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True. We're talking a BLA scheme and a COVID scheme.
Kazem denies the COVID scheme.
LOL dont ask the obvious question
Its way easier for these bagholders to accuse the FDA than to question the obvious LOLOL
This keeps their convoluted story an appearance of truth when they have to explain to their family & friends why they have lost -97%
If leronlimoob is so great why aren't they running any clinical trials? Seems like a no brainer to me.
“Kazem vigorously asserts that he and Nodder ARE NOT TWO PEAS IN A POD.
The filing provides plenty of evidence to back up that assertion.”
EXCEPT that one time when NP said file the BLA no matter what’s missing, Amarex filed the BLA incomplete and both companies subsequently PRed that a completed BLA had been filed. Besides that part of the alleged fraud, no, not in the same pod.
i think you're right. I have always believed there is value in the drug itself. In the right hands, it could create a lot of value for investors. I placed way too much focus on the drug, and not nearly enough on the leadership side when making my investment decisions. But, what I have learned (the hard way) is that for any company to succeed, you must have both - a great product, and great execution by a solid leader.
What i cannot figure out now is whether the company (and my investment by extension) can survive NPs disastrous moves. I'm not discounting the FDA and their hatred of CYDY - but I am convinced that if we had a very credible leader in place, the regulators would have treated us completely differently. They have seen us as a problem child for many years - mostly because of the way NP has behaved.
I remain very concerned, but i don't think anyone knows for sure how this will play out - despite some saying they do.
Case: 8:2022cr00440 USA v. Pourhassan - Kazem Kazempour
Kazem vigorously asserts that he and Nodder ARE NOT TWO PEAS IN A POD.
The filing provides plenty of evidence to back up that assertion.
To reiterate
I've been reading posts on other boards and I have to say that there were so many smart people who had invested in CYDY three or + years ago. They definitely were ahead of the curve or more skeptical of NP and his wiley ways. Some of us, like me, only focused on the efficacy of Leronlimab - believing its Lazarus qualities while others had the right focus looking at NP and saying "What is he doing?" My inner voice still says Leronlimab is the real thing but how is it going to play out, now?
Today's court documents have harpooned both Nader and FDA members in separate ways to CYDY's downfall. The longs take it on the chin because these FDA blowhards, who incidentally are the ones in-charge and making new rules (not observing the rules) have played whack-a-mole with CYDY and thus, maybe killing the efficacy of Leronlimab, forever.
Yes, I expect some interviews with Nader et al....ET AL. Going to be quite the interesting story should one ever get published.
Some who don't expect it may get an interview as well. Be ready!! FDA and bashers will follow the Nader interview most likely.
May well trigger some other investigations to dig some more and make a few adjustments. Probably going to be a lot of squirming trying to get the stories straight.
Meanwhile, Sidley takes good notes and may well have some contributions to add to the story.
So in the interim, keep up the incrimination bashers ,and oh yes, thanks for the cheapies anytime.
In the interim, Dr. Jay is slaving away. Get ready.
$CYDY$ 2024
“Now show us the hold was lifted in the 10Q”
Not sure what you’re referring to. The clinical hold was lifted months ago and I’m confident it was filed in an 8k and mentioned in the 10q, just like NP’s felony convictions.
Now show us the hold was lifted in the 10Q lol
“And his second conviction was , his check for $100.00 bounced ,
well , when I was an intern in the hospital , many of my checks bounced ....I must be the biggest criminal in USA , everyone else are angles here ..”
If you believe anyone is charged with felony fraud for accidentally bouncing a check for $100, then I have a bridge to sell you. That pattern was there for all to see, some caught it, some didn’t, but no coincidence he’s pending a 3rd felony.
No , today you cant be arrested for assaulting police officer , or anyone on the street .
Or if you have a bad luck and someone will arrest you , you are back on the street in few hrs.
But I guess their crime was not as big as Dr NP , sending an email to his x-wife asking about their son.
Go figure.
All imo.
And in today’s society, you can be arrested for assaulting a police officer and then get back out on the streets to do it again.
My how times have changed.
" Dr NP was convicted of sending an email to his x-wife. " email was about their child.
WOW , he is really a CONVICT , I hope the whoever is attacking him didn't make a bigger sin in their past , I am sure I may do something worse then that !!..
And his second conviction was , his check for $100.00 bounced ,
well , when I was an intern in the hospital , many of my checks bounced ....I must be the biggest criminal in USA , everyone else are angles here ..
