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It is going to take monumental amounts of time and money to undo what nada did with shoddy sloppy half baked FDA communication.
The holds remain in place.
<<On March 31, 2022, the Company announced that the FDA had placed a full clinical hold on its COVID-19 program and a partial clinical hold on its HIV program in the United States. Under each of these clinical holds, no new clinical studies may be initiated until the clinical hold is resolved. The partial clinical hold on the HIV program allowed patients who were enrolled in the extension trials to transition to other available therapeutics. 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 previously notified the FDA that it was pausing its COVID-19 trials in Brazil. We voluntarily withdrew the Investigational New Drug Application (“IND”) for COVID-19 in the United States. >>
I bet you are about to get a real education in public market biotech today. There is no data, and the only thing you can count on is a money raise in the low $1.10 range.
Been waiting almost 6 years for any reason to re-enter my $6.50+ exit.
There is none.
The cash runway is now much longer with the sale of transova and a $100 million shelf with Cantor Fitz. Sadly, hell-in flat lied in the recent conf call about raising money, and then 24hrs later we get the shelf, unreal.
<<Jennifer Kim with Cantor Fitzgerald. Please go ahead.
Hey, everyone.... And then my second question is broader, with the Trans Ova divestiture, has anything changed in your mind in terms of portfolio prioritization and added flexibility to explore opportunities that you weren't able necessarily to consider beforehand?
Answer; As Harry mentioned, we have a solid runway well to the fourth quarter of 2023, which has allowed us to basically go through our – some of the clinical timelines that we have for reporting the data. And I think that's going to be very good. And we basically do not have to take anything from the financial strength that we have, or I should say the money that we have, currently that is dedicated to our clinical trial and be diverting this for our convertible notes. And that's – obviously it's a huge, I think, pressure off at this point, especially during this financial times and not diluting our investor base. So we are very happy about that.
We have prioritized portfolio as we have mentioned in our slides and according to the three pillar of a strategy that we have and we mentioned for instance, even in regard to our AG019, which is a very exciting program for a type 1 diabetes, we feel that this has served best with partnership, which the discussions on our partnerships are ongoing and we look forward to report on that in the near future.>>
A buy out is just about the only hope of salvation for a company with only a few weeks or months left on financial life support.
What most fail to understand is what a buy under looks like.
New buyers should not place bets, just sit tight and wait for confirmation. This company has proven nothing in a very long time worthy of your bets. Biotech is a dangerous place, wait for confirmation and then decide. So many company troubles here, you are not smarter than wall street, sit on your hands and wait for confirmation.
Always pay up for success after it happens, it has not happened here in a long time.
They are keeping Kelly in a plea deal so he shows where the bodies are buried, they would be found without his help but faster with. lol, I hope they all swing from a rope.
Bring in the D
Yep, not sure why so many supported the nada. My tide turned with the mexico emails lost in a spam folder. He is a total liar.
Kelly is next out the door, what a bore.
Dr Patterson may be first on my list for CEO, that would be sweat justice against the nada fans. Maybe Recknor in the top 5 if such a list exists.
Pestell appears smarmy in the videos I have seen, hard to like that guy
Great post, wow, nice reflection of the reality, sad as it may be...
<<the drug biologic commercialization rate is abysmal.>>
Exactly why I am sick and tired of the pumpers talking book after they placed their keyboard cowboy long bets.
That abysmal record would be better served just shorting almost anything one thinks will be a winner, there is no damned way to know it before a 3rd party like the FDA or DSMC makes the affirmative call.
why a rabbit hole? Every biotech is a rabbit hole, this one especially because of the lack of absolute proven efficacy, manufacturing, money supply, cost basis, prescribed dose levels, time to approval and market if it gets there, etc etc. If any of this was not in question then it would be way more than just an attractive rabbit hole of interesting technology and uncertainty. For now it is just some people who are mostly happy to rely on hope and stories by shareholders with confirmation bias. Stories based on management who's day to day is collecting paychecks from the company they work for and promote because of said. Few among us are capable of seeing the truth for what it is today, not stories of what the future may hold if all the stars align. Put another way, it is a typical needle in a hay stack biotech. The market cap should proof enough but, alas, it is not for many.
Paying up for success AFTER it happens is a much better play, and safer financially.
Great response. The science is so darned compelling. An attractive rabbit hole
I proves the facts about nada not being very bright, 2x felons tend to be that way and never change. He had help from a quasi securities expert who was likely buying and selling on the news too. Seriously hope they all go to jail
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I hope the entire bunch of them have their heads on a DOJ/SEC pike.
