Replies to post #512494 on Anavex Life Sciences Corp (AVXL)

[Kentucky123]

Appreciate your input. What are your thoughts on brain atrophy?

[sab63090]

Doc328

Thanks very much for your detailed explanation about the wording CHMP used & it seems they actually did understand the power and it certainly needs to be addressed! You know I'm lost in this stuff though.......I see we are reducing the shots in the arm for school aged children, as in Denmark (Investor might like this)

Have a Merry Christmas, we'll be back on the 27th, but will enjoy our time with the family; we always have a lot of fun there; the beach albeit cold, the game room with me shooting some pool with my son-in-law and several other fun machines; they all like the sauna and Jacuzzi (not me)...ha ha

Merry Christmas!

Steve

[AlchemicalVoyager13]

Thanks for the professional input doc. Truly so. While I too believe they had perhaps half of the needed trial participants I am wondering if, with the inclusion of OLE which granted has no placebo for obvious reasons, the data is strong enough to warrant an exception to approve for WT only with conditional follow up data. Your thoughts on that and yes, I know the appeal is far from a certain positive outcome. That said, many countries are rejecting paying for MAB treatment.

[catdaddy]

Someone thinks differently:

No Widespread Criticism of Underpowering

Publications (e.g., Journal of Prevention of Alzheimer’s Disease, 2025) and presentations (CTAD 2025) emphasize positive outcomes without noting power as fatal.
EMA's negative opinion (trend vote) cited endpoint inconsistencies and design concerns, but not explicitly sample size/underpowering as primary issue. Re-examination is ongoing.

In summary, the SD=4.5 was optimistic but defensible for early AD and advanced methods. The trial's significant findings on cognition, secondary/global measures, and biomarkers indicate sufficient power for key effects—far from "invalidating" results. Larger confirmatory studies would strengthen evidence, but this does not represent a critical methodological flaw undermining validity.

[frrol]

I too suspect it has to do with the statistical analysis (though may not be limited to that). The "methodological issues" is a big concern, and has to be explained by the company. Company has not done so. We may not find out until next CC, when Missling gets directly asked. That's a poor way to handle it. Missling.

[LakeshoreLeo1953]

Perhaps my Father’s most enduring cautionary tale in MY upbringing

“Liars can figure, but
Figures don’t lie”

Missling is VERY close to being judged.

Hopefully those lucky enough to play the dead cat bounce at $3 have cashed before the next two weeks of selling pressure.

THEN Anavex will be ALL that can influence SP.

Travel Safely if that is your intent.