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***OFFICIAL CYDY/Leronlimab Thread***


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1 minute ago, Dwayne Hoover said:

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.

I think by the time the 75% review would have concluded, they would have fully completed the trial.  Unless they stopped taking patients during the review period.

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1 minute ago, Chaz McNulty said:

I think by the time the 75% review would have concluded, they would have fully completed the trial.  Unless they stopped taking patients during the review period.

They would have had to stop, what would that have been 2-3 weeks?  Would have put them in a better position time line wise than they are right now.

I think what Chet said about them needing to add 100 or so more patients is what is going to happen at this point.

There is just no way the FDA is going to give Cytodyn a break on the 64 patients they have but I hope people believe that.

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Just now, Dwayne Hoover said:

They would have had to stop, what would that have been 2-3 weeks?  Would have put them in a better position time line wise than they are right now.

I think what Chet said about them needing to add 100 or so more patients is what is going to happen at this point.

There is just no way the FDA is going to give Cytodyn a break on the 64 patients they have but I hope people believe that.

They might not even give them a break on this.  Again, the critical patients have been cherry-picked out of the severe/critical.  How do we know that the placebo group of the critical was your average subset?  How are they increasing the placebo group in the additional patients.  I believe currently they are just giving LL to critical patients but not monitoring the SOC patients in critical.

Are they expecting the FDA to compare all future results against the 22 placebo patients?  That would be kind.

I believe at this point that need to be 'rescued' by a country like Brazil or the Philippines.

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11 minutes ago, The Blue Baron said:

I thought Mrs. Kelly only exercised her right to sell?  Anyone know if she actually sold?

Wouldn't it be public if she sold any stock.  I can't imagine that they would risk prison by selling before the news came out to the general public.

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Well this news is a surprise.

Good luck guys, there are plenty of investors in this still believing the story. There will probably be an “Emerging Growth” article or 2 written this weekend to convince longs to hold. Maybe you can sell without too large of a hit.

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6 minutes ago, Whyatt said:

Well this news is a surprise.

Good luck guys, there are plenty of investors in this still believing the story. There will probably be an “Emerging Growth” article or 2 written this weekend to convince longs to hold. Maybe you can sell without too large of a hit.

What’s up with Hgen man. Ain’t looking too good either. 

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16 minutes ago, Whyatt said:

Well this news is a surprise.

Good luck guys, there are plenty of investors in this still believing the story. There will probably be an “Emerging Growth” article or 2 written this weekend to convince longs to hold. Maybe you can sell without too large of a hit.

I see this dipping into the low to mid 2's and maybe rebounding a bit towards the high 2's.  But it's really hard to predict.

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Just now, Dwayne Hoover said:

These numbers are good but 64 critical patients, damn

It's really a shame.  I thought the critical patient subset would be larger than the severe (desperate people more likely to go in a trial).  I wonder if they were avoiding the critical, falsely believing that they were stronger in the severe?

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6 minutes ago, Capella said:

What’s up with Hgen man. Ain’t looking too good either. 

It’s painful.

Biotech stocks are doing poorly. Covid stocks are doing really poorly. I think some are taking profits ahead of the binary news event. 

Incredibly, I have bought a few more shares, averaging up. With the news on Otilimab, OncoImmune, and Relief, (and now Cydy I suppose) the seas have parted for Hgen, and I’m confident they will share great results later this month.

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21 minutes ago, Whyatt said:

It’s painful.

Biotech stocks are doing poorly. Covid stocks are doing really poorly. I think some are taking profits ahead of the binary news event. 

Incredibly, I have bought a few more shares, averaging up. With the news on Otilimab, OncoImmune, and Relief, (and now Cydy I suppose) the seas have parted for Hgen, and I’m confident they will share great results later this month.

Well I am extremely hopeful. If they get up to 30ish a share I’ll still do great on covid stocks even if cydy tumbles.

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1 hour ago, The Blue Baron said:

I thought Mrs. Kelly only exercised her right to sell?  Anyone know if she actually sold?

Even Numbnuts Poorhoussan would have been smart enough to sell knowing the drug doesn't work but the narrative being that the company was working with the FDA on packaging details for the approval.

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Rehashing any news or PR given from NP is like the stages of grief.

Quote

 

denial.

anger.

bargaining.

depression.

acceptance.

 

I think a lot of us are at the bargaining point.

Edited by Chaz McNulty
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7 minutes ago, Capella said:

I’ve actually been at the acceptance point for months. 

