Welcome here folks. It becomes a little too obvious to me on what is going to happen. It is not if, it is when. Let's reveal the thinking on why I say this. It all goes back to the Mystery on the 2022, mid-summer daydream run up. We are living in strange times. You don't need me to tell you that. From the surface of it, it appears as if we are going to hell in a handbasket, it is almost as if we are about to fall off a cliff, however, that hasn't happened, at least not yet. I get it, though at times, it may seem that I don't. The things we have experienced holding this stock are not normal, but neither are the times.
In the long term, Leronlimab shall become the CCR5 blockade of choice, the Gold Standard. That shall happen. It will be written into the medical journals and text books as the monoclonal antibody which cured humanity of HIV and shall become the standard of care in NASH and metastatic malignant tumors. Many of us here already know that this shall happen. So, I wanted to know more about Leronlimab and to explore LL, you need to know CytoDyn and this page was born.
Both myself and a buddy of mine who you also may know, u/psasoffice come together on occasion to lay down the dirt on what it is. Today then becomes another instance of yesterday's conversation. I say this to say that in much of what follows, I am the messenger. The bike messenger who picks up the package, reads it while I peddle along, and then deliver it to you soon after the discussion. And let me tell you, u/psasoffice puts together the pieces, a puzzle master where no plot or twist is beyond his x-ray vision. As a matter of fact, He has been behind much of what I've written for over the past 6 months now; it might have been since October or even September of last year, when he sent me something which peaked my interest indicating that he liked what I was putting down, and then it just kept expounding. You can see what I've written here , but somewhere around this post , that I began talking with u/psasoffice and many of the articles has his influence.
There were many indications or hopes set that hold will lift by a certain date. That didn't happen. It has been my notion, (not necessarily u/psasoffice's notion, but it may be), that when we see that Peace and Safety become of concern, then it shall be then when the hold lifts. Well, next week, America may default on its debt so then, the markets could quiver. That could lead to unrest. What I've said is that when there is rampant havoc & distress all around us, and the masses screaming for some Peace and Safety, so it is then when things begin for CytoDyn. I said it before, that when this time arrives, we best remain still, stalwart, confident and quiet. We have seen the signs of where we are headed, and know, we are there. We have taken the exit off the highway and are nearing our destination. Therefore, when the strong winds blow, take a strong, solid and stout stance and know, that this moment was just one of the reasons why you bought your shares. This Initiating Juncture and the events which follow the triggering event of lifting the hold are not that far off, but rather, they are right around the corner. Actually, we have reached the destination, so get out of your car, take a breather and stretch. Shut your engines off. We are there. We did it. We've reached that point. Patience is a virtue. I sincerely appreciate all of you on this difficult journey together.
We have been living the same day again and again, like its Ground Hog Day over and over. All of us have been under the impression that all has been done. That all has been submitted. We understand that no more than 30 days should pass from the day the last submittal was sent before a Result is issued. However, we have the same lack of result day after day. Such a grueling process, what does all of this mean? It means that we have gone through the required process for so long and have paid a huge price, but despite becoming emaciated and haggard, we have finally arrived. Our heads were held under water by forceful hands for so long, fighting against our wills to survive, finding ourselves running out of air, finally, we break free from the strong grip and take that breath. Those still here after so long shall find the answer they seek since their desire for this answer is as much as their desire for that breath of air. Breath of fresh air is well worth the wait when forced underwater indefinitely, outside of your personal control.
Just 2 weeks ago, Cyrus took a leave of absence due to illness. Cytomight sensed he had something going on, but he probably was trying to stick it out, but in the end, he had to leave and now requires time to recover. Lets hope that when he is recovered and able to return, that the Result is already in by then; we already know that it shall be a positive one. Lets hope that on the day which he returns, that the NDAs, partnerships & collaborations which are all contingent on the hold being lifted have all or some, been already signed and activated, thereby allowing Cyrus to return as CEO. Wait! How can these agreements be signed if Cyrus lies in bed? Oh yeah, I remember now, we in fact do have an interim President Antonio Migliarese who is already versed in signing these agreements. I love the profound wisdom of this strategic team.
We recently got some awesome news in the way of CytoDyn's newly hired CMO, Dr. Melissa Palmer, who is nothing but a NASH specialist and long time expert in the field of Hepatology. Also, CytoDyn hired Dr. Salah Kivlighn, who has a rare blend of science and business acumen and has 15 years tenure at Merck & Co. What does that tell you? NASH is CytoDyn's #1 indication. Management at CytoDyn has been communicating that NASH is #1 on the docket for clinical trials since the time that Cyrus came on board, because it was his team which established NASH as having the highest revenue potential. Cyrus has been telling shareholders that NASH is to be CytoDyn's own, that is, without partnership, but this is becoming increasingly more difficult to adjudicate.
