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Posted On: 12/12/2022 1:00:29 PM
Post# of 148878
All of us have had some experience with schools and grading. If we think of the FDA as a teacher grading Cytodyn's trial submissions, we can see the FDA has very high standards (except for some of the teacher's pets).
The FDA is not going to pass your work unless it is worthy of an A grade. Unlike school, there is no advancing with sloppy, incomplete work that would rate a C, D, or F. Even B work is probably unacceptable unless there are unmet needs or nothing better out there - chemo for cancer for instance.
Cytodyn and Leronlimab are only getting past the FDA with Grade A work. Our mTNBC trial work showed that - another student got there first with work that impressed the teacher and Cytodyn's work product didn't demonstrate that Leronlimab was that much better for survival and outcome even though it is. But Stefan Gluck saw the work that wasn't turned in and is very impressed - world class result that were deserving of an A.
Cytodyn now has individuals that know what A level work is and hopefully they are capable of producing it and presenting it to the FDA. Tanya Urbach hopefully is now in charge of quality control on several areas. Besides matters with the FDA, she also controls the quality when it comes to other regulatory matters and what we need to do to get financing.
Quality, quality, quality - that is what has been Cytodyn's biggest problem (think Amarex here especially) and we have only gotten this far because of the quality of Leronlimab (AAA). That is what Cyrus said in the CC before last. He wouldn't have joined up with Cytodyn otherwise nor would the other talented people we now have on Cytodyn's team.
The now-present quality at Cytodyn must be demonstrated in everything they do. There really is no room for screw ups. If that can be done, Cytodyn and leronlimab's prospects are still very good and the share price will follow.
Quality, no screw ups!
The FDA is not going to pass your work unless it is worthy of an A grade. Unlike school, there is no advancing with sloppy, incomplete work that would rate a C, D, or F. Even B work is probably unacceptable unless there are unmet needs or nothing better out there - chemo for cancer for instance.
Cytodyn and Leronlimab are only getting past the FDA with Grade A work. Our mTNBC trial work showed that - another student got there first with work that impressed the teacher and Cytodyn's work product didn't demonstrate that Leronlimab was that much better for survival and outcome even though it is. But Stefan Gluck saw the work that wasn't turned in and is very impressed - world class result that were deserving of an A.
Cytodyn now has individuals that know what A level work is and hopefully they are capable of producing it and presenting it to the FDA. Tanya Urbach hopefully is now in charge of quality control on several areas. Besides matters with the FDA, she also controls the quality when it comes to other regulatory matters and what we need to do to get financing.
Quality, quality, quality - that is what has been Cytodyn's biggest problem (think Amarex here especially) and we have only gotten this far because of the quality of Leronlimab (AAA). That is what Cyrus said in the CC before last. He wouldn't have joined up with Cytodyn otherwise nor would the other talented people we now have on Cytodyn's team.
The now-present quality at Cytodyn must be demonstrated in everything they do. There really is no room for screw ups. If that can be done, Cytodyn and leronlimab's prospects are still very good and the share price will follow.
Quality, no screw ups!
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