Shelly, If Brazilian trials are not well execut
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Posted On: 02/12/2022 2:59:45 PM
Re: Shelly2626 #118008
Shelly,
If Brazilian trials are not well executed, Cytodyn has demonstrated both an inability to learn from past mistakes and an inability to execute a trial for critical illness.
There really is no appropriate remaining excuse.
As much as I believe the deck is stacked against small upstart companies, Cytodyn directly, or indirectly through poor oversight of Amarex/Nader-Kush friendship, bears responsibility for the failure of CD12.
Yes, FDA denied a four dose trial regimen, but CD12 was an adaptive trial which was not well executed (unequal distribution between placebo and leronlimab arms) and for which planned interim analyses were skipped.
Attention to detail and careful execution matter, not just exuberance.
With Albert Einstein and Dr. Recknor in place, I don't see those mistakes being repeated.
Sorry for preaching what is already known, but we need Cytdoyn to execute, not explain additional failures.
If Brazilian trials are not well executed, Cytodyn has demonstrated both an inability to learn from past mistakes and an inability to execute a trial for critical illness.
There really is no appropriate remaining excuse.
As much as I believe the deck is stacked against small upstart companies, Cytodyn directly, or indirectly through poor oversight of Amarex/Nader-Kush friendship, bears responsibility for the failure of CD12.
Yes, FDA denied a four dose trial regimen, but CD12 was an adaptive trial which was not well executed (unequal distribution between placebo and leronlimab arms) and for which planned interim analyses were skipped.
Attention to detail and careful execution matter, not just exuberance.
With Albert Einstein and Dr. Recknor in place, I don't see those mistakes being repeated.
Sorry for preaching what is already known, but we need Cytdoyn to execute, not explain additional failures.
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