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***OFFICIAL CYDY/Leronlimab Thread***


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2 minutes ago, Dwayne Hoover said:

I'm still casually following this one...can't completely get away

I read on yahoo from one poster that seems to know more than most, firmly believes its only a matter of time before NP is gone.

I'm not sure which would be a more positive market moving event.  EUA or NP's dismissal?

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21 minutes ago, Dwayne Hoover said:

I'm still casually following this one...can't completely get away

I read on yahoo from one poster that seems to know more than most, firmly believes its only a matter of time before NP is gone.

Lots of talk on IH about this too. They even have a bunch of speculation on how the next CEO will be.  So nuts, the amount of talk (on both sides of the fence) around this little biotech company is mind blowing. 

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32 minutes ago, Dwayne Hoover said:

I'm still casually following this one...can't completely get away

I read on yahoo from one poster that seems to know more than most, firmly believes its only a matter of time before NP is gone.

Which poster

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2 minutes ago, Capella said:

Just scanned over there and every single post is about the management team being in LA and what does it mean but of course nobody knows what it means. What a bunch of weirdos. 

Our weirdos are way cooler.

 

 

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On 3/9/2021 at 5:55 AM, chet said:

Dr. Bream rewrote the PR. This is how it could have been:

Bream (ER MD) rewrote PR. Wow 

Fellow shareholders,

I took the liberty of re-writing Cytodyn's press release from Friday.  Note, this took me 23 minutes to do.  Seriously.

Vancuover, Washington – CytoDyn (“the company”) is pleased to release the analysis of its CD-12 trial.  
Due to an over-enrollment of patients greater than 65-years-old in the leronlimab arm, a modified intention-to-treat (mITT) analysis was performed to standardize the data.  The mITT analysis of CD-12 yielded the following statistically significant results of primary and secondary endpoints:

1) When leronlimab was used in additional to “commonly used COVID-19 treatments” a clear benefit was seen in the primary endpoint of all-cause mortality at day 28 with an absolute risk reduction of death of 6.5% with a relative risk reduction of death of 28.1% (N = 309, p = .0319).  

2) When leronlimab was used in combination with dexamethasone, a clear benefit was seen in the primary endpoint of all-cause mortality at day 28 with an absolute risk reduction of death of 5.7% with a relative risk reduction of 26.2% (N=233, p=.055)

3) The mean length in hospital stay was decreased by 5.5 days in the critically ill population (p = .005)

Have they come out with the total enrollment numbers in the over 65 population for LL vs SOC?  Looking at the first point of going from 28.1% improvement when you take the over 65 group out and down to 6.5% when added in, it would seem like the over 65 age group would have to almost all be LL patients?  

LL should normally get 67% of these patients in a 2:1 trial.  If they ended up with 75%, then I don't think it's a huge deal and they come off as cherry picking.  If they received in the 90% range then they have a gripe.

I am just trying to break down the data to see if this drug has a legitimate chance of passing the CD16 trial.

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17 minutes ago, IC FBGCav said:

When you start to really break down the numbers, I think it's less and less likely that this drug will find statistical significance in a trial with only 140 critical people.  I believe it helps, but not as much as we once believed.  I also wonder if the whole "we are an oncolgy drug" talk at the beginning of the last CC, was their attempt to soften the blow and pivot away from Covid.

Does anyone know if the CD16 trial they have talked about has started or even been approved by the FDA yet?

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On 3/8/2021 at 9:43 AM, chet said:

This trial started in April and the design hasn't changed since then.  We know so much more about the disease that separating criticals from severes isn't cherry picking--it's simply identifying where the drug is most effective.  

 

 

On 3/8/2021 at 9:45 AM, chet said:

If you had a loved one on a vent with COVID, would you want them to be treated with LL?  The answer has to be an unequivocal yes.

If we agree to say the results weren’t cherry picked then you have to admit that LL actually harms people and isn’t safe for to use for several subsets.   Well I guess you could argue that saline and water should get EUA in those groups. 

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They are on the verge of running out of money.  I don't know how anyone could advise investing any money into this company at this point.  There is no revenue on the horizon and they have no money.

I'm also really sickened by how far away they are on HIV at this point.  

I knew NP was untrustworthy going in but he has raised that to new levels.

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19 minutes ago, Dwayne Hoover said:

They are on the verge of running out of money.  I don't know how anyone could advise investing any money into this company at this point.  There is no revenue on the horizon and they have no money.

