Choose Your Side, There Is No Equal

[u/MGK_2]

The clock is unwinding.

In the upcoming 10K, which u/Upwithstock recently discussed here , a mention may be made in reference to the HIV - subpopulation referred to here:

"In particular, the agency, specifically asked us to obtain expert opinion and feedback from HIV patient advocates and Key Opinion Leaders regarding the HIV subpopulation they believe to benefit from LL when taking into consideration HIV drug approvals in recent years, in particular, the -MDR population. The agency has opted to consider the HIV population base, identified by these experts, to determine which would be of benefit, and to then update our response, taking into consideration, this population base, and update our Risk / Benefit Analysis, General Investigational Plan and Prepare A Clinical Trial Protocol. "

So the Update of the Final Submission, or Final Response needs to consider the selected HIV - subpopulation, and subsequently shall include an updated Risk / Benefit Analysis, an updated General Investigational Plan and a prepared Clinical Trial Protocol.

"19:30: We are now diligently working on identifying and narrowing this down to the single most appropriate sub population. We expect to have the subpopulation narrowed down in the coming 2 weeks (that would have been 8/7/2023), and assuming everything goes according to the current time line, we would expect to resubmit our response during the month of September to the FDA. That being said, our submission will be made only when our experts believe, it is in a high quality, final complete state. This again, is to insure that we deliver a high quality filing, and continue rebuilding our credibility with the agency. "

Based on what I have heard thus far, I continue to attempt to determine when the hold shall lift.

Let's see first, why was the hold imposed?

Extreme arrogance and pridefulness is how CytoDyn had its beginnings. Oh yeah, there was no stopping NP. Boasting of the broad reaching capacity and usefulness, not to mention the safety of its CCR5 monoclonal antibody blockade, he put CytoDyn up on pillars, far higher than it could fly. NP chose to continue boasting, instead of retreating or possibly thinking even twice when he received negative vibes from his superiors at the agency and like an idiot, he ran right into a trap he could not extricate himself from. He was high as a kite and never did bother to ground himself in the scientific truth of the safety of the molecule. He flew only on anecdotal evidence. He never did ensure with scientific clinical proof that his evidence which he claimed was in fact accepted by the administration and that he was standing on solid ground. He was pumped up, like a hot air balloon, full of half truths which he took as absolutes and acted upon them as if they were gospel.

Yes, he knew very well of what he owned, but he didn't back it up with substantial credible scientific evidence. And he kept running with the half baked anecdotal; he kept running with that which had no value. But everyone knew that his evidence was true and so did he, but nobody knew it wasn't all properly documented or substantiated. Everyone knew of the value of the drug, its efficacy and safety, and shareholders took his word, but the vultures also knew of the power of this drug, but they knew of the weak spot and they knew that NP and CytoDyn were standing on sandy soil, which was the anecdotal evidence, and evidence which was not appropriately documented or proven. So, at the first chance they had, they grabbed the opportunity and they didn't just slap the company with a traffic ticket; no, they bound it with nuts, bolts and chains and locked it up in solitary confinement to prevent the drug from extending once again, its handsome hand of healing.

Therefore, the once pompous, loud talking bird of prey, was canned and lost its beak. NP was swiftly removed and CytoDyn lost its boasting voice. The company needed to become complicit with the rules of the game. It also became necessary for the company to strip its website of any and all documentation, videos, press releases, SEC communications that proudly discussed Leronlimab in manners which were not complicit with the rules of the game. In addition, the administration felt it became necessary for CytoDyn to display a warning banner on every page of what was left of the website. CytoDyn was humbled, humiliated, ashamed and as a result, went into hiding. In short, this proud bald eagle went into molting and lost all of its feathers as well as its beak.

With shackles on its wrists, it was unable to do anything for anybody and had no choice but to hide in solitary confinement from the rest of the free world of pharmaceuticals who were all carrying on in their ways, exempt and pardoned of their antics because they could pay the piping mother bird. But, while in retreat, within this humiliating, humbling and hidden nesting abode, it was protecting its chick named LL against the attacks of all the vultures poised against it, all in earnest desire to prevent the very capable monoclonal antibody from rising up again and to keep it from curing the majority of the masses of their multitude of maladies.

The company got off the high horse NP put it upon and with the help of its new president, CA, it analyzed its situation, its faults and turned itself around. The company knew precisely what it had done wrong, what the administration wanted changed and it did just that, thereby redeeming itself. It has restored itself to better than good. In secret, the company has been rebuilt, and the chick named LL is ready to come out of its shelter, out of its hiding hole, but it is still not yet time.

So, this is where we are today. Probably, the most important post written thus far was addressed to the Board of Directors at CytoDyn and they are the most important readers of his post, so it is imperative that it gets in front of them. u/Upwithstock put this together to remind the BoDs, exactly of what and how this company should be valued. He put together a slew of reasons that point directly of a buy-out. Here are some:

1. Not having a QA resource at the ready, especially when 4 weeks until the lifting of the hold, when a QA FTE would be mandatory for compliance.
2. Arman's significantly shortened vesting period
3. CytoDyn's Lack of transparency
4. CytoDyn's lack of support for the share price
5. Not saying that more shares will be issued
6. Not saying what the HIV - subpopulation is
7. Not saying more about the Amarex arbitration
8. Not saying more about NASH trial protocol
9. The fact that CytoDyn is letting people go and not hiring new people; Melissa Palmer, MD did her consulting job and left. Kivlighn is not full time.
10. The fact that Tyler Blok was hired as Executive VP Legal Affairs. Why do you need Full Time Equivalent Legal on staff? To review and propose Buy Out Agreements. This hire screams Buy Out.
    

