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Why would anyone give credence or any weight whatsoever of biotech opinions of someone who does not know that the degrees of Medical Doctor and Doctor of Ostheopathy trained in the USA are equivalent and can be licenced to practice in all areas of Medicine.
Just listen to the CC. Nader bumbles his words when talking about the EUA. He often will put contradictory statements in the same sentence when he wants you to believe something that isn't true. He has not applied for an EUA. He contacted the FDA about applying. Big difference.
Let's Talk Science Versus Enthusiasm
The FDA approves drugs based on good trial results. Good trial results come from good science, which means good trial design. CYDY has not shown good results because of the garbage design of their trial.
Now let's focus on enthusiasm. Which is not based in science, but emotion. It has no value, it can't prove anything, and can create a poor image of the drug as a snake oil product.
Enthusiasm led to a targeted harassment campaign cooked up in a dark corner of the internet.
The result was turning an FDA officials twitter account into what looked liked a digital Qanon rally.
The net effect is a poor image for the company and drug. Good science always shows through. Not guerilla PR campaigns based on an emotional response.
What does opening the year at 5.69 mean? Is there a significance to the year opening? I said YTD..YEAR TO DATE
Lenz has zero eIND's or OLE's and is down 21 percent YTD
Leron has eIND andd OLE and is up 133 percent YTD.
Ok, lets compare-
Lenz will probably file a EUA by years end, Leron did already-
No brainer!!! Cytodyn's Leronlimab for the win
Oohhh let’s partner with our big brother Gilead and do combo with Rem because we can’t cut it as monotherapy.
and let’s change endpoints multiple times during the trial
so maybe we can get a sniff from FDA because we cannot do it on our own.
If you’re going to go that route, then we’ll need to wait until cd16/17 are done given that’s essentially a new endpoint; like everyone else does mid-trial.
It's interesting you should bring up a GM-CSF mediator, like Lenzulimab, in this forum. You do know that CCR5 controls much of the downstream biology including GM-CSF, don't you? Leromlimab > Lenzulimab.
My niece in the medical field in Vancouver says Leronlimab is a lock. Give or take 3 weeks
293K t-trade after the bell.
Somebody is seriously dumping.
Not true again. Ranked 58 out of 158.
If you are going to make defamatory statements they should be accurate.
Says who?
Click this link and look at every other application -- point out to me which ones have been denied.
Sorry 4Don, you're wrong again.
Your Post:
"Got a link that proves Dr. Recknor is a joke?
He went to Medical School at the South Carolina School of Medicine. US News and World Report ranks the South Carolina School of Medicine as the worst medical school in the United States"
My post: Dr Recknor's MD is from the Medical University of South Carolina College of Medicine, founded in 1824. The school you reference in your post was founded in 1977.
You see, Words matter, including the order of words. But all your other posts must be spot on accurate, right?
"Given these data suggest a potentially important clinical benefit in a pre-defined sub-group of high-risk patients and the public health need, GSK has decided to amend the OSCAR study to expand this cohort to confirm these potentially significant findings"
Is this not what CytoDyn has done/is doing with leronlimab?
Does anyone wonder if quid pro quo was going on with the hire of Dr Recknor? Our trials had stalled with enrollment. He single-handedly kept the trial enrolling. And then they give him a ton of money for a job he is unqualified. Doesn't pass the smell test.
Got a link that proves Dr. Recknor is a joke?
And let’s remember that what they calling trial for a severe patients , is mostly for moderate , moderate- severe excluding any other secondary infection
Big exclusions .. really selected patients ..
Now I'm a bagholder....
Did not the GLAXO (BP) GM-CSF Covid drug recently fail is Covid19 trial?
https://www.gsk.com/en-gb/media/press-releases/gsk-announces-otilimab-data-for-treatment-of-covid-19/
a pre-planned efficacy analysis by age in patients 70 years and older (N=180, 806 in total study) showed that 65.1% of patients were alive and free of respiratory failure 28 days after treatment with otilimab plus standard of care, compared to 45.9% of patients who received the standard of care alone (delta of 19.1%, 95% CI=5.2%, 33.1%) (nominal p-value=0.009). In addition, in a mortality analysis up to day 60, a treatment difference of 14.4% favouring otilimab was seen with rates of 40.4% on standard of care vs. 26% on otilimab plus standard of care (95% CI= 0.9%, 27.9%) (nominal p-value=0.040) in patients 70 years and older.
Given these data suggest a potentially important clinical benefit in a pre-defined sub-group of high-risk patients and the public health need, GSK has decided to amend the OSCAR study to expand this cohort to confirm these potentially significant findings.
Recknor is tied in with the pharma space.
So does anyone have a link that shows that leronlimab in under review by the FDA or are those posts a complete fabrication? Not cool posting information from the Health Canada site and claiming it came from the FDA site.
Elevated GM-CSF levels are correlated with cytokine storm and ARDS in severe covid and other conditions. Correlation is not causation as I am sure you know.