And then he filed for BK , well , millions of Americans doing this , is this consider to be a criminal act in USA ???
Only the 5.95s must be the saints I see. Average person in USA will be happy to have ONLY those crimes against them ..
All imo.
GLTA longs
“The following information may be relevant to an investor’s evaluation of Dr. Pourhassan, as well as an investor’s decision to buy, sell or hold securities of the Company:
a. On May 3, 2006, in Superior Court of Washington for Clark County Case No. 204227D, Dr. Pourhassan was convicted of a felony domestic violence court order violation. Dr. Pourhassan pled guilty to violation of the provisions of a protection order by contacting his former spouse via email with communication intended for his son. Dr. Pourhassan performed community service, paid a fine of $100, served 24 months of probation and was ordered to comply with the protection order.
b. On June 9, 1986, in the First District Court in Logan, Utah, Dr. Pourhassan was convicted of a third-degree felony of theft by deception for overdrawing his bank account by approximately $100. Dr. Pourhassan was placed on one-year probation.
c. Dr. Pourhassan filed for Chapter 7 Bankruptcy in 1991 in Salt Lake City, Utah, case number 91-24348, and in 2001 in Portland, Oregon in case number 01-36712-elp7.”
FELONY domestic violence and FELONY of theft by deception (deception like maybe the BLA isn’t complete?). Great CEO material!
https://www.cytodyn.com/investors/sec-filings/all-sec-filings/content/0001193125-12-392638/d412647d8k.htm?TB_iframe=true&height=auto&width=auto&preload=false
In some cases Leronlimab (or Leronmybud LL) will "carry the ball across the goal," (Especially where CCR5 is involved) but more frequently, it would be a valuable adjuvant. And the, so far, minimal negative side-effects... give it some interesting advantages.
And
Makes >> LL >>> A THREAT <<< to competing drugs carrying "heavy side-effect disadvantages."
So spin us a tale on ...HOW >>>Roger Stone get some LL for his wife with (reputedly) good results?
And it seems some other "biggies" got some.
But now >>> LL could gradually, become the Newest Drug. A drug that seems to support health by helping to counter chronic inflammation. But LL's not a magic bullet.
A lot of factors apply - like what are you're eating, breathing, sharing, and on and on, etc.
But Leronlimab, Leronmybud, is something I want available.
My Opinion totally!!
***
And, sorry big-bully Pharma. We could have been working together, but events have a path of their own,
Imagine
Leronlimab
Could be
Popping up
Leronmybud
And they have their own
"on-line Docs"
to do the scripts ;)
Always entirely my opinion - do your own research
Me skeptical?
And what IS happening with the "waste Leroonlimab?"
The "game is afoot," (an allusion to 'Sherlock Holmes').
Sure, they're going to just "flush >>> the ultimate new cure >> down the drain or the collective toilets in S. Korea?
Realllllly?
(And even if it's not a proven fact...makes a delicious rumor...suggesting the drug might suddenly "appear from afar.")
And the product and formula are totally gone or beyond analysis and replication? Right!!!!!
And Suddenly...
"Hello there"
It's your 'new friend'
Leronmybud!
Yeah, it's down there, to the left of bagged fortune cookies under, yeah, the counter full of "lucky bamboo." So, cash, card, or Dillo?
And big pharma is caught "stupidly standing" as the wonder drug becomes readily available from other sources.
***
I suspect >>>it's available right now...
But not for us.
***
All my opinion
Would you take a truckload of "hope Diamonds" and dump them in the deepest ocean...(without a net cleverly concealed)?
Hmmmm?
The pen-ultimate "Ha, ha?"
Our big pharma, after battering poor old CytoDyne (My opinion)" will be lost in the dust...
Yes this mother is in medical profession-- More fucking lies from you.
A mother IN the medical profession is either currently licensed or employed via proof of paying taxes on income of said medical profession. You are neither.
A retired doctor is just that. Lets see a retired unlicensed doctor perform a surgery in a clinic or hospital. That being said, he or she is no longer a doctor.
A washed up liar losing money on a OTC penny stock is a more fitting definition of a pumping individual whom is NOT in the medical profession.
lol , you really trying with your lies and attack on people .
Yes this mother is in medical profession ,
Retired doctor is still a doctor … .
But you knew this .
Find yourself something more productive to do for living , This insulting people for money is sickening .
All imo
Truth??? These are both LIES--- 1. "a mother in the medical field" (which is patently false, the mother WAS NOT licensed in the medical field at the time of this article).
