Tuesday, July 20, 2021 9:06:23 AM
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The clinical trial website shows that these trials were single arm studies. Without a placebo arm, how have you come up with formal numbers like 300% increase in mPFS and 450% increase in mOS? Even Daniel Adams in the PR only stated that typical mPFS is 2 months while we had 6 months - which is only 200% increase and not 300. And people in stock forums claim that literature shows that Cytodyn’s median (mean?) values are no better than the typical numbers unlike what Adams claims.
Let us know how exactly you got 300 and 450; FDA will surely expect a rigorous justification based on available literature and “typical values” largely accepted in the medical community. Tell us what that is.
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