So Here is What It Comes down to: Wait, Watch and Listen
Let's wait, let's watch and let's listen, but let us also go over what we've talked about in the past couple of posts.
I have reminded us all that CytoDyn has a myriad of enemies that surround the company. That there exists a variety of entities who prefer that this molecule not be given a fair chance and that it not be developed to any further degree. I explained that these enemy entities are largely pharmaceuticals, but that Big Pharma enlists a vast variety that act as their proxies on their behalf, doing their dirty work. I've said that, CytoDyn has had its fill of insider parasites who would love to have another chance to sink their fangs deep into CytoDyn's patents on Leronlimab.
Recently, I have brought to the forefront that Amarex had been CytoDyn's #1 insider parasite. I discussed that CytoDyn has Sidley Austin Attorneys who directly deal with Amarex in arbitration. I have said that Sidley Austin is likely not being compensated by CytoDyn, but, rather, represents CytoDyn either on their own behalf or is being compensated by a 3rd unknown party to represent CytoDyn. I said that I believe that this arbitration should come to a conclusion near the end of 2022.
In addition, I spoke extensively about the clinical hold. I have said that the Amarex data needs to be aggregated and presented to the FDA in a Type "A" meeting and I came to the conclusion, that a Type "C" meeting would likely take place sometime in September which shall help in deciding about the resumption of the BLA for HIV. I have reiterated many times that in order for the NDAs to be revealed, that, it would first be necessary for the FDA to lift the clinical hold.
I have reviewed the priorities that CytoDyn has disclosed in the recent 10-K. Here they are again: 1) Removing the clinical holds 2) Advancing NASH to a Phase 2b or 2b/3 trial 3) Exploratory Study for patients with both HIV and NASH 4) Continuing mTNBC Phase 2 trial; Exploring a Colon Cancer Phase 2 trial; Exploring a Solid Tumor Trial of various cancer types. 5) Evaluating HIV BLA resubmission; Developing long acting versions of Leronlimab; Pursuing proof of concept HIV cure with AAV 6) Covid 19 strategy review.
I made this statement in a recent post: "This means only one thing. That Whoever the NDAs are with, they are not with CytoDyn for HIV. Rather, they are with CytoDyn for NASH first. Then for NASH + HIV; Then for mTNBC, Colon Cancer and other Tumors."
Regarding the shorts, I've recently said that I felt that it would be unjust if the Shorts were permitted sufficient opportunity to completely cover the mountain of shorted shares they currently have interest in, which now run probably in the vicinity of 37 million shares. I've said that the shorts are strategically using this period of low volume and clinical hold to cover and if this goes on too much longer, they would have pressed the reset button, bringing their debt balance to zero. I have said that this would be a great injustice, but, I have also raised the question, "Who am I to judge?" "Maybe it is better that this reset button is pressed?"
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How do we get to a point where CytoDyn can run a trial on Leronlimab again? The clinical hold has to go away. A Partnership / Normalization needs to be signed. The treaty needs to be enforced and protected. How/when is hold lifted? I feel that the how has already been done in a Type "A" meeting with the FDA. I believe that by end of September, the Hold will be gone, but it may not, (I don't know, just like all of us, I'm just making my guess based on what I know.) Scott Kelly said we have the data and that the problem was formatting. If they were ready to conduct a Type "C" meeting with the FDA in "September", to discuss the resubmission of the HIV BLA, then that means they had the data in the appropriate format (in September), so their discussions could in fact take place. That means they had the data in the appropriate format for the Type "A" meeting as well, (which would have been prior to "September"), and therefore, they have already discussed CytoDyn's reasoning to lift the clinical hold with the FDA in the Type "A" meeting and therefore, I think the FDA will do just that by end of September.
However, the lifting of the clinical hold will take away short's capacity to cover any longer. Shorts don't want this to happen. They want the hold in place so they can cover. This is a dilemma that our governing body finds itself in. In fact, by lifting the clinical hold, the share price would rise substantially, possibly doubling in a couple of days with the lift. Shorts will have regretted not covering more at current prices, like they regretted not covering at $0.26. But, now, when the hold is lifted, the share price climbs, will the shorts be very inclined to continue shorting once the share price doubles? Will they continue Renewing their previous short contracts? Especially with the ever looming likelihood of the unveiling of the NDA Partnerships? If they feel they can drive it back down, they will short again, but they won't cover until they drive it back down here if that is what they feel they can do. But if they fear looming partnerships, then they may regret ever doing any shorting at all.
