Anavex Life Sciences Corp (AVXL)

[XenaLives]

Almost like Anavex had a hand in helping the FDA figure it out...

What speaks volumes is that when these NEW FDA guidelines rolled out last week, all the aforementioned pioneering was already completed.

... enough said!

 
  
 283 Currently, there is no consensus as to particular biomarkers that would be appropriate to support 
 284 clinical findings in trials in early AD. For this reason, sponsors at present have insufficient 
 285 information on which to base a hierarchical structuring of a series of biomarkers as secondary 
 286 outcome measures in their trial designs. Sponsors are therefore encouraged to analyze the results 
 287 of these biomarkers independently, though in a prespecified fashion, with the understanding that 
 288 these findings will be interpreted in the context of the state of the scientific evidence at the time 
 289 of a future marketing application 
  
 

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