That's just it, Amarex was told to submit an incomplete BLA. So they may have never finished the clinical portion per Nader's directions, which it sounds like they didn't.

Today's Market Drop Explained

CYDY's headline that part of the BLA was submitted generated excitement.

Upon further investigation the market found that CYDY was merely submitting the same manufacturing portion of the last denied BLA. No clinical portions submitted.

The clinical data is still tied up with the Amarex lawsuit which CYDY failed to settle.

This continues the trend of Nader's "Nothing Burger" PR schemes.

So Nader took the part they didn't intentionally screw up on the old BLA, sent it back to the FDA. Meanwhile the clinical data is in limbo with Amarex. On top of that we don't know how that data actually looks, if that data is as Nader advertised and if CYDY has the money to satisfy the debt that allows the data to be released to them.

If it turns out that data is a mess CYDY could be in a turn around and have to do their PIII all over again.

That's why I don't like these piecemeal submissions. Nader did it last time and hid the fact he knew he was submitting an incomplete application.

Fact:

At day 28 survival fell to 31%

Fact:

No clinical trial results support the assertion that Leronlimab works for COVID.

Fact:

CYDY stated that the company and it's officers were being investigated for statements regarding Leronlimab being an effective treatment for COVID.

Fact:

The FDA rebuked CYDY for pushing a false narrative. The SEC made CYDY remove "safe and effective," and Nader Pourhassan told Amarex to file an incomplete BLA to shore up CYDY's falling stock price.

The truth can't be hidden when the facts are in plain view.

SEC doesn't determine criminal violations. That is the DOJ's job, which is why CYDY couldn't make the same statement regarding the DOJ's outlook.

But don't take my word for it. Let's refer back to Nader "The Chipped Tooth Liar" Pourhassan.

He told everyone that the DOJ was doing an "informal fact finding." We immediately know that's a lie. The big smoking gun is the fact the DOJ got a court to sign off on subpoenas for CYDY and it's officers.

Getting a subpoena is never informal. There are legal and constitutional protections that have to be overcome for a court to justify granting a subpeona. The DOJ does not go on fishing trips or "fact finding tours."

It's 5:20pm in San Francisco. That office was closed so no live operator.

Debunked.

The bold faced lies in that letter are breathtaking. The second they research that survival dropped to 31% on day 28 is going to sink all credibility.

Here is what is interesting to me. Dr Jay "Lazy With The Truth" Lalezari is pushing debunked data. Nader walked back those numbers, the FDA called out the datamining, and Dr Lazy With The Truth knows that better crafted trials are supposedly taking place in Brazil.

Yet Lazy With The Truth is punting those trials before anything has been released to the public and pushing debunked data.

Jay Lalezari doesn't even out himself as a shareholder.

Then we get to the scummiest part of the letter:

Wait proven? Nader claimed it was proven and the SEC and DOJ showed up to investigate him and the rest of the company.

What clinical trials show Leronlinmab is in fact a life saver? Regulatory approvals don't come from feel good anecdotal stories.

Let's come at this from Merk's position. CYDY has questionable scientific and business practices. They are embroiled in several lawsuits and two major investigations. Their shareholders won't come at them with pitchforks for dumping money and time into CYDY?

That is the reality of CYDY's situation. It's a dumpster fire.

I take it there are no Q & A sessions, the academics in the audience would eat him alive over CYDY's misrepresentations and shoddy clinical trials.

Negative. The Marines like to keep their honor clean.

Wow a farmer could fertilize a corn field with all that manure...

So let's break down why there a few metric tons of crap in that analysis.

Well first and foremost CYDY approached Amarex about filing an incomplete application. So this whole "secretly interfering" nonsense is one of the most laughable myths I've seen regarding CYDY. The court has Nader's email and it pretty much undercuts CYDY's claims.

Then this investigation foolishness that ignores CYDY stating that the company and it's officers are being investigated regarding statements made about Leronlimab being an effective COVID treatment. It's CYDY's own filing telling shareholders the DOJ and SEC are poking around the company. Yet someone how that gets jumbled into SEC looking into short sellers.

