This seems like conjecture to me.
The only words from anyone at Cytodyn you quote are the one Dr. Jay made on hiring Max L. Since then, I believe he hasn't been mentioned in interviews and PRs.
For example, you write, "The Randomized Structure: The decision to structure the mCRC trial as a randomized 350mg vs. 700mg study carries the signature of a seasoned drug developer. This design is intended to satisfy the FDA’s Project Optimus requirements—a regulatory hurdle that Max, with his Yale/ViiV background, was uniquely qualified to navigate."
I'm pretty sure Jay told us the FDA was the one that insisted we incorporate patients given 350mg. In any case, it's a bad idea and might cost lives if the DSMB doesn't give (or hasn't given) the go-ahead to give 700 to everyone.
Just one example.
The only words from anyone at Cytodyn you quote are the one Dr. Jay made on hiring Max L. Since then, I believe he hasn't been mentioned in interviews and PRs.
For example, you write, "The Randomized Structure: The decision to structure the mCRC trial as a randomized 350mg vs. 700mg study carries the signature of a seasoned drug developer. This design is intended to satisfy the FDA’s Project Optimus requirements—a regulatory hurdle that Max, with his Yale/ViiV background, was uniquely qualified to navigate."
I'm pretty sure Jay told us the FDA was the one that insisted we incorporate patients given 350mg. In any case, it's a bad idea and might cost lives if the DSMB doesn't give (or hasn't given) the go-ahead to give 700 to everyone.
Just one example.
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