Replies to post #430767 on Anavex Life Sciences Corp (AVXL)

[Bourbon_on_my_cornflakes]

Dead money until an NDA is filed.

Pretty clear now that Rett results need to be heroic and followed up with an immediate NDA.

Alz approval will only be made on a repositioning of the drug after Rett approval.

Years to go unless Rett results are astounding.

[WolfofMia]

The big ol elephant the shorts refuse to see lol

[boi568]

How would the FDA justify using amyloid plaque reduction as a biomarker, which is sometimes present in healthy individuals and is now being acknowledged as symptomatic instead of causative, yet reject as a biomarker excessive brain shrinkage -- clearly causative in AD and not present in healthy individuals? Brain shrinkage is certainly analogous as a biomarker to tumor size in cancers, which are obvious biomarkers.

Excuse my usage here, but accepting a reduction in excessive brain shrinkage as a new AD biomarker is a no brainer.

[Joseph_K]

MABs exacerbate brain volume loss.

People in two large lecanemab trials on the highest drug dose—which is the one the U.S. Food and Drug Administration (FDA) approved—recorded, on average, a 28% greater brain volume loss relative to placebo after about 18 months. This translated to a loss of an extra 5.2 milliliters (mL) in brain matter.
https://www.science.org/content/article/promising-alzheimer-s-therapy-and-related-drugs-shrink-brains#:~:text=People%20in%20two%20large%20lecanemab,(mL)%20in%20brain%20matter.

Hoskuld, you understated your case!

AD patients lose significant brain volume annually (unabated when using mab therapies.)

I should state that I've also come across a hypothesis that the brain volume loss from MABs comes directly from the loss of plaque itself (I suppose in contrast to loss of neurons), and so is not a bad thing. It may have been a Saabagh piece where I read that. (I'm not saying I subscribe to that hypothesis.)