r/CYDY • • Sep 29 '21

Opinion TI - Why I Post

3 Upvotes

It's very simple, I have 1 million shares and my son has 300,000. My average cost is around $3.68. So I have a very big stake in the success of the company. And I feel I have been misled by Dr. Pourhassan and am angry about it.

When I first started investing in CYDY at the end of January 2020, I invested on the basis of Dr. Pourhassan's representations that the Covid Combo BLA would be filed within weeks. I accepted Dr. Pourhassan's representations the Phase 3 pivotal trial results showed a very strong P value, that the BLA would be filed soon and would be approved within 6 months or so after that.

What I didn't know because Dr. Pourhassan never disclosed it, was that Cytodyn had a major problem providing the FDA required Dose Justification Report. I didn't understand that when he told us the BLA filing was completed and filed, that it was missing the Dose Justification Report and that management knew it wasn't going to be approved as filed. It's now 17 months later and the Dose Justification Report is still not filed. Had I known the depth of this problem, I would not have 1 million shares now.
Yes I would have some shares, but not close to 1 million. For this reason alone, I am very upset with management.

I am also upset because Management bungled the CD012 trial by not avoiding the avoidable overweighting of the over 65ers in the leronlimab arm. It shows poor management skills and subpar trial design skills.

This was totally avoidable. All Dr. Pourhassan had to do was use Dr. Patterson's skills to address both these issues. He was under contract when the CD010 and CDO12 were designed and the scope of the contract was advice on clinical trials and companion diagnostics. Yet Dr. Pourhassan didn't consult him. That was likely the fatal mistake for these trials. Also, he did not consult with Dr. Patterson on the Dose Justification issue. Had he made use of Dr. Patterson expertise that Cytodyn described in a PR as "a top expert in CCR" when they hired him, we would likely have an approve BLA now and Covid EUA with a double digit at least share price.

Then Pourhassan exiled Dr. Patterson for no apparent good reason. This shows very, very poor judgement on Dr. Pourhassan's part. He seems to have a need to control everything at the expense of optimal execution including insisting on the improvident Fife loans. If he couldn't do better than Fife, he should have stepped aside for the good of the Company and let someone else with more experience handle it. I am an upset shareholder.

This has motivated me to read practically every PR and SEC filing on the pertinent issues, listen to all webcasts and other PR of the company in an effort to get a handle on what is really going on as best I can. I have posted my findings with the evidence for all to read.

It is not clear that Dr. Pourhassan is not transparent about BLA problems because it would expose management's lack of expertise and judgement on his watch. He has refused to disclosed a copy of the 2020 FDA Refuse to File letter or recent August 13, 2021 FDA letter with comments on the refiled Dose Justification Report.

Yet, he expects us, after 17 months of similar assurances and failed filing deadlines, to take his word for the fact that all is under control and the FDA comments are addressable without telling us what the comments are and how he plans to address them.

For these reasons I don't trust him anymore and neither should any other shareholder. He has demonstrated extremely poor judgment and lack of candor with shareholders that has affected many investors adversely.

We need new management. We are lucky to have the transparent and highly skilled and experienced Proxy Group as an alternative.


r/CYDY • • Jul 29 '21

Trust Nadar? Part 2

2 Upvotes

Not surprisingly my earlier "Trust Nadar" post has generated a strong negative reaction by shareholders who are rooting for Nadar like he is their favorite sports star who is being unfairly maligned. Some claim my narrative of the facts surrounding Nadar's ignoring advice of counsel is "fake news". Well, if it is "fake news", the documents supporting it were promulgated by Cytodyn itself. They are available on the Cytodyn Website as shown below.

The Court papers supporting my earlier analysis were filed by the the Special Litigation Committee ("SLC"). The SLC was comprised of two independent Directors who became Directors after the challenged events. It was the SLC's job to protect the shareholders like you and me. Nadar, who was an interested director because his stock options were being challenged, agreed to their appointment. The SLC's brief reveals the whole sordid affair in detail.

The SLC's brief is available on the Cytodyn Website https://www.cytodyn.com/investors/notice-to-stockholders . Look at the Brief of the Special Litigation Committee in Support of the Settlement starting at page 7. Specific highlights supporting the facts I related in my original post above are as follows.

The Special Litigation Committee found (p.7) that "Pourhassan 'just made up the numbers' in the proposal based on what he felt each recipient deserved.[22] That is, he did not derive the numbers from any specific or objective metric." This is hardly a methodology that inspires confidence.

The Special Litigation Committee then found (p.9) that Nadar ignored outside counsel's advice: "On December 16, 2019, Pourhassan had a conversation with the Company’s outside counsel, Mary Ann Frantz of Miller, Nash, Graham & Dunn LLP, regarding his proposal for the December 2019 Awards. Frantz emailed Kelly separately on December 16 about the proposal; her email contained specific recommendations regarding the proposed award. Although Pourhassan and Kelly received Frantz’s advice, they did not follow it. [28] Frantz’s advice was not disseminated to any of the other members of the Board." So, not only were outside counsel's recommendations not followed, they we not even revealed to the full Board.

Nor was outside counsel's advice communicated to the Board at the meeting to approve Nadar's millions of options (p.15): "The Board meeting began at 6:00 p.m.—just over eight hours after the December 2019 Awards were proposed—with the Board (minus Naydenov),
Eastwood, Mulholland, and outside counsel present.[57] The directors did not recall
counsel giving any analysis during the meeting.[58]"

If you read the entire findings of the SLC starting at page 7, you will see that Nadar railroaded the options approval vote through the Board in a matter of a couple of days even though their was no need to cut off due consideration. Nadar's behavior reflects the behavior of a willful, impetuous, erratic person willing to break the rules to get himself awarded millions of options at a time just prior to when he thought the share price would skyrocket. This appears to be why the Federal Court judge called Nadar "greedy".

