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WHY hasnt the FDA lifted the ((((((((FULL HOLD)))))))) ???
UH OH! Leron be pimpin by 2PM today--- "Brother" in da house!!!!!
Gotcha.
Um, mohammed, leronsaline is destined for approval?
Your 4 years here has been nothing but a waste of time...prime example---
"I'm not a shareholder anymore"--- Um, mohammed, why are you continuously bitching about the share price and "manipulation" if youre not a shareholder?
Sounds more like youre trying to discourage folks from posting any DD on this co.
The best of the best cos get DD posted that longs dont like...Tesla, Apple, Walmart, Boeing, etc.
What makes this little tiny 16 cent no revenue, under FULL HOLD, no approval, under SEC and DOJ investigations piece of shit immune from scrutiny?
Simple solution old geezer--- Tell misiu to stop lying by saying the FDA told CYDY to not even apply for EUA.
Closet--- Lets say you have a name to input into the "Lookup, Verify a License" link on this "Limited License (Volunteer)" page---
https://flboardofmedicine.gov/renewals/medical-doctor-limited-license-volunteer/
You would immediately tell if the person claiming to be a volunteer was telling the truth or lying.
Shame on you Closet for DEBUNKING that liars claim of being a "volunteer" in the ICU...
Bad Closet, bad!
"volunteer free time" ??? You reply to posts within 10 minutes when somebody mentions your name.
Even during the height of the pandemic you were here posting day and night as if you had nothing else better to do.
Even when your son was allegedly at deaths door...guess what?...you were still here posting.
Stop telling lies.
If the DOJ ever asks you for confirmation of "volunteer" work, you better hope you can prove it.
Um, guido, mohammed, JJ from Good Times (brother), DC lobbyist, hedge fund manager,, US Senate insider, investigator---
Is it dilution or manipulation that got the share price where it is today?
August 24, 2016 Annual Meeting. Increase authorized shares from 250 million to 350 million. Result: No revenue, no FDA approval, 28.6% dilution of shareholder value.
August 24, 2017 Annual Meeting. Increase authorized shares from 350 million to 375 million. Result: No revenue, no FDA approval, cumulative 33.3% dilution of shareholder value.
June 7, 2018 Special Meeting. Increase authorized shares from 375 million to 450 million. Result: No revenue, no FDA approval, cumulative 44.4% dilution of shareholder value.
November 8, 2018 Annual Meeting. Increase authorized shares from 450 million to 600 million. Result: No revenue, no FDA approval, cumulative 58.3% dilution of shareholder value.
May 22, 2019 Special Meeting. Increase authorized shares from 600 million to 700 million. Result: No revenue, no FDA approval, cumulative 64.3% dilution of shareholder value.
June 2020 Special Meeting. Increase authorized shares from 700 million to 800 million. Result: No revenue, no FDA approval, cumulative 68.8% dilution of shareholder value.
November 2021 Annual Meeting. Increase shares from 800 million to 1billion, with B. Result: No prospects for revenue, no prospects for FDA approval, cumulative 75.0% dilution of shareholder value.
https://www.sec.gov/Archives/edgar/data/1863643/000110465921134864/tm2126028d21_dfan14a.htm
Since our inception, we have been insolvent and have required debt and equity financing to maintain operations. We expect our debt service obligations and our need for additional funding to finance operations will cause additional substantial dilution to our existing stockholders and could adversely affect the trading price of our common stock.
https://www.sec.gov/Archives/edgar/data/1175680/000155837024001547/cydy-20240130x424b3.htm
I can go on and on and on with DOZENS of filings citing DILUTION warnings. So think long and hard before yodeling that "manipulation" nonsense.
Heres what I asked misiu---
they didn’t because FDA told them , don’t even apply .--- Link to that info please.
But they should , to have a prove that with this mortality benefit FDA refused them--- A mortality benefit from 62 patients...the FDA would look INSANE (like some individuals) for a EUA approval based on that.
Have you ever edited, added, or deleted info on the Leronlimab Wikipedia page?
https://en.wikipedia.org/wiki/Leronlimab
Two goddam questions---
1. The link to the info that says the FDA told CYDY "don’t even apply" for EUA.
2. Have you ever edited, added, or deleted info on the Leronlimab Wikipedia page?
https://en.wikipedia.org/wiki/Leronlimab
Lets START with that.
