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

chet said:
It's traded 300k in less than 10 minutes.  Someone's buying aggressively.
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was just going to ask as I see the days volume is barely over 1 million.  30% of the volume apparently happened in the last few minutes.  Someone knows something?

 
stbugs said:
You are a glutton for punishment. I’m still just watching to see what happens.
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Eh it’s just play money. I did take some profits a few weeks ago. Unless amazon and tesla file for bankruptcy and my other funds go under and like 5 other things happen, I’ll be fine. 

 
Capella said:
Eh it’s just play money. I did take some profits a few weeks ago. Unless amazon and tesla file for bankruptcy and my other funds go under and like 5 other things happen, I’ll be fine. 
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I know, but you just can’t get away from this white whale. I made a nice chunk and reinvested it well. That June to September was a nice plateau before the Fall jump. I just can’t get myself to dive back in, been peaceful.

 
stbugs said:
I know, but you just can’t get away from this white whale. I made a nice chunk and reinvested it well. That June to September was a nice plateau before the Fall jump. I just can’t get myself to dive back in, been peaceful.
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I am, but I guess I believe in it more than I don’t. 

 
Capella said:
I am, but I guess I believe in it more than I don’t. 
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You guys are troopers. I definitely would rather see LeBron than the others.

ChiefD said:
I feel like we've heard this story before. 

:lol:
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I’ve got nothing else to add anymore, Lol. It’s like The Walking Dead, I still have to watch but there’s no stress if it’s good or bad.

 
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If this fails, it will be one of the biggest "wtf were we ever thinking" moments.

Having come this far along with it though, and profit from it, its also hard to give it up.   At this point it would bother me more to see success when Im on the sidelines than it fail.  Had I not made money already, I may have a more conservative outlook.

Its insane though.  I'm not a religious person for similar reasons in that it requires faith in some pretty crazy things.

Don't get me wrong, I do think there is something to the drug, Im just really doubting it got established in this trial

 
Some of you may have seen this post on iHub, but it's worth looking at again.  Epic dismantling of Kgromax (one of the #shortmafia) using science and logic.

Courtesy of CTMedic from iHub:

Kgro,

Thank you for reminding us of the importance of DATA (not suppositions) to demonstrate that a treatment works.

The evidence that leronlimab works includes:

64% reduction in SAEs vs SOC/placebo (severe adverse events such as death, life-threatening condition, hospitalization, disabilities)

140% increase in the number of patients with improved NEWS2 scores (23% placebo, 55% leronlimab, p=0.0185)

DMSB recommendation to continue CD12 trial to completion without modification (indicating that the trial as designed should hit its primary endpoint).Quote:CytoDyn Receives Positive DSMC Recommendation after Interim Analysis for Leronlimab Phase 2b/3 COVID-19 Registrational Trial

DSMC recommends CytoDyn continue the study as planned, with the protocol defined sample size and power to achieve the primary endpoint

https://www.cytodyn.com/investors/news-events/press-releases/detail/477/cytodyn-receives-positive-dsmc-recommendation-after-interim

15% mortality in the EIND cohort at a time when SOC mortality was ~50%.

Of course, these EINDs were documented by what you have characterized as "cult physicians"

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=162249894.

It is interesting that the "cult physicians" and their research colleagues have their results published in peer reviewed Journals.

These are:

Ahmed E.ElSharkawiaAlina LelicAlina P.S. PangAmruta PiseArash NaeimBenjamin N. BimberBruce K. PattersonBryant Yang,Byung S. ParkC. David SudduthaChristopher SugaiChristopher BoniveteDavid Goodman-MezaEdgar B. FranciscoEisa MahyariEnver AkalinEric HallGabriela M. WebbHallison RodriguesHarish SeethamrajuHelen L. WuHelen L.WugJacob P LalezariJane A. O’HalloranJennifer A Fulcher,Jenny Ahn,Jonah B. SachaKabir ModyKazem KazempourKush DhodyLama KdouhLishomwa C. NdhlovuMerlene BerroMatthew PlassmeyerMichael J. CorleyMonica HerreraNader PourhassanNicholas AgrestiOral AlpanOtto O YangPhilip A. MuddPhillip P AmodeoRaavi GuptaReejis StephenScott KellySeth A. GrossSteven F. Mosher