(I added thd bold)
US FDA
Bamlanivimab (bamlanivimab) Eli Lilly Canada Inc Treatment Authorized By Interim Order 2020-11-20
Veklury (remdesivir) Gilead Sciences Canada Inc Treatment Authorized 2020-07-27
Favipiravir (favipiravir) Dr Reddys Laboratories Ltd Treatment Under review Under review
Colchicine (colchicine) Footnote1 Pendopharm Division of Pharmascience Inc Treatment Under review Under review
Novavax COVID-19 Vaccine (NVX-CoV2373) Novavax Inc Vaccine Under review Under review
Bamlanivimab and etesevimab (LY-CoV555 / LY-CoV016) Eli Lilly Canada Inc Treatment Under review Under review
Casirivimab and imdevimab (casirivimab / imdevimab) Hoffmann-La Roche Limited Treatment Under review Under review
Leronlimab (leronlimab) CytoDyn, Inc. Treatment Under review Under review
Leronlimab (leronlimab) CytoDyn, Inc. Treatment Under review Under review
That's odd. It's showing up as "Under Review" on FDA website. Hmm. Nader's exact words were: "request was filed" I admit, that is not 100% solid, but it's on the FDA website, so I'd say it's a done deal (not approval, but submission). And Canado also.
Much of the financial risk is squeezed out by the low share price
We've got it, once they try it, they'll even want it more. Let's get this stuff out there then watch the pre-orders roll in for the next batch.
I wonder if last Friday's short attack was a complete failure and Shorts got stuck in a short position they didn't want. 2.9 million shares were sold and the stock price dropped less than $2. I'm sure they anticipated the stock price dropping further. They immediately bought back sending the stock price shooting up to $15.40. Far more shares were sold than rebought. So they might have still been short at the end of trading Friday. At some point, they'll need to buy shares to cover their position. Hopefully, some of them are now researching lenzilumab and realizing that they don't want to be short this stock when data comes out. GM-CSF baby!
Wrong you clearly didn’t listen to the last CC or read the PR correctly.
“We field for EUA 10 days ago as our scientists suggested”
NP
We filed for EUA.
So last Friday's drop was a short attack. Makes sense since they bought back right away. The stock price really didn't drop much considering how many shares were sold. They probably didn't make much or any money on it.
Knowing that Nomis is still at 9.99% ownership makes me feel better. Shorts have no idea if data will be good. Shorts have never even heard of GM-CSF.
Below is a recent quote from Janet Woodcock where she basically says testing monoclonal antibodies on Mild-to-Moderate was a complete waste of time. She actually uses the word "dumb".
And then she says that they didn't realize it at first but a study of 400 is way too small. It is almost like they was specifically talking about both leronlimab trials.
https://www.ama-assn.org/delivering-care/public-health/fda-experts-discuss-covid-19-therapeutic-clinical-trials
I think at the beginning of this pandemic, we didn't know enough about the disease and its heterogeneity.
For example, monoclonal antibodies, which I was very involved in getting them developed and studied, we took all-comer outpatients and we should have realized that most of the people get better no matter what you do. Treating them with a monoclonal antibody was a dumb idea because it's very hard to treat people. It's expensive and yet they were going to get better on their own and make their own antibodies and they do just fine.
We did very large trials, and yet we only had a very small event rate of hospitalization, and so more trials had to get done and those didn't get into the clinical guidelines and everything until later because of those definitive trials. I think many of the smaller trials were because people naively assumed this was kind of a monotonic disease and we could study like 400 people and that would be really a lot of people to study. That was completely wrong.
Simple fix: he can stay, but only if he does the opposite of any well considered path he wants to take.
Did CytoDyn management directly give us the critical numbers of 47% mortality in the placebo arm and 38% mortality in the treatment arm or were those numbers deduced from when Nader said the absolute reduction was 9% and the relative reduction was 24%?
38% mortality in the leronlimab arm of the critical patients is not good no matter if the placebo arm had 47% mortality. I realize these patients were critical but still. 62% survival just isn't a good result.
No serious investor ever hangs their hat on "after hours." The real numbers are during actual trading hours.
Uh oh, down to $13.02. Scooter, let the hate flow through you. We need you buddy.
I think I have to take CYDY off of my Google Alerts because I'm getting flooded with lawsuit notices. Do you think I can become a plaintiff despite making a bunch of money on CYDY? I sold at $6.50 but I could have sold at $10.01. But I wasn't fooled by Nader. He isn't the reason I held on past ten dollars. That honor would go to Bruce "it's rantes" Patterson. Guess what Bruce, it's not Rantes, it's GM-CSF.
HGEN is up to $13.60 in afterhours. Thanks for the boost, Scooter.
You also need to test for statistical significance and adjust for alpha spend and multiplicity. The 24% improvement is not stat sig in the case of Leronlimab and therefore per the FDA, happened by random chance. I wouldn't expect any longs on this board to understand that because if they did they would have sold.