Cytodyn Inc (CYDY)

[Borel Fields]

I just sent this to Dr. Pourhassan:

I note the mild/moderate and severe/critical trials both collect the "change in 7-category ordinal scale* at day 14."

In the interest of statistical power, would the FDA consider** pooling patients from both trials in calculating the significance of this change? More precisely, an ANOVA (or its non-parametric cousin) fits this data structure perfectly.


* The scale has death as a 1 and out of hospital with no restrictions as a 7.

** As a post-hoc, secondary endpoint