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The Federal Bureau of Investigation seized computers from the home of prominent short seller Andrew Left, the founder of Citron Research, in early 2021, some of the people said. In more recent months, the Justice Department subpoenaed certain market participants seeking communications, calendars and other records relating to almost 30 investment and research firms, as well as three dozen individuals associated with them, the people said, asking not to be identified discussing confidential inquiries.
So early 2021 they stopped by and paid him a visit. He is a small time operator compared to other operations out there. I don't think anything came of it considering he and Citron Research are still active:
We do know. The latest Q10 I cited days ago spells it out. CYDY, Nader, the remaining executives are the targets of DOJ and SEC. It regards their statements and communications regarding Leronlimab. The company expects some kind of financial damages and can't estimate how much it will be.
There is no speculation here. It's a major woe facing the company and could potentially bankrupt it.
There will be more procurement contracts by the government and private health care systems can pick up drugs ad hoc. Time is of course the annoying factor because I want my news today.
Everyone once and a while the events that led up to Nader's departure and the federal investigations get distorted. From this distortion come dangerous myths about the company and it's drug.
The Appeal To Emotion To Hid The Demand To Override Regulatory Safeguards:
couldn't help but cry when I think of FDA statement that they will not look at some " subgroup " results , the "subgroup" , the people who are on the ventilators and ECMO you described so well , patients without one good drug approved for them..
Every drug has to meet the same regulatory standards to get approved for public consumption. After the failed COVID trial Nader tried to do some datamining and interpreting the trials beyond their design. It's what caused the FDA, SEC and DOJ to all come down on him and CYDY.
The big take away is there has been a demand for CYDY and Leronlimab to be exempt from the regulatory process. Usually anecdotal stories that can be found on Zerohedge or Nader's lies get cited zealously as reasons to break the law and make an end run around safeguards.
The 31% Over The Standard Of Care Myth:
And even at 28 days , when there was no leronlimab in the system anymore , we showed 31% mortality benefit ABOVE ALL SOC drugs...
In CYDY's own filings and releases the mortality rate, those that survived, was at 31%. Any time a claim is made that the benefit was 31%% above it's always taking the day 28 number and then claiming it means something else. At no time is the Topline report ever cited or linked. Because in that report it states the magical 31% is actually the survival rate by day 28.
But, But, But 82% At 14 Days Myth...
With only 2 injections it showed after 14 days 82% mortality benefit ABOVE all SOC drugs.. SOC there are the drugs chosen by FDA as a best in a world for this patients.. And we show 82% mortality benefit ABOVE all of them..so yes we are the best ..
First notice that the survival rate for those in the study was 82% at day 14. That is true. But that does not mean it was 82% above all other drugs. The study never compares itself in effectivity to other drugs. It has a placebo wing, not a competing drug wing.
Second the study didn't run for just 14 days. The 14 day result argument always ignores the day 28 results which are less stellar and shows a die off in the drug win in the study.
CYDY/FAUCI/COVID Conspiracy Myth
Leronlimab is the best !!!! and to ignore this FDA could only say , we don't look at a subgroups !!!!!! As the subgroup is dying ..
Look to me , that we not looking for therapeutics , we want to vaccinate !!!! I will say , follow the money..
And why receiving billions of taxpayers money Dr Fauci never did a real study , without Pfizer involvement , to compare natural immunity to immunity after vaccination..
Not interested !!!
So Israel did , and now John Hopkins University did , collecting private funds to help them ..no , not NIH funds.. And all the results showing that natural immunity is about 2.5 times better then the vaccine..
So why people with natural immunity still losing jobs , even if they just recovered from the disease and understandably , don't want vaccination ...
Follow the money..
Why we still asking if someone is vaccinated or not , why not to ask if you have immunity or not..
Yep , that's what is going on now ..Cant wait when guilty will pay !!!
LOL. So this first requires the death of logic to exist. Remember all these massive conspiracies requires doctors, scientists, health care experts from all over the world agreeing to act in unison. That all the countries of the world have to get along enough to also engage in "keeping CYDY down."
