Anavex Life Sciences Corp (AVXL)

[Investor2014]

Patients with gene variants were NOT excluded... rather identified.

You really haven't read and understood my posts with the FDA/EMA/TGA definitions of Precision Medicine.

But you are right, no patient exclusion and hence not Precision Medicine, at least not yet.

As I have also said, Anavex are rightly at work to identify biomarkers of response to A2-73. So far they have identified S1R wt. vs. variant, which is highly stat sig even in a small sample, but not with a big clinically meaningful difference to patient outcomes. Hence, little point in exclusion based on the S1R biomarker.

Thus so far just ordinary give every patient the same medicine hoping that on average patients respond well enough (effect size) to get a stat sig outcome for the sample size.

We are hoping to see the effect size being large enough that overall the upcoming readouts are stat sig. If not then selecting on e.g. S1R variants and more likely other biomarkers may get us over the mark in the next Precision Medicine trials. Alternatively, the prespecified subgroup analysis show stat sig results that can lead to approval we would also have PM and a label that includes only patients matching the approved subgroup.

It would be best for investors that no exclusion is necessary and none will be part of the label should A2-73 be approved.

If Precision Medicine, then patients are selected for certain e.g. genomic characteristics and the label will reflect that. This would be best for the right patient, getting the right medicine at the right time. Perhaps then the cost of the medicine would be higher to some extend compensating for the smaller market.