Replies to post #369300 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

Yes and consequently the PDD trial was renamed as a Proof of Concept study.

I also note that the latest pipeline has the planned PD study as a P2 rather than a pivotal trial.

The two adult Rett trials were small and both had a pretty large placebo response. Yet both trials produced stat sig outcomes.

The RSBQ and CGI both yield quite volatile outcomes being observational and subjective measures. That is still true even when attempting to frame the measures with CGI anchoring and AUC rather than just baseline to EOT.

However, with a 3rd and larger paediatric Rett trial underway and convincing readout from that, it will give context to the two small adult Rett trials.

I believe Anavex depends on a great Excellence readout to file an NDA for all ages of Rett patients. We’ll see in Q1 next year.

[peeved]

I think you are spot on.

I just hope its p4 no p3 for tha Ad or else we are out years

This is why realistic buyout or partnership is the best option imo

[kevindenver]

Anavex has ran as large of trials as they had funding for. There was no "messing up", and only since the 2021 capital raise has $AVXL had a decent cash balance to run larger trials.

Also, regarding Rett, "I think he finally realised that he needs larger cohorts and this is the true reason behind expanding the Excellence trial." I doubt Dr.M "finally realized" anything...it's the public that are the ones finally understanding what has been done and why.

"The two upcoming readouts will be the endgame for 2-73 IMO." ... yes very much some put up or shut up moments ahead.

[frrol]

The Excellence trial was likely expanded for the reason you gave. The Avatar results showed potential signal, but disappointed on dose effect. More patients (and longer time period) clarify signal. (The peds may also have greater 'plasticity'.)

Hopefully we'll be hearing about the FX trial soon, since it is in planning mode according to the current pipeline chart. The company had the time between Avatar results and now to devote resources to it. Not sure how the company can be truly "planning" for the undisclosed indication's trial without having decided what it will be.

On another note, I'm puzzled by the pipeline chart not showing any planned trials yet for 3-71 (no orange).