Read all of this to the end
My Case For Why 2023 Is Going To Be A Positive Milestone Year
6/30/22 Conference Call Tanya Urbach at about 8:30:
"So, it is my true pleasure to announce that Dr. Cyrus Arman, PHD has been named President of CytoDyn. Dr. Arman is anticipated to advance to Chief Executive Officer and to join the companies Board of Directors within 6 months*. During his initial term as president, Dr. Arman will devote substantial focus to the immediate operational needs of the company, and to further the developing and refining the companies strategic plans.*
Antonio Migliarese, who has served as interim president as well as CFO since late January, will continue to serve as Chief Financial Officer. Dr. Arman employment with CytoDyn will begin July 9, 2022*. Dr. Arman is reputed to be an exceptional 1st principle thinker, able to work to both scientific and commercial considerations to* evaluate probabilities of success in sizing the market to develop different criteria's for forced ranking opportunities. Throughout his career, he has repeatedly led wargame events, where clients had to role play as their own competitors in an effort to understand how their decisions fit in the larger context of their market*. He is known to be a quick learner, to be analytical and methodical in thought processes,* a tireless worker and to have an incomparable sense of duty*. The board could not be more excited about Dr. Arman's incoming leadership and he has our unanimous full support.*"
Certainly, Cyrus' appointment to President of CytoDyn was very disconcerting and upsetting to Amarex, to Kazem and to all those in cahoots with him, who were and are poised against CytoDyn and against Leronlimab. How much more upsetting will be his inauguration as CEO. Tomorrow, January 9, 2023 will be 6 months on the job.
In the 9/28/22 Conference Call, Cyrus Arman started off on the right foot, he was letting all listening, that he wasn't ignoring this blatant attack and he was describing CytoDyn's costs:
"It is important to note, that substantially all of the data requested by the FDA that lifts the clinical hold, are items that Amarex was contracted by CytoDyn to prepare, but failed to do so*. As a result, CytoDyn has* taken on all of these responsibilities internally over the last 6 months*. Along these lines, we have also recently* completed the warning letter close out process with the office of prescription drug promotion, and we look forward to continue to improve our relationship with the FDA at all levels.
13:05: Turning now to the BLA for HIV, During the course of last few months, we have had the chance to get a much clearer look at the state of the clinical data collected by Amarex*. This showed us to perform an* internal feasibility assessment, on the clinical portion of the BLA*, With a key question of* understanding, if the data would withstand, what is commonly referred to as a good clinical practice, or a GCP audit*, which is precisely what we would expect the FDA to perform during the BLA review Process. And as a result of our internal assessment, we decided* to perform external audit of that same data and we expect to receive those results of that audit in near term. And those results will inform our next steps with the BLA. I want to make clear, that this audit is not a question of the performance of Leronlimab in clinical trials. Rather, it is an assessment of the quality of the data collection and monitoring performed by Amarex. And We are performing this purely To assess the probability that if the BLA submission had been completed, that it would pass an FDA type GCP audit."
Certainly, Amarex can not be pleased with any of this. Had Nader been in charge, it is very doubtful, CytoDyn would even be in business at this point, especially with this hold in place. Cyrus handled this situation brilliantly. When Cyrus came into power, it was an emergence of control. All of us who witnessed it, saw an out of control, violent disaster, being tamed, being controlled and handled with finesse. The company was wildly out of control, but he wrapped his arms around it and grabbed hold of the situation and then found a means to attack the instigator.
From the 10/31/22 Webcast, Cyrus summarizes:
"3:38: Due to our concerns with the CRO, we commissioned 3 independent audits of the clinical data, in addition to our own internal feasibility assessment of the same data*. Each of these audits, including the investigation of the CRO's performance and Data Management, Monitoring and Quality. We found that these multiple audits, we have concluded that, a* BLA faces a severe risk of receiving a complete (negative) response letter from the FDA*, which means* non approval*.*
4:05: Now, with that being said, we are confident that the primary findings of the study are sound. Since these assessments did not find any serious integrity issues at the level of the clinical trial sites, and due to the CRO's inadequate process and performance around the Monitoring and Oversight of the Data*, there are* significant challenges to meeting the high bar of passing an FDA GCP Audit*.*
4:27: In light of these factors, and the substantial costs associated with remediating the data*, or in* conducting entirely new trials in this population, we decided to voluntarily withdraw the BLA for the HIV MDR population*. We notified the FDA of this decision on October 25, 2022. Given the* considerable financial resources that the company has put into the clinical development program for this indication*, we did not make this decision lightly.*
4:54: It was only after an extensive review of the assessment by the External Auditors, our own Internal Assessment, Expertise from our Board and Advice from our Regulatory Consultants, that we came to this decision.
