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Re: attilathehunt post# 317149

Thursday, 06/24/2021 3:58:31 PM

Thursday, June 24, 2021 3:58:31 PM

Post# of 517416
ATH, as to your remark of "Bite your tongue" re:

"Anavex needs to perform another larger P3 trial to determine whether amyloid may be removed"



that is part of my thought on what the fda will assign to Anavex to get blarcamesine approved.

Another thought on that approval point, the fda with approval might place a black box on blarcamesine that states can't be used for 6 months after use of adu*.

AS to the doctors not subscribing adu*, let's see as to the PR campaign Biogen lays out over the next two months. If it were muted, then it is re-thinking its strategy. Given the expense it has laid out for staff, training and equipment, I think it goes heavy to gain a foothold in the AD population of people who tell their doctors, "I want to try this," or "We want our Mom/Dad to take this drug; we are tired of taking care and this our hope for betterment."

Another issue for me is that the PDD and AD trials are conducted overseas, will the fda consider those trials or decide that Anavex needs to conduct a P3 in the States, or has that issued already been cleared with the fda?

FWIW - Corruption has no boundaries!




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