Cytodyn Inc (CYDY)

[Borel Fields]

Man, I remember all those names! Remember what most of them are about.

I would love to have what I think is called the "statistical analysis package" - the stats addendum submitted with the initial documents requesting the FDA approve the trial.

The calculations you recall - hazard ratio, kaplan-meier, etc., are for endpoints that either occur at some date or not within the trial: e.g. death. Cochran-mantel-haensel is for binary outcomes stratified by groups.

I think the take away from the group convo today is that, because the primary endpoint is specified as the change in total symptom score, they are treating it as a simple, numeric, cardinal variable. Hence, a basic t-test seems likely to do the job. We'll see.

By contrast, the secondary outcome "7-point ordinal scale" by that phrasing doesn't allow adding or subtracting - I saw the calc "# of patients with a one or more point improvement" somewhere.