Signs

Yeah, here we are. Coming around towards the end of the year and hoping we can finish it blasting off over the 52 week high.

Looking here, looking there for the answer to the question of what lies ahead. About a year ago, we were given the sign, in the multi-indication 12/7/22 R & D Update. Here is the Oncology Counterpart of that presentation. We had a lot of hope following that, thinking we would be getting more into the development of the molecule with the three indications discussed, but we knew that we first needed to get the hold lifted and that was always the priority. In general, the Update headed us in the right direction and the company remains pointed in that same direction a year later.

CytoDyn was detoured off that important projected development path, held in captivity since March of 2022. During the year of 2023, CytoDyn was forced to plow its way back towards "acceptance" through the thick weeds of governmental red tape and myriads of data, solely and only for the right to pursue its main hope, ambition and mission, which is only to develop this safe and effective, life saving molecule. Unbelievable, absolutely unbelievable. No other words suffice.

YET, one has no need to look very far to find those who agree with what has happened to this company and to this molecule. In fact, they are everywhere, creepy and crawly. These waffles sound off, loving to hear themselves twat away, and are in complete agreement with what has happened at CytoDyn and these individuals have nothing but disdain and despair for the company and find pure unadulterated enjoyment in its mockery. Their expectation here is, simply put, for failure. Their pleasure is found in jesting, making the company the butt of their jokes. Banter is what they feed on. So exciting and absolutely titillating.

Their excitement is about to end however. That day shall be a mark in time. The stage is set you know, with a new but, not so new CEO at the helm at CytoDyn. You know, it is very possible that the FDA has not yet informed CytoDyn of their result. Dr. Jay Lalezari said, "2 weeks" in the Investor Meeting; however, I may have gotten the date of the meeting wrong. (Unless someone can tell me the exact date of the meeting, please do so in the comments.) I know I put in the title of that post that it was held on November 21, 2023, but instead of it being the Tuesday before Thanksgiving, now, I'm hearing that it was the Tuesday after Thanksgiving making the date 11/28/23 and if that is the case, then the 2 week deadline would be 12/12/23 without any holidays included. u/Beldar2 and a good many others believe that the FDA hasn't yet resulted. Even if it was held on 11/21/23, if you add say 1 or 2 holidays, Thanksgiving and the day after, then two weeks would be early into the coming week. Beldar2 makes the argument that as a result of the Investor Meeting being leaked, CytoDyn was forced to quickly and hastily draw up and poorly write the latest 12/7/23 Press Release as to meet SEC requirement that all be on the same playing field.

This means that had the meeting not been leaked, there may not have been a PR issued and the whole company of shareholders would all still be anticipating the company notification of the hold being lifted by the FDA. I'm here to tell you that this might still be the case. There was a post on December 1, which I can't find anymore, that gave a link to the Investor Meeting. A few hours after that post, access to the meeting was denied. Luckily, someone recorded it. If the meeting was on 11/21, why would they wait 10 days to post on 12/1? So, it makes sense that the meeting was closer to the post date of 12/1. Therefore, possibly it was held on 11/28/23. Certainly it was before December 1. So then, the 2 week point from the Investor Meeting would be just around now or even into Tuesday or Wednesday of next week. If CytoDyn receives notification of an FDA result early into the coming week, then that result would be edited into the planned webcast on Thursday 12/14/23. If CytoDyn does not receive notification of the FDA result, then the webcast might only be a repeat of the Investor Meeting executed solely to satisfy the SEC regulations that all shareholders be informed with an equal deck. If so, then, the PR this coming Thursday might just be a copy of the Investor Meeting, In the words of u/Beldar2, this may be an "old news is new news conference call", but this is kind of vague because it could have been written new news is old news and still mean the same exact thing. Listen, once this hold lifts, with Dr. Jay Lalezari at the helm, old or new, however you see it, all of us shall be sitting at the beginning of a new era with CytoDyn.

Look at how the share price ran this past week. It more than doubled, and came damn close to tripling from the 52 week low. Then, after the big run, the poorly written PR was issued and it fell again. The poorly written PR gave the impression that the FDA had resulted negatively. As a result of that PR, the share price fell from its recent high by about 40%, but it landed higher than where it started from. By an account I trust, it was all staged, but it didn't make any sense and I don't try to make sense of share price, so I look to others that do look and who do have an interest. If in fact, this was truly set up and staged by shorts, they have ended up at a loss. If it was staged by longs, then the author of the PR was not up to his game as the share price took a 40% hair cut unnecessarily and with a rephrasing, could have maintained share price.