2. "CytoDyn, appears to be the only biotech company with a proven treatment in a large randomized controlled trial for severe and critical COVID-19." which is ANOTHER blatant lie.
Which online financial publication had the story of leronlimab damaged their twins posted?
Was it posted on Zerohedge?
Zerohedge says--- the zero hedge manifesto
our mission:
to widen the scope of financial, economic and political information available to the professional investing public.
https://www.zerohedge.com/about
Dont even get me started on the never purchased CYDY warrants at a discounted price lies.
There is NEVER a crime to state the truth , but there is a crime when some trying to manipulate market posting for weeks that leronlimab damaged their twins ,
and this is a lie !!!!!!
Yes , I believe this is a crime..
All imo.
Bahhhaha those emails are hilarious. FDA saw through the charade right from the start. Hahahhahah too funny
and all of them showing us work of FDA.--- Point taken. So what is it called when "a mother in the medical field" (which is patently false, the mother WAS NOT licensed in the medical field at the time of this article) refuses to divulge her active and current investment in the drug and company touted in this article and then to add insult to injury claims "CytoDyn, appears to be the only biotech company with a proven treatment in a large randomized controlled trial for severe and critical COVID-19." which is ANOTHER patently untrue lie?
Leronlimab Anecdotes - A Patient's Perspective - Beating the System
BY CHESSMASTER
THURSDAY, AUG 12, 2021 - 22:03
CytoDyn, appears to be the only biotech company with a proven treatment in a large randomized controlled trial for severe and critical COVID-19. Proven means their drug reduced 14 day mortality by 82% in a phase 3 clinical trial. Proven doesn't mean the drug is approved by the FDA because they asked for more data. This is the rub because it's proven, but not approved and because of that the company has been under constant assault and criticism for how the management team has been handling the clinical trials. Their leading drug candidate is called leronlimab and is branded as Vyrologix and it has single handedly taken dying from COVID-19 off the table. Many of the critics of the Company are shareholders and in one special case a group of shareholders that called themselves Advancing Leronlimab and used what the Company described and illegal tactics to challenge the board of directors. Luckily for patients around the world their bid for greed and avarice failed.
When you put aside the greed and take a hard look at the company, their mission statement is to save lives and of course maximize shareholder value. This management team may be tiny in comparison to most biotechs, but enormous in terms of heart. This team actually cares for patients personally and at one time in the pandemic had the largest number of compassionate use approvals. The truth is that there’s only one reason for breaking a record for compassionate use and it has to do with the viability of the treatment. Many that have gotten either compassionate use or the rarely used Right to Try approvals have interfaced with top management as they worked tirelessly to get the approvals processed as quickly as possible.
Shareholders that have a hard time understanding how a drug with so much potential isn't approved by now don't understand how challenging the drug development process is, and they certainly don’t understand a management that seems to put patients’ lives first. At CytoDyn the CEO has gotten himself personally involved in pushing the process of many Emergency IND’s and compassionate use requests. This is not a normal thing that people are likely to see at any other biotech on the globe. The corporate culture really values human life and seems to do anything they can to preserve it.
Leronlimab has saved many lives. A very recent anecdotal report of another life saved by leronlimab underscores the importance of how truly revolutionary this drug could become. In order to preserve the privacy of the patient no identifying details will be used. Approximately 2 weeks ago a mother in the medical field was talking to her grown son who is also in the medical field and noticed over the phone that he sounded sick and nasally. The son indicated that he just had a bad cold and that something was going around because he thought since all people were all wearing masks for so long that their natural immunity was compromised and colds were on the rise. The mom was skeptical of the answer and made him take a home covid test from the pharmacy. Although he tested positive, the mom was well versed in treatment options and was prepared. She pumped him up with ivermectin, vitamins and eventually resorted to hydroxychloroquine. Nothing seemed to work, and after a couple of days his oxygen levels eventually dropped into the mid 70’s forcing him to call an ambulance. When he arrived he found himself in an unfortunate situation. The Floridian healthcare system was experiencing a surge and was overrun with patients. After many hours of waiting he was diagnosed via a chest X ray having double lobe pneumonia, no treatment was administered and the son found his way back home after picking up a canister of oxygen to use at home. During his wait in the Emergency room he was not provided water, or intravenous fluids, or a bed to lay down on. Despite his use of oxygen at home his oxygen levels continued to deteriorate to 74%. He could barely breathe or talk. This put him at severe risk of dying, he needed to get back to the hospital. The surrounding hospitals were all full capacity so the resourceful mom called around looking for open beds. Eventually he was admitted to another hospital with a compassionate doctor leading the treatment. The first treatment offered was Remdesivir and that was patently rejected by the mom who read the reports and understood it was not appropriate for her son's situation. This was a cytokine storm not a viral infection. She made it known that she wanted leronlimab to be used for her son. Instead of saying no, the doctor suggested they try one of the approved options like tocilizumab first and see if there was any change before they go the Right to Try route. After 3 days of seeing continued deterioration the Right to Try paperwork was signed by the doctor. The drug made it to the hospital the very next day. This was very A-typical because the mom was completely prepared and was on top of the communication.
