Anavex Life Sciences Corp (AVXL)

[Doc328]

I’m not sure what is happening with the PDD trial as the subjects finish. Most open label extension studies (OLE) are listed on the registries and none is listed for PDD. In most studies I have participated in, there is an OLE. When there is an OLE, it is cleared by the IRB and regulatory agents before the first patient completes the initial study. This allows a seamless transition (the last study visit of the placebo controlled study is also the initial visit of the OLE).

By now at least 60 patients must be completely done with the 14 weeks randomized study. If there is no actual study, they may just get a “Thank you for your participation” at the end. Alternatively, maybe they can be given free drug outside of a study as compassionate use. I know this is possible in the US and one 3b study I am participating in, that really just wants additional data during the first couple weeks has done this. I don’t know how this works in Spain/EU. Generally, the ability to get drug long term makes recruitment easier.