good time,  at least in terms of Covid starting to spike again.    I really think its going to make it easier to get EUA.   

The .01 chance that @Whyatt posted seems ridiculous to me.

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40 minutes ago, Dwayne Hoover said:

It seems like this interim analysis is coming at a very good time,  at least in terms of Covid starting to spike again.    I really think its going to make it easier to get EUA.   

The .01 chance that @Whyatt posted seems ridiculous to me.

Lets hope so. Who has the best drug will sort itself out during utilization. First step is to have some good results so we are given the chance..

Part of Hippocratic oath is to do no harm. LL has a very good safety record.

 

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I watched the 60 minutes episode tonight, they talked about monoclonal antibodies. They only mentioned Lilly and Regeneron, big surprise.

The one thing that I thought was interesting though is that the doctor was talking about the low numbers of patientes that both have tested so far.  Regeneron a little under 300 and Lilly more than that but they said they would need to treat thousands of patients before these trials would complete.   The doctor  stressed they were still in the early stages of testing.

If that's the case, I'm afraid that Cytodyn's 195 or so patients can't be enough.

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