I fluctuate periodically between all of them except for denial.  I don't really go through depression anymore because of my lowered expectations.

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2 minutes ago, Chaz McNulty said:

I fluctuate periodically between all of them except for denial.  I don't really go through depression anymore because of my lowered expectations.

I’ve just been at acceptance as whatever I put into it I expect to lose. I cashed out some profits a few weeks ago but immediately bought back in so I just have to be ready for it to go bottoms up. It’ll be fine. My wife may not get that new kitchen and pool patio I promised if this hit right away though. 

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CYDY Shareholders Community FB page...

Has 3k members

Moderator emailed NP

There will be a PR today, if not tommorrow explaining what FDA, MHRA, and Health Canada are saying about our results

 

xxx.  xxx

Was this NP message from today or yesterday? Was he taking about yesterday’s PR or another one expected today?

 · 

Reply

 · 12m

Chris Lonsford

Moderator

 my communication with him was this morning. The PR is expected tonight or tomorrow


------------------------------

Also...  6pm PT tonight

 

drbeen medical@drbeen_medical

· 1h

Surprise #koolbens We will have Dr. Pourhassan from @CytoDyn with us to discuss the phase III results. #koolbeens, what are your questions?

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4 minutes ago, Getzlaf15 said:

CYDY Shareholders Community FB page...

Has 3k members

Moderator emailed NP

There will be a PR today, if not tommorrow explaining what FDA, MHRA, and Health Canada are saying about our results

 

xxx.  xxx

Was this NP message from today or yesterday? Was he taking about yesterday’s PR or another one expected today?

 · 

Reply

 · 12m

Chris Lonsford

Moderator

 my communication with him was this morning. The PR is expected tonight or tomorrow


------------------------------

Also...  6pm PT tonight

 

drbeen medical@drbeen_medical

· 1h

Surprise #koolbens We will have Dr. Pourhassan from @CytoDyn with us to discuss the phase III results. #koolbeens, what are your questions?

Same posting on ihub.

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Hypothetical: the share price lingers around $4 on Monday morning. I, for one, would be selling 80% of my shares. Would many on this board sell? I assume so. I’d probably sell at $3. Makes me think this thing is going sub $3 right out of the gate. 

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46 minutes ago, Getzlaf15 said:

CYDY Shareholders Community FB page...

Has 3k members

Moderator emailed NP

There will be a PR today, if not tommorrow explaining what FDA, MHRA, and Health Canada are saying about our results

 

xxx.  xxx

Was this NP message from today or yesterday? Was he taking about yesterday’s PR or another one expected today?

 · 

Reply

 · 12m

Chris Lonsford

Moderator

 my communication with him was this morning. The PR is expected tonight or tomorrow


------------------------------

Also...  6pm PT tonight

 

drbeen medical@drbeen_medical

· 1h

Surprise #koolbens We will have Dr. Pourhassan from @CytoDyn with us to discuss the phase III results. #koolbeens, what are your questions?

He is for sure desperate if he is doing these Saturday night PRs in front of a few thousand yahoo users. 

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Quote

 

Therefore, an “age adjustment” analysis was performed and consequently, the updated results from the primary endpoint analysis are as follows:

1) Statistically significant results (p-value = 0.0319) reported for the primary endpoint (all-cause mortality at Day 28) in participants receiving leronlimab + “commonly used COVID-19 treatments” compared to participants who received “commonly used COVID-19 treatments” alone in the placebo group in the overall modified intent-to-treat (“mITT”) population.

2) Statistically significant results (p-value = 0.0552) reported for the primary endpoint (all-cause mortality at Day 28) among participants who received dexamethasone as the prior or concomitant standard of care treatment (“SoC”) for COVID-19, compared to patients who received dexamethasone (without leronlimab) as SoC therapy in the overall mITT population.

 

 

Edited by unckeyherb
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MHRA has told the Company it will accept more data from the open-label portion of the current CD12 trial. To date, an additional 46 patients have been enrolled, but the results have not yet been communicated to any agency.

The Company anticipates the Health Canada Interim Order (IO) could allow the Company to sell leronlimab in Canada, while additional critical COVID-19 patients are enrolled. These discussions are on going, and the Company has initiated the process to submit an IO with Health Canada.

The Company also confirms the U.S. FDA has received its protocol for enrolling 140 critically ill COVID-19 patients with the primary endpoint defined as length of hospital stay.