5:06: Now, we realize that this may be disappointing to some, however, it is critical to note that, this decision does not under cut the drugs performance in clinical trials, as the audit results do not change the fact that the Primary Endpoint was met*. By the time we* publish those positive results in the Peer Reviewed Journal soon*, we believe it will* help others in the medical and clinical communities further understand the enormous potential of Leronlimab."
Cyrus has outlined CytoDyn's costs beyond what CytoDyn paid to Amarex. Another cost he did not mention, would be the loss in market capitalization. When the RTF, Refusal To File was issued by the FDA on the BLA for HIV MDR, CytoDyn's market capitalization was nearly $1 billion and about half the number of shares. Today, the market cap is only about $200 million and nearly double the quantity of shares it had then. That equates to more than $800 million in CytoDyn loss. How much of a loss was the BLA for HIV MDR?
With Cyrus' leadership, what have we gained? We have gained the validity of the data despite Amarex's sabotage to attempt to destroy CytoDyn's data by not entering it in the manner which the FDA accepts it. The Good and Acceptable data which Cyrus fought and paid for via the aggregation of the raw data by Four different External FDA Type Good Clinical Practice Auditors presented in the format acceptable to the FDA shows that Leronlimab is both safe and effective. In the appropriate time allotted, within 1 year of arbitration beginning, Cyrus submitted the Investigator's Brochure, the ISS, Integrated Summaries of Safety and ISE, Integrated Summaries of Effectiveness. This then enabled Sidley Austin to file an amendment to the complaint. In late September 2022, SA submitted this amendment page to the complaint against Amarex:
https://preview.redd.it/afy4t4rwjj6a1.png?wid...cd36d5d06b
CytoDyn files to Recover material injuries which CytoDyn has suffered and continue to suffer as a result of Amarex's breach of the Amarex agreements.
CytoDyn files that A determination be made that Amarex has breached its contractual obligations under the MSA, Project Work Orders and Monitoring Plans.
CytoDyn files to Receive an award of Damages caused by Amarex's breach of the Amarex Agreements in ANY amount that WILL BE PROVEN DURING THE ARBITRAL HEARING.
CytoDyn files to Receive an award of ALL COSTS, ATTORNEY FEES, and EXPENSES in connection with this arbitration including fees to the arbitrator.
Cyrus has known from day 1 that CytoDyn is at war and he has assembled his militia as well as his strategy. Successfully, he upturned the board of directors into a board which had internal components to a board which is now 100% independent. He left in place some of those who were already independent but removed all internal directors. He in fact has completely removed Scott Kelly now leaving the company without a chief medical officer. He has brought in Stephen Simes and Ryan Dunlap. Regarding the Scientific Advisory Board of Experts, it has been profoundly expanded now boasting 10 Experts: Mazen Noureddin, NASH; Jordan Lake, HIV; Hope Rugo, Breast Cancer; Stefan Gluck, Oncology; Naoto Ueno, Oncology; Kabir Mody, Oncology; Eric Mininberg, Oncology; Jonah Sacha, HIV; Otto Yang, Infectious Disease and Jacob Lalezari all around expert.
Cyrus states in the 12/29/22 Webcast:
"8:08: This is also a good time for us to highlight the fact that we're essentially an entirely new management team at this point. Both at the executive management level, as well as at the board level. The board and the management are fully committed to a culture of compliance from the top down and we're entirely committed to our mission which includes providing economic returns for our investors."
After 5 months of working through all the headaches handed him, Cyrus and his team were able to present the Investor's Deck on 12/7/22 where shareholders were able to see Dr. Mazen Noureddin, Dr. Stephan Gluck and Dr. Jonah Sacha in their presentations on NASH, Oncology and HIV. More than likely, this presentation took time to prepare, and yet, Cyrus felt assured enough in the preparation of this Deck, weeks or months prior, to claim the following:
"1:31:15: So in terms of how we want to get there. So with NASH, we intend to raise capital and execute trials. With oncology, we do see opportunities with co-development partnership. And within the development of longer-acting agents, we intend to invest in the future there and continue to try to advance these approaches. "
r/LeronLimab_Times - My Case For Why 2023 Is Going To Be A Positive Milestone Year
Slide 98
"1:31: 40: So in terms of what potential time lines can look like, I think it's really important to highlight that from a value-creation standpoint, and I've mentioned this before, we truly do need to generate a large robust and what I call unequivocal data set that will leave no questions left on the table, right? that a strategic partner would find attractive and attractive enough to do a real value-accretive deal with the company*.*
1:32:14: And so we've gone through and knocked out what the potential time lines are across each of the different areas that we presented on today. And we're -- as I mentioned before, NASH & Oncology are our priorities. However, because this is all going to be funding dependent, we're going to focus on NASH initially and work with co-development partners to the extent that we can to develop in oncology. "
r/LeronLimab_Times - My Case For Why 2023 Is Going To Be A Positive Milestone Year
Slide 99
"1:32: 44: So what do we expect in 2023? So our largest priority is the removal of the clinical hold in HIV. This is essentially a gating step for us to be able to get back to normal operations as a company and do what biotech companies do, which is advanced therapeutics and try to bring them to market.
