Anavex Life Sciences Corp (AVXL)

[frrol]

The company will analyze the data from our trials by running OLS regressions on the data. The dependent variable will be simply the efficacy measures. The independent variables will be everything: dosage (0 for placebo), biomarkers (which will be binary: yes or no), gender, age, baseline measures, donepezil dosage, etc, etc. The correlation coefficients that are produced will show what factors were 'relevant', and to what statistical confidence. The point being that such analysis will reveal the validity (relevance) of the biomarkers, independently of anything else, including whether the participant was on placebo or not.

(They will also be analyzing covariance between independent variables. Eg, to check the relationship between changes in GABA and glutamate, and changes between efficacy measures like MMSE and ADSL.)

So whatever you're concerned about, with a large n trial that's been properly placebo controlled and blinded, whatever effects our drug, the placebo, the biomarkers, the age, the baseline MMSE, etc has on any efficacy outcomes, it will be statistically rendered for analysis, and will hopefully be clear and significant. If it isn't clear and significant, it won't be because of using placebos and biomarkers together. If that is what you were concerned with, no need to be.