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

Capella said:
No call today. Stop listening to Otis and icon. 
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:wub:  HEy now... I'm only shticking it up in here. I'm HODLing long... but also not afraid to goof around and point out some of the dumb #### surrounding this holding. 

It's the FFA babyyyyyyyyyy!
 

djmich said:
Oof.  not the press we wanted 

https://www.wsj.com/articles/with-biotech-stocks-investors-love-the-thrill-of-the-chase-11596619800
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Sadly no WSJ subscription. I always love a good recycled hit piece. 

Farcestein waking up every morning.

 
 WSJ

Some areas focused on:

Deaths in the Montefiore study

Quoted NP regarding stock sale as saying I've been  waiting all these years. I might as well have some security for myself.

Denial of BLA due to including mock data set

NP exaggerations regarding timelines and efficacy

NP going off on staff when challenged regarding his exaggerations

 
Moonlight said:
 WSJ

Some areas focused on:

Deaths in the Montefiore study

Quoted NP regarding stock sale as saying I've been  waiting all these years. I might as well have some security for myself.

Denial of BLA due to including mock data set

NP exaggerations regarding timelines and efficacy

NP going off on staff when challenged regarding his exaggerations
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That last point definitely makes me think of his calls where he asks the uplisting point guy if it will happen in a few weeks and the guy nervously laughs and says yea anything is possible I guess but probably a little longer. The exaggeration problem with him isn’t giving me the warm and fuzzies in regards to anything he’s said about the trials. 

 
  from another board​

One of the WSJ authors was kind enough to provide a response to my request for insight into their conclusion that “Most experts don’t give CytoDyn much chance of success.” He stated that that the conclusion mostly refers to investment analysts talking about odds against such companies as well as medical experts who caution that most phase 1/2 trials don't result in success. So, it does not appear that the authors did any investigation into the drug itself, which i indicated perhaps they should do for a more complete profile of the company.​
 
JerseyToughGuys said:
So CYDY makes it into the Wall Street Journal and the price action kind of yawns. 

huh
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Well it's a negative piece.

If you're holding now, I doubt you jump ship so close to the m/m study results regardless of the article (seems like nothing damning).

If you have no idea about CYDY unless you found this magic message board or sifted through the crap on Yahoo! boards it would be very hard to invest in this company. 

Hell there's people here who know the backstory and still have doubts.

 
Taken from another board. More and more mention of LL.

Leronlimab mention...LBL Hospital
In same article w Remdesivir...

"At Lyndon B. Johnson Hospital, doctors and researchers are also testing the use of leronlimab, an anti-inflammatory medication. The study measures the drug’s effectiveness in helping patients survive and reduce the severity of complications."

"....said Dr. Jordan E. Lake, who led the leronlimab study at LBJ Hospital and an associate professor of infectious diseases at McGovern Medical School."


https://www.click2houston.com/health/2020/08/05/remdesivir-effectiveness-among-35-covid-related-studies-underway-at-harris-health-hospitals/
 

 
From another board:

played a bit with the numbers to see how statistical significance works

tool used: https://abtestguide.com/calc/ settings: two-sided, 95% confidence

so far DSMB looked into result (after 28 day passed) for ~100 patient data

it's 2:1 Leronlimab to placebo ratio, let's work with 66 in Leronlimab arm and 33 in placebo arm

assume 30% mortality for critically ill patents

source: www.ncbi.nlm.nih.gov/...

thus expect ~10 deaths in placebo arm

QUESTION1: what death rate in Leronlimab arm is the limit of p=0.05 significance at current sample size (~100)?

QUESTION2: assuming death rate for the Leronlimab arm be HALF of the death rate of the placebo arm, what sample size is needed for statistical significance?

QUESTION3: what death rate in Leronlimab arm is the limit of p=0.05 significance at sample size of 1000?