1:33:10: Following the lift of the clinical hold, we expect financing to fund operations and to achieve this value inflection point that I've just alluded to. We intend on initiating a new NASH trial. We would like to commit to an investment in and advance longer-acting CCR5 molecules, as this is potentially the future of at least certainly HIV therapy, as Dr. Sacha presented*.*
1:33:35: We continue to contribute in medical meetings and peer-reviewed publications. Again, the CD02 trial data is in process for that right now*. We're going to continue to reshape our team and our capabilities in order to meet our goals. And at some point following the achievement of earlier metrics listed on the slide,* we're starting a corporate rebranding as well*.*"
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So, with all of that said, we can see that Cyrus was not sitting on his ass when he took the helm at CytoDyn back in July, 2022. He clearly has demonstrated his strategy, he has already re-assembled his team; he has eliminated players he did not see fitting, and he has made it possible to seek damages in excess of CytoDyn's costs from the arbitrage. His team remains focused on submission of the last 2 documents that the FDA has requested as he states here in the 12/29/22 Webcast:
"9:25: We expect next year, 2023 to be catalyst driven in terms of growth and development for the company and we think that the table is set for a large number of significant developments to occur in early '23, including the submission of our complete response to the partial clinical hold for HIV, new additions to the leadership team, a corporate rebranding, and then following those events, we plan on initiating a NASH trial as well as continuing the advancement of the long acting CCR 5 molecule."
I think Cyrus Arman has spelled out EVERYTHING shareholder can expect in 2023 in this last statement.
Submission of the Complete Response to the Partial Clinical Hold for HIV
New additions to the leadership team
Corporate Rebranding
NASH Trial Initiation
Advancement of long acting Leronlimab.
Let's take these one by one.
Submission of the Complete Response to the Partial Clinical Hold for HIV has to be near if not already submitted in its entirety. CytoDyn does not need to tell shareholders that these remaining 2 documents have been submitted. Cyrus may just decide to say one day or press release the day that the FDA has lifted the hold.
New additions to the leadership team. Both Chris Recknor and Scott Kelly have been recently removed. Cyrus is likely seeking their replacements and he is saying that there will be new additions to the leadership team.
Corporate Rebranding. In the past couple of days, we have seen the word Livimmune on the website, as if it is the name of a subsidiary of CytoDyn which will handle only the long acting form of Leronlimab and maybe the HIV Cure. But, just as soon as that name was on the website, it was just as quickly removed from the website as if the website designer was not told by CytoDyn to keep from releasing that update. Then CytoDyn finds out that it is there because of the message boards and orders the designer to take it down and replace it with the original.
Could that name be a part of CytoDyn's/Leronlimab's rebranding? Probably. Certainly, Cyrus states above that he wants to invest in the advancement of the long acting Leronlimab molecule.
NASH Trial Initiation. At the time of the writing of the Investor's Deck, Cyrus was very confident to include a NASH trial in the 3rd quarter of 2023 because he was and is still sure that CytoDyn will have the cash necessary to fund that trial. How was he so confident? Why does he remain so confident? As he states at 1:33:10, Following the lift of the clinical hold, we expect financing to fund operations.
Advancement of Long Acting Leronlimab and I think we have seen evidence of that in the short term release of the name Livimmune. Livimmune being a subsidiary which CytoDyn would own in part which would run the development and advancement of the long acting HIV and HIV cure. But wouldn't that subsidiary need to pay CytoDyn to have rights to manage Leronlimab for HIV? Say $100 million, but down the road, they take 75% of profits of long acting/HIV Cure while paying CytoDyn 25% royalties? Something like that? But we haven't heard of any company paying CytoDyn for that right, so could it be delayed? Could it be pending? NDA.
