Replies to post #508576 on Anavex Life Sciences Corp (AVXL)

[tredenwater2]

One question, WHY? Why was this data not allowed in one or two of the clockstops to be introduced? “Pulling” us into submission has saved us nothing unless the goal is to allow this data in the next 15 days to be submitted.

This stinks to the high heavens.

[MayoMobile]

Thanks for corroborating my claims. I was definitely doing some historical PR/presentation pulls this weekend to see what analysis the company may have had excluded from this initial filing. Will be confirming some of this at the next CC.

[DoTheRightThing]

So this is the new spin? Missling playing "4D chess"? So we're supposed to believe he purposely got the application rejected so he could bring in the mystery data on appeal?

Do you people hear yourselves? Do you have any shame at all? You're playing on people's desperation.

I urge everyone getting hope from these fantasies to be careful.

[dennisdave]

So more data saying the same thing will somehow magically convince the EMA review team?
The EMA’s negative trend vote already means the core efficacy package was judged insufficient, even after Anavex presented all their best arguments during the oral explanation. Re-examination isn’t a chance to submit a new, stronger dossier it only allows re-arguing the same data that regulators already found unconvincing.

All those ADNI comparisons, ABCLEAR analyses, and post-hoc subgroups suffer from the same fatal flaw: they are exploratory, biased, and not acceptable as proof of efficacy in Alzheimer’s. A new reviewer team won’t magically reinterpret weak, post-hoc evidence as strong, pre-specified clinical results that’s not how regulators work.

Re-examination almost never overturns a clearly negative CHMP opinion, especially when the pivotal trial failed to deliver robust, primary-endpoint evidence.

Its over. The sooner everyone accepts that the better

[123tom]

This post should be a Sticky. Very relevant. .
Thanks, ssm11.