Anavex Life Sciences Corp (AVXL)

[WolfofMia]

If there is no selection on patients characteristics biomarkers, there is no precision medicine! There may be precision research, thoroughness etc.

At present there has been no selection and as you say because it appears all patients on average may benefit sufficiently well to achieve stat sig results without the need for very large trials. We don’t know for sure yet, but we will get insights to that when eventually we see about AVATAR and EXCELLENCE.

Well there may not have been patient selection, but you may still have precision medicine in the application end of the stick if information is discovered but not proved.

You may recruit without biomarker exemptions, I would start with the whole too, then break it down and disprove your theories as they may come.

But if in a P2 you find out there are gene exemptions which limit efficacy of your drug you may or may not prove this on a P3 if you don't need to, it is to your advantage to, but is your choice ultimately to do so or not.

If your drug works, stat sig efficacy and all, then you may not need to exclude patients in your P3, delaying your over all approval timing for extra information that may give you ultimately more knowledge of MOA. and disease pathology.

However with what you found out in P2 of potential gene limitation you may dose those patients with the expression or alternations of genes on the higher dose of the medicine. Action end of the sticks with findings from the P2, yet to be verified.

Would this classify as precision medicine?