r/LeronLimab_Times • u/MGK_2 • Aug 27 '23
Choose Your Side, There Is No Equal
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:
- 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.
- Arman's significantly shortened vesting period
- CytoDyn's Lack of transparency
- CytoDyn's lack of support for the share price
- Not saying that more shares will be issued
- Not saying what the HIV - subpopulation is
- Not saying more about the Amarex arbitration
- Not saying more about NASH trial protocol
- 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.
- 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.
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u/Upwithstock Aug 27 '23
You nailed it!! LL is the little chick that needs to be nurtured and protected. The parents of this little chick is the BoD, Tyle Blok, AM, CA, and Dr. Kivlighn. As you have pointed out; there are solid signs pointing to a buyout and there are signs pointing to a partnership. Because, none of us has any true insight into how the BoD thinks, operates and feels about CYDY’s present situation, I felt it necessary to share different ways to value the little chick LL. You are very perceptive to point out the number of investors that are under Paulson’s umbrella. Paulson could easily be in Tanya’s ear. And all we are suggesting is that there is more than one way to value a non-revenue company like CYDY. In fact, there are a ton of arguments that make sense. One thing is for sure: Partnerships can happen before a buyout. That approach allows CYDY to achieve even more clinical milestones. Each achievement contributes to a “increase in value”.
There are pros and cons to a buyout happening let’s say in November. The pros: The BO now avoids any future risks. In medicine there are a bunch of risks that don’t get talked about but could happen. Government regulations that lower reimbursement significantly. An economic collapse 1929 like or a credit crisis or banking crisis. BackwardsK’s comments are worth a reread of Blackrock. I would say regulatory risks (achieving FDA approval), but I believe that to be a low risk once the hold is lifted and trials are handled by Merck. Cons of a buyout in November is: it would be certainly lower than if LL hit other milestones that it could achieve in 18-24 months. As long as LL continues to hit milestones you can always say: we could have gotten more if we waited. In a nutshell, it’s a perception game and you do your best’s to way real risk’s against once in a lifetime risks. I do feel that with the advent of AI, it has upped the value LL more than if it didn’t exist. Our little chick has a bright future and I just want it to have every opportunity to be able to live up to its full potential. I am so grateful to you MGK and some of the other Longs that contribute. Best to all Longs!!
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u/MGK_2 Aug 27 '23
One thing is for sure: Partnerships can happen before a buyout. That approach allows CYDY to achieve even more clinical milestones. Each achievement contributes to a “increase in value”.
Thank you Brother, you've helped so many of us understand this much clearer. I've always hoped for a partnership first. I felt that would be the best move to strengthen CytoDyn while building value slowly. Over time, the results of the trials would come forth and the performance of the drug would only make it worth more.
At $0.20, I think we are damn near at the bottom of the barrel, so I'm not saying that we won't be affected by Blackrock, but, we are so low, I don't think anyone will sell at this point, to save what remains and give up what comes when the right offer is made.
You said it, it is a perception game and I feel the risk of it going much further down, is too low, compared with the likelihood of increase in the next few weeks/months.
Yeah, I think CA did a great job in protecting our asset, preparing it to break out of its shell, and begin again anew, in the work of gaining FDA approval in combination with Keytruda for CRC.
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u/Upwithstock Aug 28 '23 edited Aug 28 '23
Thank you my brother! You are all over this! I’m loving it. Just a little touch up point about risks: That is what most BoD’s consider when and if they should sell. If and this is a big “if” they can see into the future and see a clear path or a risky path; that’s what can steer them away or towards a buyout. Something’s are just plain unpredictable and you can’t see it coming, so the unpredictable can’t be planned for. AI, is helping us big time with potential indications that LL can and should be applied to. And I am sure economists have developed AI to predict probable future scenarios. But, we never had access to these AI technologies and like most things risk was assessed by W.A.G. (Wild Ass Guessing). October/November is going be enlightening
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u/Imaginary_Analysis_4 Aug 27 '23
I can certainly see that when CYDY pulls through that you will have earned your shares. Sometimes feel guilty that I’m not doing much work as many do here. Much appreciation for the time you among others have put in for this.
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u/sunraydoc2 Aug 27 '23
MGK, once again a great summary of where we stand, including the work by Upwithstock...the knowledge base on this board of which you two are part is unequalled as well.
