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***OFFICIAL CYDY/Leronlimab Thread***


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Discharge alive: In addition, patients who received leronlimab demonstrated an improved probability of "discharged alive" at Day 28 (28% versus 11%), a 166% better rate than in the placebo group.

Guessing a bit on the numbers (it was 2/1 LL/placebo I think), but is this saying that 12 out 43 who got LL lived while 31 died?  And 17 of 19 on the placebo died?  And this did not include any that might have died later.  

These numbers combined with hearing the vaccines are 95% effective keeping you from going critical makes me want to get the vaccine asap.

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2 minutes ago, needanap said:

Discharge alive: In addition, patients who received leronlimab demonstrated an improved probability of "discharged alive" at Day 28 (28% versus 11%), a 166% better rate than in the placebo group.

Guessing a bit on the numbers (it was 2/1 LL/placebo I think), but is this saying that 12 out 43 who got LL lived while 31 died?  And 17 of 19 on the placebo died?  And this did not include any that might have died later.  

These numbers combined with hearing the vaccines are 95% effective keeping you from going critical makes me want to get the vaccine asap.

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

So there was 166% better rate of leaving the hospital alive, but only a 24% reduction in all cause mortality at the end point?  Anyone one have an explanation on this?

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1 minute ago, ex-ghost said:

Reddit very positive, too. Pumpers. 

Maybe we’re being negative about this bc that’s what we are trained to do? Guess it doesn’t really matter till Monday morning either way. 

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1 minute ago, IC FBGCav said:

I told the results and it wasn't bad.  But no context.  Giving the opinion on the little info I give.

Did you let her know that the 24% reduction in death was only for the 62 Critical patients.  They never gave data on the 320 severe patients.

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I just got off the phone with someone who is VERY knowledgable has been involved but not with CYDY.  Key takeaways:

1) They focused on the critical pop.  Humanigen and Relief both pulled criticals from their studies.  This is very positive because there is nothing to treat these people.

2) 24% reduction in mortality in that cohort--not stat significant because of the low number of patients (62)

3) Stat significant reduction in hospital stay by 6 days.  This is a big money saver and is what got remdesivir an EUA.

4) They've enrolled 45 OLE patients with the blessing and help of the FDA.  

Bottom line: while the results were not what I hoped, this drug is far from dead in terms of getting an EUA.  I think the stock struggles on Monday as the shorts paint a bleaker picture but there is a real opportunity with the criticals.

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5 minutes ago, Chaz McNulty said:

Did you let her know that the 24% reduction in death was only for the 62 Critical patients.  They never gave data on the 320 severe patients.

I am sure this matters alot and will text her this.

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4 minutes ago, chet said:

I just got off the phone with someone who is VERY knowledgable has been involved but not with CYDY.  Key takeaways:

1) They focused on the critical pop.  Humanigen and Relief both pulled criticals from their studies.  This is very positive because there is nothing to treat these people.

2) 24% reduction in mortality in that cohort--not stat significant because of the low number of patients (62)

3) Stat significant reduction in hospital stay by 6 days.  This is a big money saver and is what got remdesivir an EUA.

4) They've enrolled 45 OLE patients with the blessing and help of the FDA.  

Bottom line: while the results were not what I hoped, this drug is far from dead in terms of getting an EUA.  I think the stock struggles on Monday as the shorts paint a bleaker picture but there is a real opportunity with the criticals.

This is so painful. Slow bleed. I hate that we need to continue to wait. Nader is an idiot. 

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4 minutes ago, ex-ghost said:

This is so painful. Slow bleed. I hate that we need to continue to wait. Nader is an idiot. 

It is, because it screaming scam.   At the least not worthy.  Its easy.  Everyone take out the money and vested interest.  Do a pro and con list.  Its cons big. 

But doesn't mean....there is the carrot

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Just now, IC FBGCav said:

I am sure this matters alot and will text her this.