CytoDyn is pleased to show strong data for critically ill COVID-19 patients. Considering the fact that:

 (1)A higher proportion of patients over 65 were enrolled in the leronlimab arm (33%) compared to the placebo arm (23%), and

 (2)Of the 384 treated patients, 117 were over 65 with an overall mortality rate 3.5 times higher (42% - 49/117) than for patients under 65 (12% - 31/267).

Therefore, an “age adjustment” analysis was performed and consequently, the updated results from the primary endpoint analysis are as follows:

1) Statistically significant results (p-value = 0.0319) reported for the primary endpoint (all-cause mortality at Day 28) in participants receiving leronlimab + “commonly used COVID-19 treatments” compared to participants who received “commonly used COVID-19 treatments” alone in the placebo group in the overall modified intent-to-treat (“mITT”) population.

2) Statistically significant results (p-value = 0.0552) reported for the primary endpoint (all-cause mortality at Day 28) among participants who received dexamethasone as the prior or concomitant standard of care treatment (“SoC”) for COVID-19, compared to patients who received dexamethasone (without leronlimab) as SoC therapy in the overall mITT population.

3) Amongst all patients in mITT, the primary endpoint (all-cause mortality at Day 28) was not statistically significant. When age adjustment was conducted, the primary endpoint was much closer to statistically significant value. Of note, the reduction of mortality in this population of 65 years and younger leronlimab arm had more than 30% less mortality than placebo and 9% less mortality in participants over 65.

With the age adjustment analysis in all other major secondary endpoints, there was consistent numerical superiority over the placebo group, with some secondary endpoints approaching statistical significance.

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3 minutes ago, Getzlaf15 said:

MHRA has told the Company it will accept more data from the open-label portion of the current CD12 trial. To date, an additional 46 patients have been enrolled, but the results have not yet been communicated to any agency.

The Company anticipates the Health Canada Interim Order (IO) could allow the Company to sell leronlimab in Canada, while additional critical COVID-19 patients are enrolled. These discussions are on going, and the Company has initiated the process to submit an IO with Health Canada.

The Company also confirms the U.S. FDA has received its protocol for enrolling 140 critically ill COVID-19 patients with the primary endpoint defined as length of hospital stay.

CytoDyn is pleased to show strong data for critically ill COVID-19 patients. Considering the fact that:

 (1)A higher proportion of patients over 65 were enrolled in the leronlimab arm (33%) compared to the placebo arm (23%), and

 (2)Of the 384 treated patients, 117 were over 65 with an overall mortality rate 3.5 times higher (42% - 49/117) than for patients under 65 (12% - 31/267).

Therefore, an “age adjustment” analysis was performed and consequently, the updated results from the primary endpoint analysis are as follows:

1) Statistically significant results (p-value = 0.0319) reported for the primary endpoint (all-cause mortality at Day 28) in participants receiving leronlimab + “commonly used COVID-19 treatments” compared to participants who received “commonly used COVID-19 treatments” alone in the placebo group in the overall modified intent-to-treat (“mITT”) population.

2) Statistically significant results (p-value = 0.0552) reported for the primary endpoint (all-cause mortality at Day 28) among participants who received dexamethasone as the prior or concomitant standard of care treatment (“SoC”) for COVID-19, compared to patients who received dexamethasone (without leronlimab) as SoC therapy in the overall mITT population.

3) Amongst all patients in mITT, the primary endpoint (all-cause mortality at Day 28) was not statistically significant. When age adjustment was conducted, the primary endpoint was much closer to statistically significant value. Of note, the reduction of mortality in this population of 65 years and younger leronlimab arm had more than 30% less mortality than placebo and 9% less mortality in participants over 65.

With the age adjustment analysis in all other major secondary endpoints, there was consistent numerical superiority over the placebo group, with some secondary endpoints approaching statistical significance.

What means this?

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5 minutes ago, Capella said:

Literally laughed out loud at age adjustment. Did they do that overnight? 

FDA allow for adjusting when there is an imbalance between PL and Treatment arms 🤷‍♂️ 

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Well, sir, there's nothing on earth
Like a genuine, bona fide
Electrified, 4-digit monoclonal antibody
What'd I say?

Monoclonal
What's it called?
Monoclonal 
That's right! Monoclonal 

Monoclonal
Monoclonal 
Monoclonal 

What about us brain-dead investor slobs?
You'll be needing second and third jobs
Were you sent here by the Devil?
No, good sir, I'm on the level

The ring came off my pudding can
Leronlimab has an indication for that my good man
I swear it's Covid’s only choice
If it stays over two dollars Monday let’s all rejoice! 

