Replies to post #449927 on Anavex Life Sciences Corp (AVXL)

[Steady_T]

How about a little subtlety.

The Rett trial was not the clear success that was hoped. Everyone can agree with that I think.

It also wasn't stopped for futility which is a clear failure. Although that didn't stop Adulhelm from going forward after two trials were stopped for futility and it was still approved. So there's that.

There was some evidence of efficacy in the trial. That level of efficacy did not rise above the placebo effect sufficiently to meet the P<0.05 requirement.
There is also the anecdotal examples of reduced seizures in Rett girls. The trial did have a seizure log as a measure. Whether the seizure logs support that as a real result could have an impact on what the FDA thinks about the overall trial results.

So, whether the Rett trial results in approval or not is still up in the air. That decision will be made by the FDA. If the FDA says go ahead and submit an NDA the trial was was a success. If the FDA says run another trial to clarify the situation the trial was not a failure nor a success. If the FDA says don't bother with an NDA the trial was a failure.

What can be said is that endpoints were not met with P<0.05.