Before taking leronlimab the patient was on high flow oxygen consuming between 6 – 10 liters. Since leronlimab is a subcutaneous shot it takes time to enter the bloodstream and she cautioned her son to remain patient. After administration it took two hours before there was a change in his status. The patient was able to talk better and had a more productive cough and the oxygen saturation levels started to increase. After 4-5 hours oxygen levels improves so much high flow oxygen was removed and reduced to the nasal cannula. The patient's strength was coming back and he felt like leaving the hospital, but there was also pressure for him to leave to make room for the sick that were in the hallways. The patient was ultimately discharged 26 hours after being injected with leronlimab, and went home with instructions to use oxygen as needed and report back if there was a worsening of conditions.
All these anecdotal patients that took leronlimab, which numbers over 100 understand one truth. The drug works and works extremely well and in most cases quickly. The last thing these patients care about is the greed involved in developing a drug and the he said she said minutia in the boardroom. They welcome a CEO and a company with a refreshing attitude that just wants to save lives. Critically ill patients have been abandoned by both the FDA with their draconian policies and politicians whom seem to be more concerned about mandating vaccines and masks. Team CytoDyn and Hero moms need to be celebrated whenever possible.
The measures to curb the pandemic failed with over 620,000 American in body bags. Initial estimates were 200,000. History will eventually reflect upon how many lives that could have been saved if leronlimab was approved sooner. There is still a long approval road ahead for leronlimab in the United States, but Brazil has their own pivotal trial starting imminently and may be the first beneficiary of a COVID drug that takes dying off the table and flattens the curve.
The situation in Florida with respect to available ICU beds is really bad and here sits a drug that saves the lives of almost everyone it touches. It also has the potential to seriously flatten the curve in hard hit areas because if all the people sitting in the hallways were given this very safe drug they might actually go home like this patient did. People need to know about this drug and the process required to get it. Right now it's only available via Right to Try since it doesn't have its EUA approval or any active clinical trial sites in the USA. Eventually the FDA will come around to approving this drug but in the meantime it's pointless to provoke the FDA and try to force an approval. That's been tried before and has failed. People just need to work within the system to get the drug for your loved ones should they need it. The hero mom in this story was well educated and prepared on what to do in case of this eventuality. Advanced preparedness seems to be partly responsible for the happy ending. So the lesson learned here is that there is no substitute for preparation. It's clear that this drug takes dying off the table and when politicians decide they've seen enough body bags then maybe this drug will see the light of day for use in COVID-19 in the United States.
Right to Try is the only way to access leronlimab and take dying off the table for severe to critical patients. The only hitch is that you have to ask for it and you have to get a doctor at the hospital willing to step up. These anecdotal reports are just whispers right now, but they will turn into a thunderous call to action as the pandemic worsens and news of the drugs success continues to spread.
Enough with the fantasy lies--- Leronlimab was proven being effective many times
We've been over this time and time and time again and it always boils down to me asking the same question and me getting the same non-answer...link the goddam data from an OFFICIAL source (FDA, NIH, etc) proving---
—-Phase 3 pivotal study for combo HIV , finished with 81% efficacy , and not one serious side effect. When at the time 2 other approved drugs were ,maraviroc with 45% , and Ibalizumab with 43%
—- CD12 study in critical Covid showed ,
82% mortality benefit ABOVE any drug in the world , when leronlimab was in the system ..
—-small study in cancers showed really positive results …
—-as also in Nash …
-—Long Covid study was a big success , it showed that some patients immune system is hyperactive , but many are immunosuppressed , leronlimab worked as a great immunemodulator in both ..
This study was peer reviewed and published by Dr Otto Yang from UCLA..
Excepted it shows Cytodyn was nowhere and has lied to its investors. What about that BLA data claimed publicly (PR!) by the CEO Nader to have been submitted to the FDA but that in fact was NOT submitted?
A corporate scam.