I'm also really sickened by how far away they are on HIV at this point.  

I knew NP was untrustworthy going in but he has raised that to new levels.

His comments about the stock value being 3 digits (after knowing the results) seems criminal.  He may have attracted new investors with those comments, as well as prevented someone from hedging their bets on the trial.

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1 minute ago, Chaz McNulty said:

His comments about the stock value being 3 digits (after knowing the results) seems criminal.  He may have attracted new investors with those comments, as well as prevented someone from hedging their bets on the trial.

That quote is what convinced me to sell.  No matter if it is true or false, the quote is simply dumb for a legitimate company.  There is only one reason imo to make that quote, to con people.  

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3 minutes ago, IC FBGCav said:

That quote is what convinced me to sell.  No matter if it is true or false, the quote is simply dumb for a legitimate company.  There is only one reason imo to make that quote, to con people.  

Unfortunately, a lot of people thought he was reassuring people because it was taking so long to get the results out.  You are correct in that there is only one reason to make that quote.

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1 hour ago, BassNBrew said:

 

If we agree to say the results weren’t cherry picked then you have to admit that LL actually harms people and isn’t safe for to use for several subsets.   Well I guess you could argue that saline and water should get EUA in those groups. 

Agreed.  It just shows that cherry picking small populations out of trials isn't enough to prove anything.  It may be enough to explore a bigger trial with that particular subset but that's all that it is good for.

CD12 was a failure.  I don't want to hear any arguments other than that.  Now if you want to say they may have found something that may be promising to explore further as a result of the trial, I'm okay with that, but there isn't going to be an EUA for it until they prove it out in a larger trial.

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4 minutes ago, Chaz McNulty said:

Unfortunately, a lot of people thought he was reassuring people because it was taking so long to get the results out.  You are correct in that there is only one reason to make that quote.

I have to admit, I couldn't even believe he would be that bold to make that statement in the face of failing the primary.  I even gave him the benefit of the doubt that the results must be good. That was criminal.

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2 hours ago, Chaz McNulty said:

  I also wonder if the whole "we are an oncolgy drug" talk at the beginning of the last CC, was their attempt to soften the blow and pivot away from Covid.

 

100% it was, sickening.  An "oncology" company is a joke at this point.  They don't have the revenue to get there.

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18 minutes ago, IC FBGCav said:

That quote is what convinced me to sell.  No matter if it is true or false, the quote is simply dumb for a legitimate company.  There is only one reason imo to make that quote, to con people.  

PRISON

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1 hour ago, BassNBrew said:

@chet please read this and stop parroting the lies of the company insider pumpers that are trying to fleece stock holders. 

I sold all my shares a few weeks ago but anytime I read that hack I go back to multi series report on Bitcoin and how it would be worthless in a few years (2017) and this cydy report reads almost the same. It’s like he has canned reports and he just changes company names.

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Since a lot of this CYDY stuff is played out, the biggest revelation to me today is that many of you may have a subscription to Seeking Alpha?  Do you find it worthwhile?

I've considered it but have always wondered about the quality of the writers and sources.  

 

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19 minutes ago, Dwayne Hoover said:

Since a lot of this CYDY stuff is played out, the biggest revelation to me today is that many of you may have a subscription to Seeking Alpha?  Do you find it worthwhile?

I've considered it but have always wondered about the quality of the writers and sources.  

 

Its free, I only see it because it pops up on news for cydy, when you Google cydy.

 

https://www.google.com/search?q=cydy&oq=cydy&aqs=chrome.0.69i59l2j0i131i433j69i60j69i65.2333j1j7&client=ms-android-verizon&sourceid=chrome-mobile&ie=UTF-8#scso=_rw5NYKu-JMSv5NoP2_KkuAM96:0

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3 minutes ago, IC FBGCav said:

Maybe I just need to clear my cache, it says I've reached free article limit

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6 minutes ago, Dwayne Hoover said:

Maybe I just need to clear my cache, it says I've reached free article limit

I used to get unlimited access on some stuff, now it says two free before I have to clear the cookies 

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1 hour ago, Capella said:

I didn’t hear the oncology company thing though :lmao: :lmao: man god bless that guy. I aspire to have balls that big. 

In fairness, and I can’t believe I’m going to defend that incompetent jackass, NP didn’t say that. Someone else did, a Dr did who they were having speak on the results iirc. 

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1 hour ago, Dwayne Hoover said:

@chet, do you feel your group of large investors are making any progress at getting NP removed?  That would be the most interesting thing to me at this point.

