Anavex Life Sciences Corp (AVXL)

[nidan7500]

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

[quoteTime-to-Event Analysis
254
255 The use of a time-to-event survival analysis approach (e.g., time to the occurrence of a clinically
256 meaningful event during the progressive course of AD, such as the occurrence of some degree of
257 meaningful impairment of daily function) would be an acceptable primary efficacy measure in
258 clinical trials in early AD. Sponsors considering such an approach should discuss their plans
259 with FDA early in development.
260
261 E. Assessment of Disease Course
262
263 Although the demonstration of a substantial clinically meaningful treatment effect of any sort is
264 of paramount importance, this may not be feasible in a clinical trial of reasonable duration,
265 especially very early in the course of the disease, and clinical trials in early stage disease will

266 usually be intended to provide evidence that a drug has permanently altered the course of AD
267 through a direct effect on the underlying disease pathophysiology, an effect that persists in the
268 absence of continued exposure to the drug.
269 ][/quote]

So, it stands that AUS strong performer biomarkers are key to this discussion. Unless trial sponsors and regulatory bodies are able to understand and agree to markers (WHICH HAS NEVER BEEN DONE)they will still be looking long after we are all dead. Wonder why IND discussion is still open?