Jump to content
Fantasy Football - Footballguys Forums

***OFFICIAL CYDY/Leronlimab Thread***


Recommended Posts

3 minutes ago, 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

Quote

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).

Nookie in Two Weeks honey.

Link to comment
Share on other sites

15 hours ago, Dave RL said:

BreezeWoodAcres  says 6PM

Let's see if that holds up 🤥

Well, in his defense, he didn't say 6PM today (which was yesterday).  So we got that goin' for us. 

Probably 6PM in just a couple of weeks.  

  • Like 1
Link to comment
Share on other sites

1 hour ago, 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. 

There is definitely a movie to be made right in this forum!

Link to comment
Share on other sites

1 hour ago, ex-ghost said:

$4.68

and now $4.34. This stock....

 

15 minutes ago, Dwayne Hoover said:

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.

Sold yesterday's $4.10 purchase at $4.56.

Link to comment
Share on other sites

1 minute ago, Bob Sacamano said:

I notice that release doesn't say anything about an endpoint. 

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

 

first bulletpoint... 

Link to comment
Share on other sites

4 minutes ago, 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... 

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

Link to comment
Share on other sites

2 minutes ago, Capella said:

Can they still get an EAU or is this curtains?

Quote

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.

 

Link to comment
Share on other sites

6 minutes ago, chet said:

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

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.

Link to comment
Share on other sites

Quote

 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.

They are probably using the data from these patients to power up the trial.

Link to comment
Share on other sites

3 minutes ago, 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.

You're right.  I missed that it was for the critically ill segment only.

Edited by chet
Link to comment
Share on other sites

3 minutes ago, chet said:

I am referring to work that I did before.  You're right, it's a guess but a somewhat informed one.

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.

Link to comment
Share on other sites

Just now, Chaz McNulty said:

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.

I agree.  

 

Link to comment
Share on other sites

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.

  • Love 1
Link to comment
Share on other sites

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.

Link to comment
Share on other sites

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...

  • Like 1
Link to comment
Share on other sites

2 minutes ago, chet said:

I agree.  

 

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.

Link to comment
Share on other sites

4 minutes ago, 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.

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.

Link to comment
Share on other sites

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.

Link to comment
Share on other sites

14 minutes ago, chet said:

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.

Trying to get to 60 day endpoint?

Link to comment
Share on other sites

15 minutes ago, 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? 

Ok a call things are definitely bad lol 

Edited by Capella
Link to comment
Share on other sites

4 minutes ago, BassNBrew said:

Curtains.

Hopefully the bankruptcy judge awards us a vail of LL as a keepsake at the hearing.

Well, if Hgen is even moderately successful I’ll get out of this even steven at the least. We’ll see. 

Link to comment
Share on other sites

Join the conversation

You can post now and register later. If you have an account, sign in now to post with your account.

Guest
Reply to this topic...

×   Pasted as rich text.   Restore formatting

  Only 75 emoji are allowed.

×   Your link has been automatically embedded.   Display as a link instead

×   Your previous content has been restored.   Clear editor

×   You cannot paste images directly. Upload or insert images from URL.

  • Recently Browsing   0 members

    • No registered users viewing this page.
×
  • Create New...