Longs need to remain long. Traders, if you're thinking the FDA has not yet resulted, then it makes a lot of sense to buy bigtime before the FDA results to CytoDyn as that news might leak. You have seen first hand how quickly this can move upward with good news. I don't suspect any horrible or very bad news forthcoming at all. I think we have been through the brunt of all that already and have been at 52 week lows just waiting for the result. We can expect anything from neutral news, good news and/or great news. So, I wouldn't be short, but that's just me. I would be very careful if I were a short and would try my damnedest to get out, but, as you know, I'm long, so I'm just holding, but if I were a trader, I'd be buying early in the week, and if the FDA results in the coming week, it will be disclosed as such in the 12/14/23 webcast.

Maybe the PR did exactly what was expected, and that the FDA has hypothetically resulted negatively and the PR thereby resulted in the appropriate hair cut to the share price. If so, then the Investor Meeting had no impact on the issuance of the PR and this was a poor delivery of the negative result that the FDA hypothetically resulted. In my opinion, the way that was executed would be improper as it should have stated explicitly that the FDA had spoken and their result was negative and it should have spelled out exactly the reasons they had and their verbiage given.

It is a matter of interpretation. I'm a student in this like many of you. Like others here, I study this. This is how I would interpret it, but in the end, it is all my opinion and educated guessing. As a result of the study I do, I warn the shorts, just like I warned them a week or two ago. You see the short barrage that u/MathClass dolls out, it doesn't make one iota of difference to me. I don't care what he/she thinks, worthless banter. Lie after lie after lie. He/she takes the word for word transcript and re-writes the entire truth document to be chock full of his/her own made up lies. That's what it specializes in, lying. I'm going with what Lalezari, Migliarese and Blok say, and not the twisted opinions of u/MathClass. Such a loser.

Lalezari was smart, he never owned shares. Yeah, in hind sight, that was a smart move. That's a sign of what to do if you're on the outside. Now he is here with us on the inside. Now, he is here working with us, for us, for free and surely shall earn his shares. He shall earn his keep. If we all followed his lead, we would have been better off today with more to invest now at these rock bottom prices. We could have had 10-20x as many shares as we have today had we not owned until now. They would have been gifts dolled out to the many, even to those who don't even know how to spell leronlimab. Even to those who don't have a clue what a monoclonal antibody is. Even to those who don't know what "immune activation" really means. And Dr. Jay's shares shall come, at the cost to him per share of what he is being paid today, which is minimum wage. That is minimum cost of $0.01 per share deservedly so if his contribution comes to fruition.

Lalezari brings with him all of his vast, first hand experience of over the past 15 years with the molecule. He brings with him, all of his first hand knowledge on what leronlimab can and can not do. We are now just learning from him and don't even possess what he owns in just the tip of his finger. We will though, because he will teach us and bring us the information on what leronlimab can do and what it can not do. Right now, first and foremost, his focus is on getting the hold lifted. Then it will be to get the proposed trial underway. And through it all, he will let us know what is important along the way.

Once the hold lifts, he will give us his plan in more detail. u/LeClosetRedditor gives a nice, clean and concise plan, which I agree with. "Great plan laid out by Dr. Jay. Target immune activation in HIV patients with a small, inexpensive study, run pre-clinicals in cancer and NASH to attract a partner and wait for the long acting leronlimab to be developed. " I feel it is important to compare Dr. Jay Lalezari's plan to the original 12/7/22 R & D Update, this way we can know that everything is Kosher. That everything lines up as things are massaged into place so they can fit. Yes, Lalezari is the new CytoDyn CEO, but he has been around CytoDyn longer than anybody else, and so he knows what doesn't work and where its potential lies.

Yeah, as a result of the discussions with the FDA, the primary endpoint for HIV has been changed, but the indication remains HIV, however, it won't matter anymore if the viral load blips up, as long as instances of Pneumocystis Jerovicci Pneumonia and Kaposi Sarcoma are kept at bay. You see, the secondary endpoints of the comorbidities of long term ART shall be kept away with this new indication of "Immune Activation". As long as the comorbidities of long term ART remain suppressed, controlled and stagnant, then the "new" Primary Endpoints shall be met as the appropriate biomarkers do paint the picture of "Immune Activation Enabled". Certainly, CD4 count shall remain elevated above 200 even if blips do occur. But blips don't matter anymore in this new HIV trial protocol where secondary end point is to keep Comorbidities down by controlling the primary endpoint biomarkers to paint an Immune Activated Enabled picture.

