Replies to post #257639 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

1. From the P2a data Anavex decided to look for genetic and other biomarkers affecting the response to A2-73
2. Based on the KEM analysis conclusions Anavex identified that the SIGMAR1 and COMT genetic variants influence response to A2-73. Microbiome composition was added to other parameters such a disease stage and A2-73 blood concentration
3. Anavex have said ALL current trials will have pre-specified subgroup analysis, although the published PDD protocol does not included this information. The Rett and AD trials do, probably just an admin issue
4. The precision medicine approach is now being tested in the current controlled trials to see if the data driven biomarker hypothesis can be confirmed
5. If (4) proves true, then the next trials will be precision medicine trials selecting patient enrollment on confirmed biomarkers

Is that clearer?

[XenaLives]

Not true:

So the success and failure of the trial is based on full group so not precision.

Then trial can get provisional approval based on any hypothesis that the TGA accepts.