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***OFFICIAL CYDY/Leronlimab Thread*** (2 Viewers)
- Thread starter This_Guy
- Start date
djmich
Footballguy
He's an economist but I'll take the shout out, hell I think he even said he loves it and really think it works at the end. Couldn't take my eye off his nose either.
Congrats for finding a greater fool to sell to. My perspective was based on fundamentals only.
Our next wager can be, which comes first Leronlimab’s first $1 of sales or CYDY stock price of <$1.
McBokonon
Footballguy
Doesn’t matter. Trump:
A. Loves OAN because they only tell him nice things.
B. Trusts people on TV stations who say nice things about him.
C. Is promoting another snake oil solution because the My Pillow Guy likes it.
This is the best possible strategy.
Bluto Blutarsky
Footballguy
Biggest nose since Christopher Multisanti
“he could smoke a cigarette in the rain and not get it wet”
fruity pebbles
Footballguy
ILUVBEER99
Footballguy
you might want to qualify that it has to be revenue from their drug. They might put out a bunch of cytodyn apparel to bring in the big bucks.
Otis
Footballguy
JerseyToughGuys
Tough Guy
Maybe you bought these from they guy who quit the board today. He is their largest shareholder with >12 million shares you know.
JerseyToughGuys
Tough Guy
Sounds like I’m going to have even more opportunity to buy then. Thanks for the heads up!
dkp993
Footballguy
So I’ve been in the “Whyatt’s just a guy offering a differing opinion” camp for a while. But what’s bugged me since you labeled this a pump and dump is that if you knew it was why wouldn’t you ride the pump and make a bunch of dough?
ILUVBEER99
Footballguy
not saying CytoDyn is a pump and dump (probably is), but the whole point of a pump and dump is that nobody knows it's gonna happen. Pumps have to be low key.
dkp993
Footballguy
Sure but if you know it is, you buy in low and then when you see it pumping you then dump. Whyatt has been here since early on, plenty of time to buy low and wait for the pump, just like he says he knew it was.
Dwayne Hoover
Footballguy
This isn't over yet by any means. Interesting time for you to reappear for sure. Give yourself a pat on the back for today but hardly think this is game over.
Dwayne Hoover
Footballguy
None of this is new. Surprised this story got retold again today. Otto isn't saying anything different than he did back in April either.
Dwayne Hoover
Footballguy
Honestly hard to take you seriously. You came in here touting Feuerstein, who is on record as being a phony. Hell, you may even be the Night King.
Either way the guy you cite has gone beyond normal protocol to write negatively about Cytodyn. He's resorted to outright lying to make a point. He's also contacted a cancer patient and recommended an alternate treatment, which he has no business doing, as he barely writes about the science. Aside from being a complete scumbag, he's also not been genuine about this company. If that's who you hold in high regard, your opinion is virtually meaningless to me.
FreeBaGeL
Footballguy
My favorite AF moments are when he claimed to have read the 100 page 10k like 4 minutes after it was released and vaguely referenced all the "bad stuff" without being able to actually cite anything specifically, and when he tweeted that whoops my buddy at Stat News accidentally made up that thing about NovaVax patients being hospitalized from side effects of the drug.
fred_1_15301
Footballguy
I think I'm out. I'm going to hope/pray that my wife doesn't mention anything. 
Good answer. I’ll give the long version, this is all my opinion of course.
Early on the CYDY story didn’t make sense to me because I read hype that Leronlimab was going to dominate the HIV market with billions $ of sales while I knew that superior treatments are on the way. Similarly, I was and remain skeptical they can compete in cancer - how much progress have they made in 7 months anyway? Back then the pumping kept the lights on so to speak. YouTube, BLA next week, Bla, bla, bla. COVID was the real opportunity to pump. Seems to me CYDY is not alone in this as there are others like RLFTF out there right now. I’m not comfortable buying RLFTF now, as it’s hard to know when you are left holding the bag. So that’s my reason, it was a quick ride down from $10, right?
No BS, I commercialize drugs. I never daytraded stocks, I‘m a buy and hold type. I’ve never bought an OTC stock until Hgen, and on that one I’m counting on Nasdaq/buyout this month/year.
ILUVBEER99
Footballguy
The HIV thing is hopeless. They have been trying to get it approved for 10+ years. Also, even if it does get approved is anyone gonna take it knowing that other drug cocktails have a 20+ year history of working? I wouldn't gamble my life on a newly approved drug when there are proven options that work. Getting FDA approval doesn't mean it will be used.