Next we have the usual complaints about people having to get vaccines. If a business wants vaccinated employees as a term of employment, it's established that businesses can terminate employees. Especially true in at will employment jobs. Most importantly it has absolutely nothing to do with Leronlimab being an effective or ineffective drug. It's merely another emotional appeal, or purposeful disinformation tactic to distract from CYDY troubles.
These are some of the most popular myths. They will be repeated over and over again. So it doesn't hurt to repeat the facts over and over again. The truth always wins.
April, May, and June (Q2). So late Q2 is June. At that point the amended EUA is filed. Company still has to follow through with a BLA application regardless of the EUA results.
October is early Q4. This should be reasonably underway by late Q3.
Also keep in mind the NIH fully funded the study. So they aren't funding something to see it fail.
It's a good thing we have those vaccines and therapeutics that had successful clinical trials showing statistical significance. It's a good thing the FDA approved those and rejected the ones that failed. That way the public wouldn't die taking an ineffective drug that couldn't meet regulatory standards. It's a good thing Nader was fired since he is ultimately responsible for the failed trial designs. It's a good thing that the people who don't subscribe to conspiratorial thinking are in positions of responsibility.
It's a good thing that the people who spread fraud, misinformation, and bad medicine are always held responsible.
Nader made it the target of the SEC and DOJ. He made it stand out to the Delaware Courts multiple times for all the lawsuits brought against him and the company. We all know CYDY is currently a dumpster fire.
The failed clinical trials should just have been hand waved away? Not being able to scientifically prove the drug works by showing statistical significance had nothing to do with it?
FDA sent CYDY back to do more work. Also it's telling CYDY did not pursue a BLA for COVID. It took the EUA rejection and stopped. Then started another trial in Brazil.
Good thing we have those vaccines and other drugs that actually work.
So the issue with an outside CEO is first the company's reputation. No one wants to take an L because the game was already over when they got tapped to play. Second, Nader's compensation will haunt negotiations. Nader got paid way too much. Someone coming in to fix the situation is going to want more money or some sort of compensation package that makes it worth it.
That's going to be tough for CYDY, and it creates a dangerous attraction to picking an internal candidate. If they go internal the company is done. Get out, run, it will be Nader 2.0
So Scott Kelly is a piece of shit, and the board is worthless. My gut says internal candidate.
Let me put it another way. If the company is planning to liquidate and make sure the board and other executives get their payout, they will just pick an internal candidate. The whole point will be to make a token effort as they prepare to jump ship with whatever money they can.
If they go external, it's a sign they are actually trying. They have to go external and "no one wants to take the position" can't be an excuse. Otherwise close up shop because it's Nader 2.0
CYDY moving to 30 cents is only natural given it has no successful COVID trials, HIV BLA in limbo, and an ousted CEO. So that's bad. Really bad...
But if you were looking for a potential value play, where would your signal be that it's worth reentering at a lower position. There is a difference between throwing pennies into a Progressive Slot machine and hoping for a 1:9999 chance of a multiple hundred dollar payout, and making a very risky value play.
Extremely Risky
CYDY's financials are a horror show. And it's capable of crushing the company. If a drug company can't pass drug trials or get EUAs, well that's an out of business company. Well there are two things to look for:
1. Who becomes the new CEO and what that CEO does on day one. CYDY is going to require a CEO that hits the ground running. So if on day one the CEO just glad hands and writes a puff piece, not good. If the CEO comes in day one cleans house or has an actual plan, that is good. Now it also matters how experienced, credible and diligent the new CEO is.
If the new CEO is Scott Kelly or some turd on the board. Close up shop, game over. If the CEO has brought start ups to buyouts or profit, then okay. The idea CEO is someone who has specialized in turning around company's that have lunged into open graves. That's CYDY's situation former criminal CEO who committed multiple acts of fraud has all but killed the company.
2. Extending the cash on hand runway for 2 years. This is a bit of an assumption, because it assumes the HIV data is ready to go and not fraudulently put together which was Nader's specialty. So revenue and a BLA can happen if this new CEO can keep a tight schedule. Forget COVID. COVID is a red herring. It's bupkis. If COVID comes through wow great. But the HIV market is what will keep CYDY funded.
If those two things happen don't expect the share price to suddenly spike. It will stay sub dollar, even after a BLA. Because of CYDY's debts, legal woes and investor burnout, it won't be until after solid sales data and revenue that the price really moves.