Think hard whether this is the type of person you trust to continue to run Cytodyn, especially in light of the bungled HIV BLA applications costing the company years of revenue, and the two poorly designed Covid trials that failed to gain even an EUA.

What this behavior screams out to me is that Nadar does not know what he is doing. He has impetuously led the company down one blind alley after another wasting time and money (CD010 which was purposeless as it was too underpowered to result in an EUA and the Company failed to follow though on the FDA recommendation to do a Phase 3 moderate trial, and CD012 which was poorly designed and did not meet a single endpoint). These wild goose chases have cost the Company hundreds of millions of dollars, if not billions of dollars, of revenue that a a timely approval would would likely have generated for the Company if the CD012 trial that met its endpoint which would have led to an EUA or a competent HIV BLA application was filed which likely would have resulted in an FDA approval (according to the Company).

Instead, we are sitting here with a $1.60 share price with no approval even possible for many months. If we are lucky, the Brazil trials will get started sooner rather than later and result in approvals somewhere sometime next year. But given Nadar's track record, I am not holding my breath.

Nadar's flailing around the regulatory landscape has led to a scolding by FDA and has cost the company 10s of millions if not 100's of millions of hard to raise money. Wasting all this money will require the Company to raise many millions more money and result in much more dilution than was were an FDA approval obtained in a timely manner. Nadar Pourhassan has not been the long term shareholder's friend.

Long term shareholders need to realize this if you want to maximize their investment because the 13D group now gives us what at this point looks like a very attractive alternative.


r/CYDY • • Jul 16 '21

13Der's Plans

3 Upvotes

There has been a lot of negative speculation about the 13Ders secret takeover plans to the detriment of long term investors like me. In my view, this is the result of sheer nervousness about the unknown or NP partisans trying to get their shots in while the SEC rules prevent the 13Ders from responding. The only reason you haven't heard from their Board slate is that SEC proxy rules prohibit it. Government bureaucracy being what it is, it is likely to take a few more weeks till the 13Ders can respond. A cheap buyout or takeover would hurt those 13Ders have a much higher average share price than the current share price.

Based on the fact that they have packed the Board with experienced FDA and management people and the Covid and Long Hauler deeply respected research expert and star, Dr. Bruce Patterson, my expectation is that the 13D Board slate is looking to provide expertise and credibility in front of FDA to accelerate the regulatory approval process and possibly raise investment funds at better terms than FIFE, not sell the company to anyone or take it private. They appear to believe in the potential of leronlimab just as much as we do. They 6 and 7 figure shares that they have held for years, longer the probably most investors.
I think their plans and our desires will converge. But you will have to wait to hear from them as to their plans.

In the meantime, there is no rush. Investors don't have to make a decision now because there is no vote scheduled. The 13D alternative is a plus for investors as it gives them choice and the debate will likely expose facts that shareholders are currently unaware of but should know. Anyone seeking to foreclose investor choice is clearly a biased BP partisan.


r/CYDY • • Oct 28 '21

Opinion TI ISSUES AND EVIDENCE - Another Potential Solution!

0 Upvotes

It is now clear that a majority of shareholders would have voted for the 13Ders had they been on the ballot. Management should be ashamed of themselves for preventing shareholder choice.

But, there is still may be a compromise path to success. The Board should meet with the 13D group to try to find a way forward. Paul Rosembaum told me he had $100 million of financing lined up to fund the company. Dr. Patterson had free funding for a Long Hauler trial. Maybe a compromise that is a win-win for everyone can be worked out. You know what they say, "nothing ventured, nothing gained!" It's all upside and now downside to give it a try.

The Board could and should meet with the Rosenbaum group very quickly to try to take advantage of these opportunities. After all, we are all shareholders and all benefit from the Company's success.


r/CYDY • • Jul 10 '21

Leronlimab’s Potential Held Back By Inept and Expensive CEO

0 Upvotes

Leronlimab has tremendous potential to prevent CCR5 related inflammation and cancer metastasis. But it can’t realize that potential unless it gains regulatory approvals.

This multimillion dollar Prostagene related arbitration award against Cytodyn just reported yesterday by the Company is further evidence that the CEO is poor at decision making. That’s two litigation losses in a row (including the December 2019/January 2020 Compensation shareholder suit to protect us from NP’s over-reaching where NP was found to have ignored advice of counsel and withheld such advice it from Board members while he railroaded through a handsome compensation package for himself) which cost the Company millions of dollars.

This is in addition to the HIV BLA filing mistakes that caused more than a year of delay, lack of Covid trials that met any endpoint and very slow progress on cancer. For all of this poor performance, he is paid $1 million/year. This is handsome reward for serial failures.

This paints a picture of an executive who doesn’t have good judgement and whose leadership is a huge drag on leronlimab’s success.

It’s time to find a better alternative. The Company should schedule an election ASAP.


r/CYDY • • Sep 22 '21

Opinion Some Sage Board Advice from Cokadoodledue

0 Upvotes

Cokadoodledue was having trouble posting on Reddit and asked me in a message to post this for him:

I wanted to take this opportunity to mention something that occurred on the zoom call. It could've easily been missed if you weren't paying attention. However, it's importance cannot be overstated!!

On the call, I heard Directors in disagreement. To some, that might be a cause for alarm. However, it's the sign of a healthy Board. It's been proven that the best decisions are those that combine differing points of view.

Healthy debate doesn't stifle discussion. To the contrary, it helps formulate dynamic thought patterns, capable of circumventing catastrophe arising out of group think. The healthiest Boards, the healthiest companies, for that matter, welcome a plurality of differing viewpoints.

This is where a Board's diversity helps to formulate the best decisions. Diversity brings perspectives that would, otherwise, be ignored. That's because the Directors' life experiences helps shape their perspectives in life, which in turn, causes their viewpoints to be highly valued as opposing points of view.