Published here:

Clinical Characteristics and Outcomes of Coronavirus Disease 2019 Patients Who Received Compassionate-Use Leronlimab

https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa1583/5932277

CCR5 inhibition in critical COVID-19 patients decreases inflammatory cytokines, increases CD8 T-cells, and decreases SARS-CoV2 RNA in plasma by day 14

https://www.ijidonline.com/article/S1201-9712(20)32305-5/fulltext

Disruption of CCR5 Signaling to Treat COVID-19-Associated Cytokine Storm: CaseSeries of Four Critically Ill Patients Treated with Leronlimab

https://www.sciencedirect.com/science/article/pii/S2589909021000034

And yet this is how you have characterized the CD10 leronlimab study:

Quote:Failed primary endpoint, 17/18 secondary endpoints failed, last secondary endpoint data-mined with a post-hoc change of its definition, no regulators interests in any country, detailed data never published by the company. These 5 points are the very definition of a complete failure.

5 out of 5. Impossible to do worst than that.

Response:

Not to be too much of a stickler, but CD10 had one primary endpoint, 12 secondary endpoints and four "other out-mode measures". So technically, CD10 had 13 endpoints, generously 17 endpoints, but never 18 endpoints.

CD10 did fail to meet the primary endpoint (subjective criteria including cough and myalgia, as nearly all patients improved by day 14).

However in the objective assessment of the NEWS2 score, statistically significant improvement was observed.

Lest we continue to abase this criteria, please recall that this is an objective measure of clinical deterioration, utilized as an endpoint in 151 COVID-19 trials.

You have stated :Quote:last secondary endpoint data-mined with a post-hoc change of its definition

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=162249239

Response:

As a review, these trials were created in conjunction with and approved by the FDA. Certainly a company can look for subsets of patients who improve more than the entire patient population, but that is not was happened here.

The NEWS score remains unchanged. The application of this assessment tool in the trial was also unchanged. Clinicaltrials.gov provides users the ability to see changes made during the trial.

After checking, no changes in endpoint.

Very simply, 140% more patient treated with leronlimab had an improvement in their NEWS2 scores, and thus lower indication of clinical deterioration.

Your statement: "To be approved a treatment must prove that it performs better than standard of care, not that it doesn't perform worse" is partially true. Treatment must prove that it improves patient outcomes.

Reduction of serious adverse events (like death) versus placebo or standard of care is a clinical indicator that a treatment is working (again, stopping patients from dying).

I looked AGAIN on clinicaltrials.gov for Covid19 trials in which SAEs were utilized as clinical trial endpoints.

440 Covid19 clinical trials listed with SAEs as an endpoint. Interesting.

You noted:Quote:At some points the medical "science" has to be confirmed or rejected by unquestionable hard statistics. That's another "science", different skills, different rigor, and it often rejects the medical theories. Like it already did for the first Leronlimab COVID trial (a failure, the Leronlimab MOA didn't work as expected!).

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=162249894

Response:

Please see previous discussion. Statistically significant improvement in NEWS2 scores and reduction of SAEs (like dying).

You have argued that CD12 MUST fail, based on your statistical analysis. First, statistics is the science of probability. Not knowing the constitution of the CD12 trial (100% of patients on ECMO?), none of us can know unequivocally what the expected mortality is of the placebo group.

Nonetheless, reasonable assumption from the experience of the IL-6 and aviptadil studies indicated that a mixed trial population has ~30% mortality. Leronlimab CD12 has 22% mortality. So perhaps CytoDyn has done a poor job enrolling critical patients, or perhaps leronlimab works as advertised and reduced the mortality to 22%. If that is the case, and if the placebo mortality is 30%, and assuming the reported 87 deaths are correct, that indicates a 40% reduction in mortality with the administration of leronlimab.

