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The below is from the YMB and is reportedly from a reliable source.
Here is the real story of the Canadian Cancer Patient. She has been taking Leronlimab since September 2020. She started on Leronlimab as part of a trial and when the trial ended she and her oncologist had to apply for the Canadian Special Access Program to stay on Leronlimab. If she was in the US the application would have been under Right to Try. The approval for the SAP was granted one month ago. She has been on Leronlimab for 14 months and she has seen No Evidence of Disease - NED for exactly one year now. This is the first time Leronlimab has received this type of approval in Canada. This does potentially open the door for other cancer patients to apply under the same legislation as the first approval is definitely the hardest. It took Health Canada 6 weeks to make the decision. I know these are the facts because I know her personally.
He followed this up with, the patient is a Canadian citizen.
The problem is this PR doesn't work to the benefit of those who are shorting CYDY, such as calling LL "leronsaline". lol
It is emergency use approval. This person has an emergency and HealthCanada said we give you permission to sell your drug . It’s says exactly what it is , nothing less and nothing more.
Yeah, I'm seeing more twists and turns than a Tom Clancy novel.
Always interesting to watch the responses trying to twist the information
DEBUNKING the DEBUNKED: Shorts are not happy with this great news that a patient in Canada will receive LL that may save her life because it shows Canada just opened the doors to LL for treating mTNBC. Canada "Authorized Emergency Use of Leronlimab", so the shorts are now trying to convince the longs that it's not an EUA even though the PR never said it was. But the shorts know that's the next step given that Canada has opened that door. I think the real BIG news is this announcement from Canada may help expedite the FDA's approval of the BTD application for treating mTNBC. The shorts have their work cut out for them. LOL
Health Canada Authorizes Emergency Use of Leronlimab for Treatment of First Triple-Negative Breast Cancer Patient in Canada
VANCOUVER, Wash.--(BUSINESS WIRE)-- 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, today announced that Health Canada authorized the emergency use of leronlimab for the treatment of a patient with metastatic triple-negative breast cancer (mTNBC).
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, said, “We are encouraged by Health Canada’s emergency use approval of leronlimab, which we believe could have potential benefit as a therapeutic option for treating mTNBC. We now plan to ask Health Canada to allow expanded access use for all mTNBC patients who might have no other treatment options. We are also seeking similar approvals in other countries and look forward to providing leronlimab for mTNBC patients, as well as for treatment of other solid tumor cancers, in the future. In addition, we will be filing for expanded access use for mTNBC patients in the U.S. shortly.”
Unfortunately there are former 13Der(s) who are doing everything they can to keep things from quieting down before the 24th because they've invested $200k or more in IncellDX convertible notes, and they're trying everything they can to prevent CytoDyn from getting approval on the additional 200m shares they need to fund current and future LL trials that will save people's lives.
I’m sure things will quiet down by the 24th on some of these boards
Can he buy $200k of worthless IncellDX convertible notes from Bruce Patentsteal? Probably can, but NP is much too smart for that.
Wrong! It's VERY clear that Amarex is far up the river without a paddle. CytoDyn isn't going to settle for a slap on the rest.
CYDY doesn’t have a smoking gun. CYDYs gonna have to pay.
Exactly! This supports why it didn't meet the end points that were measured at day 28 given the drug was no longer in their system. Thanks for pointing that out - good catch!
The company believe it was due to patients not being administered leronlimab past day 7.
So this is what you referred to as a "saline solution"?? LOL
The results indicated that from day zero to day seven, critically ill patients receiving leronlimab (on day zero) experienced a mortality rate 78% lower than patients receiving placebo.
Further, patients receiving the second dose of leronlimab achieved maximum benefit of 82% less mortality. However, the effects diminished from day 14 to day 21 and from day 21 to day 28, as the mortality rate decreased to 50% and 31%, respectively. The company believe it was due to patients not being administered leronlimab past day 7.
So you think a drug that failed to show it was any better than saline solution in two CoV clinical trials will save lives??
Great - please share them. I can't wait to see them. Just a link will do. LOL
clearly state that Cydy executives are under investigation By SEC and DOJ for statements made about LL and its effectiveness and safety. It is in black and white in the company’s own documents.
Just as I said - NO WHERE does it say CYDY management is under investigation. In fact, it quite clearly states the following:
"The SEC 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 security."
Thanks!
