I was wrong about NP confusing the Amarex statistician with the FDA "firewall statistician". But the FDA has no such thing as a "firewall statistician". Statisticians at the FDA have three functions - review of the submitted trial protocol, review of SAE's or deaths submitted to the FDA during the trial, review of a study halt if advice is sought by the company and review of final data from a BLA submission.

It is possible Cytodyn sought advice on a halt and the FDA either advised against a halt or advised for a second interim analysis. NP may have used the term firewall statistician because he's the only one at the FDA to see the data and thus the FDA was firewalled.

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33:35
We are all blinded, everybody's blinded. The only person who's unblinded is the Amarex biostatistician who is allowed to be unblinded to do the analysis for DSMC. DSMC also saw the data and the firewall statistician at the FDA also saw the data and that's it.

1:16:20
I just got done telling everybody that the firewall statistician at the FDA has the data and they haven't stopped us from going forward, right.

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