Cytodyn Inc (CYDY)

[stockorus]

It was not pre-approval. They mention this in page 4. They say the "Models for raw ordinal data would not converge" whereas for the present repeated measures model, it does converge. From what I heard at the cc, they will propose this model to the FDA for granting phase 3.

Based on wikipedia, this is a standard way of assessing data: https://en.wikipedia.org/wiki/Repeated_measures_design

Note among the stated uses:

"Limited number of participants—The repeated measure design reduces the variance of estimates of treatment-effects, allowing statistical inference to be made with fewer subjects."

So we need not assume the entire model is adhoc. It is probably a standard model that FDA can accept as valid. And for this small trial, it probably would have made sense to use such a model.

As for the weighting score, that may appear simple or concocted but it is straightforward: severe should receive a higher score than moderate etc. So give it score 3, moderate 2, mild 1, none 0. Higher total score, worse the evaluation. Such a weighted assessment does not seem outlandish by any means; not to me.

Cytodyn is not doing something wholly deceptive by using such a scale. It is one simple scale and one standard model that shows Leronlimab works better than placebo for a good number of symptoms. If FDA thinks it is not precise enough to make conclusions, they can suggest otherwise.