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Re: Bourbon_on_my_cornflakes post# 319610

Monday, 07/05/2021 8:22:04 AM

Monday, July 05, 2021 8:22:04 AM

Post# of 518505
Agree with you, Bourbon. The first 225 were in the Australian trial and it was only after that was reached did Anavex expand into UK, Canada and Europe. Those 225 have completed their 48 weeks back in the fall, I believe.

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. Maybe Pollyanna-ish but it is the only reason why the trial had this "line of demarcation" as opposed to expansion WW earlier.



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