Yes very interesting I agree ,
Also many of them unprofessional , and all of them showing us work of FDA.
All IMO.
GLTU
Some very interesting emails between FDA staff in that long post. Some of their comments seemed to be very unprofessional.
I traveled for the last few days , opening mails this late afternoon/evening .
This came today from my friend , a great post from another message board..
https://www.reddit.com/r/Livimmune/comments/1c96auz/tomfoolery/?utm_source=share&utm_medium=web3x&utm_name=web3xcss&utm_term=1&utm_content=share_button
Yes , a very good post , showing us a little bigger window to FDA.
Sure they care for us all !!!
All IMO.
GLTA longs,
lol 82% nonsense again. FDA took the unprecedented step to disprove this data dredging 82% nonsense that Nader and Cytodyn tried to bs with.
Leronlimab was proven being effective many times , much more effective , imo , then some of the toxic approved drugs , and in contrary without one serious side effect .
But then Dr Jeffrey Murray working at the time in FDA , didn’t talk in his emails about other companies i as he did about CYDY …
“ I hate them ..”
Another FDA employee posted in her email , it was Susan S ( I dont remember her last name )
So she said .
— you know this drug is an immunosuppressant ,
Wow , who they have working there .
No, it is not an immunosupressant , it is an immune modulator .
FDA , know what you are talking about !!!
Leronlimab has a great results in following studies ..
—-Phase 3 pivotal study for combo HIV , finished with 81% efficacy , and not one serious side effect. When at the time 2 other approved drugs were ,maraviroc with 45% , and Ibalizumab with 43%
—- CD12 study in critical Covid showed ,
82% mortality benefit ABOVE any drug in the world , when leronlimab was in the system ..
—-small study in cancers showed really positive results …
—-as also in Nash …
-—Long Covid study was a big success , it showed that some patients immune system is hyperactive , but many are immunosuppressed , leronlimab worked as a great immunemodulator in both ..
This study was peer reviewed and published by Dr Otto Yang from UCLA..
Yes , leronlimab seems to be a great drug , much better then many approved for us toxic , doing nothing , or minimum good drugs !!
All imo
GLTA longs
From your lips , to God ears ..
Go leronlimab !!!!!
GLTA longs
@$5.95akadawson-m you have interesting insights of past situations with CYTODYN history..
My staying away from posting as former poster "eklab", was the loss of time spent here.
Investing in stocks, is the same as playing in a casino, in my opinion, except that money lost here on cydy or other stocks ca be used as a tax write off.
I am a long time owner of Leronlimab, and like the quality of this medicine.
Why don’t you stop lying and cut the leronsaline shit ? There is NO SUCH DRUG called leronsaline. Please provide the link showing that there is a drug called leronsaline.
Bad FDA tactics? Has leronsaline met its primary endpoints in any of its numerous clinical trials?
So cut the email and conspiracy shit...has leronsaline been proven to be effective or not?
Now one can see why investors admit to being hurt.
“The press people will be knocking on some doors to expose and interview bashers and looking to interview fda people”
Hopefully they call NP for an interview so he can hold 3 fingers up to the camera and milk his followers via a gofundme.
I am 90% with you here. In my mind there is no doubt about the bad tactics of the FDA et al which has been demonstrated repeatedly over the decades. This whole NP thing merely parallels the rampant corruption within the Administrative state in general. Is this Ukraine? This isn't Ukraine... they are being played just like the investors in CytoDyn and many others who thought we had at least an agency that cared for human life. The whole ivermectin and HCQ saga demonstrated this so vividly among so many other dirty tricks that have surfaced post covid...that MSM skips around. So NP and KareemD could see from the inside how the story was going to play out. Were they both disgusted or just buddies in the fox hole together trying to survive some nasty orders? Yes, NP was paid way too much. I believe he knew the outcome as a result of and after attempting EUA for Covid. Enter big brother. Look at all those who got shot down too. Many other non-club pharmas and university scientists who could see through the charade ... as emails have disclosed. So IMO it came down to the coup taking place with 13D. Support them and lose the whole enchilada or stay on board the ship and see where it sails? Had 13D some smarts they could have been successful, but they rallied the short bashers that no one likes... a big mistake and a costly one.
So I am more furious with the FDA than ever. Sure NP and buddy sold us down the river. So what is new? Just look at the state of affairs everywhere you find a large govt agency. Rules and regulations and mission statements are a joke for those who dangle the carrots. NP liked carrots better than the mercury found in tuna or the lead found in some skulls. The Iranian conspirators Pourhassan and Hassanpour, whatever his name is, will probably be left out to dry from all accounts unless they have some more Maji to leak out. Will Darius The Great rise again? This could get real interesting as things are quite sticky.