WRONG - the company has NEVER said their officers or the company were the subjects of the investigation, and this is why nobody can provide a link that shows otherwise. NOBODY knows who are the subjects of the investigation because the SEC/DOJ hasn't stated so. They NEVER state who is the subject of an ongoing investigation or of one that brought no charges.
Here are the true facts of the "investigation". Facts don't lie:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=166615736
WRONG - the company has NEVER said their officers or the company were the subjects of the investigation. They said executives received subpoenas, but everyone knows subpoenas are normally given to potential witnesses.
Yeah the company has said it twice that it's officers and the company itself are under investigation for statements made about Leronlimab.
Early NASH results were incredibly good and promising.
CytoDyn Reports Preliminary Results from First Five Patients in Phase 2 NASH Open Label Leronlimab Trial. Lower Fatty Deposits in All 5 Patients by as Much as 45% and Lower Fibrosis in 4 Patients by as Much as 10% Compared to Baseline.
VANCOUVER, Washington, Nov. 03, 2021 (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 today preliminary results from the first five patients treated with leronlimab in its Phase 2 trial for NASH (nonalcoholic steatohepatitis) open label. These preliminary findings from five patients treated with leronlimab suggested fatty deposits were lowered on all 5 patients by as much as 45%, as compared to the baseline measurement. In addition, fibrosis was also lowered by as much as 10%, in 4 out of 5 patients as compared to the baseline measurement (one patient exhibited no change in fibrosis).
The Phase 2 trial for 90 patients is designed to test whether leronlimab may inhibit the devastating liver fibrosis associated with NASH. As previously reported, the Company’s preclinical study demonstrated strong positive data, highlighting the potential of leronlimab in treating nonalcoholic fatty liver disease (NAFLD), a common precursor to NASH. Inhibition of CCR5 has been shown to be effective in reducing fibrosis in animal models of NASH liver fibrosis.
Nonalcoholic fatty liver disease (NAFLD) has become the most common cause of chronic liver disease in adults worldwide. There are currently no U.S. Food and Drug Administration (FDA) approved treatments for NASH, and it is expected to be the number one cause of liver transplants in 2020.1 About 30 to 40 percent of adults in the U.S. are living with NAFLD, and 3 to 12 percent of adults in the U.S. are living with NASH.2
Chris Recknor, M.D., Senior Executive Vice President of Clinical Operations, commented, “We are encouraged by the preliminary results from the open label portion of our NASH trial. The CT1 reduction from baseline for these patients is approximately 40 msec, which would be consistent with an observed reduction in fibrosis on biopsy. We expect data lock in December with results from the 700 mg double blind placebo-controlled part 1 and the remaining part 2 open label with 350 mg. We are working on a new Phase 2b/3 protocol to include biopsy to start in January 2022 with our new CRO, Cato Research LLC (CATO SMS), which has extensive experience with NASH trials.”
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, concluded, “We believe these early findings represent a very significant therapeutic opportunity for patients suffering from this disease, encouraging us to aggressively pursue a NASH indication with potential for Breakthrough Therapy designation (BTD). Our team is currently preparing the BTD application for 350 mg arm, which could include 10 patients’ data by mid-November. We are also very optimistic for our 700 mg arm, which was double blinded; and we hope to unblind the data and announce those results in early December.”
My personal opinion is that I see (speculate) the pps will continue to climb between now and the end of Dec for the following reasons:
1) Amarex lawsuit settled out of court
2) 200m shares receive approval during Nov 24 ASM
3) we continue to receive favorable NASH results as they continue to trickle in
4) another BTD gets submitted for mTNBC w/brain metastasis
5) potential approval for the first BTD (within 60 days of submitting on Nov 8)
I also believe there are numerous deals, approvals, and/or submissions that could pop up at any time, especially after we get full access to the data that Amarex has in their possession.
JPG77- how do you see this thing playing out between now and say the end of December?
What is $7.6m compared to the bozo, "fat Tony", who wasted 27 million shares by hiring Pestell??
"The ProstaGene acquisition was essentially about a prostate cancer diagnostic. The concept of the acquisition was masterminded by Executive Anthony Caracciolo who at the time was CytoDyn’s Executive Chairman of the Board when the deal was initially announced in July 2018. Nader Pourhassan was the CEO, but at the time had no decision-making power with respect to the acquisition. Many investors may not realize, but the executive chairman is higher in rank than CEO and Caracciolo stepped into that role in January 2017. Many thought that his Gilead resume would be instrumental in inking a deal. On closing of the acquisition in November 2018 Dr. Pestell was not only welcomed as the newest board member, but was also the company’s Interim Chief Medical Officer. This was all Caracciolo’s doing until a more balanced board led by Dr. Scott Kelly came to fruition in January 2019. The fact is Caracciolo didn’t resign until January 10, 2019 when David Welch joined the board. So issues that predate January 10, 2019 are on Caracciolo’s watch, not Pourhassan’s. An interesting anecdote is that Caracciolo also presided over the failed receptor occupancy test done by IncellDX."
