Replies to post #417919 on Anavex Life Sciences Corp (AVXL)

[Steady_T]

So if the proposal was rejected, then what is the issue?

So what happens if the baseline to EOS mean is not clearly stat sig, whereas AUC might be?

The trial fails. It didn't meet the SAP statistical test. That wasn't too difficult to figure out.

There is no coin flip. The endpoints were chosen, the SAP was specified just like any other trial. The FDA provided guidance on the stats which suggests to me the trial reflects the then current thinking of the FDA.

Who cares what the AVATAR EOS mean result was. The trial was sufficient to move on to a pediatric P3 trial. The AVATAR results will be presented to the FDA along with Excellence trial results and other 2-73 data.

The FDA will look at the both Rett P3 trials and the other submitted data and make a decision.