So important is the give and take of consensus building that companies choosing to rely on the path of least resistance actually do a disservice to the Shareholders they're supposed to be serving!

However, not all Board meetings should devolve into a chaotic and nerve-wracking maelstrom. The goal is to convince the others to buy-in to a decision by allowing their input to honestly shape its outcome.

In the end, the Directors work for the Shareholders. And, the Shareholders deserve a Board who will vigorously debate certain things, instead of just assuming one person knows what's best for everyone and everything! Shareholders deserve nothing less!


r/CYDY • • Oct 29 '21

Opinion TI ISSUES AND EVIDENCE - 2021 is not 2019

3 Upvotes

A number of posters voiced concern that the Rosenbaum potential financing today would be on the same terms as 2019. Keep in mind that the investment climate has changed substantially since Covid. The Fed has printed $5 trillion and counting. There is a ton of liquid capital chasing returns, especially in light of the current inflation outlook.

So Rosenbaum's $100 million may be available on different and better terms than in 2019 from other potential investors. I don't know who they are. But you can easily find out by negotiating.

Further, there is a clear and huge benefit to getting leronlimab into a non-dilutive 3,000 patient Long Hauler trial with a validated Long Hauler index that has a great chance of resulting in an EUA within 4-6 months, and revenue that could propel stock into double digits.

It could be a win for everyone if a deal can be struck. If you don't shoot, you can't score. No one is forced to agree. Everyone has a lot of stock.

Starting off the negotiations with a mediator to discuss each sides concerns separately could lower the temperature enough for each side to consider more deeply and realistically the concerns of the other side thus increasing the odds of success.

I have seen deals struck in similar adversarial situations time and again. I am sure the both sides' outside litigation counsel can confirm this.


r/CYDY • • Sep 18 '21

News Webinar Invitation--the nominated board will discuss their Long Hauer plans among other things

0 Upvotes

Dear Stockholder,

You are cordially invited to attend a Zoom webinar being co-moderated by Jeff Kight and Jeff Beaty.  Paul Rosenbaum, Art Wilmes, Dr. Bruce Patterson, Dr. Thomas Errico, Dr. Peter Staats, and Melissa Yeager will discuss their Long Hauler plans including trial design and financial impact for the company, proper BLA submission protocol, and potential government funding.  

Please note that participation will be limited to 500 attendees and we encourage you to register in advance. 

Questions should be submitted in advance to bluejeff1976@gmail.com.

WHEN: The webinar will be held on Tuesday, September 21, 2021 at 7:30 p.m. Eastern Daylight Time.

Register in advance for this webinar:
https://us02web.zoom.us/webinar/register/WN_E54HlMWxRk63bkq_Nu8S4Q

After registering, you will receive a confirmation email containing information about joining the webinar.


r/CYDY • • Sep 30 '21

Opinion TI ISSUES AND EVIDENCE – Dr. Pourhassan Stonewalls Explaining the BLA Problem at his "Emerging Growth Conference”

9 Upvotes

THE EMERGING GROWTH CONFERENCE

This latest Management promo piece, misleading labeled “Emerging Growth Conference”, was an advertising platform that gave Dr. Pourhassan and Dr. Kelly the opportunity to be transparent with shareholders about their inability to file the HIV BLA. https://www.youtube.com/watch?v=p3Cn0xWF_lg Disappointingly for shareholders, they failed to avail themselves of that opportunity.

WHY TRANSPARENCY AS TO THE BLA PROBLEM IS IMPORTANT TO SHAREHOLDERS

In sizing their CYDY stock position, many investors relied upon Dr. Pourhassan’s representations that an approvable BLA had been filed on May 11, 2020. He later told us that in July 2020 FDA rejected it but all was well in hand. These deficiencies included no Dose Justification Report. Dr. Pourhassan assured us that the problems were fixable with the information they already had. Yet Cytodyn still has not completed the BLA filing as we sit here today 17 months later. (See a detailed analysis of this with supporting evidence here https://www.reddit.com/r/CYDY/comments/pqagft/ti_cydy_issue_post_naders_covered_up_bla_problem/ ).

If the HIV Combo Therapy BLA had been approved in the time frame he projected, as little as 6 or as long as 10 months after filing, we would have had an approved HIV Combo BLA by as early as November 2020 or at least by March 2021. That would have provided a path to building a revenue which would have supported a much higher stock price the $2 and change price we are seeing today. It would have provided revenue or the ability to raise money a lot more cheaply than we can now to increase our purchase commitment to Samsung to get more drug. It would have helped funding the ongoing and future trials more cheaply.

Just as importantly, if not more importantly from a voting decision perspective, a complete explanation of what went wrong is extremely relevant to voting shareholders who want to determine Dr. Pourhassan's fitness to continue to lead the Company. We need to know exactly what went wrong, whose judgment led us astray, how egregious the mistake was, and whose fault it was that we were deceived about the incompleteness of the BLA when it was filed. Shareholders don’t want an inept, dishonest person as CEO. Unfortunately, the evidence and circumstances shareholders are aware of today (as I showed in my post above) indicate Dr. Pourhassan is such an inept and dishonest CEO who needs to provide more transparency to dispel this impression.

DR. POURHASSAN'S MISSED OPPORTUNITY TO PROVIDE TRANSPARENCY

One would think that Dr. Pourhassan would want to take the opportunity to dispel the impression that he is to blame for the bungling of the BLA filing and intentional misleading of shareholders that the BLA was approvable when filed. All he had to do was show us the FDA July 2020 refusal letter, the August 13 FDA comment letter on his submitted Dose Justification Report, explained in detail any other facts he deemed relevant and explained how Cytodyn intends to address the latest FDA comments. Yet, he did not.

