Outlook Therapeutics Inc (OTLK)

[exwannabe]

The SPA is good news (did expect it, but sometimes can drag out),

Norse 8 is a non-inferiority study,. What that means is that they do not have to prove to be better than the ranibizumab, just as good as it. That is very reasonable from a common sense point, but has a tricky stat issue,

There is no such concept as "as good as" in clinical trial stats. Either one is better or not. But we all need the real world concept, so how to fix this?

The trial stat guys came up with a concept of a NI margin. Basically OTLK will be spotted a letter or 2 (do not know the details) and with that must prove to be better. This sounds a bit contorted, but there is no easy way to solve the conundrum

Now back to the FDA.. Obviously if the sponsor just says they want their drug to be spotted some advantage, the FDA may push back. And that is why getting the SPA for a NI trial really matters. The FDA has agreed that whatever NI margin is, is OK by them.

As far as executing the trial, That should be a given. There is ton of data here, we are not talking unknowns.