Replies to post #188889 on Cytodyn Inc (CYDY)

[justdafactss]

DSMC also requests another data review when enrollment reaches 293 patients (75%) to analyze all data, including survival rate at 42 days
https://finance.yahoo.com/news/cytodyn-receives-positive-dsmc-recommendation-100000996.html

Correct me if im wrong but seems DSMC gave CYDY a chance to change the protocol (2 to 4 doses) and CYDY refused that offer right?

[kgromax]

Misiu I have already answered that point.

Again, and again, defining subgroups for a medical protocol is an ENTIRELY DIFFERENT THING from defining subgroups as part of a STATISTICAL PROCEDURE, eg the endpoints. The medical protocol needed this severe vs critical distinction, to filter out patients that could not participate to the trial. Fine. Now read the endpoints. None of the endpoints was split according to severe vs critical. None of them. So, different things.

I can repeat it ad infinitum…

[HyGro]

The protocol has to identify that the endpoints would be analyzed by Severe and Critical -- it didn't. If they were going to, they would have a stratified sample with sample quotas for each -- they didn't. All they did was define Severe and Critical by their symptoms. That's required for an inclusion criteria.