Here’s the thing Dwayne, I really don’t care much what you think about me or my posts, and I’m pretty sure you have the wrong impression of my intention here. If you were paying attention I’m pretty sure you learned things from my posts, but I maybe I was telling you something you didn’t want to hear. I don’t plan to post much more so we are all good.
So instead, google a paid by CYDY article or watch a paid YouTube, and feel better about your investment. It’s only because of a big pharma conspiracy that Leronlimab isn’t approved already, right?
Chaz McNulty
Footballguy
McBokonon
Footballguy
Chaz McNulty
Footballguy
Can I ask you what your opinion of how you think the phase 2 results of Leronlimab were in comparison to the phase 3 results of Remdesivir?
Zegras11
Footballguy
nothing wrong with a little follow up
“After about three weeks, I’m back to normal. I’m riding my bike six miles a day, I’m back to riding my horse…I feel like my life is the way it was before I had the coronavirus.”
Chaz McNulty
Footballguy
Do you just not believe in the MOA of this drug in regards to blocking the CCR5 and quieting the cytokine storm in Covid-19? I am trying to figure out why you think it's all hype. Dr. BP was talking about this in March/April, and other doctors only just started talking about the inflammation caused by an overactive immunity system in June.
Dwayne Hoover
Footballguy
Never mentioned any BP conspiracy, have also pointed out several red flags with this company so pretty sure I've got all eyes on both the good and bad.
I feel good about my investment because there are doctors from top programs who think there is potential. We know that Dr Patterson is a big proponent, but even if you want to say he's slightly compromised, there are also outsiders like Dr Yang from UCLA and Dr Seethramraju from Montefiore who have touted it. These are experts who have no reason to put their reputations on the line. So yes, I trust them more than some hack writer that you were citing in here.
They still have a severe critical trial that I believe will show good results and a mild to moderate that at least gets a phase 3, so regardless of what happened today with the stock price, its not game over by any stretch.
Chaz, I really don’t want to get too deep into this, as the response to my opinion is usually
But do you notice any difference?
https://www.nejm.org/doi/full/10.1056/NEJMoa2007764
https://www.cytodyn.com/newsroom/press-releases/detail/458/cytodyn-announces-clinically-significant-top-line-results
The Remdesivir data is there with all its mediocrity.
What is Nader bringing to the FDA for EUA? Does anyone really think that doctors will be prescribing and insurance paying $3000 prescriptions based on the information in that press release?
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Charlie Harper
Footballguy
I'm pretty sure they didn't just send the press release to the FDA.Chaz, I really don’t want to get too deep into this, as the response to my opinion is usually
But do you notice any difference?
https://www.nejm.org/doi/full/10.1056/NEJMoa2007764
https://www.cytodyn.com/newsroom/press-releases/detail/458/cytodyn-announces-clinically-significant-top-line-results
The Remdesivir data is there with all its mediocrity.
What is Nader bringing to the FDA for EUA? Does anyone really think that doctors will be prescribing and insurance paying $3000 prescriptions based on the information in that press release?
As an investor, do you think you have the right to see some of the data? That is pretty standard practice.
This stuff triggers industry folk like Feuerstein, and shareholders are like FU Feuerstein, who cares?
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Charlie Harper
Footballguy
Takes time for full analysis.
So back to the original question:
What do you make of the Phase 2 results?
Truly interested in your thoughts.
Chaz McNulty
Footballguy
So this is about how the results are being presented? We are already aware that one company has 18 employees, while the other one probably has hundreds.Chaz, I really don’t want to get too deep into this, as the response to my opinion is usually
But do you notice any difference?
https://www.nejm.org/doi/full/10.1056/NEJMoa2007764
https://www.cytodyn.com/newsroom/press-releases/detail/458/cytodyn-announces-clinically-significant-top-line-results
The Remdesivir data is there with all its mediocrity.
What is Nader bringing to the FDA for EUA? Does anyone really think that doctors will be prescribing and insurance paying $3000 prescriptions based on the information in that press release?
I am more interested in what you think of the two drugs in comparison to each other. Do you truly believe that Rem is superior to LL? Based on what you know of the two, what would you prefer to take if you or a loved one had Covid at a moderate level or beyond.
