Teetering, One Way or Another
Just a quick thanks to everyone. Good feedback and discussion on multiple boards.
Today is 9/11, remembering the twin towers fell and to all those that fell victim to that event. Also, to acknowledge the passing of Queen Elizabeth & now the bringing in of the new King Charles. Condolences to the family & to those that suffer her loss.
Daniel 2:21: "And he changeth the times and the seasons*: he* removeth kings, and setteth up kings: he giveth wisdom unto the wise, and knowledge to them that know understanding:"
With the leaving of Queen Elizabeth and the incoming of King Charles, we will be seeing significant change. And we all can see the tremendous changes between Nader and Cyrus. Now we see the headship at CytoDyn being re-built, newly arranged and set-up. Re-group and Return coming. Times & Seasons take time.
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Not much here in this week's post, mostly, a review.
What's coming?
The estimated completion date for the "Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ mTNBC" trial is this coming Friday, 9/16/2022. What is the "Estimated Completion Date"?
It is the date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date.
Therefore, based on this definition, I would not be expecting to hear anything regarding mTNBC aside from guesses, expectations, but the report on the primary outcome measures, secondary outcome, etc.. should come a few weeks after.
I suspect CYDY share holders will be very pleasantly surprised by the results of this study. There exist many critics on this study as to the way it was carried out and how it is a mish mash of prior studies and how that is so atypical from the normal means by which a study is carried out. Agreed; it is by no means the norm, but it was done this way out of necessity, to bring about a point. And it is this point, that the results will illustrate, exactly why leronlimab is feared.
It is my suspicion that this study shall reveal the powerful effect that leronlimab has on bringing metastasis to a halt. I believe, that the moment leronlimab is introduced to the patient, the quantity of Circulating Tumor Cells, CTCs and Cancer Associated Macrophage-Like Cells (CAMLs) within the blood serum take a significant fall and continue to drop precipitously to near zero or to some "low" threshold which Recknor may come to appreciate, marking a clinical "Remission" of the cancer. He may also find, that the moment that this threshold is once again crossed, this time, from below it to above it, that the signs and symptoms of the cancer's return is appreciated and marked. Depending on how long leronlimab was maintained in the patient, it may be determined how long the cancer was held in check or remission, providing that it was administered at least monthly, keeping the cancer at bay, and then, based on PFS, when the cancer returned and therefore, what the effectivity of leronlimab was. Also, some patients only received leronlimab for only 4 injections and then it was stopped. Their PFS will be noted and appreciated and incorporated into the results as well and will show why it is so important to continue treatment with leronlimab indefinitely or at least with the use of feedback bio-markers like CTCs and CAMLs.
This report may be a couple weeks away.
Regarding this recent Press Release:
Trodelvy® Significantly Improved Overall Survival in Pre-Treated HR+/HER2- Metastatic Breast Cancer Patients in TROPiCS-02 Study
-- 3.2 Month Survival Benefit Demonstrated in Patients who had Already Received Prior Endocrine-based Therapy and at Least Two Prior Chemotherapies --
-- Trodelvy Now Shows a Survival Benefit in both Pre-treated HR+/HER2- Metastatic Breast Cancer and Second-Line Metastatic Triple-Negative Breast Cancer --
It is important to understand that this Press Release has nothing to do with metastatic Triple Negative Breast Cancer. This only has to do with HR+ and HER2- metastatic Breast Cancer. So, when shareholders are thinking that Gilead has made a breakthrough in treating mTNBC, they have not. For mTNBC, Gilead's Trodelvy PFS remains 6 months and OS 12 months.
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Just want to make mention of Brazil with the Covid 19 trial, possible un-blinding to extract safety data, which I don't believe will occur.
Possible resumption of that trial. Relationship to Clinical Hold?
Or even the entry into a possible partnership for long haulers? Does the FDA even recognize Long Haulers yet as a treatable disease? CytoDyn has stockpiles of leronlimab which should certainly be used in a huge clinical trial towards treatment of long haulers, with a partner, but which partner would do so if the FDA does not recognize long haulers as a treatable disease? So, back in the day, why did the FDA request ramping and escalation of these medications to treat Covid and now they choose not to use them, or prefer to squash them?
How is all this related to the Clinical Hold? Very much so. The Clinical Hold is used as a tool by the regulators to buy time and money for those already approved by the regulating body, while our inventory sits on the shelf.
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We know the Clinical Hold will come down because Kelly said we have the data and it needs to be re-formatted and that is or has already been done, and that a Type "C" meeting is scheduled to be held in September with the FDA to work out a means to lift this Hold.
But, what I see, is an inter-relationship between this Hold, the Brazil Trial, the mTNBC Trial, Amarex Arbitration and Partnership.
Right now, "they" have the upper hand. The Clinical Hold is in fact imposed. Yet, for how long? What if they refuse to lift it? Then they have won, correct? CytoDyn would need to start a new? But CytoDyn has sufficient data and has shown what it needs to show regarding leronlimab in order to attract partnerships and relationships to initiate combination trials with leronlimab. So, I see, that the point that CytoDyn finds itself sitting on right now, seems to be a Teetering point, where almost anything could happen, trying to keep everything under control, where the Clinical Hold could and should be lifted or that it should be, but they refuse to, or won't. Certainly, "they" wish that the Hold never be lifted and that CytoDyn be forced to do it all over again or that CytoDyn just go away all together, but, regardless of which way the cleaver falls, I see positives for CytoDyn in either direction, because, even if it falls outside of CytoDyn's favor, as a result of the work which CytoDyn has already done, CytoDyn shall be brought out of the apparent mire.
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Again, I keep thinking that everything which is happening at CytoDyn is inter-related. That the Hold is the power "they" have to thwart all of CytoDyn's milestones and goals. But that the Hold can not be held forever. I am thinking that the Amarex Arbitration resolution shall have an important impact on this Hold decree in some way and may force that an Enforcer be enacted to maintain fairness, to maintain rules and regulations and to maintain equality between all entities in relationship with the regulating body. I keep thinking that this Enforcer will likely be CytoDyn's first Partnering Entity. The Entity who initially Normalizes with CytoDyn will be a Powerful Entity. They will act almost like a liaison between CytoDyn and the regulators as they will run the combination leronlimab trials with their already proven trial expertise and experience. That Enforcer will already be an acceptable Entity to the regulating body.
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Have a Nice Day All!
Posted Sep 11, 2022, 2:37 PM UTC