If CytoDyn does in fact have a clinical trial for NASH in design and development and in the running, then the Mystery of which I speak is, how does CytoDyn pull this off?
Lets look at some of the details. A Phase 2 clinical trial for NASH would be pretty expensive ($35-50 million) and large, (150 to 200 patients) and it could take 12-18 months before we see any results. In the 12/7/22 R&D Update, Management stated that they had hoped to initiate it by 3q 2023 and to be fully enrolled by end of 2023.
As a reminder of the 12/7/22 R&D Update Investor Deck found here. :
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? And 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.
• 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.

Now back to what I was saying about the large and expensive clinical trial for NASH. What about the problem of recruiting the patients? There is huge demand for these patients. There is a lot of competition here. NASH patients are like gold to enroll as so many Pharmaceuticals compete for those patents for their own NASH trials. How does a small Biotech, pre-revenue company with only $5 million in available funds pull this off? Not only paying for the trial, but how can it show itself as having the clout required to round up those patients in a rapid way? My feeling is a partneCRO needs to be involved somehow.
First off, we know for sure, that the NASH clinical trial will not be entered into until the hold lifts. Once the hold lifts, we can expect near immediate revelation of how this will be accomplished. But, we can speculate as to how this will get done. u/psasoffice suggests that if we follow the money, we can find our answer. But you might ask, What money? We don’t have any. So then, what if we follow the share price?
Remember back to mid-summer 2022, when Cyrus was hired as President, share price was low and even fell following his hiring, but soon thereafter, in late July through August of 2022, the share price rapidly rose to $1.26 per share and then progressively diminished once again over the course of ensuing 6-9 months to where it is today.
Lets take a look at this so we can get to the secrets which will be revealed, where we can open the doors of the collaborations. You may ask, How did we get someone to accept a collaboration? When were the collaborations accepted? Along with Mazen Noureddin and Jonah Sacha, Cyrus presented the R&D Update Investor Deck on 12/7/22 and he was able to say all the things which were said then 6 months in advance and he said them essentially in a DEFA14A SEC filing. The forecasts made in this document and in this presentation were filed with the SEC in an 8-K.
So then, how long before Dec 7 did Cyrus know that the very things which he would plan for the company which he wrote about in the Investor Deck were so very possible to file it with the SEC? Let's say he knew of the strength of his forecast say 1-2 months in advance. Therefore, by mid October he was aware of secret agreements, Cyrus must have known of specific collaborations which would allow those prognostic statements to be made in the Investor Deck, but which were predicated upon the hold being lifted. Therefore, How long did it take Cyrus and collaborators to sit down and make the agreements of NDA? Again, another 1-2 months? So by August, 2022?
Now you can see why the share price inexplicably rose in July / August, 2022. A Collaboration on a NASH clinical trial occurred which also explains the result of these words spoken on 6/30/22 Conference Call by Scott Kelly after his trip to EASL in London: "37:10 Scott Kelly: OK, so we certainly acknowledge being more metered and conservative in our publicity. We will be announcing important presentations and studies on a going forward basis. Regarding the NASH, about how NASH attracted partnerships, we just presented the PDFF and cT1 and biomarker data at EASL in London, just to shed some color on the importance of the EASL meeting, there were over 7,000 delegates present or online from 114 countries. There were 1,722 abstracts presented. There were only 4 poster presentations selected for a walking tour with the chairman at EASL. And We were one of those 4. I was present and I can tell you, it was well received by the scientific community. We can not comment on potential partnerships. But there are multiple opportunities for NASH and NASH HIV."
What also happened in August? Only the removal of the first management player who’s experience was in Negotiation and Partnerships, Brendan P. Rae. No longer any necessity for Negotiation? I guess not. As time went quickly by, without any word of what was taking place, the share price began to fall. It became uncomfortably obvious that by mid November, Recknor had been let go. He was CytoDyn's most experienced scientific, medical and managerial player for NASH, but in the game of a collaboration, anyone and everyone is a commodity and all are replaceable. On the same topic, a significant stock bonus was paid to the president in September of last year after only two months on the job. Was a deal struck? Also, our very own CMO, Scott Kelly who coined the phrase: “There are many ways to structure a partnership.“ himself gets terminated in December 2022. A CMO possessing far more experience in the #1 indication than he could ever have was already being eyed and prepared to take that role for the biggest proving ground party that will show that Leronlimab eradicates steatosis and fibrosis in NASH and NAFLD. Welcome Dr. Palmer.
