growingpain
Nice find. It clearly means that AVXL intends to try to get A2-73 approved based on AVATAR and possibly EXCELLENCE too.
I think it also may mean that a regulatory body has agreed that it can be considered a PH 3 trial, and that such agreement with a regulatory body (if I am right) would only come about by sharing something about the AVATAR data with the regulator.
This could potentially be why TGD chose the word "around" which is not specific, since he might be indiscussions that he wants to complete before releasing the data.
I have been suggesting for some time that the voucher is very important, probably for its potental use to speed consideration of the AD trial for approval. That, I believe, would be worth much more than the money they could potentially get from selling it; and it would mean they would not rush AVATAR to approval.
However, this PH3 designation could suggest that TGD is trying to get AVATAR to approval on the strength of the first two Rett trials, and he needs one of them to be PH 3.
I also suggest that they may need both the EXCELLENCE and AVATAR study to gain approval; and having them both be considered PH3 studies would be an important part of that goal. This would mean that TGD is trying to get the pediatric indication of Rett approved first, which would be after Excellence data is released; and it could mean the AVATAR data is being submitted as part of a rolling submission for pediatric approval.
I suspect the FDA might be cooperating with AVXL on this endeavor IF they have seen the AVATAR data and think it is good.
Cautionary Disclaimer:
Please do your own research and DD and don't rely on posters.(Except I think you can rely on George)
