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***OFFICIAL CYDY/Leronlimab Thread*** (7 Viewers)

Dwayne Hoover said:
Well, that's what we are hanging our hat on.  Hopefully the drug works AND the FDA is willing to work with Cytodyn. 

And if you can find a reporter that will pick up this story, it could be one hell of a story.
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Yes, but I imagine the movie screenplay with three main through lines. Nader tries to snatch defeat from the jaws of victory by ineptly guiding this company with a revolutionary drug but hindered by his bizarre mismanagement. The short sellers must get a little screen time, too, since every story needs antagonists. And then of course, our heroes at FBG led by chet (played by Christian Bale, naturally) sailing off into the sunset in their cleverly named Joe Bryant boats. I’d watch that. Heck, I have watched that. 

 
unckeyherb said:
Updated criteria for the Long Haulers clinical trial.  It appears that it didn't actually start in December.

https://clinicaltrials.gov/ct2/history/NCT04678830?A=1&B=3&C=merged#StudyPageTop
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Men and women of childbearing potential and their partner must agree to use  at least one highly effective two medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], or one of the following methods of birth control (intrauterine devices, bilateral tubal occlusion, or vasectomy) or must practice complete sexual abstinence  ) for the duration of the study (excluding women who are not of childbearing potential and men who have been sterilized).
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Nookie in Two Weeks honey.

 
pecorino said:
Yes, but I imagine the movie screenplay with three main through lines. Nader tries to snatch defeat from the jaws of victory by ineptly guiding this company with a revolutionary drug but hindered by his bizarre mismanagement. The short sellers must get a little screen time, too, since every story needs antagonists. And then of course, our heroes at FBG led by chet (played by Christian Bale, naturally) sailing off into the sunset in their cleverly named Joe Bryant boats. I’d watch that. Heck, I have watched that. 
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There is definitely a movie to be made right in this forum!

 
Im a masochist but going to try and scrape a few pennies today in a bass and brew style trade.   Just picked up some at 4.24, hoping for a true power hour today where I can turn these around for some fish and chips.

 
Capella said:
Survival benefit: There was a 24% reduction in all-cause mortality (primary endpoint of the study) in the leronlimab versus placebo.

first bulletpoint... 
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Looks like they might have missed statistical significance by one death (p-value ~0,058).

 
Capella said:
Can they still get an EAU or is this curtains?
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The trial’s data has been reported to the U.S. Food and Drug Administration (“FDA”), the U.K.’s Medicines & Healthcare product Regulatory Agency (“MHRA”) and Health Canada (“HC”), and the Company is in discussions with each to determine the best path forward for approval of leronlimab for treatment of COVID-19 in critically ill population.
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chet said:
Looks like they might have missed statistical significance by one death (p-value ~0,058).
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It's impossible to figure out the P-Value because they only gave the statistics for the critical patients and they only accounted for 62 patients.  They do not give a value for the other 320 severe patients.

https://www.cytodyn.com/newsroom/press-releases/detail/501/cytodyns-phase-3-trial-demonstrates-safety-a-24

Highlights from the trial’s data for this critically ill population include the following:

Survival benefit: There was a 24% reduction in all-cause mortality (primary endpoint of the study) in the leronlimab versus placebo.

 
 The Company has continued to enroll patients (45) through the open-label arm of the CD12 trial, and is working with regulators here and abroad to expedite this process.
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They are probably using the data from these patients to power up the trial.

 
Chaz McNulty said:
It's impossible to figure out the P-Value because they only gave the statistics for the critical patients and they only accounted for 62 patients.  They do not give a value for the other 320 severe patients.

https://www.cytodyn.com/newsroom/press-releases/detail/501/cytodyns-phase-3-trial-demonstrates-safety-a-24

Highlights from the trial’s data for this critically ill population include the following:

Survival benefit: There was a 24% reduction in all-cause mortality (primary endpoint of the study) in the leronlimab versus placebo.
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You're right.  I missed that it was for the critically ill segment only.

 
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chet said:
I am referring to work that I did before.  You're right, it's a guess but a somewhat informed one.
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I really wish they just put the data out there.  Cherry-picking results is not a good look and it just gives the detractors ammunition.

 
Swing and a miss.  

We wanted this so bad we talked ourselves out of the obvious (the trail was a failure when they didn't release results earlier).  On Monday we reap the reward of our stupidity. On the plus side, at least I trimmed 70% of my position during this timeframe.

 
It's a shame that the critical component of the trial was so small.  I imagine the results from the severe patients were probably negligible, as they don't even mention it in the PR.  It looks like the company is pivoting to the really sick patients now.  

It's probably better, but this is another example of the company fumbling around.

 
So isn't this basically what they did for the mild/moderate trial?  Released some cherry picked data, said they would release the raw data later, and then just kept kicking that can down the road until everyone just got tired of asking?

The stock price did not react well to that...

 
chet said:
I agree.  
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At least they are giving you a chance to get out Monday in the 2's rather than in the 1's.  It won't be as good of a price as the company insiders got, but at least it's something.  I suspect with all the LL ordered and on hand this company is bankrupt shortly.

 
BassNBrew said:
At least they are giving you a chance to get out Monday in the 2's rather than in the 1's.  It won't be as good of a price as the company insiders got, but at least it's something.  I suspect with all the LL ordered and on hand this company is bankrupt shortly.
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Unless they get some positive news from one of the governing bodies they are supposedly in discussions with this weekend, then I believe you are correct.

 
This way worse than I thought it was going to be but the FDA is still working with them and they've enrolled 45 OLE patients.  That tells me they're scrambling to get more data.

 
HaFo SaFo said:
Nader Pourhassan will hold a webcast on Monday to provide an overview of the future path forward.

I'm sure that will be awesome.

I guess the good news is that it can't go below $0, right? 
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Ok a call things are definitely bad lol 

 
Last edited by a moderator:
The good news is it will drop like a rock Monday first 30 minutes and rebound some.  Sell then.  If you have faith buy back some.   But I will be out unless it hit under 2.

 
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