Anavex Life Sciences Corp (AVXL)

[Investor2014]

Depends how it will be handled in practice. It is either quite clever or an additional delay over the hope of some investors.

The original 12 week study had a 4 week observation period in front for each of the 50 - 80 girls to be enrolled.

Now it could be that the 7 week P1 like study in only 15 girls eliminates that 4 week observation period for the full P2 placebo controlled trial. This would as far as I can work out reduce the total elapsed time of the trial.

Further more as the P1 like study includes efficacy endpoints, we get a much early peak into the potential outcome of the full placebo controlled P2 trial.

I say that is a win, especially if we take into account that, not least, you suspected all along that a tolerability study would be needed since we are dealing with adolescents patients.

So Anavex cleverly managed to swap a 4 week observation period for the full 50 - 80 cohort for a 7 week dose escalation study in 15 patients - the work of Fadiran perhaps shining through here?