Replies to post #508564 on Anavex Life Sciences Corp (AVXL)

[Gravedigger1]

Corrections:
435 Congressional HOUSE seats up 
And 
 The Path Forward
If this thesis is correct, the sequence looks like:1. FDA Meeting 2. NDA filing with priority handling/ accelerated or conditional route 3. Approval coinciding with 2026 political calendar 4. EMA adopts shortly thereafter 

[Gravedigger1]

This did not print in the original post 
Alzheimer’s, in particular, represents:the largest medical cost center in Medicarea high-turnout voting demographic - seniors a high-emotion disease category, second only to cancer and gaining traction and now a regulatory mechanism tailor-made for rapid approval (the Commissioner’s  National Priority Voucher) All 435 Congressional seats are up for election in 202635% of the Senate is up for election in 2026Midterm primaries are May 2026General election is held in Nov 2026 Talking points and campaigning begin late March and run through the General election in November. 

[sab63090]

Gravedigger1

Wow! Your post on 11/11 was prior to the last severe take down and I can now appreciate it more!

You are so well informed and make a logical case for FDA approval before the EMA and also bring up the potential for the voucher!

It was a bit long, but worthwhile reading! Psychology plus logic....step by step!

My personal thinking is that Missling is pretty much trapped and apparently did not want to spend money on a normal process with patients and a long trial; my feeling is that now some entity needs to take over with a substantial profit (for themselves), the shareholders will get much less than the sky high hopes they thought was a "lock"..

[boi568]

This reads like AI going wild.

[xodcode]

Hey Gravedigger1,

Thanks you for a most compelling and detailed FDA - 1st argument. I was unable to comprehend why CHMP would delay their final decision when Blarcamesine provides the best option for 70% of early AZ patients. The FDA - 1st argument does cogently explain why that might be.

As a consequence of your highly sophisticated postulate, I purchased a few thousand more shares at the open today and look forwarding to riding out the current storm until the mists subside.

The Blarcamesine story is far from over and I await a successful outcome in 2026t

[Schmiggins]

Question for Gravedigger:

Maybe I missed it in your analysis, but why, given your argument that the FDA must approve first, didn't Missling take it to the FDA first?

Possibly, he wanted the extended clock-stop infested EMA approach in order to collect more OLE data, perhaps? Also the FDA has still not changed their approval criteria where they are supposed to be dropping the primary endpoint we missed?

Possibly he heard whispers of the new voucher lottery thing coming down the pike? I think not on that one as it was a very recent Makary/Prasad thing. But I agree it does play right into our hands.

If your scenario is what's really going on here, it may be in Missling's interest to begin a new trial on that cohort we liked the best. It would be ongoing as the FDA might be considering us under the next voucher candidate group, and that would be a plus if only that it would show we had faith in a positive confirmatory outcome.

[Bourbon_on_my_cornflakes]

Not because FDA dictates EMA -
but because once the U.S. steps first, the risk of being wrong disappears for Europe.
And that is the core insight:
EMA hesitated not because the drug is weak - but because being first carries political and financial risk.
If a drug can’t swim, it sinks. They could not sink it after 210 days.

So...bureaucratic CYA is exactly what is sinking us under your thesis. My biggest worry.
That said, they have nothing submitted to the FDA, so expecting them to be first approver is wrong.
It's either that the ABCLEAR data allows the EMA to grow a pair....or we fail.

[north40000]

See FDA PR today re actual changes in Real World evidence that may be submitted and considered by FDA in medical device approval applications, and similar potential approvals of Real World evidence submitted by drug and biologic applicants in connection with NDAs.

[sage4]

No CNPV voucher for Alzheimer’s yet. I'm hoping that Anavex gets one in comming 2026.

[Bourbon_on_my_cornflakes]

Best option seems the FDA rout, a no brainer if we get fast tracked.
EMA might as well request re-review.
The bigger question, should AVXL go it alone, or get a BP partner with experience and leverage.
Originally I would have said no, but given the total BS from the EMA, maybe it is time to partner.