Cat Let Out Of The Bag

CytoDyn was forced to find a niche. A place of safety from its surrounding enemies. The FDA told CytoDyn, you're not needed in the mult-drug resistant indication, that is already covered. Find an HIV indication where you are needed.

CytoDyn must build itself up. It requires an indication upon which it alone can stand, and one which nobody else can stand. Upon this solid rock CytoDyn stands and it is that indication upon which it must stand, such that, upon standing, CytoDyn is then lifted up. This lifting up then becomes the purpose of this special, never before seen, never before tried, never before even dreamed of indication, but through which, CytoDyn shall be elevated and delivered.

From the time of its earliest beginnings, back say 20 years ago, even unto the point where this new trial will attempt to prove out leronlimab's capacity in reducing immune activation inflammation in HIV+ patients, CytoDyn has never been shown any favor. That is because of CytoDyn's inherent disarray. After completion of the coming proposed HIV trial "the proposed next study is to look at leronlimab in HIV+ ambulatory subjects (we know it is safe in that group) in individuals who demonstrate elevations of immune activation levels, so known evidence of immune activation and inflammation, and tentatively looking at both doses (350 and 700) and looking at a nested placebo arm, so that at the end of 24 weeks of treatment we can at least get a real measurement of whether leronlimab has moved the needle there or not ", this trial shall prove to the world that CytoDyn no longer is in disarray. Following the coming trial, CytoDyn shall be blessed with favor.

It is clear by the sheer consensus of the meeting that CytoDyn has the capacity to run the proposed trial and they also have the resources to run the trial. It appears as if Dr. Jay Lalezari already has the patients at the ready to go. The cost of the trial is within their ability to manage with Migliarese indicating about $300k total cost over the 24 week treatment for all the patients slated. Lalezari says leronlimab stores are sufficient for this trial. With this post written by u/1975Bigstocks discussing Gilead and Jordan Lake, MD, it is super clear, that Dr. Lake was to some degree fueling the push for this special indication. u/1975Bigstocks attaches this article. Jordan Lake, MD is one of CytoDyn's Scientific Advisors. As such, the design of the trial will probably be headed by Dr. Jordan Lake. Now, Dr. Jay Lalezari, as CEO of CytoDyn, in on the meeting with FDA for the special HIV subpopulation, as well as Dr. Lake, and who knows, possibly, even Gilead present along with KOLs and FDA? At least it is probable now that Dr. Lalezari is talking and in discussions with Gilead with whom he is already quite familiar.

Dr. Lalezari said that most Big Pharmaceuticals were not interested in leronlimab because it was a subcutaneous injection lasting only a 1 week half life. BP wanted either a daily pill or a monthly subcutaneous injection, or an every 3 month subcutaneous injection. So, because of this, we can be assured that at least Gilead is interested in long acting leronlimab. VIR is also interested in long acting and in fact, they are developing their own VIR-1338 cytomegalovirus vector vaccination for HIV, but, I suspect, it is not working as well as they would have hoped. With their history with Scott Hansen and Jonah Sacha, MD, they are keenly aware of leronlimab and how it is being developed at OHSU with AAV as a cure to HIV. It is clear from VIR's recent 10-k, that they are capable of manufacturing monoclonal antibody and therefore, given all that, I suspect VIR is the recipient of leronlimab's manufacturing technology transfer and if so, then VIR and CYDY have an NDA partnership in place, and we know the ties between VIR and GSK are strong. Keep in mind, GSK has a failed MASH drug and a strong PD-1 blockade, second only to Keytruda. Both drugs of theirs could use leronlimab's augmentation. In addition, CytoDyn has a 3rd party AI partnership in place with ASCII who is at work with the biomarker details.