If they had gotten 24% reduction across the board, we would all be doing the happy dance.  I believe that would have put the P-value below .05.  Unfortunately the trial had a really low number of Critical patients.  62 patients just isn't enough to power results.  

We could be talking about 10 out of 21 deaths for Palcebo, and 15 out of 42 deaths for LL.  

 

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2 minutes ago, Chaz McNulty said:

If they had gotten 24% reduction across the board, we would all be doing the happy dance.  I believe that would have put the P-value below .05.  Unfortunately the trial had a really low number of Critical patients.  62 patients just isn't enough to power results.  

We could be talking about 10 out of 21 deaths for Palcebo, and 15 out of 42 deaths for LL.  

 

This from the statement -- probability of "discharged alive" at Day 28 (28% versus 11%) -- makes it seems the number of deaths is much higher than 10 and 15.

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4 minutes ago, IC FBGCav said:

After sending chas concerns:

I know. But they are still enrolling critically ill for that reason. So I think that's a good sign. 

The thing is, no one knows what it needed to be statistically significant. I'm not sure what the FDA says they needed to meet. 

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1 hour ago, IC FBGCav said:

The thing is, no one knows what it needed to be statistically significant. I'm not sure what the FDA says they needed to meet. 

500k dead and we have a 68 patient study that shows basically nothing.  If the severe is showing no improvement you have to wonder if you critical results were dumb luck.

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8 minutes ago, BassNBrew said:

500k dead and we have a 68 patient study that shows basically nothing.  If the severe is showing no improvement you have to wonder if you critical results were dumb luck.

One of the problem with the severe trial is that it takes more then 28 days to progress from severe to critical to death.  I really wish we could see the actual data as well as any more information regarding the extension to 48 and 60 days.

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18 minutes ago, IC FBGCav said:

Let me say the obvious.  If and its a huge if it works for late stage.....you hit a niche market.

Dude, don’t you want to invest in a cutting edge stage coach?

Also repeating myself, but congrats on playing this perfectly and turning it into a 2nd home. :tebow:

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Just now, BassNBrew said:

Dude, don’t you want to invest in a cutting edge stage coach?

Also repeating myself, but congrats on playing this perfectly and turning it into a 2nd home. :tebow:

I have never regretted taking my profits when I did.  I don't think I ever will.  I will always hold 10k of cydy just in case.   

 

I will have a cornhole at the cabin!

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Gotta give it to NP. Knows how to string them along.

First bullet point and primary end point...no mention of statistical significance. That says it all. 

My hospital in the Bay Area has 20 Covid patients and was as low as 13 last week. This was after being in the low 100s in December and January. 

Vaccines are rolling out in developed countries. Not sure poorer nations can afford the drug. CYDY missed the boat. Guess it's onto the next disease since HIV and COVID haven't been approved yet.

 

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If this was for some other indication for a disease with a long-term horizon, I would be excited and wait for the results of another trial.  Problem is, COVID with the vaccines along with other potential treatments from HGEN, MERCK, EDSA, AVIR, etc. there is a short-term horizon.  They did not provide how many more patients will be required for another trial to meet statistical significance or even if this will be approved by the FDA.  I suspect we are looking at another trial with 200 critical patients.  When will it start?  April Fools if we’re lucky and perhaps end sometime in the fall and how long will it require to report these results?  If we’re looking at 2022, how much revenue can be made when most of the population should be vaccinated?  If other treatments are approved, how many patients will reach critical stage of the disease?  If Pfizer was running this, no biggie but CytoDyn is small and strapped for cash.  They needed revenue yesterday and they missed their endpoint and did not advise so in the PR and did not provide the other numbers.  I don’t remember all the details but at some point they halted the trials and doubled study locations.  If only they had known to focus on critical or started with more locations to enable them to potentially start another trial.  From a risk/profit benefit, is it even worth it to pursue this for them?

 

Adam Feuerstein has already tweeted and you can be sure there will be a STAT news article.

 

“leronlimab ph3 study in patients w/ severe Covid19 failed its primary endpoint - improvement in mortality. As with its previous failed study in moderate Covid, the company is spinning the data to cushion the blow of a negative outcome.”

