Cytodyn Inc (CYDY)

[Bill_ENG]

CD12 was not an abject failure. It did not meet it's endpoint. In other words the goal was not met. But there are a couple of reasons for that.

It was a double blind randomized trial, so lets say that the way that the patient populations ended up was random and chance went against Leronlimab.

The difference in the age stratification that ended up happening meant that the Placebo arm without any other considerations was given a headstart due to the naturally lower mortality rate of younger patients vs older patients. The intended 2:1 ratio of under 65 ended up as 3:1.

Leronlimab plus SOC had to be better than the placebo plus SOC just to get to an equal mortality rate. So to improve on that means that yes, Leronlimab worked but technically did not meet the p-value and most likely because of Leronlimab being held to 2 doses. So this was a 4 week trial with only 2 weeks of treatment.

The next Trials should be home runs due to the Cytodyn team now being aware of the pitfalls of simplistic Trial design.

Just fixing the age stratification and number of dosages should net the required P-values. Going with time to release from the Hospital should be easier than mortality also. They should go with criteria that the CD12 showed they do better at.

They do need to take care to run the Trials in Brazil and India to FDA standards in order to be able to use the data for EUA and/or Full Acceptance in the US.

jmo