Not my group but there is movement afoot.  I talk to many of those guys every day but for legal reasons I cannot be in that group and am not in that group.

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19 minutes ago, dkp993 said:

In fairness, and I can’t believe I’m going to defend that incompetent jackass, NP didn’t say that. Someone else did, a Dr did who they were having speak on the results iirc. 

Oh. Well darn. 

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40 minutes ago, dkp993 said:

In fairness, and I can’t believe I’m going to defend that incompetent jackass, NP didn’t say that. Someone else did, a Dr did who they were having speak on the results iirc. 

It was Scott Kelly and he's basically an NP puppet.  Whatever he says, NP is on board with.  Wouldn't be surprised if NP didn't even suggest to Kelly say to say it

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11 minutes ago, Chaz McNulty said:

I think it would be good for somewhere between .50-1.00

Unfortunately that might be the “double up” amounts soon at the rate things are going

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Can't wait to see the next set of financials.  Wondering how much that $99,000,000 worth of of LL will balloon.  

By the way...How does one go about establishing a value on inventory that helps PAC12 North division lacrosse fans with Covid but apparently kills Florida Panther fans?

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1 hour ago, BassNBrew said:

Can't wait to see the next set of financials.  Wondering how much that $99,000,000 worth of of LL will balloon.  

By the way...How does one go about establishing a value on inventory that helps PAC12 North division lacrosse fans with Covid but apparently kills Florida Panther fans?

Man, you just don’t stop. 

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Letter from Jay Lalezari to Janice Woodcock:

Quote

From: Jay Lalezari <drjay@questclinical.com>

Subject: Leronlimab for critical Covid

Date: March 10, 2021 at 3:32:08 PM PST

To: "Janet.Woodcock@fda.hhs.gov" <Janet.Woodcock@fda.hhs.gov>

Cc: Jeffrey S Murray <jeffrey.murray@fda.hhs.gov>, Debra B Birnkrant <debra.birnkrant@fda.hhs.gov>, "Kimberly.Struble@fda.hhs.gov" <Kimberly.Struble@fda.hhs.gov>

 

Dear Dr. Woodcock,

 

The FDA has protected the American public during Covid by issuing various EUAs, but no treatment has been advanced that specifically helps our most vulnerable citizens-those who are critically ill. And unfortunately, with variant strains now circulating, a potential 4th wave is possible.

 

CytoDyn’s CD12 trial is the first randomized, double-blind, placebo-controlled study to suggest a striking survival benefit for critically ill Covid patients (24% reduced mortality; p value nss). The study demonstrates statistical significance on a variety of crucial secondary endpoints including shortened hospital stay (6 days; P=0.005), improved survival in patients who received SOC therapy (N=309; P=0.031), and improved survival in patients under 65 years of age, including both all patients under 65 (N=221; P=0.02) and well as those who were critically ill (N=44; P=0.006). The study also demonstrated no safety concerns, consistent with the benign safety profile seen in about 1,000 other HIV+, cancer, and Covid patients who have received leronlimab. The unfortunate imbalance in randomization of patients > 65 years of age (and especially > 75 years) in the CD12 study should not, however, prevent patient access to a potentially life saving medication now while a study of additional critically ill patients is underway. Taken together, the CD12 efficacy signals in critically ill patients combined with the consistently benign safety profile, provide a compelling risk:benefit ratio and ample justification for FDA to issue an EUA for leronlimab for this population now.

 

I am consulting in the care of a 57 year old man with critical Covid who was on ECMO for 61 days at St. Thomas hospital in London. He received emergency leronlimab on day 79 of his hospitaliztion and starting weaning off ECMO 4 days later. I have attached the case report below, which has been peer reviewed and accepted for publication.  Please give it your consideration. Though anecdotal, this case underscores the dramatic recovery that is possible with leronlimab even in the most critically ill patients with Covid.

 

I have been an independent investigator on about 50 POC studies of novel antiviral agents over the last 31 years (including HIV, CMV, HCV, HBV, HSV, HPV, and Influenza). Also, I have no equity stake in this. 

 

I know leronlimab to be safe and I believe it can help save critically ill patients with Covid-19.

Please give these patients and their medical teams a fighting chance.

 

Respectfully,

 

Jacob Lalezari, MD

Director, Quest Research

SF, CA

 

(w): 415-353-0800

(c): 415-939-0783

www.questclinical.com

 

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