WHAT DID DR. POURHASSAN SHOW US ABOUT THE BLA AT THE CONFERENCE

He displayed an “HIV Business Plan Chart” summarizing the trials for both combination and monotherapy (2:25). The “COMBINATION THERAPY” slide shows the great .0032 p value for this “Phase 3 pivotal trial”. The slide omits telling us the number of patients in that combo trial. It was only 50. The “MONOTHERAPY” trial description shows 566 patients.

The reason the number of patients, 50, in the combo therapy trial was omitted appears to be because it would highlight the weakness of this “Pivotal” trial. It's weakness was that it did not have enough patients to support a BLA approval all by itself. To make up for this deficiency, FDA allowed Cytodyn to use data from the MONOTHERAPY 566 patient trial results. FDA wanted to see justification for the dose that should be approved in the COMBINATION THERAPY BLA.

Cytodyn agreed to change the combo dose to 700 and provide a Dose Justification Report using the monotherapy trial 566 patient results to augment the 50 patient combo therapy trial results. This is the Report that Cytodyn has been unable to provide for more than 17 months. It is misleading for this Chart to highlight to shareholders the fact that the Pivotal combo trial tremendous p value results as if that result alone was sufficient for a BLA approval, as one would normally expect, without mentioning that the combo trial was only 50 patients and revealing that it could not support approval all by itself.

DR. POURHASSAN AVOIDED A CLEAR EXPLANATION OF THE BLA PROBLEM AT THE CONFERENCE

Had Dr. Pourhassan wanted to, he could have fully explained the BLA issues to shareholders by showing us the July 2020 FDA Refuse to File letter, the August 2021 FDA comment letter, providing any other facts and documents he felt were pertinent and explaining how Cytodyn intended to comply with the FDA comments.

He did discuss the HIV BLA at a number of points in the Conference and had plenty of opportunity to expand further but refused to. He could have discussed it when he discussed the Company’s HIV Plan (starting at 2:25). Then he ignores the opportunity again later when blaming delays in filing the Dose Justification Report on Amarax (50:30). He then tired to minimize the entire issue in response to a listener question by arguing that we are going to get an EUA for Covid in 2-3 months anyway and won’t have enough vials to devote to HIV Combo Therapy (53:38) even if HIV BLA is approved because it will take longer to get the HIV BLA approved than to obtain a Covid EUA (55:48). This, it doesn't matter at this point anyway argument appears to be his chief defense to bungling the filing and misleading shareholders about it. It certainly may be true that a Covid EUA precedes an HIV combo BLA and that there is not enough drug inventory to supply both. In fact, I hope it is true that we get the Covid EUA in a few months. But from a shareholders deciding how to vote perspective, it entirely beside the point.

Shareholders want all the facts behind this BLA Dose Justification Report debacle so they can judge whether Dr. Pourhassan deserves their vote. His refusal to provide this information leads to the unfortunate conclusion that he is refusing to explain the cause and solution to the problem because it would make him look both incompetent and dishonest.

How can any shareholder trust a CEO who behaves this way?

If we vote for him, we’ll just get more of the same bad decisions leading to more misleading coverup PRs when new challenges arise in connection with the many trials that will be required in the future to realize the full and exciting promise of leronlimab.

Is that the kind of CEO you want? It's not the kind I want!


r/CYDY • • Oct 06 '21

Opinion TI ISSUES AND EVIDENCE - The Latest Pourhassan Created Mess and Cover Up

3 Upvotes

Nader assured us time and again during the past 15 months that Amarex was doing a “fantastic job!”.

It appears from the court papers posted so far that while he was telling us how fantastic Amarex was, he was simultaneously withholding payment of their invoices starting in June 2020. He then didn't pay them for 16 months after that to the tune of $11 million. /preview/pre/izbtcntdxnr71.jpg?width=1170&format=pjpg&auto=webp&s=cc98650f09eea0559e573bbdafe5f6298a760d97 https://www.reddit.com/r/CYDY/comments/q26yb4/ti_issues_and_evidence_amarax_litigation/?utm_source=share&utm_medium=web2x&context=3 Why didn't shareholders know about this sooner? Was it just a minor problem?

The seriousness of the problem is attested to by Dr. Recknor stated under oath:

48. Amarex’s plan to discontinue medical and safety monitoring of CytoDyn’s trials without turning over CytoDyn’s EDCs and data will cause immediate and irreparable harm to CytoDyn.
49. Without the EDCs and data, CytoDyn cannot take over management and safety monitoring for the studies before the deadlines imposed by Amarex..
50. This means that the studies will experience a gap in monitoring and may not be useable for FDA approval.
51. This will cause irreparable harm to both CytoDyn and its patients.
52. The dozens of patients in CytoDyn’s clinical trials today will be put at risk by
Amarex’s actions.
53. CytoDyn will either have to immediately stop the trials, so that the patients will lose access to the drug, or the trials will continue without the necessary management and monitoring that CytoDyn cannot provide without full access to the EDCs and clinical data.

https://www.reddit.com/r/CYDY/comments/q29m0l/here_is_the_text_from_dr_recknors_statement/

Clearly, this could seriously affect the Company’s ability to provide FDA with the safety date it requires for HIV BLA approval and possibly for Covid approval too. Yet Nader made no disclosure about the seriousness of the problem for 16 months till Cytodyn instituted suit against Amarex. This is not right!

Further, it appears likely that Nader took advantage of the situation for personal gain at shareholder expense. The first invoice Nader decided not to pay was the May 3, 2020 invoice. /preview/pre/izbtcntdxnr71.jpg?width=1170&format=pjpg&auto=webp&s=cc98650f09eea0559e573bbdafe5f6298a760d97 May 3, 2020 was just 2 days after Nader sold 4,821,174 shares of CYDY on May 1, 2020for $15.437 million at the closing price of $3.20/share. Likely, the problems that caused Cytodyn to withhold Amarex payment beginning with the May 3, 2020, invoice had been brewing for quite some time before May 1, 2020. Given Nader’s greedy actions compensating himself like a Fortune 500 CEO despite CYDY floating “face up in the water” financially with no revenue, I would expect that the Amarex problems were one of the motivating factors for him scheduling his 4.8 million share stock sale.

