What is behind the CYDY Curtain?

Dear Longs,

I wanted to help with broadening our collective understanding of several things that may be happening behind the CYDY curtain:

1. CYDY may still be finalizing IRB approvals at the various investigational sites that are being targeted for the HIV Chronic Inflammation trial. I mentioned this before but it takes time to get things through the IRB process and if everything went perfectly the first patient could be enrolled mid-late June. We will see!

2. Costs for those trials are tethered to exactly what biomarkers are being studied. We are aware of two main inflammation markers: CRP and ENGAGE. According to a recent post by u/MGK he quoted Dr. JL as stating: "and a HOST of other Biomarkers". I just did a general search for the cost of ENGAGE and lots of other info came up but not a direct cost tied to ENGAGE. I spoke to my primary care physician recently and asked if he knew about Interluekins. He was aware but was not sure if they had a test that he could order. He looked at his computer and they did have a blood test he could order, but it was not covered by Insurance. He did tell me it was close to $10K to test for the Interluekins. I declined but it got me thinking about all of the unusual biomarkers that CYDY will be studying and how much it might cost per blood test. So I copied and pasted my standard blood test done recently and all of the associated costs. Take a look ....this is standard stuff!

My Blood work:

Laboratory - General Classification
TOTAL $3,893.60
HC Albumin, Urine/Other, Quant - 82042 (CPT®)
$132.00
HC 6956 Lactoferrin Detect,Stl - 83630 (CPT®)
$28.60
HC Cbc W/Auto Diff - 85025 (CPT®)
$264.00
HC Venipuncture - 36415 (CPT®)
$85.00
HC Urine Routine-Micro - 81001 (CPT®)
$277.00
HC Psa Total - 84153 (CPT®)
$556.00
HC Lipid Panel - Calculated Ld - 80061 (CPT®)
$315.00
HC Free T4 - 84439 (CPT®)
$460.00
HC Highly Sensitiv Tsh - 84443 (CPT®)
$511.00
HC C Reactive Protein - 86140 (CPT®)
$375.00
HC Metabolic Pnl Comp - 80053 (CPT®)
$489.00
HC Creatinine Urine - 82570 (CPT®)
$266.00
HC Esr Automated - 85652 (CPT®)
$135.00

You can see that for standard testing it is $3900 and CRP was $375 by itself. The less standard a biomarker is, the more expensive it probably is; including the $10K for the Interleukins. So I would imagine theENGAGE, CD4 and CD8s and whatever other 'host" of biomarkers will add up pretty quickly. So I am making an informed assumption that each blood test for the 90 participants in the HIV Chronic Inflammation trial is going to be close to $20K - $25K. Let us start with $20K per patient per test. That is $1.8 million. I believe that at a minimum CYDY will have to do a baseline test, an interim test at 12 weeks, and a final test at 24 weeks. That puts our test total at $5.4 million. This does not include any funding towards the institution (clinic) administering the blood tests and administering the LL doses. Plus, hiring the CRO to make sure study protocols are followed and all electronic files are updated and in compliance with FDA standards. Lastly, somebody has to pay for the DSMB, and that is always the sponsor and I have no idea what those folks get paid. Therefore, my final estimate is this trial will cost CYDY anywhere from $6.0 mil to $6.5 mil. I hope I am completely wrong, but the minimum of $5.4 million comes from just the testing which is critical to our trial.

WHAT ELSE IS HAPPENING behind the CYDY CURTAIN:

3. From the beginning of my time investing in CYDY; I screamed for funding from BARDA, HHS, NIH, and any foundation with money. NP responded once to all of us (not me) and said Government grants would slow us down. I truly believe the Gov't was not going to grant any funds to someone who has been convicted of a crime. Obviously, we don't have to worry about that anymore and Dr. JL has a whole presentation to NIH on his Quest website. It is not a leap to suggest that Dr. JL is trying to get some NIH grant money for PASC. Getting grants to fund research/trials is nothing new or novel. Just look at our friends at VIR, the very basis of their key studies were all funded by a variety of grants but mostly the Gates Foundation. Therefore, it is easy to understand that a study like PASC should be funded by NIH, especially since the Biden administration publicized a very large amount of funding to NIH for PASC/Long Haulers.

It takes a lot of groundwork to get funding from NIH and you have to make a strong detailed case to receive a grant from them. I believe this is what CYDY is working on behind the scenes and having Mitch work on the costs is paramount in requesting this amount. Otto Yang and Dr. JL are banging out a suitable protocol and Cyrus might be working with potential partners and or a suitable CRO to execute the study. All of these things have to be costed out and this would take a lot of time. What gives me pause on this study is what are we going to measure as success. I feel like to a certain extent, I would want to understand the outcomes of the HIV Chronic Inflammation trial before proceeding with PASC; but we may have some of those answers already as u/MGK pointed out in his post the other day. Dr. JL stated that they went to the NASH study and pulled evidence from there as to LL's MOA on inflammation. So maybe there is enough evidence there to promote a successful PASC study using NIH funds.

4. We are all curious about the Glioblastoma, also known as glioblastoma multiforme (GBM) mouse study at Montefore/Einstein Hospital in NY. I believe we will not hear anything soon. Why? Several reasons:

A) This trial has three arms and two of those arms used a Merck drug. I believe the drug is: TEMODAR; nonetheless, we never heard the results from MDA on Keytruda and LL in mice but we are very aware a study took place. If Merck is involved with this GBM study in any way, we may not hear because of that reason alone..until such time Merck announces a partnership of some kind (which is what I am hoping for).

B) Most Scientific journals as a general rule despise data being bantered about in public before it is published. It greatly diminishes the need to read the scientific journal if the data is out in public already. So most researchers respect the scientific journal's requirement not to let data out to the public before publication.

C) Some researchers also keep quiet about their research and don't let info out to the public because they don't want others to perform a validation study so closely on the heels of the publication of their manuscript. They want the scientific community to have time to absorb the details and the work that went into the original study before it gets reinforced or refuted.

5. Who knows what could be happening with Long Lasting LL? I am sure that Dr. Sacha and Dr. Hansen are busy trying to move that project forward.

6. Still more manuscripts need to be finalized and then submitted for publication. As a reminder, once a manuscript is accepted, reviewed, and approved it takes 6-9 months (in Cardiology) to get published. Not sure what scientific journals CYDY has submitted to, but no matter what scientific journal manuscripts are submitted to there is a line of other manuscripts waiting for approval and publication. We will know when we see the publications and not anytime soon.

LASTILY

CYDY is moving at the pace that a company with limited funding and limited resources can move at. it is a slow pace and a step-by-step pace. I know it hurts all of us Longs to see the share price as low as it is, but I and many many other longs have never associated the SP with the value of Leronlimab. I know the story up until today and when the rest of the world knows the story the SP will change accordingly. Please note: the final chapters are being written now. The trials that definitively prove the worth of LL, have not been written yet. Those chapters prior have only been a tease of sorts. Earlier chapters of the story have only proved "provocative". The chapters that will be written will change everything for all of us and IMO the story of LL will be BIGGER than KEYTRUDA and HUMIRA combined. As my dear friend (who used to be a stockbroker) once said when your favorite stock went down in price: "Don't get sore buy some more"

I LOVE the LONGS, I LOVE LERONLIMAB, I LOVE LONG LASTING LL and I LOVE Dr. LALEZARI.

Go LIVIMMUNE!