Replies to post #23201 on Cytodyn Inc (CYDY)

[Northstar42]

The ASM Release is consistent with the Poster Presentation, but includes specific information I did not find on the Poster and vice versa. As I said in a prior post, I hope the company posts the complete Poster Presentation on the website. Here are a few more points mentioned in the Poster Presentation:

Anti-PRO 140 antibodies were not detected
Favorable PRO-140 PK profile that allows once-weekly dosing
No change in co-receptor tropism at virologic rebound

Safety Summary -
Generally well tolerated
No discontinuation due to AEs
No pattern of toxicity
Administration-site reactions were infrequent, mild
transient and self-resolving( in less than 10% of subjects)
No dose-limiting toxicity in preclinical or clinical studies.

[finesand]

re p ~ 0.0032 interpretation / correction (oops)

Just got a correction to my previous post here
from my biotech peer. She states the following:

- p 0.05 -> 5% chance of result being by error
- p 0.01 -> 1% chance of result being by error
- p 0.003 -> 0.3% chance of result being by error

The p value efficacy only correlated to quantification of achieving the assumption, here reaching 0.5log10 VL sup.
Any patient achieving more than 0.5log10 VLsup won't increase p, but just one notch below cut's them off from the succeeding population.

Knowing the 'mean 1.65log10 VLsup' makes this high quantification success above 0.5log10 even better.

Since we don't know exactly how they statistically analyzed it, but using ITT (Intend to Tread) and Pro140 arm against placebo baseline, we cannot now yet how many patients actually achieved 0.5log10 VLsup, but we know it is a multiple of the required population.