Retired dermatologists don’t have patients
Active dermatologists don’t treat COVID patients in the ICU.
That, plus EUA (that was never applied for) on data from only 62 patients.
More PROOF of a psychotic fantasy dreamworld.
Someone asks for a verifiable fact, ie, a link.--- Yes kgro, POLITELY requested a link.
And you see the rant filled reply...
On top of that, no response whatsoever when I asked this question---
Have you ever edited, added, or deleted info on the Leronlimab Wikipedia page?
https://en.wikipedia.org/wiki/Leronlimab
they didn’t because FDA told them , don’t even apply .--- Link to that info please.
But they should , to have a prove that with this mortality benefit FDA refused them--- A mortality benefit from 62 patients...the FDA would look INSANE (like some individuals) for a EUA approval based on that.
Have you ever edited, added, or deleted info on the Leronlimab Wikipedia page?
https://en.wikipedia.org/wiki/Leronlimab
Find another hobby...stocks and arguing about stocks isnt right for you.
And EUA is not the same as approval , that what should be given , and lives would be saved !!!!!!
CYDY never applied for EUA even though they released a PR to the public stating they DID right?
RIGHT?
None from what I know ,--- Thats exactly what I thought...NONE
NO drug on the planet received approval based on data from 62 patients...thats what the REAL WORLD looks like.
And to DEBUNK your little 82% mortality benefit EUA yodeling, check out the Lalezari to NIH colleagues video..."certainly not something good enough to base drug approval on" (start @ 29:03 mark)
To show 82% mortality benefit ABOVE any other drug , in 62 patients , happens only with the best .
Which drug or drugs have received FDA approval based on stats from only 62 patients?
Name at least one (1). A non reply will indicate you cant name any...
If you do reply and cant name at least one, your yodeling here is a waste of time and makes no sense.
LAUGHING at todays headfake...major dumping just before the close.
(sigh) Oh well...
Fess up, who bought the top?
You sure about that gramps?-- (ii) a new “full hold” had been applied related to the clinical trial protocol the Company submitted in November 2023 alongside the Company’s complete response to the partial clinical hold.
https://www.sec.gov/Archives/edgar/data/1175680/000155837024001547/cydy-20240130x424b3.htm
The hold was lifted but another hold for the protocol was imposed, Idiot, says here---
LOL!--- I don’t trust FDA and I feel there is no point for me to contact them .
What if the FDA said "full hold lifted"...would you trust what they said?
blind denial of the truth--- Do you believe CYDY when they posted yesterday the full hold lifting was/is unsuccessful?
Youve contacted the FDA in the past right? RIGHT?
Why not contact them right now and ask if CYDY has received an answer in regards to their "late January 2024" submission.
So CYDY posts a statement in a SEC filing 22 days (3 weeks) after the submission saying they are unsuccessful in getting the hold lifted right?
RIGHT?
But in your mind, it will take another week for CYDY to reveal an answer.
That correct?
Heres a civilized discussion...the FULL HOLD not being lifted.
Any comments?
What "physician" goes to a internet financial stock message board to get advice on how to receive "Right To Try" ???
Is that standard procedure used by hospital physicians?
Do they go directly to the drug distributor or internet chat rooms first?
What are your thoughts on last nights FULL HOLD revelations?
H-O-L-Y S-H-I-T Good one fd--- BTW, looking at the Wikipedia page for the drug. Looks to me like you've done a TON of editing to the page. Very interesting for someone who isn't here for the money. Care to explain?
https://en.wikipedia.org/w/index.php?title=Leronlimab&action=history
Yes, me stupid, me no know how to speak or write english after being in the US for over 20 years.
Me come from the mean gritty streets of Warsaw, but me have enuff money to graduate from medical school.
Prove right here and now where I was wrong about your non disclosure of having a financial interest in this stock in the Zerohedge article.
Any comments on the FULL HOLD still being completely intact or not?
You seem a little rattled right now so I will attempt to decipher your post.
Are you saying the Zerohedge article was not about you?
Do you need the links to the conversations of you admitting the article was indeed about you?
CYDY was unsuccessful in getting the full hold lifted...how does that make you feel?
Um, misiu, a couple of red flags--- First, you, a physician, coming to an internet stock chat board seeking advice instead of contacting Cytodyn directly...
