Replies to post #445808 on Anavex Life Sciences Corp (AVXL)

[WolfofMia]

Just on these three alone we check all boxes.

first-in-class approvals; 10 (47.6%) previously received an Orphan Drug Designation; 13 (61.9%) received an expedited review pathway from the FDA.

We have RWE, the open label, genomic, and blood biomarkers that can still trend positively helping our case for approval on missed end points.

It would be nice to see the genomic differences between placebo and dosed.

Similarly, it would be nice to see the placebo express these genes also in the open label trial, along with further improvement way better than their current scores.

I keep forgetting how low the bar is for these indications, which is why the FDA approves drugs that miss endpoints.

Can wait to see further data, which will be in a long while. Now the focus should be that darn AD peer review.