Licensing Exceeds Flaunting
Well, PL had a post requesting that we focus. Unfortunately, that post was taken down. But, I'll honor his request that we focus. The next few weeks are important.
Yes, in the next 10 days, the inauguration for POTUS draws nigh. But, what ever is happening at CytoDyn really doesn't have all that much to do with the land mass of the USA. It has scant little to do with Mexico. However, a modest comparison can be made if the annexation of Canada is considered. Also the intentions of POTUS concerning Greenland, the Panama Canal and the Gulf of America can be analogized to Partnerships and/or licensing. Why does Trump seek out the annexation of Canada, of Greenland, and the Panama Canal? Natural Resources that afford the US Government an improved capacity to protect itself. The Panama Canal and the Gulf of America gives the US Government increased capacity to protect itself. Well, why would anybody want to partner with CytoDyn or license leronlimab? The answer is quite similar. It gives that licensing suiting company the ability to augment its current medication per indication. It gives that partnering company the ability to expand into other indications it desires to enter.
Trump is Pro-CytoDyn, pro-expansion, pro-cure, pro-health, pro-successful enterprise. Those policies are a blessing to CytoDyn. Big money BMGF emerges as a blessing to CytoDyn because of our breakthroughs in HIV. GSK transforms into a blessing to CytoDyn because of our breakthrough everywhere else.
Everywhere else and everything else around the world is of no concern, only what happens at CytoDyn and that which is of interest to our suitors. What happens at VIR is not of interest. Let's focus in on one area which I believe is necessary to focus in on. That is all which is hidden right now from CytoDyn. All the Unknowns:
- What is the true Mechanism of Action of leronlimab in MASH?
- Can CytoDyn expect a licensing or a partnership based on the murine study's findings?
- Functionality of leronlimab in MSS metastatic Colo Rectal Cancer
- How much of an improvement can we expect to achieve in the current Phase II Clinical Trial in:
- Overall Survival
- Progression Free Survival and
- CytoDyn's #1 endpoint Overall Response Rate?
- How much of an improvement can we expect to achieve in the current Phase II Clinical Trial in:
- Functionality of leronlimb in GlioBlastoma Multiforme
- Will the addition of the chemotherapy agent temozolomide improve the outcome of the new murine study like Dr. Pestell strongly believes?
- Functionality of leronlimab in TNBC
- How do the new murine studies improve upon what we already know concerning mTNBC?
- Functionality of leronlimab in Alzheimer's Disease
- Who is the outside foundation fully funding this Pilot study?
- What is the neuro-radiology endpoint of the study?
- Functionality of leronlimab in Pulmonary Fibrosis
- Who is the major Academic Institution that would fund a Pilot study at their own institution in their own patients?
- Will the determined mechanism of action of leronlimab in Pulmonary Fibrolysis be similar to what it is in MASH fibrolysis?
- Functionality of leronlimab in Long COVID
- Will the NIH award CytoDyn with this Granted Clinical trial determining leronlimab efficacy in Long COVID?
- If so, will it be permitted that aspects of the the Inflammation - Immune Activation Clinical Trial be incorporated?
- Functionality of leronlimab in Chronic Fatigue Syndrome
- Who would be fully funding this Pilot Study?
- How big is this Pilot study?
- Who would be the CRO?
So, how does the system have us by the balls? They have us because we are forced to play by their rules. There is no choice in the matter. If you want to get a drug out there, these are the steps necessary to get the job done. This is what you have to do. We do have to get the drug approved therefore, we must play by their rules. That is what we are doing, and it means running trials. But 80% of what we're doing is being funded by somebody else. CytoDyn only seems to be funding the MSS mCRC Clinical Trial. Despite this incredible benefit, the clinical trials still do take a lot of time just to get them going because they require design, planning and approval, but that is currently ongoing and in the works.
If it hadn't been for this requirement, CytoDyn would simply unleash leronlimab onto the world stage and watch it work and derail all the currently approved medications like Keytruda and Humira. CytoDyn can't do that because it is unlawful. Playing by the rules means that you move ahead much slower, but if you're better than your competitor, then you should theoretically, move on ahead if you are playing the game fairly.
There comes a time when the surrounding enemies of CytoDyn do get eliminated because leronlimab is simply that good. Leronlimab is better and CytoDyn is playing fair. CytoDyn fights the multiple battles listed above simultaneously. If CytoDyn is chosen for the NIH Long COVID trial, then Long Hauler's becomes another battle front. If not, then Chronic Fatigue Syndrome is ready and set to go. If the repeat GBM murine study is proved to be successful by Dr. Pestell, then yet another Pilot study opens up in GBM. If leronlimab defeats liver fibrosis regardless the cause, then still yet another Pilot study opens up in Pulmonary Fibrosis. The only thing that stops CytoDyn from progressing in an indication is if leronlimab fails in that indication, or if the funding sponsor decides to bail. Otherwise, there would be no reason to stop.