That is where the deep value will come from. When the expectation that a company that's supposed to die hasn't and will be around for a bit. But anyone doing that kind of investing has to understand the reality of the situation:
Nader was bad. Scott Kelly is crap. The board is to blame. COVID trials took to long, cost to much, and were poorly designed. HIV BLA fraud was committed by Nader. CYDY has a ton of bad debt. The FDA is not to blame. Big Pharma isn't out to sabotage the company, Nader did that just fine. The path forward is very narrow. Being unhappy with the company is not a thought crime and being critical of management, poor drug trial performance is reasonable.
CYDY probably has a 5% chance of coming out of this alive. Which means the share price will drop more and buying more at sub 50 cent prices will yield a big win if the company shoots the moon. BUT, it's really unlikely and another trial failure or investors attacks on the FDA and others will just speed up the end.
So again CYDY is pretty crap right now. It has only a narrow path forward and if you are going to invest, please do so realistically and just do keg stands off the Kool Aid.
Well there is nothing to "telegraph" since CYDY's focus is finding a new CEO.
The company was rightfully slammed for Nader's lies and false promises. If a new CEO comes in, isn't a liar and can deliver then no one is going to complain.
Leronlimab does not have a proven safety record. That only comes with an official sign off from a regulatory agency. CYDY doesn't have that yet.
I think there is a lot of confusion over people being angry with Nader and mismanagement and it being confused for "destroy the company at all costs."
This isn't an episode of Law & Order or a simple Liquor Store robbery. This is a massive fraud perpetuated by Nader and others. It could involve a lot of people and if they are all knowingly involved, could even be a RICO case since the money bilked from shareholders was used to line their pockets.
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.
Company executives received subpeonas for their statements. The DOJ asked for the documents pertaining to the company's communications from relation consultants to their litigation with former employees. It includes not just COVID now, but cancer and HIV now.
I'm not worried about it. The company did the right things, is transparent and was proactive when the EUA was denied. I can invest in confidence based on my own DD and I came into this starting from an Anti-HGEN bear thesis.
Researching the sales they were automatic. That could be for any number of reasons. My guess, they probably expected an EUA was likely and thought it was worth it to set up the sales. Also as already pointed out C Suite members aren't eligible to buy yet.
I am looking to late Q3 and late Q4 for things to happen. I don't think we will see any speculation till after results. Then I am counting on the FDA being slow, and building in for the chance that instead of an EUA it ends up just being a BLA that happens.
Ideally an EUA comes, and then the BLA there after of course. But I am plotting out the potential for the FDA to be fine with the treatment options out there and wanting to encourage vaccines.
But no one has declared the COVID crisis over. Politically it's a bad idea, health care wise it's a bad idea because it's still an issue for a lot of places in the US and the rest of the world. Having a therapy with better results than the current standard of care would be welcome, and a well functioning therapy let's a lot of places get back to normal. At the very least a therapy with a good standard of care will allow a lot of places to accept the presence of COVID as a given and roll on. Just like the flu.
FDA wanted HGEN to have more people in the study before ruling on an EUA.
There are no current monoclonal therapies out there. So a need still exists.
COVID numbers are on the rise. Vaccinations are still around 60% and that is problematic.
The drug has applications beyond just COVID, including dealing with immune induced inflammation.
Far down the road, cancer studies will finish up.
Also this is Humanigen, not Cytodyn. The C Suite has experience and better transparency than the other company which has thrown a cloud over monoclonal research.
I think Nader turned down Operation Warp Speed because of the fact there was government oversight and that money came with responsibilities he was unable and unwilling to meet. Nader's turning down funds and BLA fraud were two major milestones of his tenure.
Think of the PR value of being apart of Operation Warp Speed. For such a small biotech that gets to take part in that, it's a major PR win even if the trial didn't work out. Shows the company is capable of operating on a larger scale.
Sadly Nader was a greedy, arrogant and deceitful asshole. I can't wait for the prison cell door to slam shut on him.
CYDY has to find a CEO, one that has solid credentials and a past that is not in question. The previous CEO was a nightmare of incompetence, arrogance and criminal behaviors he had been repeating since college. A good CEO that can restore integrity and confidence can help fund raise. It will keep the company on life support until approvals come through.