 

I wonder if Mrs. Kelly will sell her shares Monday morning or wait for the Nader Pump?

Edited by The Blue Baron
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From Yahoo board.  The numbers workout with the details from the PR.

Quote

Here's one potential scenario: 62 critical patients. 40 on LL, 22 on SOC. 29 died on LL, 19 died on SOC. Can only guess at this, because no death counts included in the PR. These #'s align with the PR percents on improvement and survival. P value is 0.106, significance of 89.4%. If you double the trial size and keep the same death rates, P value drops to 0.039 with 96.1% significance. My take...EUA should be a given, if the OLE confirms the death rates of the RCT. If someone is in danger of being put on a vent,the first therapeutic given will be leronlimab. One other observation - these people were REALLY sick - all in this subset were on vents. Almost 86% mortality with SOC and 72% on LL.

 

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2 hours ago, Capella said:

Those people are very very much in a cult. There is no reasoning with them. 

These are some of the dumbest people I've ever met and knew I shouldn't have been on the same side as most of them.

calstang66 3 hours ago

"Severe data not in the PR. Leronlimab may have reduced death in severe by 100%"

Amy 3 hours ago

Monday morning PR announcing mind-blowing severe population results. Had to release the critical data now to give lay investors time to get any confusion under control.

Edited by Dwayne Hoover
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3 hours ago, Chaz McNulty said:

From Yahoo board.  The numbers workout with the details from the PR.

 

62 patients isn't getting them anywhere.  This is the same cherry picked data they did in CD10 that went nowhere.

I can only hope that there will be some buyers on Monday.  
 

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3 hours ago, Dwayne Hoover said:

62 patients isn't getting them anywhere.  This is the same cherry picked data they did in CD10 that went nowhere.

I can only hope that there will be some buyers on Monday.  
 

What's the strategy.  I'm thinking market order and keep my fingers crossed it sells for over $2.  Usually there's a pretty significant bounce off the bottom but I can't imagine anyone wanting to own this stock again as they will be out of business by the end of the year.

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8 hours ago, The Blue Baron said:

I wonder if Mrs. Kelly will sell her shares Monday morning or wait for the Nader Pump?

She already sold here shares when she became aware that the study failed to meet it's endpoint.

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10 minutes ago, BassNBrew said:

What's the strategy.  I'm thinking market order and keep my fingers crossed it sells for over $2.  Usually there's a pretty significant bounce off the bottom but I can't imagine anyone wanting to own this stock again as they will be out of business by the end of the year.

Lol this is way too pessimistic. This is becoming a cult stock, there will be plenty of buyers. 

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43 minutes ago, Capella said:

Lol this is way too pessimistic. This is becoming a cult stock, there will be plenty of buyers. 

Hoping this PR was confusing and gives enough hope that some are hesitant to sell right away.

Are Chet and his cohorts gonna sell at open?

If I get out without too much further damage would be minor miracle

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If the FDA grants an EUA, the stock will soar.  If they say you need 100 more patients, the stock will be crushed.

Woodcock has been very vocal about being more lenient in the pandemic. Let's hope that leniency extends to small companies and not just BP.  However, after the story about Mexico suing Gilead for trying to block other HIV treatments, I am sure they are also in Woodcock's ear urging her to get more data from CYDY.

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I really think the company screwed up by not looking at the data at the 50% point.  They would have been able to see where they were hitting and where they were missing.  And at that point they could have pivoted to the more critical patients.  Also surprised that the board had them just carry on with the study and not recommend this themselves.

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Just now, Chaz McNulty said:

I really think the company screwed up by not looking at the data at the 50% point.  They would have been able to see where they were hitting and where they were missing.  And at that point they could have pivoted to the more critical patients.  Also surprised that the board had them just carry on with the study and not recommend this themselves.

I think if there was a review at 75% they would have gotten recommendations to adapt the trial.  Not getting that review was a killer. NP and team screwed that up.

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