ANSWER1:

placebo 10 death out of 33, lerolinmab X death out of 66

X=8 is the limit for significance

and the death rates are placebo: 10/33=30%, lero: 8/66=12%

that is, the death rate for Lero must be 2.5 times lower at this sample size

ANSWER2:

14 death out of 46 in placebo arm and 14 death out of 92 in Leronlimab arm is the limit for the results be statistically significant

ANSWER3:

placebo 100 death out of 333, lerolinmab X death out of 666

X=160 is the limit for significance

and the death rates are placebo: 100/333=30%, lero: 160/666=24%

that is, the death rate for Lero must be 1,25 times lower at this larger sample size

==> the sample size DOES matter and matters a LOT

that is in order to win, you need 2 things at least:

1. a good drug (according to Dr. BP we have it)

2. LOT of data

the negativity from Citron and Co. here does 2 things:

1. bashes the stock price, that is hurting CYDY's ability to finance the trials --> less data

2. destroys patience confidence --> less data

some experts is statistics should comment and correct if I'm on the wrong track...

 
Capella said:
I’m not an expert on this topic but if he says this and it’s not the case he’s looking at lawsuit city isn’t he? 
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I'm not sure a guy accused of selling Elizabeth Warren's rantes is really concerned about a lawsuit.

 
4:12 mark -- "In CD-10 we announce that we found parameters.  Phase 2 is a proof of concept. Any parameter in your secondary outcome or your primary outcome is just perfect if you can find a perfect difference between Leronlimab and placebo. We found them.  And I told everybody that we believe it is statistically significant and we're going to give the P value... we have to finalize those reports before we can give exact... but that's my opinion that we will announce statistically significant parameter." 

 
If m/m results are not statistically significant then I would know its time to significantly reduce exposure.

As Dr. P and Dr. L are firmly endorsing LL, as well as other docs, got to roll with it for now.

 
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Moonlight said:
If m/m results are not statistically significant then I would know its time to significantly reduce exposure.

As Dr. P and Dr. A are firmly endorsing LL, as well as other docs, got to roll with it for now.
Click to expand...
Who's Dr. A?  Lalezari?

 
So two main questions/comments based on the interview.

1) So was he saying that the DSMC review was NOT the interim review that could end the study and get an immediate EUA?  It sounded like he was saying this was something separate, and that an interim efficacy review was still scheduled for soon (next week maybe, can't recall).

2) Based on the way he spoke about statistical significance and endpoints I am guessing the endpoint he's referring to was one or more of the secondary endpoints, not the primary.  I don't think this is a problem as wasn't remdisivir approved on a secondary endpoint that didn't even quite reach the .05 p-value?

Then the other big question is whether he's using the term statistically signficant in the defined manner as something that had a sub .05 p-value or if it didn't and he's just saying he believes it is a number that is significant.

 
Moonlight said:
As Dr. P and Dr. L are firmly endorsing LL, as well as other docs, got to roll with it for now.
Click to expand...
At the end of the day, this is critical.  We always have to keep in mind that it's not just NP.

Now I know the Waiting is the Hardest Part (cue Tom Petty to sing another lyric) but maybe we need to put into perspective how much momentum this stock has behind it since the beginning of the year.  Fully realize that its not currently helping Otis's side piece much but it hanging around $5 when it was at .30 back in December, is very positive.   It has a lot of support.

Im okay with patience in general if the good news does come.   The only thing that does concern me is the race to get to market.  Not sure if this is a legit concern or not but am worried about being surpassed.  Otherwise all we need is just a little patience.

 
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FreeBaGeL said:
So two main questions/comments based on the interview.

1) So was he saying that the DSMC review was NOT the interim review that could end the study and get an immediate EUA?  It sounded like he was saying this was something separate, and that an interim efficacy review was still scheduled for soon (next week maybe, can't recall).

2) Based on the way he spoke about statistical significance and endpoints I am guessing the endpoint he's referring to was one or more of the secondary endpoints, not the primary.  I don't think this is a problem as wasn't remdisivir approved on a secondary endpoint that didn't even quite reach the .05 p-value?

Then the other big question is whether he's using the term statistically signficant in the defined manner as something that had a sub .05 p-value or if it didn't and he's just saying he believes it is a number that is significant.
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Yes, the DSMC review was not the interim review that could end the study.  The interim efficacy review is scheduled for when they get the 195 patients enrolled.  That's how I understand it anyway.  This week was just a safety review and the DSMC recommended they continue the trial without changing any endpoints.  I think that's good news. 

2) It was unclear, but probably one or more of the secondary endpoints.  You are correct about remdisivir.  They ended up changing one or more endpoints, IIRC.  