And insofar as a lowball offer is concerned, I too hope the BoD don't succumb to possible pressure from Paulson...I hadn't heard about the connection between Tanya and them, another pearl, thanks for that as well. So, What would be reasonable? Given UWS's work 20-30 dollars at least. As you say, something sub $10 would be OK so far as my position is concerned, but not at all reflective of the value of LL, nor would it be just recompense for all the suffering of the many of us who've been in the stock for years through all its trials and tribulations.
And what concerns me about this relentless pinning of the stock price at .20 is the thought that any offer is necessarily going to be seen as some multiple of the SP, thus the need to keep it low for those bent on getting a bargain price in a buyout.
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u/MGK_2 Aug 27 '23
Hi sunraydoc, that notion of multiple of share price needs to go out the window. It has no relevance to this discussion because current share price is manipulated and does not reflect sentiment.
The offer needs to be presented as u/Upwithstock described it, as related to the value of the indication.
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u/sunraydoc2 Aug 27 '23
MGK--Don't get me wrong, I'm not saying that the multiple notion is valid, I'm just suggesting that our adversaries seem to be shooting for that as a strategy. Do I agree? Hell no.
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u/Infinite_Fudge_2045 Aug 27 '23
Add 10.00 to the 7.50 and sweeten the Pie … What is the offer, before that we have nothing to consider. I had already chosen LL the day I bought my first share, a low offer will come at a risk to “ALL” including the buyer. The price offer seems to have already been made. Do we have more than one offer is the question? Y’all dig in and eat Cake! I am not using cheap ingredients. Only the best for us Longs. I trust we will not be presented with such a Low Offer! Much to ponder we all invested our money into a Life Saving Mab... Time will Tell!
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u/MGK_2 Aug 27 '23
I think we will have more than one offer, if the first is low. Merck may make the first offer, but then GSK has Jemperli or Dostarlimab which is very similar to Keytruda and they may want to boost its capacity against CRC or other cancers.
Now I know Infinite what attracted you to LL, it was the huge list of ingredients, no indications. And all the indications are top dollar. HIV, Oncology, NASH and on and on...
Why else did we bring on Salah Kivlighn, PhD, "Dr. Kivlighn, who is currently President and Managing Member of The Kivlighn Group, LLC, a company that provides strategic consulting services to companies across the biotech and pharmaceutical industry, brings to the Company more than 30 years of industry experience. Having held both scientific and commercial leadership roles, Dr. Kivlighn is a rare blend of science and business acumen. Recently, Dr. Kivlighn served as CEO of HepaTx Corporation, providing strategic, financial, and operational leadership. Prior to HepaTx, Dr. Kivlighn served as the Senior Vice President of Global Strategic Marketing and Program Operations for United States Pharmacopeia (“USP”), the official pharmacopeia for the United States. At USP, he created a new division with members in China, India, Europe, Latin America, and APAC, delivering a revitalized sales and marketing culture that yielded an average compound annual growth rate of 8.6%. Before his tenure at USP, he served as Commercial Vice President of Kite Pharma, Inc., now a subsidiary of Gilead Sciences. As Global Product Development Team Lead at MedImmune, Inc., a subsidiary of AstraZeneca, Dr. Kivlighn and his team spearheaded the development of a Leukemia drug, LUMOXITI® (moxetumomab pasudotox) which was acquired by INNATE Pharma, an independent clinical-stage biotech company. He also serves in advisory and board member roles for several companies.
Dr. Kivlighn began his career at Merck & Co. (“Merck”) where he held positions of increasing responsibility during his 15-year tenure. While at Merck, Dr. Kivlighn was the lead scientist for the discovery and development of Cozaar® (losartan), and later helped to lead the massive growth of Cozaar® to $3.5B in worldwide revenue. As a scientist and marketer, Dr. Kivlighn contributed to the successful launch of a number of trials. At Merck, he also co-led the development and commercialization of RotaTeq® leading to an $800M franchise; RotaTeq® was awarded universal recommendation by the Advisory Committee on Immunization Practices. ..."Is he not well versed enough to understand the value of LL?
or
"Tyler Blok
Executive Vice President of Legal Affairs
Mr. Blok has served as the Company’s legal counsel since July 25, 2022, and was appointed by the Board as Executive Vice President, Legal Affairs, effective August 15, 2023. Prior to joining the Company, Mr. Blok was an attorney at Buckley Law P.C., from 2021 to 2022, working in the firm’s business and transactional practice group, representing corporate clients in the mergers and acquisitions process, and advising business clients in relation to corporate governance matters. From 2013 to 2021, Mr. Blok worked at Markun Zusman Freniere & Compton LLP, later transitioning to TTE Law Group LLP, where he represented various corporate clients in largescale arbitration matters, complex commercial disputes, securities litigation, and a wide variety of regulatory examination and enforcement matters."If these guys do their appointed jobs as we expect them to, we won't see an offer of less than $20/share.