Monoclonal
What's it called?
Monoclonal
Once again!
Monoclonal

But the vaccines are effective and not even slightly broken!
Sorry, Mom, the mob has spoken!

Monclonal!
Monoclonal!
Monoclonal!
Monoclonal!!

Mono, d'oh!


 

 

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57 minutes ago, pecorino said:

Hypothetical: the share price lingers around $4 on Monday morning. I, for one, would be selling 80% of my shares. Would many on this board sell? I assume so. I’d probably sell at $3. Makes me think this thing is going sub $3 right out of the gate. 

I dunno, people on other boards see this as a positive.

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1 hour ago, Getzlaf15 said:

MHRA has told the Company it will accept more data....

The Company anticipates the Health Canada Interim Order (IO) could allow....

The Company also confirms the U.S. FDA has received.....

CytoDyn is pleased to show strong data for critically ill COVID-19 patients. C

Other words for dangling the carrot and cherry picking data...

Exact same stuff they said with CD10.

Edited by Charlie Harper
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Just now, ChiefD said:

This stock will probably be up 79% on Monday.

I don't think so but there may be a short window to get out on Monday morning without too much further damage.

At least that's what Im convincing myself of right now.

This subsequent PR that "clarified" things is worse than the original one though, so I'm not sure

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13 minutes ago, Dwayne Hoover said:

If you havent figured it out yet, the people on the other boards are not capable of anything but pumping

Yeah, I get that.  But that is why the SP might not dive dollars.  A lot of true believers out there.

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7 minutes ago, IC FBGCav said:

Yeah, I get that.  But that is why the SP might not dive dollars.  A lot of true believers out there.

This is what I was referring to yesterday when somebody said who are the buyers. There are a lot of believers in Nader and this company. 

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36 minutes ago, Dwayne Hoover said:

I don't think so but there may be a short window to get out on Monday morning without too much further damage.

At least that's what Im convincing myself of right now.

This subsequent PR that "clarified" things is worse than the original one though, so I'm not sure

I don't see how.  We've seen this countless times before.  It tanked immediately with similar PR after CD10.  Tanked immediately with similar PR last week kicking things down the road.

I mean I'll take it, but I would be surprised if I can get out above $2.75.  Doesn't help that I own my shares at TDA and they are terrible at getting fills on OTC orders.

Edited by FreeBaGeL
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7 hours ago, FreeBaGeL said:

I don't see how.  We've seen this countless times before.  It tanked immediately with similar PR after CD10.  Tanked immediately with similar PR last week kicking things down the road.

I mean I'll take it, but I would be surprised if I can get out above $2.75.  Doesn't help that I own my shares at TDA and they are terrible at getting fills on OTC orders.

Agreed. I doubt I’ll be able to sell above $3 which probably means I’m holding. 

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After a night of reflection, I am still on the sidelines; however, I hope the FDA shows compassion in guiding CytoDyn on the best path forward.  The CEO needs to stay off the Kool Beens and focus on the tasks at hand.  From the information available, certainly appears more patients will need to be enrolled in critical.  The age factor is intriguing but I’m not even sure if this is legal?  Could you advise a patient, “I’m sorry you’re over 65, you can’t enroll in our trial?”  Then you also have to work in factors of overall health.  All because you’re over 65 doesn’t mean, you may not be in better health than someone under 65.  I don’t even know if they could have designed the original trial to maintain the balance for age? 

 

In any case, if they believe LL can help, they should publish all the mortality in % and numbers everyone can understand, increase trial sites, and wrap this up in a few months.  If it stretches on until the end of the year or early next year, it will likely be a case of too little, too late.  I wonder how long the trial would have taken to fill up if they imposed age restrictions?  If anything, this proves the company is too small without the experience to moves things forward.  I’m watching from the stands.  The 2nd PR, the vague 1st PR, the appearance on the Kool Beens, and, everything yet to pass is the equivalent of watching Fran Tarkenton in a mad scramble trying to find the time and space to make one last gasp Hail Mary pass with no time left on the clock.

 

·        If Pfizer CEO, Albert Bourla, made an appearance on the Kool Beans pitching his product, his board would likely demand his resignation the next morning.

https://www.youtube.com/watch?v=3CwsfdY5o08

 

 

Edited by The Blue Baron
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