Replies to post #215603 on Anavex Life Sciences Corp (AVXL)

[ElsaSara]

My guess is that those two sites are recruiting a number of patients in addition to the 120 originally planned and therefore total full enrolment takes a little longer than originally anticipated.

I agree. It has been always my thinking, but n in Rett Usa at the beginning was 15, later they updated to 21, I think that since last presentation we know that n in Avatar study is 33 , not 30.
If n was different than 120 they could have updated this number in last presentation as well.

[F1ash]

Why the PDD trial expansion is the key question. Did Australia/MacFarlane request participation? Did Anavex want to increase the statistical power of the PDD trial? Did Anavex want to support the approval process for A2-73 in AU and collaborating authorities in the region with the PDD indication?

Could it be that Australia was willing to allow 30 and 50 mg unlike the EU dosing?


https://www.anglicare.org.au/about-us/media-releases/new-anavex-trial-for-parkinson-s-disease-to-open-in-sydney/

“Trial participants will be randomly assigned to receive orally 30 or 50 mg of Anavex 2-73 or a placebo for 14 weeks.”

The trial is only registered on clinicaltrials as high dose / low dose so would Anavex be able to avoid updating and therefore avoid having to discuss why the lower doses in the EU?