Cytodyn Inc (CYDY)

[Badge04]

If they say to continue as is and keep enrolling patients to meet the primary endpoint, that’s a good thing. It means they are on track for statistically significant data and approval.

If they opt to unblind and take a penalty, if the data shows that they are not on track for a statistically significant endpoint, essentially the study is terminated. There’s no upside to doing especially if the recommendation is to enroll 60 some additional patients.

If they request to see the data and it looks good, they FDA is still going to recommend continuation but now the penalty for unblinding makes it more challenging to hit the primary endpoint. I’m just not sure what the advantage would be to asking to see interim data unless you want a reason to terminate early due to funding concerns or some other motivation to terminate the study.

I probably did a poor job explaining but it’s how I interpret what he said and the strategy around the decision