I'll be waiting to see CYDY go below a dollar soon.

It's right in the filings, they are being investigated for statements regarding Leronlimab as an effective treatment for COVID. Again right in the filings, facts are facts.

The facts say different. Explain why CYDY said it is being investigated by the DOJ and SEC.

Okay then explain why in CYDY's own filings they state the SEC and DOJ are investigating officers of the company and their statements made regarding Leronlimab as an effective treatment for COVID?

Why doesn't it say "DOJ and SEC are looking into unusual price fluctuations regarding CYDY as a stock?"

Why does the company say it can't estimate the potential damages to the company regarding the outcome of the SEC and DOJ investigations?

CYDY Is Anti-Science

If you look at the standards and practices in place at CYDY, Nader's choices, Scott Kelly throwing his medical training to the wind following Nader down the rabbit hole of lies. CYTODYN has a distinctly anti-science bent to his philosophy of drug development.

First and foremost, we have Nader ordering Amarex to file an incomplete BLA. Important data left out intentionally to appease an angry group of shareholders that post online. No fidelity to good science, ethical drug development, or ensuring efficacy in Leronlimab. We have the emails, they are in a court filing, they are uncontested by Nader, Kelly, or Cytodyn's legal representation. It is an iron clad fact.

Next we have the datamining from the COVID trials. The purposeful manipulation of data to reach an outcome not supported by science. Nader went from correctly announcing the trial had failed, to 84% efficacy, to walking back the 84%% claim. It then attracted the attention of the DOJ and SEC for the fraud Nader was trying to push on investors. Companies practicing good science, data collection and ethical reporting don't become the target of major criminal investigations. Companies like Theranos and Cytodyn playing modern day snake oil salesmen attract the ire of regulators and law enforcement agencies.

Again we have CYDY's own filings stating it is being investigated by the SEC and DOJ, including it's officers for statements and claims regarding Leronlimab's use as a COVID treatment. It's in CYDY's filings and another iron clad fact.

Then we have Scott Kelly. A doctor of poor standing. I say that because he constantly champions the line about "Anecdotes don't just get up out of bed." The dishonest push that anecdotes somehow supersede clinical trial results. It absolutely is a dishonest push because he is getting to pick and choose what stories get shared with shareholders. He never tells you about the requests were people received Leronlimab and did not survive. This is why clinical trial results are so critical, because they can tell you how effective a drug is, and that it's not mere coincidence or good luck that someone recovered.

Another iron clad fact, we have Scott Kelly's pronouncements from multiple conference calls and Q & As. There is no question that he pushed anecdotal stories over clinical trial results. Even when those clinical trial results came back and told another story, he opted to deflect and remind everyone of the anecdotal tales of a miracle drug that has been anything but in clinical trials.

The running theme through many of CYDY's fumblings besides a corrupt CEO, is the fact good science is not being followed and churning out misinformation. "Conditional EUAs," "84% efficacy," "File an incomplete application," "Anecdotes don't just get up and walk out of beds" and all the other head shaking moments in this company's history.

Cytodyn is anti-science and contributing to COVID misinformation as a result.

Funny I don't see any filings dismissing the case.

Any updates on the Cytodyn V Amarex front? I know they didn't settle which means a lot more is going to come out surrounding Nader's fateful decision to file an incomplete application to appease a message board.

Pretty much more of the same. Nader fires off a less than factually correct PR. Nothing is actually happening and CYDY sits in Limbo until another regulatory watershed moment.

Meanwhile no announcement that CYDY is no longer being investigated by the DOJ and SEC.

CITIBANK DEBUNKED

This is why everyone thinks Citibank is covering CYDY:

DEBUNKED: PATIENT GRANTED RIGHT TO TRY BY CANADA

After a review of the article. The patient granted Leronlimab for cancer is receiving the drug under Canada's version of right to try. An Emergency Use Authorization would be the drug available for sale to the entire country for it's intended use, in this case cancer.

