Replies to post #87074 on Anavex Life Sciences Corp (AVXL)

[neiu]

Fair, and yes I do remember him saying that but my question is not where else they will run the trial. The question is if the trial in Australia that we know will get the go ahead will be enough for the FDA to approve from. As of the guidelines that I have posted, the answer is yes provided that they meet those requirements with the study in Australia. I am hoping the company will be able to answer my question directly and not go by what Stephen Macfarlane has said. Stephen Macfarlane is the Principal Investigator NOT employed by the organization sponsoring the study. This will be be part of the results published on clinicaltrials.gov stating this fact on the agreement I am sure. I want to hear it from Missling.

[XenaLives]

There will have to be a Japanese trial for Japanese approval, that I know. The only possible exception would be if there was an ethnic Japanese cohort in the Australian trial, which I don't really expect.

Yes, eventually there will be U.S. trials and trials in other places around the world too. But since S.O.C. is so incredibly awful and we are really talking about an historic first here, there is no way to project how the FDA will handle this.

Missling, however, probably has a much better idea, and this information may have been shared with Biogen or another perspective partner under NDA.

We will know when we know, but personally I don't believe 2017 is out of the question.