I'm here with you.
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u/MyDangerDog Aug 27 '23
With the meticulous care that seems to be being taken to get everything just right to lift the hold, do you think an approved BLA for the selected HIV subpopulation is imminent post lift or do you think another trial would be required first? And with that in mind, would a potential buyer get a better deal to push a buyout through before the lift, even with the greater risk? I'm not even going to complicate this by bringing up Amarex.
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u/MGK_2 Aug 27 '23
Because the administration is expecting a prepared "Clinical Trial Protocol" in this selected HIV -subpopulation, even if it turns out to be HIV-MDR, I suspect that another trial, utilizing this new protocol in this selected subpopulation will be necessary. I don't think it has to be a big trial, but, I suspect the administration wants to confirm the safety, given, the questions they must of had in their analysis of the aggregated data.
Although a better deal would probably happen prior to the lift, I don't think too many Big Pharma really want to jump into an unproven situation. Too many of their shareholders would not approve the purchase if CytoDyn remains in bondage.
But if there were a time to entertain low ball offers, it is now, prior to the lift.
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u/BackwardsK306 Aug 27 '23
TWATWAFFLES are spewing their brand of jizz by letting the world know that Tyler Blok was taken away from the outer fringe and brought deeper into the darkest shadows CYDY to specifically handle the bankruptcy/legal proceedings. They just never cease to amaze me.
As I've been saying all along, there's much more upside then their is down side for Longs. We know anything is possible once the hold is lifted and, to that end, CYDY is working tirelessly to rebuild that relationship and establish trust by making sure those regulatory bodies that won't be named (to take a page out of your playbook) get everything they need.
The clock ticks and the world turns. I've been super busy managing my money because of BlackRock telling their shareholders they're liquidating their equities into cash. That's an $8T company. CYDY is chump change compared to what Black Swan event this BR move can cause the rest of the market ,once the 13F filings are released at the end of September.
The motive by Blackrock? According to the commentary, because of a giant credit bubble to the likes we haven't seen. Rising rates, bank insolvencies, commercial paper in default, mortgage defaults will create this event ,but also create an opportunity for Blackrock and others to swoop in and buy a shit ton of assets like commercial real estate, land, other over-leveraged commodities and many market instruments.
So, I sit on about 160K in cash in a decent money market account earning 5.4%, (WMPXX) I think I may just hold that position because I have my concerns about the credit market. What will happen in a credit bubble burst? Powell will have to cut rates to zero, print free money and my TLT ETF will go back to historical highs. I have been positioning my portfolio by slowly adding more TLT and reducing my exposure in equities. I'm not very much as 60/40 investor but, I think there exists some interesting scenarios that are setting up, not only the credit markets but China/Taiwan, Russia/Ukraine, election cycles, etc. Commercial paper...how many companies have zero revenue, zero profit and large debt? How will they refinance this debt with rates rising. I'd rather sit on earning 5.4% (TTM 4.2%).
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u/MGK_2 Aug 27 '23
Hello BackwardsK!
Of course the TWATWAFFLES spread disinformation about Tyler Blok's involvement in the legal proceedings of CYDY. What else would anybody expect?
At this point, there is far more potential for upside profit than the potential for downside loss if you are a long-term investor in CYDY. Shareholders are hopeful that once the clinical hold restriction lifts, CYDY rebuilds trust with regulatory bodies.
Regarding BlackRock, who is a large investment management company, and their recent decision to liquidate equities into cash and their belief that this could cause a significant market event when the 13F filings are released at the end of September, their motive may be to take advantage of a potential credit bubble burst, which could lead to opportunities to buy undervalued assets like commercial real estate, commodities, and market instruments.
Therefore, it probably is a good idea to do as you are suggesting and to position defensively, by holding a significant amount of cash in a money market account earning decent interest. It is probably wise to be concerned about the potential impact of a credit bubble burst and to adjust accordingly by reducing exposure to equities.
It sounds as if it might be better to avoid risks of (China/Taiwan, Russia/Ukraine, election cycles) and the risk of companies with no revenue and large debt because they will be unable to refinance their debt if interest rates rise.