Consequently, I don't expect much but a lot of damage control. The sugar coated version is due out. Should make an exciting end to another great chapter in the leronlimab saga.
And to remember who let the light shine out of darkness? Thank goodness for Dr. Jay. who has penetrated this darkness with a ray of bright light.
Ready for the new chapter to continue lighting the path to success? I am. $$CYDY$$ 2024
We are working with American press regards to the leaked documents and bashers. The press people will be knocking on some doors to expose and interview bashers and looking to interview fda people. Anyone volunteer? Or they just show up at door, first amendment freedom.
Huh? NP? What? You are laughing at the longs, no doubt with that statement...
NP took out what looked like a gun and turned a laser on us.
Poof.
Ah the nice little delusion.
Of course it must a good news. Like 100% of the “100% sure things” you have promised before, that ended up being 100% wrong.
Wake up: Cytodyn is toasted. But you can choose to sink with the boat LOLOL
You must not have been privi to the court documents that are being posted, read them and BINGO! There's your answer. Trust me, you and your fellow bashers are not going to like it
Hmmmm the forbidden question longs refuse to ask: why was the Amarex "last hope" settlement postponed to November, hmmm???
CYDY is running on fumes and hiding information.
NP was the best thing to ever happen to longs and they blew it. Guys come on learn when to take the win.
Lol nice volume. Almost a billion shares and you can't even crack a million
Pathetic loser longs invested in a dead stock lollllllllll
Today from another poster who was Ihub born in 2000. "There are some individuals on this platform who have made over 700 posts about a single company and all of them are negative. This speaks volumes in itself. To all the short bashers out there, bring it on! If your stock is being bashed, take it as the ultimate compliment. Don't waste your time, just report these traders who are trying to manipulate the market and keep them where they belong."
I would venture to say we have exceeded this with some short bashers here on CYDY.
Why is this? One simple word, leronlimab. So we got it, they want it and until they get it they will pay bashers to bash so they can try to buy up the company.
Secretly they are buying shares little by little just below the threshold of moving the stock up. Accumulation on the sly by those who know the value of leronlimab which is pretty much everyone. This is how the game is being played which is why I buy on any worthwhile dip especially now after the hold was lifted with assistance from the FDA on protocol development. So we know the company is going forward and in my opinion they are being extra cautious to insure an airtight HIV protocol along with continuing basically from where it was left off. Once a new trial gets started then is when I would start contemplating a collaborative effort with another pharma . Most likely I think for another indication perhaps in the wide arena of cancer. The company has definitely made good strides in 2023 revamping. 2024 is shaping up fine with the new CEO who masterfully assisted in the back and forth FDA negotiations to rectify to their arduous demands with ending the long slug of a year plus hold on trials. Patience will pay as the data will lead the way for very nice gains. A lot more of the medical science world now knows about leronlimab. We enter a new era much more grounded and savvy as to the obstacles. Don't forget the new possibilities even outside of the new longer acting leronlimab. You can add to that whatever else the contracted artificial intelligence company discovers. Things are going to get more exciting from here on. So for me, thanks basher pigeons for the cheapies. $$CYDY$$ 2024
Is stating nobody interested in 15 cent shares "bashing" or a fact?
LAUGHING at hurt dupes.
Hold was lifted why no trials? Why no partnership? Why no buyout? Huh longs? Why you promised.
Sure thing or bust!
Just reading the posts, good or bad , patiently waiting for the end of the year. Then, wake me up please.
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DISCLAIMER:
Securities and Exchange Commission and Department of Justice Investigations
The Company has received subpoenas from the United States Securities and Exchange Commission requesting documents and information concerning, among other matters, leronlimab, the Company’s public statements regarding the use of leronlimab as a potential treatment for COVID-19 and related communications with the FDA, investors, and others, and trading in the securities of CytoDyn. The SEC has informed the Company that this inquiry should not be construed as an indication that any violations of law have occurred or that the SEC has any negative opinion of any person, entity or securities trading activity.
In addition, the Company and certain of its executives have received subpoenas in connection with an investigation being conducted by the United States Department of Justice. The subpoenas seek testimony and/or records concerning, among other matters, leronlimab, the Company’s public statements regarding the use of leronlimab as a potential treatment for COVID-19 and related communications with the FDA, investors, and others, and trading in the securities of CytoDyn.
