Cytodyn Inc (CYDY)

[tikotiko]

Thanks again for confirming that I used the software correctly. I put together the simple table below to show a wide range of possible scenarios (I only show 3). I kept the assumption of 17 placebo patients and 34 Leronimab patients, but it would be easy to test other sample sizes. The table can help us gain a better understanding of the efficacy that Leronimab must achieve in order to prove that it is better than placebo with enough statistical significance (p<0.05). It is also interesting (and perhaps surprising) to notice how the required efficacy for p<0.05 of Leronimab strongly depends indirectly on the failure rate in the placebo group.

Failure (Mortality) Rate with Placebo. Maximum Allowed Failure Rate with Leronimab
(assumed) (required for p<0.05)
6/17 = 35% < or = 4/34 = 12% (Tough case for Leronimab)
9/17 = 53% failure < or = 9/34 = 27% (Example you presented)
12/17 = 71% < or = 16/34 = 47% (Easier case for Leronimab)

The million dollar question is can we guess where the placebo and Leronimab trial results will end up? The answer is obviously not for now, until they finish the trial or decide to unblind and release preliminary results. I am sure that many in the CYDY staff are looking at this, because it is probably the most important outcome facing them and us. I trust their judgment, plus the anecdotal evidence tells me that we will be ok, and so does my gut....

The only other information that I can think could help us guess outcomes, but probably not by much, is the limited information from the initial anecdotal results in NY, UCLA and elsewhere. Have you or others here looked at these anecdotal results to see if any of them may help us form a better guess of placebo vs. Leronimab results?

I would also be interested in knowing more about the possibility of the FDA providing a bit of leeway in approving Leronimab, but I don’t know if this is possible. For example, it would be nice if the FDA would consider giving CYDY a bit of a break because it gets convinced that Leronimab’s benefits clearly outweigh any concerns on the statistics and it has no side effects. This would only be needed if the results do not not attain the required p< 5 % or if there are some unusual conditions in patients, tests, protocols or outliers. It would seem like a reasonable decision based on the huge break Redemsivir recently got. However, I think that most here will sleep better if the results simply kick ass and we don’t need any favors, which I think will be the case.

Exciting times ahead and fingers crossed....