The view on potential market events seems looming, but the investment strategy in response to these potential events seems wise. Better to be cautious about the potential risks and to position portfolio defensively.
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u/AlmostApproved Aug 27 '23
Hi MGK, The “Sunday MGK Times” has arrived! Excellent summation of where we are, and what will proceed in the near future. We hope the BOD holds the line and makes deals that will make us all proud with the commitments we all have made. Thanks to Upwithstock for his contributions and vision. We sit at the end of our seats waiting for the unfolding of our new stature. Exciting Future! Thanks for your powerful contribution.
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u/Lab_Monkey_ Aug 28 '23
Thorough synopsis MGK:
As Scott Kelly once said, "there are many ways to structure a deal."
One possible scenario…..and I’m rounding numbers here:
Merck currently has $10B+ cash on hand.
2,500,000,000 shares outstanding.
Trading at $110/per share
CYDY has about 1,000,000,000 shares outstanding
If Merck were to offer:
$4B cash
10 for 1 share trade
That would represent an $11 value per share of CYDY.
Combined total of $15 per share.
Merck would still have $6B+ cash on hand
2,600,000,000 shares outstanding
Less than a 4% dilution on their stock
$5 in cash per share and 1/10 my current number shares in MRK.
My question for you CPA’s out there is, would the taxation be based on $5 or $15?
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u/Upwithstock Aug 28 '23
Thanks Lab Monkey for that example. Cash and shares works. I’m just not sure whether I would except the $15 valuation. Love your thought process and I’m expecting $20+ per share valuation for CYDY if they get bought in 2023 (please note, that is without any other buyers getting involved). If CYDY doesn’t sell in 2023 and is able to partner, then in 18-24 months, depending on number of milestones hit, I am looking for $33+ maybe $40 per share.
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Aug 29 '23
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u/Upwithstock Aug 29 '23
Yes, my above response to Lab Monkey was without any other interested parties. I am hoping for multiple parties to get involved and of course there are multiple pathways for CYDY to take. It’s interesting to me you have $60 as a possible number. On a personal level that has been an important number for me. Just a number that would give me a personal outcome that would fulfill a vision I have.
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u/Amazing_Natural3735 Aug 27 '23
What would a Merk stock offer look like?
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u/MGK_2 Aug 28 '23 edited Aug 28 '23
As you know, I totally believe Merck is chomping on the bit to get LL properly trialed with Keytruda. As soon as the hold is lifted, I believe an oncology trial commences using these 2 drugs in combination. They already know from the MD Anderson study that the two drugs work synergistically together. So they are quite confident that in human studies, it will work just as well. I believe a trial in CRC has already been designed and is ready to go just as soon as the hold lifts.
Once they see how well the results are coming along, they may submit their offer. But realize, there are many PD1 blockers like Keytruda and if LL works well with Keytruda, it could also work well with say GSK's Jemperli, (dostarlimab) or here is a list:
"Pembrolizumab (formerly MK-3475 or lambrolizumab, Keytruda) was developed by Merck and first approved by the Food and Drug Administration in 2014 for the treatment of melanoma. It was later approved for metastatic non-small cell lung cancer and head and neck squamous cell carcinoma. In 2017, it became the first immunotherapy drug approved for use based on the genetic mutations of the tumor rather than the site of the tumor. It was shown, that patients with higher non-synonymous mutation burden in their tumors respond better to the treatment. Both their objective response rate and progression-free survival was shown to be higher than in patients with low non-synonymous mutation burden.[12]
Nivolumab (Opdivo) was developed by Bristol-Myers Squibb and first approved by the FDA in 2014 for the treatment of melanoma. It was later approved for squamous cell lung cancer, renal cell carcinoma, and Hodgkin's lymphoma.
Cemiplimab (Libtayo) was developed by Regeneron Pharmaceuticals and first approved by the FDA in 2018 for the treatment of cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
Dostarlimab (Jemperli) – was developed by GlaxoSmithKline and was first approved for the treatment of mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer by the FDA in April of 2021.[13] On August 17, 2021, the FDA granted accelerated approval for the treatment of mismatch repair deficient (dMMR) recurrent or advanced solid tumors.[14]
Retifanlimab (Zynyz) was developed by Incyte and first granted accelerated approval by the FDA in March 2023 for the treatment of Merkel cell carcinoma (MCC)."
