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Re: Jonjones325 post# 409154

Thursday, 03/30/2023 5:56:50 PM

Thursday, March 30, 2023 5:56:50 PM

Post# of 460694
Well said Jonjones when considering the all facts below.

TGA needs to get some balls. They see what’s out there and see what has just been approved.

They know we are better, safer and cheaper. No brainer here. Conditional approval with P4.

Or give your people Leqembi. The more we hear about it the worse it sounds. No sense it letting people suffer when there could be some relief now.

Relief for the people and your healthcare system potentially. Or what? Wait another 3 years for us to do another huge trial when you can plainly see we have a positive effect?

You’ve been subsidizing our trials. Might as well be the first to reap the rewards.

Can anyone give a reason not to give conditional approval?

Safe safe and safe. Upstream and safe. Genetic effects documented. A range of other peripheral benefits also seen. Biomarkers out the wazoo. Sigma one research piling up. And oh yeah. Safe.

No sense in waiting. Not pumping. Just common sense and compassion for humanity.

Let’s go. Get some balls. Mother F ers!!



If Leqembi can be FDA approved with the brain swelling and brain bleeding on very weak Ph-2 data that did not show efficacy, then for CNS conditions A2-73 Blarcame for PDD/PD and AD should be an easy approval right now with a lot better safety and much, much better efficacy. There are no other treatment that help efficacy and with no significant adverse reactions, other than Anavex's A2-73 Blarcamesine for AD and PDD/PD.

One has to wonder why a NDA could not be submitted with the Anavex data to date that improves efficacy and is very safe, since Biogen got approval on weak Ph-2 efficacy data and causes brain swelling, brain shrinkage, and brain bleeding.

Any thoughts on why not, while considering Biogen's poor data ?

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