But in MASH, there are no offers yet. At least no disclosed offers. No plans for another MASH trial. So then why else does CytoDyn pursue MASH? Because, in this indication, leronlimab can already successfully treat it and CytoDyn appreciates incredible value in the indication. So then why did CytoDyn stop its presentation at the MASH-TAG conference of the new MASH murine data which shows that leronlimab exceeds resmetirom in reducing both liver steatosis as well as liver fibrosis? By withholding this information from the public at large, who then would be benefited? Who then would not be hurt? Is CytoDyn just playing a game of compromise?
If that information were to be presented, who would this information be against? Madrigal. Madrigal would lose face if this information were presented. CytoDyn has chosen not to present it, at least temporarily. Could Madrigal have made mention that they might be interested in licensing? Licensing seems to me the only way Madrigal could get a piece of leronlimab. Partnership is not an option.
If a licensing deal comes through, CytoDyn would be looking at a tremendous cash influx. A licensing deal for leronlimab gives Madrigal the capacity to turn its partially approved resmetirom into a completely approved medication, an approval free from restriction. Of course Madrigal would need to get leronlimab approved, but once they achieve that feat, a year or two down the road, the entirety of the whole MASH indication becomes theirs, unrestricted. Currently, they are allowed to treat only about 315,000 patients while the entire MASH patient population exceeds 15 million. Madrigal is only permitted to treat up to a NAS 3 while MASH has patients that range all the way up to a NAS 8. Licensing leronlimab, very conservatively, would give Madrigal revenue of $15 billion annual sales instead of the $300 million they are limited to today. That's a cool 50x over what they can currently bring in and that is considering only 1 injection of leronlimab per week per 15 million patients pricing each leronlimab injection at $1k. In contrast, in the Phase 2 NASH Clinical Trial, leronlimab was injected weekly for 14 weeks and the same weekly schedule was done for all the murine studies which were carried along for 12 weeks.
If CytoDyn is discussing a licensing deal, I'd like to think that a cool $300 million would be a fair number in order to to license leronlimab to Madrigal, which would include a royalty to CytoDyn of 10% on all sales indefinitely. The $300 million would be payable: $200 million up front and $100 million upon leronlimab approval. What would that do for CytoDyn? Right now, that would be a Bonanza for CytoDyn, because CytoDyn really needs the cash. But is that what the deal should be priced at? Hardly. Leronlimab affords Madrigal 50x over what they are currently limited to and therefore maxed out at. Resmetirom has no chance at eliminating the fibrosis at NAS 4-8. Its only hope is to combine leronlimab if it hopes to do so. Given the combination with leronlimab, the licensure is certainly worth $1 billion minimum. However, even at $300 million + royalties, at this point, it becomes a bonanza for CytoDyn. But for Madrigal, maybe not so much, but in the long run, it would be proved that they would have stolen the license. If this deal is announced, it becomes a very bad day for G, the Big Pharma who weighs their heavy thumb over and upon CytoDyn's parade. This is just one part of the avalanche of stones which hits G behind the knees.
Consider that right now, there is a table covered in sawdust. It requires cleaning by an air blast burst from an air gun/pressure nozzle. Hit it and boom, you can again see the table top. That sawdust is G, Big Pharma, who presses their heavy thumb over and upon CytoDyn's parade. With G out of the way, for a moment in time, CytoDyn can see the clear skies despite the thick layer of saw dust density hovering about, (Thank you Evil). A time is opened up to where they believe that they can branch out to do that which is necessary to expand their next indications for leronlimab. A time for Peace and Safety. A time to do what they absolutely must do in order to play this necessary game at the level of their competitors. Currently, $200 million goes a very long way for tiny CytoDyn and then another cool $100 million not too long thereafter would immensely help them out exceedingly.
CytoDyn has the Inflammation - Immune Activation Clinical Trial that is already approved and set up with CRO and only requires that it be run. Well, if CytoDyn decided not to present the MASH findings at MASH-TAG because of a potential licensing deal in the works, then maybe this Inflammation - Immune Activation Clinical Trial would soon become a reality through a MASH licensing fee via LIVIMMUNE license. In this case, such a licensing deal is far better than showing off, far better than flaunting.
In one fine day, just as the POTUS seeks out the annexation of grand land masses and portals of entry, with one cool burst of air, in a likewise manner, so does the lure of billions of dollars sufficiently entice some noteworthy players to license leronlimab so as to harness that power it may provide. On that day of the announcement, the sawdust is cleared off the table. Bye bye bye G and Bye bye by to all your proxies.
Similarly, an oncoming deal for a long covenant is established also in oncology, similarly in HIV, likewise in brain related pathology, furthermore in the pathology related to fibrotic scarring.
Annexation soon becomes the focus. POTUS similarly supports CytoDyn at least sufficiently enough to stand behind any/all collaborations between CytoDyn and its suiting companies.
PL, this is focusing in.
Posted Jan 10, 2025, 11:20 AM UTC