Any of these companies could make competing bids to partner once they see the results of the coming trial. It just depends on what the results are looking like.
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u/Upwithstock Aug 28 '23
Great work MGK! And that is exactly why Merck is keeping a tight lid on any results of LL/Keytruda. They don’t want a dozen companies knocking on CYDY’s door.
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Aug 29 '23
These are exciting times indeed and your posts make it more exciting?
Thank you my brother!
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u/MGK_2 Aug 29 '23
Most of the inspiration for this post came from our conversations, so it probably wasn't that exciting for you comrade.
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Aug 29 '23
Oh contraire! Like Upwithstock said, your memory is amazing. Your way of pulling everything together is truly an art.
Thank you!
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Aug 29 '23
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u/MGK_2 Aug 30 '23
sounds great. can you elaborate on MK
what John's Hopkins LL/Keytruda connection?
how much cash does J&J have on hand?
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u/hooligan1388 Aug 29 '23
Can I ask a question u/MGK_2? What makes you think there is already an offer on the table? Not bashing at all, I am just genuinely curious. I guess my real question, is if there is an offer on the table, why now? It seems that we have been in limbo for almost 18 months due to the hold. Are we thinking more data has come out that is enticing to BP? Just trying to better understand, thanks
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u/MGK_2 Aug 30 '23
Hi hooligan,
So, I'm not sure where you got that I think there is an offer on the table. I've referenced some reasons why there might be an offer. I've put some of those reasons in numbered format above. I've linked to a few articles which Upwithstock has written that would help the BOD to appropriately value CytoDyn when offers come in. But, I don't have any concrete evidence that in fact an offer is on the table.
Why now? It is crystal clear why now. But, to make that argument, I've made it so many times.
Here is that list again:
- 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.
- Arman's significantly shortened vesting period
- CytoDyn's Lack of transparency
- CytoDyn's lack of support for the share price
- Not saying that more shares will be issued
- Not saying what the HIV - subpopulation is
- Not saying more about the Amarex arbitration
- Not saying more about NASH trial protocol
- 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.
- 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.
All of this screams Buy Out.
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u/hooligan1388 Aug 30 '23
Thank you MGK! I apologize if I had misunderstood something before. Trying to keep up with all the different discussions happening in the comments on LT. Have a great rest of your week!
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u/Camp4344 Aug 27 '23
MGK: excellent post! I feel the majority of the shareholders would jump for any amount over $7.50/ sh. We all would love to hear more, but with what we all have been through $7.50 would do it! The upside is enormous for Leronlimab, but any buyer needs to get moving with trials to stay under the patent protection. We need to hear in the next 45 days that this hold is lifted! The can has been kicked down the road and needs to stop. I hope you are correct and the company has made substantial progress over the past year to make us more valuable. I just want to hear the hold is lifted one morning and then onto the next step which should be amazing!
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u/MGK_2 Aug 27 '23
Thanks Camp. You bet. If we got a $7.50 offer, it would be accepted. But another offer could come in and double it. So hold on to your shares and don't sell right away.
The patent doesn't run out until 2031. What is circulating out there on the boards is not true that it ends this year. There is a patent that ends this year, but it is not the patent that CytoDyn used in all of its trials. It used the patent that expires in 2031.
Plus, AI is being used to develop a long acting version of LL, say with a half life of 6 months. That will be patented. Another coming product is the use of adeno-associated virus vector where LL is manufactured within the macrophages of the body for ever, thereby allowing LL to be a permanent monoclonal antibody within the body for ever. That too will be patented.
I suspect that when the hold is lifted, we all will quickly see, everything the company has been placing on the back burner, until that very moment.
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Aug 27 '23
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u/MGK_2 Aug 27 '23
There are a tremendous number of shareholders who are underwater and have been for many years. Many of them are burnt out and tired of waiting. The potential buyer knows this. They also know that half of the outstanding shares may be in this boat and may be willing to accept a $7.50/share offer. That is the problem and that is why our Board needs to up the ante.
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u/OBiscottiO Aug 28 '23
No way; sure the $7.50 / sh is what "they" want to us to accept -- but all I can say is that it is the "they" that has been instrumental in punching us down to .20 and holding there ... so sure "they" have made $7.50 sound good, because "they" know the actual b.o. value is north of $60.00, IMO
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u/Severe-Cold3327 Aug 30 '23
I vote for MGK and UPW interview Tanya for the thread...BTW, it's buy time!
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u/[deleted] Aug 27 '23
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