Perhaps this why your statement is seemingly premature in its conjecture that:Quote:As for the FDA, they are precisely the only ones, along with regulators from other countries, to block CytoDyn.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=162210033

Response:

Last I checked, CytoDyn is in conversations about the CD12 trial results, with not just the FDA, but the MHRA and Health Canada. Unless of course we are to believe that these regulatory agencies have joined the aforementioned physicians and researchers in perpetuating the CytoDyn "fraud".

"Old" news perhaps in today's fast-paced world, but here are the salient points from last week's press release.

CytoDyn in Discussions with U.S. FDA, MHRA and Health Canada After Unblinding its CD12 Trial Data for Severe-to-Critically Ill COVID-19 Patients

and

Quote:CytoDyn expects to release CD12 data and complete discussions with various regulatory agencies within 2 to 3 weeks

[14-21 days] - [8 elapsed days] = [6-15 days]

Quote:CD12 COVID-19 trial data has been unblinded and the results will be reported when the Company has concluded its ongoing discussions with regulators.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are eager to reach conclusion in our discussions with all the regulatory agencies for the path going forward and will release the details of our data and the results of our discussions with regulatory agencies in the coming weeks.” Details of the Company’s ongoing discussions with the regulatory agencies are confidential.

The wait is excruciating for all of us, but there is no recourse but to be patient.
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Capella said:
That’s a good post but that kgromax guy doesn’t even have 200 followers on Twitter. Not sure why anybody gives him the attention he craves. 
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The guy working on identifying these criminals think he's a hedge fund trader for Quintessential which is based in Italy. 

 
Capella said:
That’s a good post but that kgromax guy doesn’t even have 200 followers on Twitter. Not sure why anybody gives him the attention he craves. 
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I give everyone their chance to make their case but that guy is so bad I had to mute him outright on Twitter.

I don't ever want to see another post from that bozo.  I don't block anyone so he's a special case.

 
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Outside of, @chet, and I know there are a couple other people that have a ton of shares under $1 each, how many of us are holding capital gains positions now?

I made some nice money last summer selling in and out of spots, but I still hold a piss ant 1000-shares (my original buy) at $1.34 per share from February last year. 

No matter what, it's been a fun ride and now I'm at the point of being one of the diamond sphincter types that rides this to the end. (Quote this line in bold and insert jokes here)

:banned:

 
Quick note, my cover band name is:

Sphincter Crickets  

When I showed up to my boat in Charleston, South Carolina, I met a "band" composed of crew members that had given themselves that name. I'm ripping their name in honor of SSN-660.

:banned:

 
Feel like we're in limbo and would not be surprised to see this thing close below $4 today.  While I personally feel like the ongoing lack of info portends good/great news is coming, I admittedly am biased and continue to manufacture the storyline in my head to fit this narrative.  Plenty of shareholders out there are probably not doing this and I fear we are going to hit a point where patience wears thin and bulk selling occurs.  SP will drop like a rock when that happens.  

 
unckeyherb said:
Feel like we're in limbo and would not be surprised to see this thing close below $4 today.  While I personally feel like the ongoing lack of info portends good/great news is coming, I admittedly am biased and continue to manufacture the storyline in my head to fit this narrative.  Plenty of shareholders out there are probably not doing this and I fear we are going to hit a point where patience wears thin and bulk selling occurs.  SP will drop like a rock when that happens.  
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I think we see more of a slow bleed downward.  

 
unckeyherb said:
Maybe, I just think everyone are simply waiting for a binary answer from the FDA and will have itchy trigger fingers if we get the wrong one.  
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If that is what you are saying, yes no doubt.  If we don't get EUA here, expect this to go back into the low 2s (probably in 1s actually), unless we find out something good on HIV front at same time.

Otherwise just a slow bleed like we've been seeing into the decision from the FDA

 
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Consider yourself lucky if you only have CYDY right now.  HGEN getting crushed worse and of course no one has any clue what is going on there.

 
Haven't heard a peep from any patients lately that are seeing benefits from eIND or OLE.

Usually we get one or two that are raving about how positive an impact leronlimab had

Crickets lately

 
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