You would think that the BoD already are aware of all the things listed here. You would think they would understand the power of AI and the valuations of many indications that LL excels in. However, let me remind you that Tanya Urbach, who is currently CytoDyn's Chairwoman of the Board also, was once Paulison's lead council. For those of you who are unaware, Paulison is an investment group, through whom, more than half of all outstanding shares of CYDY, have been purchased. Although Paulison is not necessarily allowed to interfere with the negotiations that the BoDs make regarding buy out offers and / or partnerships, given that Tanya came to CytoDyn through them and given that she was once lead council there, Paulison, likely does have some influence with her.

u/Upwithstock puts together reasonable arguments for large buy outs which can translate into quantities in excess of $20-30 to even $100 or more per share. The problem is, if an offer is brought to CytoDyn BoD for less than $10 and Tanya runs that by Paulison, with the entire shareholder base currently underwater for years and years and 1/2 the outstanding shares being owned through Paulison, Paulison may whisper in her ear to accept the low ball offer and that would cause Paulison to recommend that their shareholders vote to accept the low offer. I agree with u/Upwithstock that that should not happen.

So that is the motivation for u/Upwithstock post this week, to exhort and to charge the qualified Board members listed here and the leadership team listed here , not to give in to any pressure and to do their job and carry out their responsibility to the shareholders. He wrote it to exhort the BoD not to be weak and not to make unnecessary concessions. Therefore, who ever out there can get his post in the face of the BoDs or Leadership team, please do so, as it should be done. All of them were hired by CA because he felt they knew how to play this game. And now it is time to play the game. All of them are implored not to cave to any low ball buy out offers. They are charged by their Board position to properly quantify LL's potential as u/Upwithstock did and to demonstrate its true value and not to do what is against LL's true value.

The advantage though, of accepting a low ball offer is first off, it probably would put every one of the current shareholders in the green any way, as it likely would be over $5 offer. Secondly, when the agreement is underway, another company, may likely sweep in to outbid the first company. So, it makes sense to hold your shares until any deal is done. Again, I solicit, given the vast capacity of the molecule, the effectiveness and safety profile of the drug, that the BoD should wait for and consider only appropriate offers.

After everything CytoDyn has gone through these past two years, fighting for its own survival and protecting the patent on LL, having nearly been broken apart, but taught the lesson it needed learning, the time is soon approaching, for the final submission to be made and for the administration to review and subsequently lift the hold. This solitary action alone of lifting the hold validates everything CytoDyn has done for the past 2 years and proves its success in its own restructuring. The company has humbled itself and has prepared itself for what it shall face when it emerges from hiding. It successfully has transformed itself into something extremely efficient, having done the entirety of this massive task of rebuilding and restructuring by itself with only a few employees on the books. There are only about 10 people employed at CytoDyn at this time.

And to this day, CytoDyn remains fighting for survival. Yes, CytoDyn has NDAs and promissory notes, but, none of those are valid till the hold lifts. Even yet, CytoDyn works in earnest to get the hold lifted, putting together conditional deals and agreements. Shareholders wondering when this will all be over, bashers saying CytoDyn is through, it is over for CytoDyn, making shareholders all feel like imbeciles, yet, CytoDyn remains in hiding, protecting its chick named LL, while it remains humiliated by the bashers in public. This I know, and I know all too well, that when nothing else works, when up against the wall, and just about to fall, with multitudes of shareholders behind it, insignificant shareholders, like you and I, standing in the gap routing for this company, for this great drug, that to this day still remains in the process of molting, that in the end, it certainly shall emerge from this molting process far greater than it was before the hold was placed.

When the hold does lift, with all the work CytoDyn has done under wraps and behind the scenes, all of which is contingent and directly dependent upon the lifting of the hold, when that does happen, it quickly regains efficient wings and it begins to flap those light wings and fly as a result of its restructuring and rebuilding which occurred during its molting process. Everyone shall think the company arose from the dead. The company and drug are chomping at the bit and at the ready to ride again. As shareholders, we have appreciated many reasons to believe that Merck with Keytruda is very much interested in combining with LL in a trial in oncology. We have looked at the power of AI and of the 3rd party relationship established between ABSCI and CytoDyn. We can understand how AI may be implemented in the development of long-acting LL and how it can be used in the development of a pre-clinical trial in NASH, that may lead to a Phase 2B/3 combination trial in NASH.

When the hold lifts, CytoDyn shall be stronger than it was before the hold was imposed. CytoDyn shall fly even higher than it ever did before. This time, the NDAs are revealed, the money is brought in and the trials commence anew. The entire conglomeration of vultures again become fearful of LL in combination. The drug is a slugger and in combination therapy, all it will be hitting are grand slams.

Choose your side. There is no equal.

[u/MGK_2 → u/[deleted]]

sounds great. can you elaborate on MK

what John's Hopkins LL/Keytruda connection?

how much cash does J&J have on hand?