Anavex Life Sciences Corp (AVXL)

[nidan7500]

Ahhh, this is gonna take a while...a quick look suggest that if/when you have established a clinically meaningful biomarker then...YOU DA MAN.

From FDA Guidance doc on defining start, etc.

Assessment of various biomarkers may provide supportive evidence for a drug that has an 279 established clinically meaningful benefit, but the effects on biomarkers in AD are not sufficiently 280 well understood to provide evidence of a persistent effect on disease course. 281 282 Currently, there is no consensus as to particular biomarkers that would be appropriate to support 283 clinical findings in trials in early AD. For this reason, sponsors at present have insufficient 284 information on which to base a hierarchical structuring of a series of biomarkers as secondary 285 outcome measures in their trial designs. Sponsors are therefore encouraged to analyze the results 286 of these biomarkers independently, though in a prespecified fashion, with the understanding that 287 these findings will be interpreted in the context of the state of the scientific evidence at the time 288 of a future marketing application.

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM596728.pdf