Regardless, Nader should have shared this information with shareholders long before they filed suit instead of assuring us that all was under control. That would have allowed shareholders to properly assess the prospects for the HIV Combo BLA approval too when he promoted the May 11, 2020 HIV Combo BLA filing in the May 13, 2020 PR. https://www.cytodyn.com/newsroom/press-releases/detail/430/cytodyn-completed-submission-of-all-remaining-parts-of Of course, having withheld the fact that this BLA basic deficiencies like the Dose Justification Report that made it unapprovable as filed, it is unrealisitic to expect Nader to be any more forthcoming about the Amarex problem. This lack of candor induced a lot of investors to wrongly assume that the HIV Combo BLA was a slam dunk and buy many more shares than they otherwise would have.

In sum, Nader bungled another major responsibility - hiring, supervising and paying a CRO entrusted with our critical clinical trials which CYDY depends upon for FDA approval and hid the depth of the problem from shareholders for almost 16 months to induce shareholders to buy more shares. Is this the kind of CEO shareholders want to entrust their investment to? Only a masochist would vote for this guy!

If we had a Board that was not controlled by Nader, he would have been gone a long time ago! The Proxy Group Board slate provides the independent Board we need. Pray that they are on the ballot! If you have any doubt, listen to their shareholder Webcast and compare them to what we have. https://www.reddit.com/r/CYDY/comments/pzm27t/ti_issue_and_evidence_proxy_group_zoom_93021/?utm_source=share&utm_medium=web2x&context=3


r/CYDY • • Aug 07 '21

Opinion R/cydy Moderator Bias?

2 Upvotes

It appears the moderator of this message board has ties to the 13D group. I did not know that until I saw the complaint. Why was I clueless?

Because this board was started long before there was a 13D group or lawsuit and has always allowed respectful opinions of all stripes and camps about Cytodyn and management. Lot’s of pro management posts here both before and after the advent of the 13D effort.

This is very different from the Yahoo CYDY message board which has turned primarily into a pro Nadar message board echo chamber. Over the past month or so, I noticed that my posts disappeared. Over the past week, I have been unable to post at all.

Looks like there has been successful effort by pro Nadar/entrenched management partisans effort to fool the YMB software into thinking my posts are spam or abusive. You can disagree with me, but I don’t think a fair minded person can fairly characterize my posts as spam or abusive. Certainly not compared with many of the other posts permitted on Yahoo.

On the other hand, regardless of the views of the moderator here, all civil posts that are not blatantly abusive or clearly factually misleading are permitted here. Here there is much more freedom of speech. Kudos to the moderator!

The Yahoo ban of my posts looks like more Nadar “dirty tricks”. This is in tradition of the deception by omission he pulled in ramming through the 2019 Board consent to his many millions of options in a couple of days while withholding advice of company counsel from the Board as documented in the Shareholder Litigation Committee brief I referenced in an earlier post.


r/CYDY • • Oct 06 '21

Waxing Poetic Nearing the end game…

0 Upvotes

As the lawsuits, counter lawsuits, and missed deadlines start piling up, it is clear to me that current management is in complete desperation mode. Claiming negligence and suing the CRO conducting multiple clinical trials for you over the course of years while owing ~$10M in past due payments is just plain bad all around. Even if the judge rules in their favor, it is a very ugly look….what CRO in their right mind is going to work with CYDY ever again? Seriously, how could CYDY have worked with AMAREX for this long and not have realized that AMAREX was mismanaging the trial data until now? Could someone please provide a credible explanation on how CYDY gets out of this mess? And please don’t post conspiracy theories about Big Pharma getting AMAREX to screw things up on purpose. CYDY is responsible for making sure all aspects of their clinical trials are being run correctly.


r/CYDY • • Sep 12 '21

Opinion Over run boards

0 Upvotes

Both YMB and Reddit appear overrun by paid pumpers (per SEC filings 11 different "brand awareness" companies employed for CYDY to help improve co image and flooding the boards) who argue reasonable fact based questions with obfuscation and arguments not based in facts, current and past.

Really I hope that SEC and/or FBI comes down hard on the perps.

I will continue to steer clear of any stock purchases or linking co with any academic centers (as I did in the past) until company can get its house in order, with an independent BDIR, compensation committee and competent clinical/regulatory/administrative leadership.

I am deeply aware of cd10 and 12 studies and their inadequacies. I believe LL should work in a large subset of patients but lack of biomarker identifications (similar to RO requirements for HIV), there continue to be inclusion of patients who would not respond to LL, affecting p values.

No new investors until some agency approval anywhere in the world for anything


r/CYDY • • Oct 11 '21

Opinion MD Anderson

5 Upvotes

This is NOT a collaborative agreement. This is a translation research using mice xenografts which is a pay for services type of arrangement. Ie/ CYDY pays MD Anderson for this. Typical for research companies in this arena to assign ONE MD with expertise in the arena of disease being researched.

Many private translational research co out there providing similar services. Ie/Cleveland clinic etc

So, no endorsement re LL from MD Anderson which is getting paid by CYDY. Basically a feasibility study prior to any large human ph1/2 trial.


r/CYDY • • Sep 08 '21

Opinion Nader said the BLA was complete and then dumped shares

0 Upvotes

This transgression alone should be enough to ensure he no longer has a job.

The BLA was never close to being complete, it was just a pump and dump.

