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

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. 

 
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. 
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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.

 
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.
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You have more faith in regulating organizations than me.

 
Charlie Harper said:
You have more faith in regulating organizations than me.
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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.

 
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unckeyherb said:
two weeks.
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arrow1 said:
melting green
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dkp993 said:
Short attack!  😉
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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 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.
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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.

 
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.
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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.

 
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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.
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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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Don Hutson said:
Thanks, but I'll be out within a week.  It's once 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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So, the ex-girlfriend

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

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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dkp993 said:
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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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.

 
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.
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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.

 
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.
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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.

 
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.
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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.

 
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.

 
One other good thing is that they asked the doctor whether he would rather have a vaccine or therapeutic and he said therapeutic.

 
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Dwayne Hoover said:
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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I think it also makes a difference for what they are testing for.  If the primary is death, you probably don't need a huge test group.

 
Chaz McNulty said:
I think it also makes a difference for what they are testing for.  If the primary is death, you probably don't need a huge test group.
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I hope so.  Wish Cytodyn was more on the public's radar.  The FDA approving this would come out of nowhere, makes me think it won't happen, hope that I am wrong.  Still think it has a better than .01 chance.

 
Dwayne Hoover said:
This place is officially dead.   Little Phillipines news here, although if you tell me this a bait and switch, I will believe you.  Language a little vague on what it means. Reminds me of Mexico, hope Im wrong

https://www.cytodyn.com/newsroom/press-releases/detail/474/cytodyn-appoints-chiral-pharma-to-secure-leronlimab-for
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Not worth too much based on previous CYDY history. So they hired someone to get approval. What's that worth?

It does makes sense to partner with someone who knows how the Philippines system works. But its not an application or trial, its a very preliminary step.

 
Moonlight said:
Not worth too much based on previous CYDY history. So they hired someone to get approval. What's that worth?

It does makes sense to partner with someone who knows how the Philippines system works. But its not an application or trial, its a very preliminary step.
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I don't like this news to be real honest.  It feels like a pump to me with little behind it.   On a week where we are supposed to get an interim look at the data, we are pivoting towards Phillipines and not with any real news, just "to register for potential approval"

If NP hadn't let us down before, perhaps I would give a little credibility to it but this seems pretty weak to me.

 
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Dwayne Hoover said:
I don't like this news to be real honest.  It feels like a pump to me with little behind it.   On a week where we are supposed to get an interim look at the data, we are pivoting towards Phillipines and not with any real news, just "to register for potential approval"

If NP hadn't let us down before, perhaps I would give a little credibility to it but this seems pretty weak to me.
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Nader had promised that Philippines news would come this week.  So he is just doing what he promised.  It is good that some groundwork has been laid in other countries in case an EUA isn't granted.  If the EUA isn't granted, Nader can unblind the data and sell to any country that wants leronlimab.  All of this is going to have to happen very quickly if we're going to ramp up production.

 
Don Hutson said:
Nader had promised that Philippines news would come this week.  So he is just doing what he promised.  It is good that some groundwork has been laid in other countries in case an EUA isn't granted.  If the EUA isn't granted, Nader can unblind the data and sell to any country that wants leronlimab.  All of this is going to have to happen very quickly if we're going to ramp up production.
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We will see if the market cares (likely not much), hope we don't drop

 
Trump is going to be on Michael Savage's show today.  Michael Savage is a supporter of leronlimab.  Although, a question about leronlimab would probably have to be prescreened and okayed which isn't likely.

 
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Don Hutson said:
Trump is going to be on Michael Savage's show today.  Michael Savage is a big supporter of leronlimab.  Although, a question about leronlimab would probably have to be prescreened and okayed which isn't likely.
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Could also backfire if asked.  POTUS says he's never heard of it, or says they don't think it works as well as REGENERON!!!!!

 
Don Hutson said:
Trump is going to be on Michael Savage's show today.  Michael Savage is a supporter of leronlimab.  Although, a question about leronlimab would probably have to be prescreened and okayed which isn't likely.
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Trump will never say leronlimab because he can't pronounce it. 

 
I want to unload some of my shares before any official news comes.  My guess is the news will be that they saw no reason to halt the trial and they should complete.

Does NP have any more parlor tricks to run up the share price before that happens? It will have to be one that people haven't seen before.

 
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Likely unloading about half my shares today. Hope I'm wrong but think by next week they will be worth less than they are now.

Not sure what else NP can pull out of a hat but guessing nothing that is imminent. I don't think he will unblind the data so we are likely pushing this trial out to completion in the dark. That's too much time of battling this share price.  If things look promising I will buy them back for what I think will be a better price.

 
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