Anavex Life Sciences Corp (AVXL)

[Steady_T]

The OLE has two purposes. The primary is to aid in recruitment. The OLE tells people that if they volunteer for a trial and the drug is working for them they will be able to continue receiving it for a longer period of time. That also lets people know that if they are assigned to the placebo group and the drug is providing some benefit that they also can receive the drug and obtain the benefit.

The second purpose is to obtain longer term data for the company, if the drug shows promise and people volunteer for the OLE. In the case of the AD trial the OLE continued for 5 years at the request of the people involved.

The OLE is an unblinded trial so it has considerably less value in proving efficacy. It does provide a comparison for people that were on the placebo and then are then receiving the drug. But that comparison is not as robust as the random assignment at the beginning of the trial. The reason is that with the knowledge that they are receiving the drug expectations can create confounds in the person receiving the drug and their care givers.