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 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 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.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.
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 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 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.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.
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.I thought Mrs. Kelly only exercised her right to sell? Anyone know if she actually sold?
For sure and I'm not sticking around to find outThey might not even give them a break on this.
What’s up with Hgen man. Ain’t looking too good either.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.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.
Cautiously optimistic that this is very possible.Maybe you can sell without too large of a hit.
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?These numbers are good but 64 critical patients, damn
It’s painful.What’s up with Hgen man. Ain’t looking too good either.
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.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.
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.I thought Mrs. Kelly only exercised her right to sell? Anyone know if she actually sold?
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.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.
I think a lot of us are at the bargaining point.denial.
anger.
bargaining.
depression.
acceptance.
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 actually been at the acceptance point for months.
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.I fluctuate periodically between all of them except for denial. I don't really go through depression anymore because of my lowered expectations.
Same posting on ihub.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.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?
CytoDyn to File Accelerated Rolling Review with MHRA and Interim Order (IO) with Health Canada for COVID-19
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.
What means this?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.
FDA allow for adjusting when there is an imbalance between PL and Treatment armsLiterally laughed out loud at age adjustment. Did they do that overnight?
Right. Why was that not in yesterday’s Pr then?FDA allow for adjusting when there is an imbalance between PL and Treatment arms
Good question. Listening to NP now. See if we get more clarityRight. Why was that not in yesterday’s Pr then?
The answer is because he’s trying to toss the water out of the sinking boat.Good question. Listening to NP now. See if we get more clarity
I dunno, people on other boards see this as a positive.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.
Other words for dangling the carrot and cherry picking data...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
It's overOther words for dangling the carrot and cherry picking data...
Exact same stuff they said with CD10.
If you havent figured it out yet, the people on the other boards are not capable of anything but pumpingI dunno, people on other boards see this as a positive.
I don't think so but there may be a short window to get out on Monday morning without too much further damage.This stock will probably be up 79% on Monday.
Yeah, I get that. But that is why the SP might not dive dollars. A lot of true believers out there.If you havent figured it out yet, the people on the other boards are not capable of anything but pumping
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.Yeah, I get that. But that is why the SP might not dive dollars. A lot of true believers out there.
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 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