NADER FIRED PESTELL WITHOUT CAUSE, COSTING SHAREHOLDERS $7.6M.
I don't see NP's name mentioned anywhere in the PR. Actually, it was Big Tony that took all of the credit.
"Richard is a driving force in CCR5 antagonist research and we gain significant expertise and intellectual property with this acquisition that advances the development of PRO 140 as a novel cancer metastasis therapeutic,” said Anthony D. Caracciolo, CytoDyn’s Chairman. “We are privileged to have Richard join CytoDyn to expand our executive and scientific team, and we enthusiastically welcome him as the newest member of our board of directors.”
Pestell was brought to CYDY by Paulson. NP, TC, and the entire board approved the deal.
If I remember correctly, NP took all the credit
The same Pestell that was hired by the former Chair "fat Tony" that squandered 27 million CytoDyn shares by buying a worthless company from his buddy Pestell?
NP tried the deadbeat game with Pestell
Wrong - these ARE facts and include quotes from the filing. This isn't some opinion from a failed 13D paid basher.
These are not facts, this is info from a posterboard “lawyer” aka a paid pumper.
From a lawyer on another board commenting about yesterday's filing:
"Interesting is the direct interaction between CytoDyn and NSF International (the company that bought Amarex), at the end of the Amarex/CytoDyn relationship. Sounds like Recknor is the one that caught these problems and went forward to fix them, including by contacting NSF directly. Also, all does not seem hunky dorky in NSF/Amarexville:
Quote:
47. On June 8, 2021, Lush emailed Dr. Recknor and introduced himself as the “Global VP of NSF Health Sciences which includes Amarex.” Lush stated that he had engaged in “detailed discussions” with both Kevan Lawlor—NSF International’s CEO—and Chestnut about CytoDyn’s issues with Amarex, and Lush asked Dr. Recknor not to disclose their discussion to Amarex.
What company (NSF) tells their client (CytoDyn) not to talk to the actual vendor involved (Amarex) about issues like this? Were NSF and Amarex keeping secrets from each other? Oh, and the next filing after this Amended Complaint (same day) was a letter that there are imminent settlement discussions and the case may settle."
Paragraph 1, in part, of the Amended Complaint filed by CytoDyn yesterday says:
Quote:
It is undisputed that CytoDyn owns the data, as acknowledged by the NSF executive in charge of Amarex, Martin Lush. Mr. Lush wrote in a June 9, 2021 email to CytoDyn that “[y]ou own every piece of data generated by the CRO. . . . I’m just trying to better understand why KK [Kazem Kazempour, Amarex’s CEO] is refusing to release non executable data files since this is usually a contractual requirement.”
So, this sounds "ridiculous"? How can Amarex "free data" that they themselves said they don't own and belongs to CytoDyn??
The idea on these boards that somehow Amarex is guilty and owes CYDY free data and millions of dollars is ridiculous.
Saying the FDA doesn't respect NP is an opinion. If it was factual, there would be evidence that nobody has provided.
The FDA does not respect CYDY.
WRONG...there's NOWHERE in the letter that rebukes Nader. If so, please share it. LAUGHING!
WRONG…FDA BOMBSHELL letter rebuking Nader for touting unproven LL and poor trial design, is proof positive of lack of respect by FDA. The unprecedented public rebuke of the company and CEO during trading hours is the exact definition of lack of respect.
In response to your statement that "Big Pharma and institutional investors.. and Nasdaq I guess" have said they do not respect NP, my question to you is "what BPs, Institutional investors, and NASDAQ(??) said they have no respect for NP?"
Please feel free to share a link.
What BPs, Institutional investors, and NASDAQ(??) said they have no respect for NP? Please feel free to share a link.
Big Pharma and institutional investors.. and Nasdaq I guess.
So -- where did it say the "FDA doesn't respect NP"??? I believe the answer is "NOWHERE".
It even says "Aggressive demands from shareholders to approve leronlimab now” which proves the FDA's frustration is NOT with NP.