Based On Current Clinical Trials Leronlimab Is Far From Amazing.
So far Leronlimab has failed every trial for COVID. Now that could be because of terrible trial designs that have cost the company. Or the drug isn't as effective as Nader previously advertised. Brazil trials will have to bare that out. The HIV BLA was a nightmare and crippled the company's credibility. Nader should have been run out on a rail the second it was revealed he intentionally tanked the BLA just to announce it had been submitted in a short term stop gap solution to falling share prices. HIV is in limbo.
PARTNERSHIPS AND BUYOUTS WILL NOT HAPPEN UNTIL SOLID CREDIBLE RESULTS COME IN AND THE DOJ AND SEC INVESTIGATIONS CONCLUDE.
CYDY has a ton of debt, toxic financing and little cash on hand. Now couple that with liabilities from the fallout of a DOJ and SEC investigation, the damages from which would send the company into bankruptcy. Now keep in mind CYDY has yet to have solid COVID trials and Nader's stunt with the HIV BLA makes it an asymmetric risk for another company to come in and partner up or buyout. It won't be until after a BLA happens that someone might come in to partner. But that's after CYDY has shown the FDA credible data and a complete application. No company would be so irresponsible or stupid to get near CYDY right now.
CYDY has a very long journey ahead of it and it is not going to be easy.
So the FDA reject Leronlimab because Nader is in fact a snake oil salesman is the FDA not doing it's job? Leronlimab did not pass it's clinical trials, it's not received any BLAs or EUAs, and that's not the FDA doing it's job.
When the FDA issued that rebuke letter informing people of the misinformation Nader put out, that wasn't the FDA doing it's job?
When the DOJ and SEC got tapped to carry out the civil and criminal investigations of Nader and CYDY, did that just fall out of the sky?
Both the FDA and FAA would receive the respective applications, review and reject as needed. If there is something criminal taking place a law enforcement entity handles the rest.
So CYDY sends in it's bad applications, FDA rejects. In this case Nader did something criminal so the DOJ showed up. If there was no criminality then the xompany could spam applications until it went bankrupt. The FDA would review and reject all the bad applications.
No mystery here, no hidden double standards. Just the FDA denying a bad drug and investors angry a payday got denied.
Well it would be "protector against snake oil salesmen" for a start. Second in the FDA mission statement I provided the job is to ensure "drugs are safe and effective." That's part of why Nader is in spectacularly deep shit is because he kept saying Leronlimab was "safe and effective." Only a regulatory agency can determine that and using that language on a drug product or supplement without FDA approval will get the DOJ and SEC on you for the criminal and civil enforcement portions.
Not really that hard. CYDY has been poorly run, it needed better management. Calling Leronlimab "saline" is a jab at anyone claiming "Leronlimab has an amazing safety record." Well so does saline, but saline actually does something. Right now Leronlimab's trials for COVID have all flopped and we have no idea what's actually going on with HIV at this point or if that data will ever see the light of day.
Basically it all boils down to bad management and bad drug trials.
Some where out there, Nader Pourhassan is serving someone a Subway Sandwich. That person is trusting him to make that sandwich correctly. They have no idea how badly he wants to mix the chicken cuts and tuna together and call it a cheesesteak. I just hope the manager of the sandwich shop keeps a close eye on him, and the cash register.
Nader's PR was misleading, also let us not forget the attack on the FDA by certain investors leading a misinformation campaign. The FDA was absolutely right to take a firm hand in the situation.
But let me extend an olive branch:
Is that what they do, what department of the FDA handles that? If NP was lying that’s the SEC/DOJ responsibility.
Yes it is the FDA's job to protect the public from snake oil salesman, junk science, posion pushed on people as miracle cures. It is also the SEC and DOJ's job to go after Nader for his lies. Which they are, in fact we have the company's own Q10s stating the reasons for the investigation and the fact the investigations expanded.
So yeah agencies doing their jobs even in the face of an irrational and hostile public.
Proving my point. Mortality at day 28 was 31% survival. Current standard of care mortality survival is 30%. Not possible for CYDY to be 31% higher than the SOC.
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