We will, hold or no hold, too many good things about to pop. How now with long weekend? HOLD LIFT IS NOT ALL SO WHETHER IT COMES NEXT TUESDAY OR THE FOLLOWING....Let this sink in, a little morsel by way of Biloxi who like me loves his tequila and bourbon so he had this to say:
As per this article, this is where we stand, waiting: “The FDA identified five distinct areas it wanted the company to remediate. CytoDyn has addressed and submitted documentation for all five, Arman said. The (FDA) regulator then came back in February with a sixth item, for which the company has since submitted documentation.”
Yes, the FDA is scrutinizing CytoDyn’s submissions. They are tightening their analysis and questioning every detail of this harmless molecule. As Cyrus has said, everything is complete, everything has been submitted, and he is confident in all of it, that it has fulfilled every request made by the US FDA. If Cyrus is right, and if the submitted documentation meets all the requirements of the US FDA, the FDA has no choice but to lift the hold. The FDA is a government agency. They have rules by which they operate. If CytoDyn has fulfilled all of its imposed requirements and if those submissions are also up to par with their thresholds of acceptance, then the FDA has no choice. They will have no basis upon which they can lay claim to deny lifting of the clinical hold on Leronlimab. So then, Big Pharma may attempt to influence the FDA in their decision-making process, but their hands are tied here.
Cyrus made these five submissions and then the 6th in the most rigorous fashions. If I were to venture to guess, I’d say that his two workhorses in producing these 5 documents were both Bernie Cunningham, Vice President of Supply Chain and Project Management and Joseph Meidling, Senior Director of Clinical Operations. The foundation of these 5 documents was the finalized data which was verified and validated by (4) External FDA Type Good Clinical Practice Auditors, hired by Cyrus, who worked with CytoDyn’s Internal Audit Committee on the Aggregation of the Raw Data which was obtained by a court injunction from Amarex through a $6.5 million bond put up by David Welch, so that it may be transformed into the FDA accepted Type GCP formatted data. All of that was perfectly executed by Cyrus and CytoDyn team. It has been done.
18 months ago, we learned that MD Anderson would be conducting a xenograft study in mice of Leronlimab in combination with a check point inhibitor, a PD-1 blocker for the treatment of various breast cancers in this BioSpace article: https://www.biospace.com/article/releases/cyt...kade-icb-/
As Jake alludes to their already being 18 months since the study began, and his equating 6 weeks of mouse time equivalent to 6 years of human life, the facts are that not even a few months would be necessary to determine the approximate effectiveness of Keytruda combined with Leronlimab in the treatment of various breast cancers. In the most recent mTNBC trial which Leronlimab was a part of, Leronlimab obtained an overall survivability (OS) of about 13 months and a progression free survival (PFS) of about 4 months. But mTNBC is the most aggressive type. In HR+ and HER2-, those numbers are much greater, let’s say they are 3 times better for those types of cancers, (which they are not, and I don't believe they are even twice as good), so, just for worst case scenario, we can say that 3 years for OS and 1 year for PFS for HR+ and HER2- type breast cancers. So if 6 weeks = 6 years, then 3 weeks of mouse time = 3 years of human time and 1 week of mouse time = 1 year of human time. So therefore, the results of the effectiveness of this combination of medications should not take long at all. If the medication was very effective, even allowing these mice to survive for just 4 weeks, or 5 weeks after being inoculated with the cancer tumors, then we can know that the combination is effective in these MSS tumor types. MSS being Microsatellite stable, which are a type of tumor which are very difficult to treat, but 85% of breast cancer is MSS. Keytruda alone is only indicated currently to treat MSI or Microsatellite Instability. But, with Leronlimab, Keytruda + LL may become indicated to treat the MSS tumor population or about 2,000% more than what it currently treats in breast cancer alone.
The BioSpace article says that “Leronlimab is currently being trialed in combination with Keytruda (pembrolizumab) in a breast cancer xenograft model in partnership with MD Anderson Cancer Center.
Arman said CytoDyn expects to observe an enhanced anti-tumor effect from the combination and identify immunological biomarkers.” In my opinion, both Cyrus and Merck have already observed an enhanced anti-tumor effect from the combination of Keytruda and Leronlimab. Again, in my opinion, I don’t believe the study is currently still on going; rather, I believe that it has already completed. The Top Line Data too may already be written and determined, just not yet released. Why would it not be released? Waiting for the hold to lift. Even if the Top Line Results need to be written yet, usually, it would take about 6-9 months or at most a year to write Top Line Results and a study like this should be finished quite rapidly even accounting for the cataloging of the immunological biomarkers. I feel we should see this Top Line publication in April or May 2023, but it will follow the lift of the hold.
The BioSpace article would not have been published had the MD Anderson results been unfavorable to Merck. Certainly, both entities are comfortable revealing that the study was conducted as a combination of Keytruda with Leronlimab. As Jake states, in the original Press Release, the identity of the actual check point inhibitor was concealed, but now that the results do point to a favorable outcome of this combination drug, both CytoDyn and Merck are comfortable revealing the identity of the PD-1 blockade and of the company. CytoDyn is comfortable making this announcement because the outcome must be positive. Merck is comfortable with the announcement because they need to find future indications for Keytruda and it seems they have found their answer and they too must believe that the hold will soon be lifted.
So this is astounding news here at CytoDyn and it is like a trumpet blast. It is almost as if the whistle has been blown that a partnership is in the works, but just cannot be revealed until the hold is lifted. Think about it, how can Merck announce to its shareholders that it intends on partnering with a company with a drug which is currently held by US FDA? They too need this hold lifted for this partnership to begin. They too need these Top Line Results written to present to their share holders so they too know how well Leronlimab works with Keytruda. And when Merck makes this announcement to their shareholders, about their plans to dramatically increase their tumor indications by combining Keytruda with Leronlimab, that will be a massive day for both Merck and CytoDyn. Yes, the massive Merck, joins together with the crippled CytoDyn in an undertaking that will raise both beyond their wildest dreams. 2,000x current breast cancer indications.
Merck didn’t miss anything. They looked beyond the disheveled appearance of the company and found the sparkling gem within it. They have taken up the heart aches and the troubles which have been laid upon CytoDyn and wait for it to completely up right its act. And it will be a marriage made in heaven. Merck has found its answer to expand and enhance the list of indications for its blockbuster Keytruda. The results must be very, very good for this mega-corporation to fancy the likes of CytoDyn because of what Leronlimab will do for Keytruda. Expand breast cancer indications by 2,000 times. This will utterly change CytoDyn from what it is right now. This is a company changing event and it sits at our doorstep but when it happens, it will make history in the big pharma world.
This is more than bread crumbs we are eating. This is like a slice of blueberry pie or my favorite, chocolate fudge cake with chocolate icing on top and on the sides. A big slice has fallen off that table which we can dig our teeth into and lick the icing off our lips. As Cyrus said, “9:25, We expect next year, 2023 to be catalyst driven in terms of growth and development for the company and we think that the table is set for a large number of significant developments to occur in early 2023, including the submission of our complete response to the partial clinical hold for HIV, new additions to the leadership team, a corporate rebranding, and then following those events, we plan on initiating a NASH trial as well, as continuing the advancement of the long acting CCR5 molecule.”, but in this tasty slice of chocolate fudge cake, we have received more than just a morsel of the fine delicacies that we are about to feast on.
YES I WILL FEAST AND DRINK THIS long long WEEKEND AND GIVE THANKS ABOVE FOR LERONLIMAB/CYRUS/CYTODYN $CYDY$
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