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RedShoulder

06/24/21 3:52 PM

#317156 RE: attilathehunt #317149

"My hope is that Down Under, TGA moves positively on blarcamesine next week"

They better! Otherwise they will be subjecting their citizens to Adu!!



That's an interesting thought attila.

Do they go for a very expensive drug that shows no cognitive improvement, requiring injections in the Dr office, expensive and periodic scans for brain swelling and brain bleeding?

Or go for a drug they know very well, a single pill not overly expensive, and most importantly 'safe', shown to improve cognition, no brain swelling or brain bleeds, no periodic and expensive scans, and already with a SAS approval?

TGA knows Anavex A2-73 Blarcamesine very well, and they have been very supportive. I think you may be on to a probability that they will not go for Biogen's ineffective and very expensive drug, and go for Anavex's A2-73 Blarcamesine.
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powerwalker

06/24/21 3:58 PM

#317159 RE: attilathehunt #317149

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!




ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!



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Biostockclub

06/24/21 4:07 PM

#317162 RE: attilathehunt #317149

ATH,

I’d like to see a BANNED IN AUSTRALIA label hit the press in this pile on re Aduhelm’s media attention.

If other countries step up…I’ll buy the drinks!

Nice,
Bio