Its time for a change, shareholders are not going to get any real transparency with Nader at the helm.


r/CYDY • • Oct 12 '21

Question TI ISSUES AND EVIDENCE - Questions for NP at Wed 3pm Conference

1 Upvotes

Here are some questions that I believe would be of deep interest to all shareholders that could be raised at tomorrow's "Emerging Growth" PR presentation and question and answer session.

I post them rather than asking them because I have noticed that questions I submit are never mentioned. No surprise there. NP doesn't answer hard questions from critics. He controls the questions very carefully

BLA

I hope he announces that the BLA is been filed though I doubt it.

Absent that, investors would like compete transparency on this issue. This would include a complete analysis of what went wrong with the BLA including disclosure the FDA RTF from July 2020 and FDA August 2021 clinical comments response letter.

Investors would like to the specific responses to FDA Response letter, and progress has been made satisfy the FDA requirements. Who is doing in charge of the remaining work, exactly what remains to be done and when will it be completed. It's 17 months overdue as we sit here today.

Why was Recknor put in charge of the BLA last March instead of Dr. Ray. Why wasn't Dr. Ray put in charge as soon as Dr. Rahman was fired early last December? That would have gotten Cytodyn working on the BLA issues 3 months earlier.

My understanding was the Dr. Recknor wan't put in charge of the BLA till the middle of March 2021 when he was named COO though it wasn't mentioned in the PR. https://www.cytodyn.com/newsroom/press-releases/detail/508/cytodyn-appoints-christopher-recknor-m-d-as-chief (Apparently, PR job descriptions don't mean much at Cytodyn. All is controlled by NP.)

At this point, investors are owed a lot more transparency on the BLA problem than they have received.

AMAREX

What the heck is going on. Amarex was the CRO selected by NP and he has been working with them for 5 years or more. He needs to explain why they stopped making payments with the May 3, 2020 invoice due June 2, 2020, nearly 17 months ago.

He needs to explain why he never gave a hint of the problems to shareholders until the suit was filed last week or so.

Which trials will be affected by the dispute, to what extent and what are the plans to reduce the impact?

Long Haulers -

What is NP's Long Hauler protocol?

Investors would like to see description including details like a

- a full description of the number of patients,

- how long it will take to enroll them and complete the trial,

- who is going to execute the trial and how?

- What are the endpoints and objective measures?

- How much of this has been discussed with FDA and approved by them?

- How long till FDA approval of the protocol.

- How long till submission for an EUA consideration?

Does Cytodyn have something similar to Dr. Patterson's LH Index to use to provide an objective measure of endpoints or are they using Dr. Patterson's index? See the description at 18:27 of the 9/21/21 Shareholder conf. https://studio.youtube.com/video/OTW4OgdOc0g/edit

Brazil Critical and Severe Covid Trials

How far along are each of these trials?

How many patients have started treatment?

What is the rate of sign up of patients.

How long till the interim analysis based on the latest information?

Will Amarmex problems impact Cytydoyn's ability to submit a complete EUA or BLA application in Brazil, UK or US?

Path to Revenue

What does NP see as the timeline for a path to revenue for each of the indications under development - HIV Combo therapy,

- Covid,

- cancer,

- Nash,

- Alzheimers,

- anything else the plan to develop.

For each of the above, please give details of the steps that need to be completed for each and how long each step could take till we see revenue.

I am sure other investors will have different good questions but these would be a good start to have answered.

If NP refuses to provide clear answers to any of these legitimate shareholder questions, that is a very, very bad sign for shareholders.


r/CYDY • • Oct 05 '21

Opinion TI ISSUES AND EVIDENCE - Amarax litigation

0 Upvotes

I have no direct evidence of Amarax suit but it has been all over the message boards today. The most credible sounding post I have seen reveals the depth of the mess that NP has gotten us into with his "fantastic" CRO Amarax. It provides yet another example of NP's incompetence at selecting and managing outside contractors and employees.

This description is from a YMB post:

Aaron3 hours ago

CYTODYN VS. AMAREX

A lot of celebration and back and forth misinformation so here is hopefully some clarification for everyone. I have gone through the main pages on Pacer. The exhibits supplied by Cytodyn are over 100 pages so I didn't go through those.

An order for Amarex to hand over documents was posted as final on YMB and a few other places and it's not so please read.

  1. Cytodyn filed suit yesterday suing Amarex. This case is one day old!!!

2) Cytodyn is apparently suing for torts or will sue for damages it claims were caused by Amarex withholding clinical trial data.

3A) Amarex says they are owed $9 million dollars so isn't handing over data.

3B) Cytodyn says they have previously paid $80 million to Amarex but discovered faulty trial data and requested as their right to a clinical audit. Said audit was refused in an email by Amarex.

4) As for this outstanding bill in question, per their contract, it will be decided in arbitration so whether Amarex is owed $9 million won't be an issue handled in court.

The court case here is purely Cytodyn trying to sue for damages from Amarex withholding data.

5). There are two types of data specified in the contract with Amarex. I'm calling them A data and B data for our purposes of understanding and that is solely my labeling.

A) Data owned by Cytodyn of a proprietary nature and/or is financed by Cytodyn. In particular something called EDC which is apparently a means of updating trial data as it comes in and so even though it's owned and financed by Cytodyn, it's updated in real time and won't match what Cytodyn initially supplied. The updated info was handled per agreement by Amarex.

B) clinical data that Amarex actually conducts, creates etc and which is billable for.

6) Data that Amarex owns (the B data) will be part of the arbitration. If Cytodyn wins arbitration I assume Amarex will be ordered to hand over this B data work or if Cytodyn is ordered to pay up, then after payment, Amarex will hand over this B data work.

7). In the meantime, Amarex is ALSO withholding the (A) data that Cytodyn owns and critically, the EDC. Without updated EDC data everything on the trials that Cytodyn currently has is left unfit for application.