So what is left? What did Cyrus not discuss? Amarex is not mentioned, yet it should decisively close quickly in the first quarter of 2023. Amarex attempted to squash CytoDyn with their shady attempt of sabotage, by botching the collection of CytoDyn's data and improperly recording that data while purposefully filling out fields incorrectly or leaving those fields blank. And when CytoDyn confronted Amarex for that data, Amarex refused to yield it to the rightful owner, CytoDyn. Amarex, led by their CEO Kazem, was crafty, doing all their dirtywork in secret and they kept their forgery as a clandestine as long as they could. Amarex's intention was to cut CytoDyn off from being a pharmaceutical and to cut off Leronlimab from being an approved drug for HIV MDR indication. That is because, once it would be approved for this indication and once patients were to see how easy it is to administer, and how infrequent and with so few side effects, it could be prescribed off label for nearly anything else. So of course, Amarex was promised some very good future prospects if they would only botch this trial against CytoDyn. If they would just ruin this BLA so that it would not be acceptable to the FDA. And that is what they did. This professional CRO forgot who they were and recorded the data for this trial as if they were kindergarteners. Their CEO Kaz, being bought and paid for.
Cyrus has taken up the fight as if he had been violated personally. He has worked along side Sidley Austin. Kazem has also been indicted by SEC and DOJ. I hope Kazem and those who made him grand promises get their due justice. I feel SA has what they need to get 'er done to our satisfaction. I feel that Cyrus did as much as could be done to get it right with the FDA that the hold be lifted. I feel that Cyrus did as much as could be done to be granted the right for damages in excess of CytoDyn's costs.
Certainly, even an award of CytoDyn's costs would help out our company greatly. If CytoDyn were to receive an award of only $100 million, the $55 million Fife loan would be paid for. The $30 million we owe Samsung would get paid and we would still have money to initiate the NASH trial. Remember, without debt, bankruptcy is off the table. Without risk of bankruptcy, institutional investors are less wary and they see the opportunity.
Cyrus speaks confidently that he EXPECTS funding. However, $100 million is far below what Amarex owes and Amarex knows this. NSF knows this. CytoDyn knows this. Sidley Austin knows this and the Arbitrator knows this. Will they settle or will it go to the Arbitrator? Because of everything I talked about here, and the moves Cyrus has made since he became president, and because of what he is expecting for the coming year, I believe that this arbitration settles for no less than $300 million, with $200 million going to CytoDyn and $100 million to Sidley Austin for an awesome job. The outcome of this award shall have many purposes. But, I do expect an award in damages in excess of CytoDyn's costs.
With the lifting of the clinical hold, the FDA will be saying that Leronlimab is safe. With the Peer Reviewed Journal Article that is coming out, it will be saying that Leronlimab is effective. CytoDyn no longer has Safety or Effectiveness as an OBSTACLE. Those obstacles are gone completely very soon. The 5 things I listed above which Cyrus tells shareholders to expect in 2023 all come true. Submission of the last 2 remaining documents. New talent to augment his already outstanding board of experts. Corporate Rebranding begins and signs have leaked that it has already begun. NASH trial initiates and the advancement of long acting Leronlimab is proactively pursued. With each of these bullet points, the stock rises. Lifting of the hold by itself will do wonders to share price and then it continues rising as all of these other points start to hit. These other points become the traction which will hold the share price at its new found level and keep it from falling down lower. If the arbitration settlement/award pays what I'm expecting, then CytoDyn pays off its debts and institutional investors, without the fear of bankruptcy, plow in.
Where is all this taking us? Where is all this leading us to in understanding? To realize how close we are to something happening within CytoDyn? Weeks? Months? I think Weeks for #1. Months for #'s 2-5.
I hope that the accumulation of events which have transpired since Cyrus Arman has become President of CytoDyn 6 months ago, until now, when he will be inaugurated as CEO, are beginning to help shareholders understand how important it is to remain strong in your conviction and not to cave, but to remain patient, because before too long, the wait will become worth it. To those who are shorting, good luck. But instead of covering and getting the hell out at $0.25, you still remain a short, well, you will regret that you did not cover down here. At $0.25, you can own the most versatile and effective monoclonal antibody which blocks cellular communication which results in reduced inflammation, and the loss of tumor progression and the inhibition of HIV from entering cells. It is almost like a free gift at these prices, but that gift won't be around for too much longer.
In Cyrus, CytoDyn has, as soon to be CEO, a very strong and influential powerhouse that has effectively and will effectively bring about the appropriate changes within CytoDyn that bring about the eventual approval of this monoclonal antibody CCR5 blockade.
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