Replies to post #120411 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

It is only a couple of weeks ago that the pre-screening website for Rett patients was launched. Would the Rett org and Anavex agree to do that if they were not reasonably assured that approval for trial start is in hand?

It would be unethical to just string these girls and their families along without sight of FDA trial approval, would it not?

Rett trial will start this year! If not...

If one trust that, then it would be rational to expect the other two trials start this year too.

Does all that imply a common master protocol? Perhaps, but for that idea I have no concrete evidence from company communications.

[nidan7500]

If the FDA is allowing multiple trials to start, with the idea that 2-73 can treat multiple indications, and somehow streamline approval, with direction and guidance from the FDA

Agree with your thought process. Almost too good to be true. Suggesting that informed people (medical experts) can review data and actually make a decision on risk to pt. and then actually ACT on the decision. Again, the safety/risk profile of A2-73 is critical at this point, which is probably why Dr. M. has emphasized this so often.

So, let me see if I got your thought process here. A2-73 presents no risk to patient, data suggests efficacy w/Rett (other indications), quickly design a trial to assess efficacy in humans, execute the trial, monitor and measure process/results. Review results according to best clinical practice and cGMP/trials protocol. Can we do that? Binary event day coming. TOGA, TOGA...

[attilathehunt]

I think Rett can start when ready and if prelim date shows efficacy (i.e. fewer seizures) then perhaps the other trials (AD, PD, MS, Angelman, Fragile X, etc.) can be attached to the Master Protocol with fewer patients thus speeding up the approval process (and with lower costs).

This may be part of the "tip of the iceberg". The Rett trial (the tip) with bring along all the other trials.