Anavex Life Sciences Corp (AVXL)

[Steady_T]

I agree with you about the reduction in brain vol loss as being a valid biomarker.

As I read the draft it was making clear that there are few valid measurements for AD in the pre stages and stage 1. Their point being that there are biochemical tests being developed that show very early stages of AD where there is still not a measurable cognitive deficit. Hence the need for biomarkers to follow the disease development.

Overall the draft had little to say about later stage AD development.

My sense of this is the FDA is recognizing that by the time there are measurable cognitive deficits it may be too late in the treatment process to recover much lost ability. Therefore the FDA is focusing on very early detection and treatment before significant damage is done to the brain. To do that will require biomarkers of the disease process rather than cognitive measures of decline which reflect the extent of brain damage already done..

This new focus does suggest that there may be an opening for 2-73 or 3-71 to be used as an early treatment to prevent or significantly slow disease progression. That bad news is that the trials to show that will be long and won't have any impact of Anavex for several years if ever.

The immediate problem is to get 2-73 approved for any indication and get the MOA validated. For AD that will fall under the stage 2 & 3 AD patients in the current trial.

Notice that the draft didn't mention any biomarker other than plaque. I read that as a call to the medical establishment to find and validate new AD biomarkers and it indicated a willingness of the FDA to consider new AD biomarkers.