Securities and Exchange Commission and Department of Justice Investigations
The Company has received subpoenas from the United States Securities and Exchange Commission (“SEC”) and the United States Department of Justice (“DOJ”) requesting documents and information concerning, among other matters, leronlimab, the Company’s public statements regarding the use of leronlimab as a potential treatment for COVID-19, HIV, and triple-negative breast cancer, related communications with the FDA, investors, and others, litigation involving former employees, the Company’s retention of investor relations consultants, and trading in the Company’s securities. Certain Company executives have received subpoenas concerning similar issues and may be interviewed by the DOJ or SEC in the future. The SEC informed the Company that its inquiry should not be construed as an indication that any violations of law have occurred or that the SEC has any negative opinion of any person, entity or security.
The Company is cooperating fully with these non-public, fact-finding investigations, and as of the date of this filing, the Company is unable to predict the ultimate outcome and cannot reasonably estimate the potential possible loss or range of loss, if any.
VANCOUVER, Washington, March 30, 2022 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on its HIV program and a full clinical hold on its COVID-19 program in the United States. Further, the Company elected to pause its Brazil COVID-19 trials pending results from its previously scheduled data safety monitoring committee meeting and is in the process of reevaluating the timing of its HIV BLA resubmission.
The Company was not enrolling any new patients in the trials placed on hold in the United States. The partial clinical hold on the HIV program impacts patients currently enrolled in extension trials. These patients will be transitioned to other available therapeutics and no clinical studies can be initiated or resumed until the partial clinical hold is resolved. CytoDyn intends to work closely with the FDA to resolve the partial clinical hold as soon as possible. Under the full clinical hold on the COVID-19 program, no new clinical studies may be initiated until the clinical hold is resolved. The Company is not currently conducting any COVID-19 trials in the United States, as it is evaluating the most optimal programs on which to focus its resources and attention.
“CytoDyn is committed to FDA compliance,” said Scott A. Kelly, M.D., Chief Medical Officer of CytoDyn. “We are evaluating our clinical programs and are working to resolve the issues underlying the clinical holds as soon as possible in close communication with the FDA. We will provide an update when we have additional information.”
Up to 205,652,848 Shares of Common Stock
This prospectus supplement updates, amends and supplements the prospectus dated October 11, 2023, relating to our Registration Statement on Form S-1 (Registration No. 333-272815) (as supplemented or amended from time to time, the “Prospectus”). Capitalized terms used in this prospectus supplement and not otherwise defined herein have the meanings specified in the Prospectus.
This prospectus supplement is being filed to supplement the Prospectus with the following information:
The information in this prospectus supplement includes forward-looking statements relating to, among other things, future clinical trials and our business strategy. The reader is cautioned not to rely on these statements, which are based on our current expectations. Please see below for additional information about risks involving our securities.
This prospectus supplement is not complete without the Prospectus. This prospectus supplement should be read in conjunction with the Prospectus, which is to be delivered with this prospectus supplement, and is qualified by reference thereto, except to the extent that the information in this prospectus supplement updates or supersedes the information contained in the Prospectus. Please keep this prospectus supplement with your Prospectus for future reference. The Prospectus, together with this prospectus supplement, relates to the resale of up to 74,903,789 shares of our common stock, par value $0.001 per share (the “common stock”), and 130,749,059 shares of our common stock underlying certain warrants (collectively, the “Shares”), by the selling stockholders identified in the Prospectus under “Selling Stockholders”.
Our common stock is quoted on the OTCQB of OTC Markets Group, Inc. under the symbol “CYDY.” On February 29, 2024 the closing price of our common stock was $0.2575 per share.
Investing in our securities involves risk. You should carefully consider the risks that we have described under the section captioned “Risk Factors” in the Prospectus on page 8 and in Part II, Item 1A of the 2024 Second Quarter 10-Q before buying our securities.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if the Prospectus or this prospectus supplement is truthful or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus supplement is March 1, 2024.
November 3, 2023
November 2023 Letter to Shareholders
Dear Shareholders,
We write to provide an update on CytoDyn Inc. (“CytoDyn” or “Company”), and to thank you for your continued support of the Company.
