Anavex Life Sciences Corp (AVXL)

[Steady_T]

The FDA doesn't design trials. That is the job of the trial sponsor. Part of the trial design is the statistical analysis package (SAP). All of that is submitted to the agency for approval prior to trial start.

The SAP details the statistical analyses that will be performed on the data. The trial design specifies what types of data will be gathered from the trial and the frequency that it will be taken. The SAP is not an immutable document. It can be changed under certain conditions. It may be changed prior to data lock for example. There are certain circumstances where it can be changed after data lock although that is unusual and can compromise the validity of the trial.

The point of this is, the required checklist of required data points and analysis is specified by the trial documents and approved by the agency.

Much of the discussion about stat analysis is because we haven't had access to the SAP. As I understand it most SAPs are not made public so that is not a "red flag".

Dr. Jin does have access to the SAP and also knows the various ways that the FDA is willing to see the data analysis based on the SAP.
The FDA can request the raw data and perform its own analysis of the data using whatever techniques it sees ae appropriate without regard to the SAP. Again, as I understand it, that is not done most of the time but if the FDA sees something it doesn't like or thinks there is a better approach it can do so.

I hope this is helpful.