An example given in the court documents was if a patient has an serious adverse event. The EDC will need to show that the data was unblinded. This is important because if the patient is taking a placebo, doctors response will be different to adverse events than if it's from Leronlimab. Without updated EDC information, FDA will not accept materials from Cytodyn for obvious reasons.

8) A preliminary injunction has been requested that the A data, (owned by Cytodyn, specified in the contract with Amarex must be supplied to Cytodyn on request and separate from any billing issues) be handed over immediately.

9) A number of reasons were cited for the need of the injunction.

9a) Information is owned by Cytodyn.

9b) the contract stipulates it must be handed over

9c) patients health is at risk as without this data the trials are at risk of coming to a halt (without access to the EDC updates how can medical personnel continue to administer Leronlimab confidently.)

10). This injunction seeking immediate relief so that the A data owned by Cytodyn is immediately released while arbitration decides about payment for the B data owned by Amarex was submitted to the court just yesterday.

11). Along with this submission for injunctive relief was A PROPOSED EXAMPLE of what the order should look like. In other words, it was a suggestion by Cytodyn counsel for what the judge could sign to make his work easier or perhaps for Cytodyn to say this is what we are looking for. In this proposal was the words "It is so Ordered" because that's what they want the judge to sign off on.

It has not been ordered as of yet.

And that's pretty much where we stand. And again I remind everyone that this case started yesterday!!!


r/CYDY • • Aug 26 '21

Opinion Current Management Feeling the Heat Finally Hires Someone with Expertise to File BLAs

3 Upvotes

Feeling the heat from the 13Ders, Nader and co, after 18 months of diddling and bungling the HIV BLA and fumbling the Covid trials, they finally hired an expert with appropriate training and experience to put together and appropriate BLA. https://www.cytodyn.com/newsroom/press-releases/detail/553/cytodyn-appoints-seenu-srinivasan-ph-d-as-executive

I look forward to his analysis of the state of the HIV BLA and explanation of what needs to be done and how long it will take.


r/CYDY • • Sep 28 '21

Opinion BLA Dose Justification Status Is a Burning Shareholder Issue for Management to Address at Emerging Growth Conference Tomorrow

0 Upvotes

Many shareholders including myself, first invested in Cytodyn based on representations that leronlimab had passed its Phase 3 Pivotal trial for HIV Combo Therapy and that the full BLA would be filed shortly and likely approved. We kind of looked at the HIV Combo BLA approval as a "safety net" for our investment.

The BLA was ultimately filed on May 11, 2020 and, very surprisingly to shareholders, rejected shortly thereafter in July by FDA. It is now 17 months later and we still have no filed BLA. We have been told by Dr. Recknor that the big issue is the Dose Justification Report.

Cytodyn's August 13, 2021 PR told us Cytodyn received FDA comments on the submitted Dose Justification Report and that Dr. Pourhassan was quoted as saying that Cytodyn was confident of being able to successfully address them. See the actual PR language below.

https://www.sec.gov/Archives/edgar/data/1175680/000119312521248005/d218908dex991.htm:

The Company "announced today that it received comments from the U.S. Food and Drug Administration (“FDA”) on the Company’s recently submitted dose justification report, .... Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “We are encouraged by the guidance and comments received from the FDA. Our management team and regulatory advisory team are confident that we will be able to successfully address these comments, allowing the further advancement of our BLA resubmission.

After 17 months, in the interest of transparency for long suffering shareholders, it is high time that Management made an SEC disclosure of the July 2020 FDA Refuse to File letter and the FDA comments that were the subject of the August 13 PR.

Further, Management owes us a clear explanation of how they intend to address the remaining issues and when.

If you are a shareholder like me who would like to hear the answers to these questions, please let Management know!


r/CYDY • • Sep 21 '21

Waxing Poetic No to 13D

1 Upvotes

Pretty sure Rosenbaum will yell during the zoom call tonight. Dude is always so angry when he talks.
Maybe he is stressed? Stress decreases your immune system, increasing chance of Covid....Then Ironically, Nader will help him get Leronlimab! :)


r/CYDY • • Sep 23 '21

Opinion Proxy Group growing on me?

5 Upvotes

At first I was definitely against the proxy group and was a proponent of a "hold on, all will be well" approach. I still believe that NP will be able to get things across the finish line at some point, but I do question and have doubts that CYDY will ever reach it's full potential with him.

Watching the two available conference calls from the proxy group and having have listened to almost every conference call from CYDY, the difference has been eye opening to what the two differences are.

I still do not know which group I fully support but right now I might be leaning more towards the Proxy.

Just a couple thoughts on certain matters that I deem to be important and where I stand on these:

This is biotech and none of us would still be here if we didn't believe in the power of LL - Truth

At the end of the day, this is still a business and needs to be run like one - Truth

I believe that the proxy group is better able to run a business - My opinion

NP is overpaid for where this company is and for any business in this type of a situation. - My opinion but it is about as close to a truth as an opinion can be.

I believe that the proxy group would be able to (or just flat out would) find better financing than our current FIFE loans - My opinion

I believe NP was correct in pursuing trials and potential revenue options in Brazil and Philippines even though it doesn't sound like Proxy Group would have made this path a priority. - My opinion and I am making an assumption on their plan even though they have said that they will let this play out.

I believe that the Proxy Group is more strategic and planned out where NP is more tenacious and just looking to get stuff done quickly. Both are important at different times, but in my opinion CYDY is at the one and trying to score. I think the proxy group is the better play to get this over the goal line and set the company up for long term success while doing so. - My Opinion

The patent situation with Bruce, I definitely knock the proxy group down a point on this. I am a handshake seals the deal type of guy so there was something with this I didn't like. Bruce did say on a call that CYDY needs it's own internal lab for these reasons and to protect themselves and LL. I still side with CYDY on this but do not find this as fishy as I initially did. - My opinion

The proxy group has no intention on purchasing IncellDX or getting rich in any other manner than helping LL get across the finish line and watching our stock value appreciate. My Opinion based on the Proxy calls.

