Anavex Life Sciences Corp (AVXL)

[Kettilbjorn]

If you couldn't understand the data ... its most likely because you don't understand research in general and/or have been bamboozled by FUDsters.

It's pretty basic TLD, although definitely shown on slides that were a bit thrown together last minute. I'd have organized it like this:
1) Evidence of slowed progression:
ADAS-Cog (gold standard cognition scale) difference scores (Endpoint - baseline), ~45% reduction in decline in drug group, p < .05
CDR-SB (gold standard combined cognition and function scale) difference scores (Endpoint - baseline), ~25% reduction in decline in drug group, p < .05

2) Evidence of improvements (rather than just slowed progression)
ADAS-Cog responders defined by -0.5 change (i.e, 0.5 better than baseline since scores go up with decline). Drug group ~90% more likely to produce responders. p < .05
ADCS-ADL (a function scale) responders defined by +3.5 change (i.e., 3.5 better than baseline since scores go down with decline). Drug group ~170% more likely to produce responders. p < .05

(Note that the primary outcome in other trials, such as lecanemab, is just CDR-SB change EXACTLY as shown by AVXL. Aducanemab failed this measure and still got approved on biomarker effects.)

Its not especially tricky, confusing, or shady. Its just incomplete ... just like Biogen/Easai's lecanemab data was when it was first PR'ed (go take a look). They filled the gaps at CTAD and then got their FDA review set up. AVXL's additional data will come (its absolute ignorance or FUD to say otherwise since they have ALREADY officially stated multiple times the data will be submitted for peer review and publication). There's also plenty of reason to expect the coming data to be even better. The company basically said so, and all previous science predicts that stronger responses will be shown in pre-specified sub-groups including those with the wild-type S1r allele (~80% of the pop) and those in the 50mg drug group. You never know, though, til you see the data.