FreeBaGeL
Footballguy
That Remdisivir article is from almost a month after the primary study completion date. wHaT wErE tHeY tRyInG tO hIdE fOr A mOnTh?Chaz, I really don’t want to get too deep into this, as the response to my opinion is usually
But do you notice any difference?
https://www.nejm.org/doi/full/10.1056/NEJMoa2007764
https://www.cytodyn.com/newsroom/press-releases/detail/458/cytodyn-announces-clinically-significant-top-line-results
The Remdesivir data is there with all its mediocrity.
What is Nader bringing to the FDA for EUA? Does anyone really think that doctors will be prescribing and insurance paying $3000 prescriptions based on the information in that press release?
Dwayne Hoover
Footballguy
Feuerstein lies to embellish his story. He deceives shareholders for his own gain, which is pretty hypocritical seeing that's what he accuses NP is doing.
The Night King has a shelf life. Maybe he luckily avoids it from backfiring on him here, although I'm skeptical. If this is how he goes about his business, he's going to get burned hard sooner or later.
Dwayne Hoover
Footballguy
Let's not forget that Rem also changed their primary endpoint to meet their data. Didn't here about them datamining to try and find something significant.
When CYDY finds something significant that was not their primary endpoint, they are completely fluffing things, right?
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Moonlight
Footballguy
CYDY working late hours. Fast track review occurs within 36 to 72 hours in the UK for co-vid txs.
https://www.cytodyn.com/investors/news-events/press-releases/detail/462/cytodyn-requests-fast-track-approval-for-covid-19
https://www.hra.nhs.uk/covid-19-research/fast-track-review-guidance-covid-19-studies/
CytoDyn Requests “Fast Track Approval” for COVID-19 Patients from U.K.’s Regulatory Agency MHRA based on its Top-line Report Showing Statistically Significant Endpoint, NEWS2 (p < 0.023) and Notable Safety Results
Download as PDFAugust 19, 2020 1:25am EDT
VANCOUVER, Washington, Aug. 18, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the Company provided its Top-line Report from its recently completed Phase 2 clinical trial for patients with mild-to-moderate COVID-19 symptoms to Medicines and Healthcare Products Regulatory Agency (MHRA), an executive agency of the U.K. government sponsored by the Department of Health and Social Care. The Company requested the regulatory pathway for Fast Track approval noting the efficacy and safety results from the Phase 2 trial.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “As we recently reported, we are working diligently with several governmental agencies throughout the world to provide leronlimab to patients suffering from COVID-19. We believe the statistically significant results for NEWS2 is critical to identifying those patients who are at risk of progressing to a more serious condition. Importantly, in addition to the statistically significant efficacy findings, the safety results from this study were very notable with less SAEs and AEs identified in the leronlimab arm, as compared to placebo. Double-blinded clinical trials that are randomized 2:1, like our study, are very challenging to reach significant results as we demonstrated in a small population of a tough COVID-19 population in which to show efficacy and safety. We are eager to see the capabilities of leronlimab in our Phase 3 clinical trial for the severe-to-critical patient population. Our enrollment is now at 182 and we are very optimistic we will reach 195 by the end of August.”
UK NIH
Our fast-track approval process provides dedicated support to researchers to enable their study to be swiftly reviewed by a Research Ethics Committee and approvals specialists. This page provides information about how we decide which studies will be fast-tracked, how long the fast-track review takes, and what you need to do to apply.
How we decide which studies will be fast-tracked
COVID-19 studies are assessed by the HRA’s Director of the Approvals Service or their delegate to determine whether they will be accepted for fast-track review. New studies or amendments to existing studies will be accepted for fast-track review if they fall into the following categories and will produce interim or final published results within one year, or are funded through the UK-wide NIHR call for COVID-19 Recovery and Learning.
Reviewed within 36 - 72 hours of submission:
A study of a vaccine, treatment or diagnostic for COVID-19
A study to understand immune response to COVID-19
A study to understand prevalence or transmission of COVID-19
Reviewed within one-two weeks of submission:
A study of the wider impact of COVID-19 (including on mental health)
A study to enhance general understanding of COVID-19 (e.g. in specific patient populations)
A retrospective analysis of existing data
Some studies have been identified by the Chief Medical Officer as an urgent public health study, or have been determined to be studies of national interest by a government department (including in devolved administrations) or by Public Health England or equivalent national bodies. These studies are reviewed within 24 hours of submission.