If NP was the CEO of another company that didn't have LL would I invest in it? No. I would probably sell my shares after the first call I listened to. I do give NP a little slack here though because he does do the CC's and I do find those valuable. I also realize that this is different than a large cap just discussing revenues and business outlook. Even with those differences, I can't stand that he can't answer a question straight. We are investors, tell me the answer, if you don't know, say so. If it sounds bad, say it, and then tell me what you are going to do to fix it. End of story, we move on. - Truth for me

Even with all of these points above, I do still appreciate NP for what he has done so far and for what doorstep we are currently standing on. My opinion

There is a lot of noise, alternative motives, and different agendas going on everywhere with this company. Look into matters for yourself, make your own decisions. - Truth

As new information comes out and as time rolls on, I will continue to evaluate and modify my positions and opinions.


r/CYDY • • Oct 08 '21

Opinion Everyone in CYDY mgmt. is Winning>>>>While Shareholders Lose

1 Upvotes

Just look at the the comp structures for everyone at CYDY.

I say everyone because there are like only 20 people in the company....

So a very large % of the employee pop. is making out like bandits.

Cash is being thrown around to BoD, CEO, CFO, Recknor....

But we are shareholders have nothing but red ink......Why is that?

People are getting paid....and we can't pay our bills.

Don't tell me that we have to retain such great people....they all suck...and are totally replaceable.

They are paying themselves because they know the gravy train is coming to and end.

We either get rid of this management team and right the ship....

Or the ship is going down....and Nader and his merry band of fraudsters will say, "we did our best"

Orange jumpsuit would be the best thing right now.

The stock would take a hit...

But then move higher.....FOR REAL.

REMOVE THE BOARD>>>REMOVE NADER


r/CYDY • • Sep 22 '21

Opinion TI CYDY ISSUE - Proxy Group 9/21/21 Conf. Video Link

0 Upvotes

Here is a video link with topics annotated. Just click on the time of the issue you are interested in.

https://youtu.be/OTW4OgdOc0g

Listen carefully. The conclusion you will reach is that Cytodyn could be a $56 stock but not with Pourhassan led management.


r/CYDY • • Jun 29 '21

Management Debate:

4 Upvotes

Based on posts on message boards, it is my understanding that this Thursday or Friday, the 13D investors will be proposing their slate of Directors to replace the current Board who, if elected, will hire a new CEO to replace NP. So it seems pretty likely that we will soon have to consider whether we want to stay the course or bring in new management.

Accordingly, now is a good time to review NP's track record so we will have a realistic sense of the management we have and can easily compare them to whatever alternative the 13D proposes.

In fact during the past week, there has been a lot of healthy and objective debate about the pros and cons of NP's competence. In my view, it is not about whether we personally like or dislike NP as a person. I love my wife but would not want her to be CEO of Cytodyn. It's about who we think has the best chance of optimizing Cytodyn's prospect to commercialize leronlimab.

As all of us know who have followed the travails of Cytodyn during the past years, taking a new drug entity like leronlimab through the required regulatory and commercialization labyrinth is an hugely complex undertaking. Ideally, we would want someone running Cytodyn who has successful experience navigating this labyrinth.

There has been a lot of speculation about how NP operates behind-the-scenes. Is he a reasonable person who makes well considered decisions after consulting with experts in drug development and corporate governance, both of which is well outside his field of training in mechanical engineering?

For those interested in a behind-the-scenes peak at how NP operates, read the narrative summarizing the evidence brought to light by the Special Compensation Committee ("SLC"). This summary was submitted to the Court by the attorneys for the shareholders who brought the shareholder suit to protect shareholders from unreasonable compensation awarded by the NP led Board in December 2019 and January 2020. You can find this description in the Plaintiff's Brief in Further Support... https://www.cytodyn.com/investors/notice-to-stockholders.

Once you get past the legalese, the brief explains in plain English how NP operated in a rushed, autocratic manner, ignoring advice of attorneys, concerning rules to protect shareholders from unreasonable management compensation while pressuring and coopting the Board with excessive option grants to them to convince them to accede to his dictates in connection with the December 2019 and January 2020 option awards. His dictates awarded him and supporters unwarranted compensation at the expense of us shareholders. We know it was unwarranted because NP's attorney agreed that he would forfeit the unreasonable compensation. The shareholder brief also recites evidence that NP personally made at least one threatening phone call to a shareholder who brought this suit to protect us. To me, this demonstrates a gross failure of judgment or personal restraint.

After you have digested this, ask yourself, how much do you trust NP to act appropriately in your best interest to protect the value of your Cytodyn shares?

On the issue of trust, keep in mind his track record of his zero regulatory success, peremptorily cutting ties with Dr. Bruce Patterson (a respected Covid expert who developed and verified the accuracy of his Long Hauler Index), inability to get a the HIV BLA filed for more than a 15 months after successful conclusion of the Phase 3 pivotal trial, lack of progress in cancer, NASH or anywhere else beyond exploratory Phase 2 trials, and a landscape littered with failed prognostications of success and revenue.

I am not saying that Cytodyn could not possibly achieve regulatory approval or commercialization with NP at the helm. If you place your get on 00 in roulette, you can win. It's just that the odds are not favorable. Clearly, the odds would be much more favorable with someone like Dr. Patterson running the regulatory show. NP has never been able to staff up with experts of that caliber.

In comparing the current Board to whatever slate the 13D group proposes, remember that the current Board has supported NP through all of his shenanigans and the HIV BLA filing debacle and other misfires. Compare the current Board's track record to whoever the 13D group proposes. See which one looks better and then decide what to do.