Anavex Life Sciences Corp (AVXL)

[nidan7500]

In patients in the earliest clinical stages of AD (Stage 2 patients), where only subtle cognitive
188 deficits detected on sensitive measures of neuropsychological performance are present, and there
189 is no evidence of functional impairment, it may be difficult to establish a clinically meaningful
190 effect on those subtle cognitive deficits during the course of a trial of reasonable duration.
191 Nonetheless, a possible approach is to conduct a study of sufficient duration to allow the
192 evaluation of the measures discussed above for Stage 3 patients. As patients transition to Stage 3
193 during participation in the trial, the principles applicable to outcome assessment for Stage 3
194 would apply.

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


This suggests to me why the FDA abandoned decades of massively expensive AD trials which ultimately could not be justified as clinically useful.