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***OFFICIAL CYDY/Leronlimab Thread*** (7 Viewers)
- Thread starter This_Guy
- Start date
Dwayne Hoover
Footballguy
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.
Chaz McNulty
Footballguy
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.
The Blue Baron
Footballguy
I thought Mrs. Kelly only exercised her right to sell? Anyone know if she actually sold?
Dwayne Hoover
Footballguy
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.
Chaz McNulty
Footballguy
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.
Chaz McNulty
Footballguy
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.
Dwayne Hoover
Footballguy
G
Guest
Guest
Definitely put in a market order sell before the market opens. It never gaps down all the way to the bottom. For instance, it might gap down to $3.00 at open and then fall to $1.50 in the first 30 minutes that the market is open. It feels risky to sell with a market order at open without knowing what price you'll receive but you'll get a far better price doing it that way.
Capella
Footballguy
Chaz McNulty
Footballguy
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.
Dwayne Hoover
Footballguy
Dwayne Hoover
Footballguy
These numbers are good but 64 critical patients, damn
Chaz McNulty
Footballguy
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?
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.
Capella
Footballguy
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.
BassNBrew
Footballguy
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.
generactor
Footballguy
A way to gauge it premarket is to watch what happens to the stock on the Stuttgart exchange, which will open at 2 AM EST Monday.
https://www.bloomberg.com/quote/296:GR
Chaz McNulty
Footballguy
Rehashing any news or PR given from NP is like the stages of grief.
I think a lot of us are at the bargaining point.
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Chaz McNulty
Footballguy
I fluctuate periodically between all of them except for denial. I don't really go through depression anymore because of my lowered expectations.
Capella
Footballguy
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.
Zegras11
Footballguy
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?
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?
unckeyherb
Footballguy
Capella
Footballguy
He is for sure desperate if he is doing these Saturday night PRs in front of a few thousand yahoo users.
unckeyherb
Footballguy
Zegras11
Footballguy
CytoDyn to File Accelerated Rolling Review with MHRA and Interim Order (IO) with Health Canada for COVID-19
unckeyherb
Footballguy
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Zegras11
Footballguy
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.
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.
ex-ghost
Footballguy
Dave RL
Footballguy
Dwayne Hoover
Footballguy
The best news contains the words "anticpates" and "could"
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.
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.
Capella
Footballguy
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!
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!
Capella
Footballguy
Right. Why was that not in yesterday’s Pr then?FDA allow for adjusting when there is an imbalance between PL and Treatment arms
Dave RL
Footballguy
Capella
Footballguy
IC FBGCav
Footballguy
Charlie Harper
Footballguy
Other words for dangling the carrot and cherry picking data...
Exact same stuff they said with CD10.
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Dwayne Hoover
Footballguy
Dwayne Hoover
Footballguy
If you havent figured it out yet, the people on the other boards are not capable of anything but pumping
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Dwayne Hoover
Footballguy
I'm hopeful to get out around $4. It actually might happen and I will call that a big victory
Dwayne Hoover
Footballguy
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
IC FBGCav
Footballguy
Yeah, I get that. But that is why the SP might not dive dollars. A lot of true believers out there.
Capella
Footballguy
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.
FreeBaGeL
Footballguy
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.
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