Replies to post #317121 on Anavex Life Sciences Corp (AVXL)

[Gernee20]

IMO the Lilly BTD and AA submission opens us up for BTD and AA for PDD. If I remember correctly, Jan 2021 Lilly announced results of the 272 patient Trailblazer AD trial. 6 months later they have been granted BTD. Timeline is similar for us with PDD.

Hopefully we applied for BTD in PDD many months ago.

[RedShoulder]

So, Anavex takes its data from 450+ participants and presents it to the fda. In the data, blarcamesine is show to improve cognitive performance, but does not clear amyloid as amyloid is waste and blarcamesine stops waste, but it doesn’t clear. These results put fda in a dilemma: no amyloid removal, but cognition. The current AD staff at the fda decides, that since amyloid removal is more important than cognitive improvement (on which its previous decisions were based), that Anavex needs to perform another larger P3 trial to determine whether amyloid may be removed and/or more data to ensure cognitive improvement is achieved throughout the participants population and/or any other outlandish reason it concocts.

I don't agree with this part of the post, FDA is not going to overlook cognitive improvement in favor of reducing amyloid plaques, which is already sporting a black eye from professionals in the medical community.

Futhermore A2-73 Blarcamesine works upstream to clear out the plaques too.

[Investor2014]

So we now have (all) four theories presented:

1) Cunning plan by the FDA to once and for all convince the public and science that amyloid plaque clearing is not the answer to halt or reverse AD - all perhaps even ESPECIALLY for the benefit of Anavex

2) FDA were just desperate and under pressure to approve something new with a glimmer of hope for AD

3) Although aduhelm might be crap its approval is great for better candidates to clear a low bar and charge a good price

4) Big hurdle to unseat Biogen and the amyloid crowd, bad news for Anavex

Think all we can do is wait and see if the Anavex P2b/3 AD trial data comes out with a trump card or joker. If the former let's hope and expect the process and system works without having to dodge too many cabal bullets.

[attilathehunt]

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

Bite your tongue! :)



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

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

[Biostockclub]

Power,

Excellent post (even in light of our different views!)

I believe that the FDA has put there foot in it with this decision and the media and advocacy backlash. Now, add in Congress, Medicare, private insurance companies and prescribing doctors.

I believe that our biomarker will be a guarded move on the board even though it is not purely amyloid clearing. Please don’t forget our drug is amyloid preventing(!) upstream.

The FDA could pivot from amyloid clearing to amyloid prevention on a dime if outpouring of heat.
That’s our pawn guarding the move: the press, advocacy groups, doctors, payers.

We can take our finger off the piece, imo.

Thanks for your valuable contributions always, especially regarding Benny recently. He’s still with us on this journey.

Peace,
Bio