Secondly, the Zerohedge article made absolutely no mention of your financial interest in this stock, leronlimab, or the company Cytodyn.
I will give you props on being right about the FDA response within the 2 week-ish time frame...you were spot on about that.
CYDY fessed up to be unsuccessful in getting the full hold lifted.
Um, misiu, where in this article does it disclose "I was already a shareholder in CYDY since 6 years"????
Yes janice, as in the infamous NP (Nader Pourhassan) days of old, CYDY has slipped an important tidbit of info into a filing other than a "other events" SEC 8K filing.
The word is out.
CYDY has been UNsuccessful in getting the full hold lifted.
FULL HOLD lifted yet? Todays filing says.... NOPE!
Fact check--- We believe that leronlimab shows promise as a powerful antiviral agent with the potential advantage of lower toxicity and less frequent dosing requirements as compared to certain daily drug therapies currently in use for the treatment of HIV. Leronlimab belongs to a class of HIV therapies known as viral entry inhibitors that block HIV from entering and infecting specific cells. Leronlimab blocks HIV from entering a cell by binding to a receptor called CCR5, a normal cell surface receptor protein to which CCR5 tropic strains of HIV, referred to as “R5” strains, attach as part of HIV’s entry into a cell. Leronlimab binds to a precise site on CCR5 that R5 strains of HIV use to enter the cell and, in doing so, inhibits the ability of these strains of HIV to infect the cell. As a result, we believe leronlimab represents a distinct class of CCR5 inhibitors with advantageous virological and immunological properties and may provide a unique tool to treat HIV-infected patients. We plan to explore the potential for leronlimab to be used in
Since the 1990s, not ONE single success to mention--- We believe leronlimab prevents CCR5 tropic strains of HIV, which are the majority of all cases, from using the CCR5 receptor as an entry gateway for healthy cells. Pre-clinical research has shown that leronlimab blocks calcium channel signaling of the CCR5 receptor when present on the cancer cell surface. Research also suggests calcium channel signaling of the CCR5 receptor is a crucial component to the spread of metastatic cancer. We view the CCR5 receptor as more than the door for HIV to enter T-cells; it may also be a crucial component in inflammatory responses. The CCR5 receptor has been identified as a potential target in HIV, graft-versus-host disease (“GvHD”), MASH, cancer metastasis, transplantation medicine, multiple sclerosis, traumatic brain injury, stroke recovery, and a variety of inflammatory conditions, including COVID-19. This could present the potential for multiple opportunities for leronlimab, such as MASH, cancers, and transplantation rejection, among other indications.
Better make that a double vodka gramps. Looks like the news is out.
Oh I read it alright, todays filing says 3 weeks after the co submission the FDA HAS NOT lifted the ((((((((FULL HOLD)))))))).
The Company anticipates moving forward with the contemplated clinical trial during the 2024 calendar year in the event that its efforts to obtain lifting of the clinical hold are successful.
https://www.sec.gov/Archives/edgar/data/1175680/000155837024001547/cydy-20240130x424b3.htm
Take that last swig of vodka and go to bed old man. Your fantasy and conspiracy dreamworld starts pretty early in the morning.
UH OH--- In late January 2024, the Company made its responsive submission to the FDA’s December 2023 comments and guidance in relation to its proposed clinical trial protocol. The Company anticipates moving forward with the contemplated clinical trial during the 2024 calendar year in the event that its efforts to obtain lifting of the clinical hold are successful.
https://www.sec.gov/Archives/edgar/data/1175680/000155837024001547/cydy-20240130x424b3.htm
I could be wrong, but it looks as if the late January 2024 responsive submission to the FDA’s December 2023 comments and guidance has been denied.
3 weeks after the late January 2024 submission and co hold is un-successful.
Did CYDY say the FDA denied lifting the full hold?--- The Company submitted a revised protocol to the FDA in January 2024, and will remain on clinical hold until the FDA clears the protocol.
https://www.sec.gov/Archives/edgar/data/1175680/000155837024001547/cydy-20240130x424b3.htm
From todays filing--- The securities class action lawsuits filed against the Company in March 2021 have exhausted certain coverage allowances under the Company’s D&O insurance applicable to the relevant time period.
https://www.sec.gov/Archives/edgar/data/1175680/000155837024001547/cydy-20240130x424b3.htm