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leronfloplimab will save the world
I said IF the science is good, so far I have grave reservations about anything they ever said and the price is a good example of why I have doubt.
27 cents is speaking pretty loud
misiu, I agree the price will be higher IF IF IF the science bears fruit before the new BOD members put out the raging fires set by nada. What a train wreck he has caused by his total incompetence at running a biotech. So sad if the science is good and gets sold for pennies anyway.
The data and drug process approval thru the FDA requires very complex and sophisticated teams of consummate professionals run and funded by also highly skilled management teams. None of that ever existed at cydy. Period. Full stop. End of story.
Buying this stock is pure gambling before anything gets confirmed as actionable positive data. There is always time AFTER to pay up for success.
p.s. nada was a classic engineer. The m-cat medical school entry test has some messed up success numbers (read failure rates). Almost exclusively because of the large number of engineer students who take it thinking they are smart enough to be doctors.
lol, I think I can answer this
Q1 why Nader got shit canned
A1. nada got shit canned because he is a self enriching 2x felon liar, could screw up a one car funeral, has zero business acumen, education or experience, and he taught engineering at a JUCO.
Q2 why is the stock 28 cents
A2. See #1
Q3 why the FDA halted the trials
A3. Never tug on superman's cape, or, paraphrased, don't be a dickhead with safety data when tugging on superman's cape.
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Good luck to all the gamblers too at this perilous junction in company history, which is about 99.99% of the shareholders. Remember, most of the worthless BOD who facilitated this nada train wreck are still there.
Misbranding of an Investigational Drug
Under section 502(f)(1) of the FD&C Act, a drug shall be deemed to be misbranded unless its labeling bears adequate directions for use. Under FDA regulations, adequate directions for use means directions under which the layman can use a drug safely and for the purposes for which it is intended. 21 CFR 201.5. The video describes the use of leronlimab for the treatment of COVID-19. This use is one for which a prescription would be needed because it requires the supervision of a physician and, therefore, for which adequate directions for lay use cannot be written.
Although 21 CFR 201.115(b) provides an exemption from the adequate directions for use requirement in section 502(f)(1) of the FD&C Act if a new drug “complies with section 505(i)…and regulations thereunder,” your investigational drug fails to do so6. Among the requirements for this exemption for investigational drugs, 21 CFR 312.7(a) provides that, “[a] sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.”
The video includes claims that promote leronlimab as safe and effective for the purposes for which it is being investigated or otherwise promote the drug, including the following examples (underlined emphasis added):
“In the United States, we did a trial of 394 patients which included severe and criticallyill population. In the critically-ill population, our results were really strong. . .”
“Our critically-ill population that we did in the United States when we gave a dose of leronlimab, the survival rate was 78%. Once we gave them another dose, the survival rate went up to 82%.”
“Imagine, if 78% went to 82, the next one would be maybe 88, and then 95. I am making up numbers, but if it goes to that kind of numbers, if it just follows the same pattern what we learned, this is going to be the most fantastic results anybody could ever imagined to have. Now I’m not saying that’s what we’re going to get, but I’m saying that’s what the results are showing.”
“The primary endpoint…is the discharge, the rate of patients who get on ventilator and get discharged. That endpoint was 166% better in our trial that we did in the United States versus placebo…166%.”
The above claims make numerous conclusory statements that suggest that leronlimab has been established as safe and effective for the treatment of COVID-19. However, leronlimab is an investigational new drug, for which the product’s indication(s), warnings, precautions, adverse reactions, and dosage and administration have not been established. Furthermore, the video is extremely concerning because it significantly mischaracterizes the clinical trial data for leronlimab in the treatment of COVID-19, and the stated conclusions based on this mischaracterized data create a misleading impression regarding the safety and efficacy of the product. As was noted in FDA’s May 17, 2021 statement, the larger trial that CytoDyn conducted in patients with severe COVID-19 disease (CD12) failed to find any effect of the drug on the primary study endpoint of Day 28 all-cause mortality (20.5% in the leronlimab treatment group and 21.6% in the placebo treatment group) or any predefined secondary endpoints. In addition, as was also noted in FDA’s statement, with the conclusion of the CD12 trial, it has become clear that the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19. The suggestion that leronlimab has established “really strong” results in the treatment and the “survival” of critically ill COVID-19 patients is especially troubling given the public health emergency related to COVID-19, the limited available treatment options, and the fact that COVID-19 is a disease that, in its most severe form, can lead to hospitalization, respiratory failure, and death.
