Anavex Life Sciences Corp (AVXL)

[NWDR]

Regarding stopping and un-blinding a trial before the end date.

For each trial there is a Data Monitoring Committee (DMC) that looks at safety and efficacy. The DMC will do interim assessments at pre-determined times in the trial of how the patients are doing... those on placebo and those on the drug being tried. IF the patients on the drug are doing significantly better than the patients on placebo then the DMC can recommend to the company that the trial be stopped and all patients switched to the drug. The company then has the decision as to whether to continue the trial or stop and un-blind.

The point is that the company never sees the data about how the trial patients are doing, those on therapy or those on placebo. The DMC evaluates this data and makes recommendations to the company.

Of course I would expect that if A2-73 works as we expect then the DMC will see this at the first interim assessment and recommend the trial be halted and all patients switched to A2-73. In our AZ trial when would the first interim assessment be... 12 weeks, 24 weeks?? The company has a much better understanding of how well A2-73 works, at the proper dosage than we currently do. If I was designing the trial I would set up the first interim to be at the time I thought a majority of the patients would respond to therapy at the optimum dose.

Cheers. Go AVXL