Replies to post #319618 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

If the fda dictated that 450 were needed in the trial for it to review the results, why does the TGA and Australian authorities need that number since it is a much smaller population there.

The population size of a country has nothing to do with how large a clinical trial population needs to be for statistical power.

[Bourbon_on_my_cornflakes]

BINGO: If the fda dictated that 450 were needed in the trial for it to review the results, why does the TGA and Australian authorities need that number since it is a much smaller population there.

I think that that TGA and Anavex had agreed on 225 was the number needed for TGA review and that is why the first half of the trial's participants was there. Those 225 have completed their 48 weeks back in the fall, I believe

yes, get the data from those analyzed and into the TGA with an application. we already have a partially opened door. TGA has already seen a lot of 273 data.

saving it all for the corrupt FDA is a bad gamble.

Better to have a TGA approval in the bag to keep the FDA honest.