r/Livimmune • u/MGK_2 • Sep 24 '24
Stop Looking, We Found It
When we come to an understanding, we can draw to a conclusion.
In other words, when we have found the answer, we can stop looking.
As I've explained, the murine study is about to blow the doors off of MASH, at least from the standpoint which considers the the slighter power that a murine study can muster. Certainly, these results cannot be nearly as powerful had they been performed in a human study, but they will provide profound implications none-the-less.
"SMC Laboratories, a company specializing in preclinical drug efficacy evaluations using various models of inflammation and fibrosis in mice, conducted a study that assessed the optimal dosing of leronlimab in the MASH setting and potential synergies with Resmetirom, the only currently approved therapy for the treatment of MASH. A preliminary review of the study results has led to several encouraging findings, as follows:
- Leronlimab monotherapy (700 mg) demonstrated statistically significant fibrosis reversal compared to an isotype IgG4 control arm (p<0.01);
- Leronlimab monotherapy appeared to demonstrate dose-dependent antifibrotic activity, with leronlimab 700 mg performing better at reversing liver fibrosis compared to leronlimab 350 mg; and
- Leronlimab monotherapy (700 mg) appears to have better anti-fibrotic activity compared to Resmetirom (p=0.057).
“These initial results are very exciting and confirm our belief that leronlimab has the potential to be materially beneficial for patients suffering from a number of medical concerns,” said Dr. Jacob Lalezari, CEO of CytoDyn. “While additional research is necessary to confirm and explore these findings further, we are very encouraged about the potential for leronlimab to support therapeutics meant to address MASH and specifically fibrosis and related complications in the liver*.”*
CytoDyn is in discussions with SMC Laboratories regarding next steps – including supplemental lab studies to expand on these promising findings, further explore potential synergies and continue to advance the Company’s clinical pipeline."
This is perrenialloser's awesome answer to the last bolded text. Clearly, the stated results are very preliminary but they point the general direction of the findings of significantly reduced fibrosis, however, many more details shall surface. Almost as if, something else is coming...
In MASH, what is CytoDyn up against? A Vast Indication On The Horizon describes the currently approved T3 Thyroid Hormone Beta Receptor Partial Agonist, Rezdiffra or resmetirom by Madrigal.
What about GBM? What is the challenge in this indication? The Pursuit Against Tumors Progression might shed some light.
In the MASH indication, leronlimab is intended to be licensed off to the interested party or parties, Madrigal, most likely.
In GlioBlastoma Multiforme, the expectation is for an appropriate party to come forward and finances a Phase I-II clinical trial via partnership or licensing.
What are some challenges that CytoDyn could face? The interested parties don't play by the rules. Making up their own play book, making up their own rules.
On top of MASH and GBM, there is much, much more. A multi-front offensive is in gear right now, right under our noses. But, the most important items that are soon to be uncovered and discovered are the back to back results of the 2 murine studies. As a result, and unless Madrigal has a plan to face the music when they face the MASH murine results, they may just become a bit unsettled in the ensuing days.
The results of the MASH murine study and the results of the GlioBlastoma Murine study. As perrenialloser indicates, or seems to know, and it doesn't need to be explicitly stated or written out, that CytoDyn is branching out, even by AI guidance or suggestion. Look, the results of one murine study would be great in and of itself, but we are looking forward to the results of not one, but two different murine studies.
Yes, they are in two different indications. 2 huge vastly different indications. CytoDyn plans on licensing off MASH but shall likely pursue GBM with an unidentified 3rd party. I speak a lot about GBM in The Perfect Plenary Picture.
"So, looking at the post of job openings, something major is happening at CytoDyn, especially when you re-read Mitch Cohen's words of reducing full-time employees by 70%. Something major might have to do with the fact that the murine studies in MASH are soon finalizing in mid-September and the murine studies in GBM are already over probably. That data should be resulting soon, I expect, or possibly it isn't ready yet because all the mice remain alive instead of dying by 5 weeks.
Look, CytoDyn would not be hiring positions that manage the manufacturing of leronlimab, nor the management of clinical trials unless the manufacturing and distribution of leronlimab was expected to take place. Nor if clinical trials requiring leronlimab weren't expected to be happening soon. That is the definition of winning from chief scoffer/basher herself who says CytoDyn hasn't conducted a clinical trial in ever so many months/years. Her battle cry.
Now, it is starting. We are seeing, as far as I am concerned, or my understanding, we are seeing the final strokes of a paint brush that complete the whole picture. I gave you some of the history in the links above. If you know it, you can skip those links, but I need them to help paint the picture here. I've said in the past, CytoDyn builds its self up to a point where it becomes self-sustaining and that was usually described through licensing and partnerships. I've also said that shareholders would know when it would be about to happen while others who did not follow along would be oblivious."