There is absolutely NOTHING in that statement that says the FDA doesn't respect NP. Like I said, there's nothing to substantiate misstatements from the failed 13D(ouchebags) that the FDA "doesn't respect NP". A complete fabrication from the former 13D gang of miscreants.
Please feel free to share where it says "what's being investigated" given that it's not stated anywhere.
The reasons for the CYDY SEC and DOJ investigations are specifically stated in the SEC filings.
Yes, I agree. I guess we can thank the failed 13D(irtbags) for the low price again. After the Nov 24 annual shareholders meeting, their relentless attacks will be falling on deaf ears.
$1.10 new year low! Time to back up the truck for more CYDY shares.
So, there is NO EVIDENCE that the FDA "doesn't respect NP", especially given that nobody can provide evidence. Laughable!
“What EVIDENCE do you have that the FDA "doesn't respect NP"?”
The evidence is everywhere, you just have to be willing to see it.
What EVIDENCE do you have that the FDA "doesn't respect NP"? The failed 13D(irtbags) continue to spread misinformation after their failed hostile takeover because they desperately want to convince investors to not allow CYDY access to the additional shares they need to fund the current and future trials. They want to force CYDY into borrowing $100m from the same 13D(irtbags) that failed in their hostile takeover group. And, astonishingly, some of these former 13D(irtbags) foolishly invested over $200k in IncellDX convertibles.
If I’m asking these questions, then the FDA, who doesn’t respect NP, is asking similar questions.
Wrong! It's widely known the FDA refused CYDY's request to allow 4 weekly injections so the patients would get LL throughout the 28 days that were required for the end points, however the FDA refused to allow more than 2 injections, so the patients only received LL on day 1 and day 7. The results during the first two weeks were incredible and cannot be disputed, but they evaporated towards the end of the 28 trial period due to LL no longer being in their system. THIS IS A FACT. Now, the failed 13D(irtbags) continue to ignore this fact and try desperately to make it look like the trial failed because of NP, and that Dr. Lalezari didn't request the 4 doses during a meeting with the FDA. Why do the 13D(irtbags) continue this SHAM? Because they failed with their hostile takeover and now they want to destroy the CEO by encouraging shareholders to withhold approving the 200m shares the company needs to continue funding the trials that so many critically patients desperately need. Sadly, these 13D(irtbags) put money over saving people's lives.
The COvid trials were poorly designed and roundly mocked and did not hit statistical significance in stated endpoints.
Wrong. NOBODY knows what's being investigated or if the investigation is still active given that it was announced by CYDY last Spring. Where has there been an official statement declaring securities fraud? It exists only in the minds of shorts and the 13D(irtbags).
We do know what's being investigated.
The only ones who are saying this are shorts and the failed 13D(ouchebags). Everyone else relies on commonsense.
Some say Nader purposely sabotaged the CYDY HIV BLA
I believe the failed 13D(irtbags) would disagree. They got a public spanking by Sidley Austin followed by the Delaware Court of Chancery telling the 13D losers to take a hike after it was disclosed their entire hostile takeover attempt was a "sham" against the CYDY shareholders.
Just because you sue someone doesn't mean you win or that your suit can't be shown to be a sham.
Any pre-revenue biotech that sells shares to fund their trials are "idiots"??
Proves these idiots are in serious financial trouble.
When "what" is over? The 13D(irtbags) attempt at running CYDY into bankruptcy, or Rosenbom Jr. trying to force CYDY into borrowing $100m from his daddy? What a scandalous bunch of losers. They don't know when it's over!
“ when it’s over” , Nader will be in jail.
Please feel free to share a link where we were told the RTF was ONLY "Due to a syringe"! LMAO The failed 13D(irtbags) are misleading everyone at best! This reminds me of the failed former Chairman of the Board, Fat Tony! No proof - no truth!!!
The RTF on the HIV BLA was also released by released by AMAREX…HATE TO RUIN THE ENDING, BUT THE RTF WAS NOT “ DUE TO A SYRINGE “.
WHERE IS THE "PROOF"??? This is nothing more than an email that's taken out of context and doesn't say or show ANYTHING that NP "sabotaged" the BLA . LOL This only supports what everyone is saying - that NP was desperate to have Amarex file the BLA after Amarex sat on it for 2 years so that he could get the FDA's feedback, especially knowing they had a "rolling BLA" approval from the FDA that allows for the BLA to be submitted in sections.
Here is the proof:
All $3.5m is going to their pay?
Just enough to keep their bloated paychecks rollin in...