Once the NASH deal was struck in July/August, it wasn't long before the share price began to rise but just as quickly, it fell as well. Rumors of a partnership must have gotten out, the price ran way up, but then later, in late August, down it went. The stock price dropped because there were no announcements by either party backing the deal. That’s due to the fact that it is contingent on the hold lifting and that it could be a year out before this collaboration moves forward. The collaboration was put on hold along with the clinical hold. It was not revealed outright and therefore, shareholders were not aware of it, but it still exists and therefore CytoDyn remains confident. It is not a traditional partnership, but rather a non traditional one which we may use to answer the questions of how can the NASH trial be funded and how can CytoDyn have the utter confidence to put together such a timeline for proceeding in such a large scale Phase 2 trial in NASH without possessing the necessary funds itself.
How then can we define a Non traditional partnership? CytoDyn will not get a large upfront payment. Instead, CytoDyn continues on its own, however, all the CRO work shall be done by our collaborator. What’s is in it for the collaborator? They run the NASH trial because they believe Leronlimab helps their drug get over the finish line. But Cyrus was saying NASH would be Leronlimab monotherapy and wouldn't be combination therapy. CytoDyn just can't go it alone, it is too small, and a hard luck story company which has failed in its history thus far at every turn. For NASH, u/psasoffice is thinking GSK, while I'm leaning towards Merck.
All of us know that Leronlimab could do it alone in NASH, but that’s not how the Pharma game is played. CytoDyn needs help, and it has 4 different plays, and each play is devoid of a deep enough data pool which would bring in funding for that indication. Cyrus' long term goal is to build out a strong enough clinical trial data pool to present it to a partner or a buyer. So then, without any cash of our own, Cyrus' plan is to have someone else's funding, partner with CytoDyn and build for us that data pool and in the end, have exactly those same partners compete for the entirety of it, for the whole or part once that data pool is firmly in our grasp.
The same story goes for HIV-Prep and HIV-Cure which is probably being run by the 3rd party Research and Development Bio-Tech company Vir, in collaboration to develop the long acting or a more longer acting molecule of CCR5 blockade. Vir is pretty much a given with Scott Hansen's strong connections there. This was kept secret, but somewhat hinted at by Cyrus in the 4/11/23 Webcast .
We can apply the same logic in the Oncology study being run by MD Anderson using Merck's Keytruda in combination with Leronlimab. We had all been waiting to find out what had happened with the results of the MD Anderson study, and Cyrus threw us this line: "Leronlimab is currently being trialed in combination with Keytruda (pembrolizumab) in a breast cancer xenograft model in partnership with MD Anderson Cancer Center." From here, he gave us a hint of what is to come.
It can be assumed that as these collaborations are announced, there shall be share price inflection. In his astute fashion, Cyrus has given us the secrets, but, because of these strange times, the share price has not yet moved. But what it has done is it has held us here, because we are above the times. And we may be seeing a default on the debt in the coming week as well, but remember to remain strong.
CytoDyn knows its has a problem. Therefore, while our collaborators are running these trials for us, CytoDyn itself, remains detached as we pursue other similar non traditional collaborations. The perishable, flesh and blood CytoDyn uses the strategy of its intellect and the power of its IP to become the imperishable CytoDynasty. As Leronlimab has many, many, many indications, so shall CytoDyn have many, many, many collaborations. This is the direction until Merck goes up against GSK who bids against TAK , (thank you Jake!!), for the likes of little CytoDyn who at that point, possesses the grand data pool which Cyrus coveted which was freely obtained in only a few short years of time well spent.
Oh Black Hole, do yourself a favor and swallow and regurgitate everything you just read. Where then shall you find your victory zzy? I see you stabbing yourself and choking on your own stinger of death. Cyrus spelled it out for you dumb ass. Watch it happen before your blind eyes and you still will deny it has even occurred. Oh, I hear it at the door knocking. But you are both deaf and blind. Why are you here? Only to be robbed and the longer and deeper you choose to remain here, the worse it will be for you. However, it is easily avoidable. Cut the short position and go long.

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Going to go with a Zaffiri ZPS.P Ported Slide with a Danger close armament barrel along with some other goodies that are on the way