So CYDY will receive no revenue from this. They are not able to sell the drug in Canada yet. Canada has not given any form of regulatory approval for the drug. Any results from this will be anecdotal and not clinical.

Yeah I was about to say that was a solid piece of good news until I read the entire article. It is in fact a right to try, and the problem for CYDY is it's another case of Nader wording something to make it seem bigger than it actually is. Which is bad because of the DOJ and SEC hovering around.

I don't see any announcements from Amarex being the target or subject of an investigation. So far the subpeonas have been aimed at Nader and pals.

SEC doesn't deal with criminal violations of the law. That's why Nader can get away with that statement there, but not when it comes to addressing the DOJ.

They are being investigated. Charges come after the investigation, just like the financial damages.

https://www.sec.gov/ix?doc=/Archives/edgar/data/1175680/000155837021013132/cydy-20210831x10q.htm

Yes it has. Even Nader called it a "Fact Finding Investigation" which the DOJ does not do. The DOJ does not go on "fishing expeditions" as there are numerous legal protections against that.

If this was a non-issue CYDY would have followed up with an announcement all was well. They haven't. In fact they went into further detail just what was being looked into, and that it expects potential financial damages to the company resulting from the investigation.

Yeah the company has said it twice that it's officers and the company itself are under investigation for statements made about Leronlimab. If Nader wasn't under investigation the company would be able to announce that. They haven't.....

Doubtful. Probably negotiating a payment plan out of Nader in return for not moving forward.

We do know what's being investigated. The company has stated twice in filings. We know Nader and the board are up a creek without a paddle. We know Amarex dropped a case ending bombshell with it's response to CYDY's lawsuit.

Yes those posts pointed out how evidence was needed. At the time none of them had nothing. None had access to the emails Nader was sending to commit securities fraud.

Flash forward to now, Nader sues Amarex. Amarex has a smoking gun that actually shows Nader's actions and criminal intent.

It's going to be a heck of a show.

Watch the lawsuit fall apart. Just because you sue someone doesn't mean you win or that your suit can't be shown to be a sham.

Here is the proof:

It's evidence submitted to the court. Evidence that CYDY and Nader have not decried as fake. No one has alleged fraud against Amarex for it's response. Nader has been humbled and shamed into silence, finally.

What good is the proof when people are willfully blind to the truth?

How very murky. Most of all it only raised 3.5 million, not nearly enough to keep the lights on.

It's a well established opinion that Nader will have to be drug out from the company. Either through an arrest for securities fraud, or the company folds. Nader lacks the good grace to step aside and let someone have a shot at saving the company.

It will be a miracle if the shareholders band together and oust him and most of the do nothing board. After all what kind of board sits by after it's revealed the CEO ordered an incomplete filing to be pushed forward in a stock manipulation scheme?

Had I known the HIV filing was intentionally incomplete I would have dumped the company far sooner for it's mind boggling mismanagement and cult following.

Fierce Biotech Slams CYDY

https://www.fiercebiotech.com/special-reports/fierce-biotech-s-rotten-tomatoes-2021-cyto-dyn

Fierce Biotech pulling no punches regarding the current state of the company. Highlights Nader's negligence, legal fiascos, and crooked business practices.

Well we will have to wait and see, but solid prospects.

That's easy. They were first to the finish line during the height of the crisis. No one is saying the bar set isn't low. It's just that CYDY has yet to get over that low bar. If CYDY had gotten finished first it would have been approved, but that's not what happened.

This is part of the cost of having Nader as CEO.

The only crooked thing here is Nader. It's well established and the smoking gun from the Amarex filing makes any other attempt at debate moot.

CYDY is in Brazil because it launched failed studies which Nader mindlessly nodded along to. The same mastermind that told Amarex to file an incomplete BLA out of sheer effeminate panic.

The failures have been from Nader, they are his responsibility. Sour grapes with the FDA is a smoke show, and a dubious one at that.

You'd be surprised how many times lawyers get surprised with clients tanking their own cases. I doubt Sidley knew about Nader's fraudulent BLA filing email, I doubt they would have taken the case having seen that.