https://www.cytodyn.com/investors/news-events/press-releases/detail/462/cytodyn-requests-fast-track-approval-for-covid-19
https://www.hra.nhs.uk/covid-19-research/fast-track-review-guidance-covid-19-studies/
CytoDyn Requests “Fast Track Approval” for COVID-19 Patients from U.K.’s Regulatory Agency MHRA based on its Top-line Report Showing Statistically Significant Endpoint, NEWS2 (p < 0.023) and Notable Safety Results
Download as PDFAugust 19, 2020 1:25am EDT
VANCOUVER, Washington, Aug. 18, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the Company provided its Top-line Report from its recently completed Phase 2 clinical trial for patients with mild-to-moderate COVID-19 symptoms to Medicines and Healthcare Products Regulatory Agency (MHRA), an executive agency of the U.K. government sponsored by the Department of Health and Social Care. The Company requested the regulatory pathway for Fast Track approval noting the efficacy and safety results from the Phase 2 trial.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “As we recently reported, we are working diligently with several governmental agencies throughout the world to provide leronlimab to patients suffering from COVID-19. We believe the statistically significant results for NEWS2 is critical to identifying those patients who are at risk of progressing to a more serious condition. Importantly, in addition to the statistically significant efficacy findings, the safety results from this study were very notable with less SAEs and AEs identified in the leronlimab arm, as compared to placebo. Double-blinded clinical trials that are randomized 2:1, like our study, are very challenging to reach significant results as we demonstrated in a small population of a tough COVID-19 population in which to show efficacy and safety. We are eager to see the capabilities of leronlimab in our Phase 3 clinical trial for the severe-to-critical patient population. Our enrollment is now at 182 and we are very optimistic we will reach 195 by the end of August.”
UK NIH
Our fast-track approval process provides dedicated support to researchers to enable their study to be swiftly reviewed by a Research Ethics Committee and approvals specialists. This page provides information about how we decide which studies will be fast-tracked, how long the fast-track review takes, and what you need to do to apply.
How we decide which studies will be fast-tracked
COVID-19 studies are assessed by the HRA’s Director of the Approvals Service or their delegate to determine whether they will be accepted for fast-track review. New studies or amendments to existing studies will be accepted for fast-track review if they fall into the following categories and will produce interim or final published results within one year, or are funded through the UK-wide NIHR call for COVID-19 Recovery and Learning.
Reviewed within 36 - 72 hours of submission:
A study of a vaccine, treatment or diagnostic for COVID-19
A study to understand immune response to COVID-19
A study to understand prevalence or transmission of COVID-19
Reviewed within one-two weeks of submission:
A study of the wider impact of COVID-19 (including on mental health)
A study to enhance general understanding of COVID-19 (e.g. in specific patient populations)
A retrospective analysis of existing data
Some studies have been identified by the Chief Medical Officer as an urgent public health study, or have been determined to be studies of national interest by a government department (including in devolved administrations) or by Public Health England or equivalent national bodies. These studies are reviewed within 24 hours of submission.
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Insoxicated
While these guys have proven to defy logic over and over, I'm going to ASSUME they performed a "full analysis" before submitting the data to the FDA. It would be insane not to.
They've supposedly submitted to the FDA already, correct?
So why haven't WE seen the data?
Occam's Razor screams the answer.
What was shared was obvious data mined hard. What was not shared was most of the data - I read they shared 1 of 17 endpoints, and only for a subset of patients. I can’t make a judgment on the Phase 2 results based on this, and those who do are fooling themselves.
You are joking right? the study results on Remdesivir were shared faster than the CYDY press release touting efficacy, no?
[icon]
Insoxicated
Mornin! Would love a bit more info on HGEN and your targets with NASDAQ / Buyout. Still holding about half my position on this. Half considering adding if there's tangible hope of uplift/buyout.
I know they got OWS money right?
Steeler
Footballguy
Don Hutson
Footballguy
I back into CYDY at $3.02. What'd I miss?
https://www.makestickers.com/design/200818112108-549kz9xmna0c6yqhpij8pkgx?pgid=cb689947-8001-4c34-911b-8c1b96e80dd2
https://www.makestickers.com/design/200818112108-549kz9xmna0c6yqhpij8pkgx?pgid=cb689947-8001-4c34-911b-8c1b96e80dd2
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Steeler
Footballguy
You no longer sound like a guy who is trying to provide an alternate perspective - you sound like a guy that wants to pound his chest about being right. What's your reason for quoting this post "for posterity"? So you can come back and rub salt in his wounds if the stock price continues to plummet? It's not a good look.
