Anyone going to the ASM this week should ask TGD if they considered the AA pathway from Australia's TGA first...as opposed to going through the FDA here in the U.S.?
Which brings up another question...
If Anavex fails to get AA status through the FDA, does it disqualify them from applying through Australia's TGA as a backup plan B?
Fast Track Approval Pathways in Australia.. It may be Anavex has its best chance for FAST FIRST approval of Anavex 2-73 in Australia.
Fixed it for you. It should be approved everywhere if the data is true.
That said, I would push hard in Oz as they have already granted compassionate use and funded the trials. IT would be good for them to show it yielded a breakthough. Also I dont think this would preclude the voucher in the USA for Rett approval.
sokol--great post---really hoping the co. pushing hard "down under" getting Aussie approval--we do have Micheal Kornhauser there as one of our employees--he worked at Hammond Care along with Dr.Macfarlane and I assume is active "getting things done"---Aussie's need to approve and show the world "they can lead" !!!!!!!!
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