Cytodyn Inc (CYDY)

[HyGro]

There was NO protocol specification to read a critical subgroup or any other subgroup. If there was an attempt to read a specific subgroup then the protocol would have specified it and their would have been recruiting specification for a minimum sample size to have a readable sample size (not 62), and the matched demographics.

Comment:
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"It was random within the constraints of the protocol"
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NP did a post-hoc data dredge to find subgroups that he could claim success. He also manipulated the statistical analysis using inappropriate p-values computation. This was not appropriate and the FDA Statement reprimanded CYDY for misrepresenting and manipulated the clinical data analysis INCLUDING the critical subgroup. NP didn't even do an EUA submission as he knew the FDA's opinion of his data analysis.

As you said, the FDA indicated that post-hoc subgroup analyses (after trial protocol failure) are useful for informing future trial activity but not for marketing approval application.