Replies to post #376510 on Anavex Life Sciences Corp (AVXL)

[boi568]

If the results go as you just described -- an eminently reasonable possibility -- the p value will be tiny, the safety record, as you note, immaculate, and the results unprecedentedly strong. The science is also well enough developed. There will be no reason whatsoever for the FDA to find fault. To the contrary, this result would be a Godsend to a Medicare system that is increasingly in need of a financial lifeline.

The most likely case is Accelerated Approval. Alternatively, just an approval without requiring a Phase 4.

The market cap will not stop at a $3B valuation for any length of time, partner or no partner. It will inevitably head toward $10B. Upon approval, that can double, but only because Anavex will need to share profits with a partner. Otherwise, it would be higher.

We just need the strong results. As the current market cap indicates, almost no one sees this coming.

[bas2020]

Exactly right!

[poonch1ne]

Nice

[LBSR TO DA MOON]

I for one hope to look back on Veliger's post below and say, "son of a gun...that Veliger was right on the money!"

Biogen burned the FDA once. Don’t count these Lecanemab chickens quite yet.

I’m tired of this phase 3 debate. It’s comical. If our data shows anything near stable disease for half the treated population at one year its done…approved. I guess you’re also just ignoring the massive safety delta and the fact 2-73 is in patients age 5 to 75 across 3 indications and on par w/ placebo vs the brain swelling/bleed numbers ranging from 20-40% across our large molecule competitors. Everyone here keeps comparing trial sizes with Lecanemab and Aduhelm, while failing to recognize both those products FAILED primary endpoints in their initial 2B/3 studies. They had to overwhelmingly prove stat sig with very large numbers because of previous FAILURE, manipulating trial design for the statistics to pan out.

I’m done responding to any more posts on the “oh no, it might need another phase 3”. Wrong. If the data is strong and safety aligned with 5 other trials for 2-73 across 3 indications this is going to happen. A phase 4 is the worst case scenario. The end.

[ExtremelyBullishZig]

That isn't how it works. The percentage of people on the actual drug may not be considered representative of enough of the population to the FDA. I am getting tired of the comical side of the debate that it will be approved just because...