Viral load shall be controlled by an Anti-Viral, exactly which one is not known right now. Leronlimab won't be responsible for that, (Gilead maybe?). The Anti-Viral shall be responsible for the HIV Viral Load primary endpoint while Leronlimab hits secondary endpoint by keeping the Comorbidities away and at bay as the patient is kept healthy. The Primary endpoint is met by viewing the painted biomarker picture which scream, "Immune System Activated and Enabled" and those biomarkers will be our Primary Endpoints, and the comorbidities our Secondary Endpoints.

Soon, Dr. Jay Lalezari shall be telling us about this trial. How it works and what it measures, etc. Then, he tells us about NASH, about Cancer. He tells us about the 3rd party partner and the AI partner. He tells us about who has become our new manufacturer. He speaks about our prior trials, our prior results and what the data actually has shown and who on Earth actually is interested in that data. These are the pertinent topics of conversation and we need to be having these conversations. But that time is coming. Those three indications were in the initial R & D Update, HIV, Oncology and MASH and so, far, they remain the same with some re-shaping. Yet, there have been many obstacles which have interfered with CytoDyn from closely approaching its goals in those indications due to the ongoing dilemma, but they still have. Despite the massive obstacle of the imposed hold, CytoDyn has contrived and developed a new protocol in HIV, a new protocol in MASH and is working towards partnerships in Oncology. It has also engaged in 2 Partnerships, most likely with ABSCI in AI and with who I'm considering is VIR who I also believe is CytoDyn's manufacturer. But, as always, I'm forced to speculate and make conjecture because much of this is under NDA and there has been no official release or notice of any of this. Why NDA? Because the hold hasn't yet lifted. So, in March of 2024, it will have been a rough 2 years since the hold has been implemented, but things are happening behind the scenes and I think it is about to be over soon and CytoDyn shall make it through to live and to never fight this battle again as it has learned its lesson big time. No matter who you are, this has been a rough road traveled to say the least, but if you've been here and are still here, long and strong, now, things should take a turn and go on the up and up.

With a lift of the hold, essentially, the hand cuffs shall be removed from CytoDyn's wrists. Essentially, the FDA gives CytoDyn the go ahead to proceed on the new HIV Immune Activation Clinical Trial and the rest of what CytoDyn needs to accomplish. Therefore, Hold Lift = Freedom. Now, the FDA never would lift the hold without a Forward Plan which defines how CytoDyn shall proceed once the Hold is lifted. So this Plan is in Place. The answer from the FDA needs to be concise, clear, definitive. So come on FDA, what is your result?

It seemed to me as if you were pleased and satisfied with Dr. Jay Lalezari's clinical trial protocol for the new HIV subpopulation. If you were pleased, did you also find the new HIV clinical trial protocol satisfactory and capable of producing a favorable result that would be successful in gaining approval for our drug? What about the 5 submissions CytoDyn made to you over the course of the previous year? Are they also acceptable? What about the Investor's Brochure, was that acceptable all submitted on Cyrus' watch? What about the audited and aggregated data? Does everything look satisfactory, aligned and ready to go? Surely you have been made aware of the AI Partnership CytoDyn has? Are you in agreement? Are you aware of this possible partnership signed in March, 2023? Will you allow CytoDyn to actually deliver her baby, or does she still need to writhe and suffer the agony of continued labor pain? Are you of the opinion that she is ready? That the baby is ready? To me, Everything is pointing to her popping. Just look at her, she is ready to pop. Her water already broke and it is everywhere. We are speaking Plain English and it is crystal clear.

Is this too hard for you to do? Do you need someone else to execute it for you? We are waiting and what ever you decide, we must go with it. We are at your beck and call, subordinate to you and must accept your decision. We shall move forward regardless of what and how you decide. Straight ahead, we fix our gaze and we don't look back like Lot's wife once did. We won't turn around nor look back. We know there is nothing for us back there and behind us. Everything is straight ahead of us and that is where we fix our gaze. We stand. We raise our heads. The hold soon lifts and the future is beckoning us to enter, doing exactly that which the company has purposed for. Shorts, you should go Long.

Blessings to all of you folks.

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