Dr. Lake has learned which biomarkers are affected by long term HIV patients. She knows their comorbidities and she has studied which biomarkers are affected. She already knows through the NASH trial the effects of both leronlimab 350mg and leronlimab 700mg on patients. Some of effects of leronlimab on biomarkers is detailed here in the 6/30/22 Conference Call, Reduced Biomarkers and BioMarkers in NASH Trial. These biomarkers show what happens to the body when leronlimab is injected. These are the inflammatory biomarkers which are increased during a long life of HIV, while the patient takes AntiRetroViral Therapy, ART. "Because immune activation inflammation is the primary driver of mortality in HIV patients: Strokes, heart attacks, and kidney disease*. ... in individuals who demonstrate elevations of immune activation levels, so known evidence of immune activation and inflammation, and tentatively looking at both doses (350 and 700) and looking at a nested placebo arm, so that at the end of 24 weeks of treatment we can at least get a real measurement of whether leronlimab has moved the needle there or not.*"

Dr. Jay Lalezari appears to have the patients ready, so once the hold lifts, the trial may commence immediately.

Towards the end of the statement, it says, "Half of the patients we are going to enroll are going to be transgender women who have elevated activation markers because of the hormonal therapy they are taking*, and in fact what I had mentioned earlier is that* the FDA, having received the protocol, has asked if they can cross reference the IND file for NASH -- which is exactly the right question to be asking which is ‘what other evidence do we have that leronlimab is mediating inflammation and immune activation*?*"

The NASH data I pointed to above, was requested by the FDA to assess leronlimab's affect on these biomarkers. It will allow the FDA to understand how to interpret the effect of leronlimab on the patients in this special HIV population. It will help CytoDyn secure a stronger MASH partnership as well once the FDA has gone through the MASH data. So, who might want to be in the MASH space with leronlimab? There are many BP, but certainly, GSK has a failed MASH drug which could be augmented by leronlimab. Also, it seems that everywhere CytoDyn is, there too you will find Gilead. I would not count out Gilead being keenly interested in leronlimab for the indication of MASH, especially, when it becomes clearly functional as a long acting subcutaneous injection.

Is it possible to rebuild the relationship between CytoDyn and Gilead? Like it was mentioned above, u/1975BigStocks made it clear the strong relationship our Scientific Advisor Dr. Jordan Lake has with Gilead. From his long and vast experience working with HIV, Dr. Jay Lalezari has strong ties with the company as well. The FDA works very closely with Gilead. The FDA would prefer that CytoDyn and Gilead were on the same page. So would Dr. Lalezari. I think it may be possible to find a peaceful solution that brings together the two companies. Maybe a coalition that has the ability to put into place what the consensus between FDA, Gilead and CytoDyn becomes. Maybe this is what the FDA is seeking to achieve? Maybe they want to forever prevent CytoDyn's runaway recklessness which it portrayed prior to the hold being implemented? Maybe, the FDA is seeking a concentrated effort of all CytoDyn's partners to unite together behind the company, to keep CytoDyn on track? But, then, why the do it yourself special HIV sub-population trial?

Was the cat let out of the bag? This trial? Maybe, there was not enough time and CytoDyn had to do something right now. Like it is now or never. With Dr. Lalezari, CEO recently coming on board, before Thanksgiving, and a week later conducting this fund raiser, CytoDyn clearly has one last chance to get 'er done and then, either submit a BLA for the Phase III trial or a Phase IV trial, or at the end of the 24 weeks, it may be an EUA, it is unclear, but, it will result in something big, that is what Dr. Lalezari said, "something big". CytoDyn doesn't have any time to waste. It is now or never. Pressure has mounted and is overflowing to bring all of the uncertainty to an end. A concentrated effort of our partners is in play that keeps CytoDyn on a path. Manufacturing, AI partners and then also, with our Scientific Advisors, Dr. Lake and Dr. Noureddin in consideration of the endpoint biomarkers in both HIV and MASH and lastly with potential collaborators and suitors in discussing the Top Line Results of the coming proposed trial.

We have a situation here where it appears that the hold lift is imminent. They are expecting it, "So that is what we are waiting to hear, and I believe the clock is ticking, and that we are expecting to hear one way or another from the FDA in the next two weeks and from there we are either off clinical hold and we are raising money and we are launching this study, or we are dealing with whatever else is being sent our way." I think the meeting where this was spoken was held on the Tuesday before Thanksgiving. That means, they are thinking that the FDA answer is received by 12/6-7.