His use of statistically significant was unclear.  He did mention p-value but didn't commit to saying they will definitely have a sub .05 p-value.  

Dr. L reiterated that he is surprised LL reduced SAEs in the M/M trial (I think the M/M trial).  Said he's never seen that in a clinical trial, for whatever it's worth.  

 
Charlie Harper said:
Do you believe him?

#Selling or #notselling?
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This is the most unsettling piece for me.  I’m long and not overly sweating the day to day swings but Chets been awful quite about his stance the past few weeks.  That makes me way more nervous then NP being NP.  

 
dkp993 said:
This is the most unsettling piece for me.  I’m long and not overly sweating the day to day swings but Chets been awful quite about his stance the past few weeks.  That makes me way more nervous then NP being NP.  
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56 pages into this thread and a few hundred buried in the stock thread....I think we surpassed Chets knowledge about CYDY a long time ago.

Think about it, we know he didn't have a glimpse into the COVID trial results when he originally recommended and COVID didn't even exist. 

At this point I'm guessing he's learning things from us and has the exact same thoughts regarding pro/cons.

I don't mean that in a bad way...he saw the potential a long time ago and we're all now waiting for results.

 
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I'm only peripherally aware of this thread and don't know if this drug has been discussed a lot in it, but I thought maybe this memo I got would be of interest to ya'all.

(I'm a doc that takes care of covid patient - lots of 'em lately unfortunately)

MEMO:

This past week, Roche Pharmaceuticals, the manufacturers of Tocilizumab (Actemra), released an

update on the Phase III COVACTA trial of Actemra in hospitalized patients with severe COVID-19

associated pneumonia. The following is a summary of the information provided in this update:

 Primary endpoint not met: The difference in clinical status between Actemra and placebo in

patients assessed using a 7-category ordinal scale at week four was not statistically significant

(p=0.36; odds ratio [95% CI] = 1.19 [0.81, 1.76], a statistically significant odds ratio greater than

1 would have favored Actemra).

 There was no difference between Actemra and placebo in the percentage of patients that died

by week four (Actemra = 19.7% and placebo = 19.4% with a difference [95% CI] of 0.3% [-

7.6%, 8.2%], p=0.9410)

 Time to hospital discharge or ‘ready to discharge’ was shorter in patients treated with Actemra

than in those treated with placebo. The median time to discharge or ‘ready to discharge’ for

Actemra was 20 days and for placebo was 28 days (median time [95% CI]: Actemra = 20.0

[17.0, 27.0]; placebo = 28.0 [20.0, NE], p=0.0370). However, the difference cannot be

considered statistically significant as the primary endpoint was not met.

 The difference in ventilator-free days between Actemra and placebo was not statistically

significant (median of 22 days for Actemra and 16.5 days with placebo, difference in medians

[95% CI] = 5.5 [-2.8, 13.0], p=0.3202).

 At week four, rates of infections were 38.3% and 40.6% in the Actemra and placebo arms,

respectively, and the rates of serious infections were 21.0% and 25.9% in the Actemra and

placebo arms, respectively. The COVACTA study did not identify any new safety signals for

Actemra

In this major trial, Actemra did not meet its primary endpoint of improved clinical status nor its secondary

endpoint of reduced patient mortality in the studied patient population. Based on this compelling data,

it is the recommendation that this medication no longer be used in our patient population for the

treatment of COVID-19. Effective immediately, its use for this indication will be prohibited

 
growlers said:
 Time to hospital discharge or ‘ready to discharge’ was shorter in patients treated with Actemra

than in those treated with placebo. The median time to discharge or ‘ready to discharge’ for

Actemra was 20 days and for placebo was 28 days (median time [95% CI]: Actemra = 20.0

[17.0, 27.0]; placebo = 28.0 [20.0, NE], p=0.0370). However, the difference cannot be

considered statistically significant as the primary endpoint was not met.

 The difference in ventilator-free days between Actemra and placebo was not statistically

significant (median of 22 days for Actemra and 16.5 days with placebo, difference in medians

[95% CI] = 5.5 [-2.8, 13.0], p=0.3202).
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This is as good or better than Remdesivir.  But Rem had someone change the Primary endpoint for them before the trial ended.  

This whole approval thing, atleast how it worked out for Remdesivir, seems very sketchy.

 
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