Replies to post #347995 on Anavex Life Sciences Corp (AVXL)

[kund]

if the FDA is the one recommending the changes and you believe it? Misleading has been talking to FDA since 2015 he never ever showed any concrete things on these discussion, guy just lies though his teeth time and again.

[LBSR TO DA MOON]

Nothing here is screwed up if the FDA is the one recommending the changes.

Assuming this is true and accurate, shouldn't AVXL issue a PR as soon as possible explaining that all of the changes were per the direction of the FDA?

[pcguy]

What you are suggesting is that data was collected under the original trial design. The post I responded to suggested that there is not sufficient data to report on the original trial design. This is the perception piece... when the design was changed it should have been changed at that time, with a press release explaining the changes. Instead, we now have data based on a trial design change, at the end of the trial. Whether the FDA recommended or not, the perception is that the trial design was changed after the fact. When did the actual trial design change, and where is the communication?

[imho]

Nothing here is screwed up if the FDA is the one recommending the changes.

Lying or not, I don't know. But if the FDA did in fact make these recommendations, it is a game changer. Given this from the PR,

“This is now the second successful placebo-controlled study of ANAVEX®2-73 in adult patients with Rett syndrome, and this Phase 3 study builds on the platform potential of ANAVEX®2-73 and its ability to demonstrate clinically meaningful improvements in Rett syndrome symptoms in the ANAVEX®2-73 treatment group compared to placebo,”

it may imply the FDA is coming around to the "platform potential" mentioned above.

IMHO