Cytodyn Inc (CYDY)

[stockorus]

Very interesting what he says on NEWS2, which was checked on days 3, 7, 14.

Subjects on leronlimab were more than twice as likely to improve their NEWS2 score compared to placebo at both Days 3 and Day 14 (p < 0.05 for both).

Cytodyn must have claimed meeting this endpoint, meaning for days 3 and 14, I don’t recall how they clarified in their communications. I wonder what the technical reasons would be for not meeting the endpoint for the trial according to fda. Perhaps they had to get this result on day 7 also in order to call the endpoint successful. The fallout of the fda letter for the general reader is that this important result is made to look like it never occurred and has no meaning to suggest possible clinical benefit of LL.

(But to make a better case, we have to also know what the day 7 comparison was. For instance, we don’t want something weird like on day 7, placebo is twice as likely to improve NEWS2 compared to LL. Rather ideally, LL is still better on day 7 but just not with such low p value.)