Throughout our history, CytoDyn has made great strides in developing leronlimab from a single indication molecule into a platform molecule with the potential for multiple therapeutic indications. Through CytoDyn’s investment in clinical trials, we have generated valuable data demonstrating how leronlimab might be used in HIV, oncology, metabolic dysfunction-associated steatohepatitis (“MASH” formerly “NASH”), and metabolic dysfunction-associated steatotic liver disease (“MASLD”). We have also successfully transferred our manufacturing technology allowing us to manufacture leronlimab at scale in preparation for clinical trials and potential FDA approval.
Fiscal year 2023 proved to be a very difficult year for CytoDyn. We had planned to be off clinical hold and back to conducting clinical trials by now. Unfortunately, to date, we have been delayed in our efforts to satisfy the FDA with our clinical hold submission(s). We have embarked on a more comprehensive effort to resolve the FDA’s lingering questions. These efforts include the Company’s hosting of a number of advisory board meetings with key opinion leaders (KOLs). Adding to our delay was the unanticipated medical leave taken by our then President, Dr. Arman creating additional delays in our subsequent resubmission.
However, these unforeseen circumstances provided the time needed to help us gain new insights and understanding of leronlimab in the current HIV treatment environment. Further, we were able to receive and incorporate the perspectives of some of the top HIV KOLs worldwide as to how they believe leronlimab can play a significant role in helping HIV patients, notwithstanding other therapeutic options currently available to patients. As part of this process, the Company engaged various new clinical, regulatory, and medical consultants and advisors with relevant experience and expertise that we believe will continue to benefit the Company for years to come.
The Company has taken necessary actions to position us for near-term and long-term success. During the last fiscal year, the Company implemented significant reductions to its workforce, cash burn rate, and operating expenses, in order to conserve our resources and devote them to critical corporate priorities. In addition to our work in HIV, we have worked with top experts to develop a MASH clinical trial protocol and identify potential MASH pre-clinical combination therapy trial concepts, which trials we believe could be attractive to a partner and position the Company for a greater chance of success within the MASH space. We also began development of a longer-acting therapeutic with a partner who has a very strong and reputable artificial intelligence (“AI”) platform, which we believe may provide significant increases in shareholder value in the years to come. We also believe that the Company is positioned for success in the Amarex litigation. We fully funded Sidley Austin LLP – the preeminent law firm representing the Company in this matter, filed a more-detailed statement of claim, and scheduled a final hearing date (August 12, 2024) in the arbitration.
We understand that CytoDyn’s recent challenges may have tested your confidence. We want to assure you that we remain dedicated to developing important therapeutics that can make a difference in
patients' lives, and at the same time provide value for our shareholders. Again, we are grateful for your ongoing support and trust.
We will continue our efforts to prioritize and execute on goals that will enhance value for all shareholders. Our efforts are focused on successfully completing the resolution of the FDA’s partial clinical hold – having recently made a submission that we hope will be successful – and strengthening our leadership team. Additionally, the Company will be evaluating the various potential indications for leronlimab to maximize the effective and efficient use of our resources. We have always believed leronlimab holds great promise, and we are determined to explore all avenues by which patients and medical practitioners can benefit from its use. We believe that with the improvements we have made and continue to pursue, our company is positioned for long-term success.
We deeply value your investment in CytoDyn and are committed to acting in your best interests. We look forward to continuing to communicate as additional developments occur. We realize the updates above may not answer all the questions you have. We therefore include a November 2023 “Frequently Asked Questions” supplement with this letter. This FAQ supplement is something we intend to update from time to time and it will be posted on the Company’s website in the near future.
Finally, in advance of our upcoming Annual Meeting on November 9, 2023, we want to remind you to submit your votes, if you have not already done so. If you were a shareholder as of September 11, 2023, you are considered a shareholder of record. Notably, the Company has asked for the shareholders’ approval to amend the Company’s Certificate of Incorporation to increase the total number of authorized shares of common stock. This increased share allowance is critical to the ongoing viability of the Company, and we therefore encourage everyone to vote if you have not already done so. If you have any questions or require any assistance in voting your shares, please call the Company’s proxy solicitor, Alliance Advisors LLC, at (833) 814-9456.
Sincerely,
Tanya Durkee Urbach
Board Chair
Note Regarding Forward-Looking Statements
This letter and the accompanying Frequently Asked Questions supplement contain forward-looking statements relating to, among other things, future operating and financial performance, product development, market position and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and/or our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review the Annual Report on Form 10-K for the fiscal year ended May 31, 2023, including in the sections captioned “Forward Looking Statements” and “Item 1A. Risk Factors”, as later supplemented by our Form 10-Q for the quarter ended August 31, 2023, in the section captioned “Item 1A. Risk Factors”. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments.
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