In summary, the video represents the drug as having an established role in the treatment of COVID-19, when leronlimab has not been proven as safe or effective within the meaning of the FD&C Act and has not been approved as a drug, nor granted an emergency use authorization under that authority for any use.
Conclusion and Requested Action
For the reasons discussed above, the video misbrands leronlimab under section 502(f)(1) of the FD&C Act and in violation of section 301(a) of the FD&C Act. The claims in the video are concerning because they make representations in a promotional context regarding the safety and efficacy of an investigational new drug that has not been approved or authorized by the FDA.
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CytoDyn recently disclosed in its Form 10-K that the DOJ and SEC served subpoenas on the Company and “certain of its executives” concerning the Company’s communications with the FDA and its “public statements regarding the use of [L]eronlimab as a potential treatment for COVID-19 … and trading in the securities of CytoDyn.”
Gosh, I wonder what ever happened to the health canada approval? And the UK? And the Philippines? And Mexico, oops, those got stuck in a spam folder.. Some of us have been following this long enough to remember all of nada-pumphanson's lies and we hope he and some of the BOD go to jail for it. As for what happens to the company, who knows, what happens to the CCR5 antagonist, who knows. Most of us have been smart enough for long enough to know it does not look good.
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The next thing you are likely to hear about is a settlement with amarex and a tacit letter of apology from cydy to them and the court for filling such frivolous lawsuits in the first place. nada was the one at fault, 2x felons do not change their stripes.
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BK for shorts in July 2021 eh? And just a short 1 year after mexico email scam, oops, I meant to say spam
Revenue shortly you said in September? Due tell us an update, please?
My experience predicting prices up or down is fraught with peril. Todays bump was probably just an XBI/biotech index rebound, if that continues then we could see it back to my .32 cent re-entry. If they publish any believable numbers, not some fanciful nada-esk bullshite, then we could be in for a nice base here. I think the bulls and bears rarely plead a reasonable case on most threads anyway. Choppy waves in this Sargasso sea at best
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Misiu143, I wish us both the best of luck and hope the science is real. The company is in deep deep trouble, nada did that and 100% his fault (with help from the complicit board), ugh. Stay safe.
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let us knot forget, Pumphanson received 908,418 shares in partial payment of severance pay under his employment contract. Think that sleeze bag weasel is holding those shares?
They can't afford to pay attention either.
2 for one sale and you get a free waffle cone with every order!
Yep, paraphrased, Mice lie, monkeys exaggerate, and 5 humans is anecdotal at best. Peer review papers are a dime a dozen and prove nothing, a quick review of the share price is more important
I am going with what the company and samsung say about expiration, anything beyond that is hopium I do not embrace.
Even if all the greatness about this drug is true, and I have grave reservations because it has not been proven, It costs hundred(s) of millions to prove any indication. cydy does not have that kind of money and probably never will.
This company is wild eyed speculation at best, a roulette wheel has better odd's
Sadly, people sell jewelry and expensive items at hock shops for 10 cents on the dollar every day. The question remains, can cydy get .10 cents on the dollar in the face of going flat broke with hat in hand? No buyer is going to pay top dollar to a beggar on the street corner.
the future is yin and yang at best, pure gambling against insurmountable odds at worst.
Cytodyn values its Samsung inventory at $93 million dollars total.
The inventory expiration dates are:
Feb 28, 2022 $5 million
Feb 28, 2023 position: absolute;6 million
Feb 28, 2024 $31 million
Feb 28, 2025 $33 million
Its all gone, expired, useless, by Feb 28, 2025.
No chance they will ever use that much "life saving miracle drug" so many "investors" espouse.
Holding or buying shares in this company is pure gambling on very thin odds. Nothing can be trusted or believed except the level of debt and the failed management running out of money.
Biotech is crazy dangerous, pay up for success AFTER it happens, there is always time for safer bets based on proof in the most dangerous game in town where failure is the standard.
A buyout at market cap today would require $340 million, not likely given the depth of problems. A buy under is much more likely and that will all but wipe out common shareholders.
Extreme caution is advised
Correct, the testing company and the test itself are not FDA approved. Typical of a nada scam, not saying it is, just that it smells of nada.
