Anavex Life Sciences Corp (AVXL)

[sokol]

Measuring effectiveness of AVXL 2-73, see:

Early Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industry

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

This is interesting. How has Anavex designed the phase 2/3 AD trial in Australia? If designed this way, this may be a measure (or an acceptable substitute for a measure) of effectiveness of AVXL 2-73, assuming these new guidelines (or at least the below alone) are/is adopted by the FDA.

”A randomized-start or randomized-withdrawal trial design (with clinical outcome measures) is the most convincing approach to demonstrating a persistent effect on disease course. Generally, a randomized-start design would be most appropriate for use in AD. In this study design, patients are randomized to drug and placebo, and at some point, placebo patients are crossed over to active treatment. If patients in the trial who were initially on placebo and then assigned to active treatment fail to catch up (after a reasonable period of time) to patients who received active treatment for the entire duration of the trial, a persistent treatment effect on disease course would have been shown.”

To find the above quote, go the the website reference and begin reading on line 270. The lines are numbered.