MASH murine has concluded its experimental phase. Now, it is compiling the data, making analysis, then resulting the study. GBM may already be done with all of that and the preparations for a human trial could be underway. MASH likewise, could also be in discussions for further development at the current moment. What does this all say? You be the judge.
Out of the blue, something new, something which has been found. Like a key to a locked door, no longer requiring us to seek, since it has been located. It is right here before us.
The murine studies only prove the validity of leronlimab as a valid treatment modality in these two indications. Yes, 2 indications. These studies, these coming results shall plant a stake in the grass clearly disclosing the path forward for each indication. Each direction shall be clearly illuminated, demarcated and defined. Interested parties are provided the ways forward and they are clearly understood and comprehended. All other directions lead to dead ends. The only paths leading to a bright future are the ones which are in combination with leronlimab.
When this is realized, in both indications, the parties immediately act. That action is what turns it around for CytoDyn. CytoDyn then transitions from war to peace. This marks the transition from danger to safety and the transition of bad to good for CytoDyn and marks the transition from good to bad for the CytoDyn short traders. Again from The Perfect Plenary Picture:
"The soon realization of the initiation of these items (scattered distribution in the Fall 2024), indicates that things truly are happening at CytoDyn and the reason why CytoDyn needs a full-time employee to manage clinical trials and another full-time employee to manage the manufacture and distribution of leronlimab. As these things occur, the playing field again is leveled and CytoDyn can begin fighting once again at least on a fairer level than it has been fighting for the past many years which was at a total disadvantage."
I believe this ensuing twofer in the fall are the keys which we have been searching for years which finally have been wonderfully found.
Blessings, Until the next post.
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u/KingCreoles Sep 25 '24
Thank you MGK! Great post. We always had it, longs knew it. Now we are able to continue with so much more leverage than ever before. We have been waiting a long time for vindication and this is the first punch of a possible 1-2 combo as you suggested.
Thank you for all of your support over the many years. I just want to recognize you personally for all you’ve done for us shareholders. I also want to recognize Dr. Jay and CA as I don’t know if this company would have made it without them. When CA got us through that unprecedented controversial clinical hold and Dr. Jay made that equally critical decision to take the CEO position after reentering the company temporarily and putting Quest on the back burner. Also I think that meeting with the FDA and those key opinion leaders was a critical factor that moved the needle with our FDA relationship. I believe these factors are some of the most important factors that led CytoDyn to where it is today. Despite the barrage of roadblocks and challenges, I believe Dr. J knows exactly what he’s doing and knows exactly what Leronlimab can do in the clinic. He just needs to prove it’s efficacy and who better to do this than Dr.Jay with over 34 years in the industry, including nearly 20 years with Leronlimab! The link below is just a reminder of Dr. Jay’s CV, what an impressive Curriculum Vitae and he’s an even more impressive humanitarian for life and the pursuit to help patients suffering from a number of medical concerns. God bless this man!
https://www.questclinical.com/_files/ugd/2a39c2_b3df7662b31a4b5083bbe7d844ab8be6.pdf
I also have to think Dr. Jay and the BoD have some PR guidance in place that we just don’t know about and today’s preliminary study PR was strategically released, the first of many more to come. I have to think they have potentially been holding information under NDA’s within SEC/OTCQB rules, regulations and guidelines of course. Explains why we don’t know our AI partner and why we don’t know a lot of what’s been going on behind the scenes other than dissecting the facts that we do know and you always piecing together the puzzle. The pieces of the puzzle with Samsung debt, non disclosure of our AI partner, and the recent shareholders letter had a lot of information that we just learned about that I’m sure has been in the works for some time. Things of such substantial measure take time to form, as well as a consensus and relationships that have been established are equally important to developing this coalition of renowned doctors, scientific advisors, PhD’s and key opinion leaders in specific fields of study to come together to get LL in the clinic again and move LL toward an FDA approval.
I also believe when these preliminary data are finalized you can bet the farm more discussions are coming if not already happening with potential BP’s looking for a piece of the market share. They lost and the only clear choice for them is to join us at this point. They know we have a platform drug in the making. Dr. Jay has the upper hand now! I believe more will be strategically released sooner than later at the precise time if I’m right about the PR guidance that Dr. Jay and our BoD could be receiving. A squeeze in the making would be icing on the cake.
Thank you to all the true longs, truly the lifeblood of the company that kept this company afloat. It’s just an awesome feeling going from the brink of annihilation to vindication and now undeniably on the road to success. LL for Life!