<< “LifeTracDx tests have broad international patent protection and are currently used in over 20 clinical trials. Creatv is seeking to license the technology, and license or partner with diagnostic and drug companies. In the end, clinical application of these highly sensitive and specific tests holds great potential for significantly improving outcomes and reducing mortality for cancer patients,” said Tang.>>
Maybe it works as advertised but the test is looking for macrophages in blood.
<<The LifeTracDx tests were made possible by Creatv’s discovery of cancer-associated macrophages in cancer patient blood>>
Oooops, one of things LL does is CCR5-dependent regulation of macrophages.
Are we sure this is not just a nada cart before the horse story.
Great post, all of this begs the question of how the officers and members of the board who allowed this travesty continue collecting pay.
I suspect a buy under is probably going to save the company from bankruptcy and wipe out common shareholders.
Wildly positive clinical NASH/tNBC data is the only possible Phoenix from the ashes. Wildly implausible too.
Dire straits for sure, nada drove this car in the ditch, the entire thing is his fault and those who remain on the BOD that looked the other way, all criminals.
As for price predictions, I learned a long tome ago not to do it. It is a fools game to pump or dump the price prediction.
Unless there is proven success, then a general positive trend can be established.
Always pay up for success AFTER it happens, if it happens in this case, lol
AACR Annual Meeting 2022 Itinerary Planner Home Print Page Share Page
Session PO.CT01.01 - Phase I Clinical Trials 1
CT156 / 24 - Changes in circulating tumor associated cells predicts progression free and overall survival in metastatic TNBC patients after induction of the anti-CCR5 drug leronlimab
April 11, 2022, 1:30 PM - 5:00 PM
Abstract
Background: Metastatic triple negative breast cancer (mTNBC) is a highly invasive breast cancer subtype that has limited treatment options and poor clinical outcomes for patients. Recently, the C-C chemokine receptor 5 (CCR5) was identified in preclinical models as a potential drug target that inhibits pro-migratory tumor progression in breast cancer by blocking tumor motility and subsequent tumor cell spread. Leronlimab (PRO140), a humanized IgG4? monoclonal antibody, is a competitive inhibitor of CCR5, with 3 active clinical trials ongoing in TNBC patients. Here we report on a preliminary pooled analysis of n=28 mTNBC patients to evaluate effects of Leronlimab on circulating tumor-associated cells (TACs) found in peripheral blood as an early predictor of drug response, with end point outcomes of progression free survival (PFS) and Overall Survival (OS).
Methods: Blood samples were drawn from mTNBC patients from 3 blinded prospective clinical drug studies, Phase 1b/2 (NCT03838367), Compassionate Use (NCT04313075), and Basket Study (NCT04504942) to evaluate the predictive value of TACs, measured by the LifeTracDx assay. All subjects received ≥1 dose of Leronlimab (range 1-33 doses), ranging from 350mg - 700mg, with 4 subjects having dose escalation. Anonymized blinded peripheral blood samples were available from (n=28) patients, obtained as part of the exploratory portion of the trials, prior to drug induction (BL) and after one treatment cycle (T1), ~26 days. TACs, i.e. Circulating tumor cells (CTCs) and Cancer Associated Macrophage-like cells (CAMLS), were isolated using a low-flow CellSieve microfiltration system and changes in TACs were quantified by the LifeTracDx assay. A univariate analysis was used to analyze changes in TACs to predict for PFS and OS over 12 months.
Results: A total of 28 mTNBC patients were pooled from Phase 1b/2 (n=10), Compassionate Use (n =16), and Basket Study (n=2) all of which had available BL blood samples, or T1 samples. CTCs were found in 29% (n=8/28) of patients at BL, and CAMLs were found in 96% (n=27/28). Evaluating CTC change was limited, as only 5 patients had any CTC increase, although the absence or drop of CTCs at T1 was significant for better PFS (HR=13.7 CI 95% 2.0-93.8, p=0.0296) and better OS (HR=397.7 CI 95% 19.3-100+, p=0.0019). By comparison, CAMLs or CTCs were evaluable in 100% of patients, with an increases of either population at T1 also significantly predicting for worse PFS (HR=5.8 CI 95% 1.4-23.6, p=0.0354) and worse OS (HR=36.0 CI 95% 6.2-207.6, p=0.0004).
Conclusions: We observed that treatment with Leronlimab resulted in rapid decreases in the presence of multiple populations of TACs in 75% of patients, which also significantly correlated with better PFS and OS after 1 year analysis.
and if cydy does not pay samsung (likely) then what? cydy needs a 2nd supplier badly, enter AGC biologics after all these years from stage left for the small batches required to run trials and research.