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When the FDA lifts the hold, many things will begin to happen at once. The revelations of the NDA Partnerships will be resulted. But, in the past, I've written of the need for the Enforcer to enforce these treaties or contracts. I feel Sidley Austin will play a large part in this regard as they will uncover many dark secrets used by Amarex and Sidley Austin will be best equipped to protect CytoDyn and Leronlimab from any future attacks. Therefore, it is possible that CytoDyn enters into an agreement with Sidley Austin to act as Enforcer in every Partnership agreement. (Speculation of course).
But with an Enforcer in place, the Partnerships are initiated and the development of Leronlimab resumes once again, but this time, in conjunction with other drugs, in combination with Leronlimab. Considering the priorities of the recent 10-K, A (250 - 1,000) person, Phase 2B/3 trial for NASH, as this is #2 on the priority list. Sidley Austin working in the background, ensuring that CytoDyn & Leronlimab remain protected. Not too long thereafter, in a Press Release, another Partnership is revealed, regarding an exploratory study revolving around NASH and HIV together. It should be very interesting which combination drug is used for this partnership, or if Leronlimab monotherapy is to be the therapeutic treatment in this group. Still yet down the road, another Partnership which combines Leronlimab with either GSK's Dostarlimab PD-1 inhibitor or Coherus' Topiralimab PD-1 inhibitor for metastatic TNBC and metastatic Colon Cancer.
The coming meeting, I believe it will be September 30,2022. Within it, CytoDyn shareholders will learn far more about the status of the clinical hold and will hopefully learn that it shall be lifted on or around that time. Within that meeting, any remaining blockades to CytoDyn's advancement or Leronlimab's development will be made known. If the clinical hold is already lifted by then, then it may be that the first of the NDAs may be revealed then in that meeting.
CytoDyn advances with Leronlimab's development in this way. It seems to me that CytoDyn has had its share of tremendous tumult and ever since Nader Pourhassan's departure, the company has been reeling, but its board has taken a step back, has quieted itself significantly. Surely, the board has cleaned up its act. the website has been revamped and the balance sheet is improved. Any outstanding law suits have been resolved or settled. 350 Million more shares have been authorized and approved.
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Lately, I have come to feel as if there is a "No More" to my understanding. As if this is the end, as if this is all there is to it. Many times, new ideas or things come to me, but it was modest today. So, I'm thinking, is this all?
Not yet, but yet, something is going to happen. I can't say what that means. I can't say what will happen in next few days. All I know is to, Wait, Watch and Listen. Just being honest. Straight up.
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So the next few weeks leading up to the meeting may be telling, but they may not be telling. It would be great if we get some kind of Press Release, but we may not. It would be great if the clinical hold is lifted by then, but it may not. But, I believe the company meeting, which I believe is on 9/30/22, will be quite revealing, especially if the hold is lifted within that meeting. I believe that meeting will answer many questions we have and will be the first step we take to ushering in the revelations of the 1st of many partnerships.
CytoDyn needs a win in one way or another. Any kind of win. Even if it is a loss for our enemies and any loss of Gilead is a win for CytoDyn. Right now, the greatest win we can get is the lifting of the hold. We need a win in the Amarex arbitration. We need astounding results in the mTNBC trial and that may be revealed in the 9/30/22 meeting. CytoDyn needs announcements that reveal current NDAs and partnerships. CytoDyn needs announcement of contracting Enforcer and their role in each partnership.
Look, some times it is better to let go and that is what I will do. I'll ease off a bit and wait it out. I want to see it play out. It seems that this is what this time is telling me to do. To let go, and in the coming days and weeks, keep an eye out, an ear out and if necessary, come back out with guns ablaze. But, I will stick with this approach of not sensationalizing, but bringing forth the information in the way I see it, but I feel the next two weeks may pack a surprising twist before the company meeting which no one could have foreseen coming.
Posted Sep 18, 2022, 6:48 PM UTC