The length of the trial being short and the disease in the early stages it is unrealistic to use ADL changes as pivotal since under these limits they will be very difficult to quantify.

The open label extension data could be more significant in evaluating changes to ADL.

A 90 minute prime time presentation should give a lot of detailed information we haven’t seen before.

Reduction of “brain atrophy”
Nice to see that part of the equation leading to approval.
Anavex already meets that new biomarker of efficacy.

However the moment a positive peer reviewed article is announced in a major relevant medical journal the boat will levitate into an airplane . 🤷‍♂️
That could happen tomorrow or in six months.
I’m holding.

This recent piece concerning the APOE4 gene and its AD predictive value would be a good bio marker justifying prophylactic dosing of Blarcamasine.

https://www.cnn.com/2024/05/06/health/alzheimers-apoe4-gene-risk/index.html

I’m disappointed about the every 8 hour dosing.
Not really bad like infusions with serious side effects but requires the kind of discipline Schitzo patients may not be realistically able to self dose.

Exactly.
That is the headline we should be seeing in the retail press.
You don’t have to be a scientist to understand what this must mean.

Yes unless we get a PR with new data I’m expecting Missling to repeat what we have already heard.

The peer review wait now approaching 16 months brings serious doubts to my mind the data isn’t as clear cut and positive as we hoped for.

If it wasn’t for the EMA process under way I’d have little reason not to sell and move on due to declining trend line with nothing to stop it but getting a positive peer review article.

Unexplained delays in Initializing other long promised trials is inexcusable since it adds to the feeling progress has halted.
At the least tell us the company is saving its cash for potential AD Phase 4 or additional Phase 3.

This NY Times article on aging is interesting since it describes a number of causes that 2-73 positively affects.
Autophagy, inflammation, misfolding of proteins, mitochondrial malfunction.

Hints at possibly a healthy lifespan increase for those taking it regularly.
Would take many years of observation to confirm however.

https://www.nytimes.com/2024/03/20/well/live/aging-biology-dna.html?unlocked_article_code=1.eE0._Rvn.l_Ds8nQ2xbwc&smid=nytcore-ios-share&referringSource=articleShare&sgrp=c-cb

I would have hope if Missling had made a comment about continuing to pursue Rett.
The adult data by itself was good enough

This trial has a lot of moving parts and since the condition has a lot of interested parties those reviewing the trial results I suspect are being extra careful knowing they will be subject to withering attacks by those promoting alternative therapies.
All ducks in a row with a bow on top.

The mention of Karuna was pretty direct heads up to those first looking at Anavex.

https://www.nytimes.com/2023/12/22/business/bristol-myers-karuna-drug-deal.html

In addition a peer reviewed article would give cover for main stream journalists to at last inform the general public that there is finally a successful AD treatment fast approaching.

Maybe the Alzheimer’s Association newsletter will finally mention us.
Up to now crickets.

Trofinitide is both the standard of care as well as the only approved Rett drug.
Since 2-73 clearly is more effective than Trofinitide why should Anavex not proceed with an NDA ?
Lay it in and challenge the FDA to not approve it.

Rett compensation rate possibly up to $500,000 a year compared to maybe $5,000 a year for AD does make the Rett market still very lucrative.

Ok , so let’s submit for approval for adult Rett since it’s Phase 2/3 trial was successful.

Whenever you have many moving parts under different scientific and regulatory controls and individuals when any one can delay progress the more delays you should expect.

In Biotech the science, the money needs and regulatory agencies all have the power to delay, and why it usually takes about ten years from initiating a drug discovery program to approval.

With the vast majority never getting across the line including many with good potential that never get past the financial support barrier needed prior to any revenue.

Happy Saturnalia
https://en.wikipedia.org/wiki/Saturnalia

Unfortunately the trial is in early stage AD.
Not sure if the label will allow for more advanced AD and covered by government payment or insurance.
However with its excellent safety profile I’m sure every AD patient and their family will want access to it even if it helps anxiety and insomnia

Good point.
Apparently Biogen wasn’t impressed enough to put serious money into a trial in MS.

The treated MS patients were noted as having significant reduction of brain lesions as shown on imaging.
A direct 2-73 induced biomarker suggesting effect on disease progression.

The treated MS patients were noted as having significant reduction of brain lesions as shown on imaging.
A direct biomarker supporting reduced symptoms.

It has been suggested the dosing to occur prior to going to sleep.
Trial dosing is in the morning and the
side effects of dizziness and confusion exhibited by some trial participants at the higher dosing could possibly be acceptable once in bed and with its calming effect may be what has shown in the trials to aid in sleep.

Worth a careful read.
On page 7 noting treated patient examples in different indications including pediatric Rett are positive.
Of course cherry picking from a large group possible but still used as a basis for this approved patent application.

Missling wouldn’t even look at an offer until we have an approved NDA for both Rett AND AD.
We’re at the 99 foot line of a100 foot race.

I’m wondering if our lengthy wait for the Peer Reviewed medical journal article promised looking at our Phase 2b/3 AD data is because they wanted OLE data included.
The longer the trial period hopefully the clearer the therapeutic value.

Maybe ANAVEX needs to chip in $50 K if that is what it takes to get noticed.

When is the Alzheimer’s Association going to get the word out on 2-73 to its supporters?
That will turn the spotlight on a treatment offering real relief.

Excellent job summarizing where AVXL is at this point in time.

Whichever part of the world first approved 2-73 will become a destination for medical tourists looking to stock up and bring it home for themselves or their loved ones.

We have been expecting multiple new trials to start for a long time since TGD first told us of them.

I hope this will happen soon but if precedent is prelude I have stopped holding my breath.

Agree
We are used to not meeting implied release dates of data but 2H23 was explicitly stated by Missling and now some language about delay due to additional time needed for safety data is a kick in the gut.
Just confirming 2H23 would have supported share price rising.

Nice bump in share price but my guess mostly retail.
Institutional buyers will spend some time digesting this news before they move.
Small cap bios like Anavex are not on their radar for fast moves.
However this company move in Europe gives them credibility and will deserve some time to get up to speed by the tuts.

The key words here are “improvement of symptoms”

Not slowing of progression but improvement.
This claim must be supported by submitted data.
No other AD drug has ever made that claim.

Reduction in brain volume loss should be a headline in mainstream media.
You don’t have to be a research scientist to know what that probably means.

Significant that the application is based on competed Phase 2b/3 trial with no mention of a Phase 4.
OLE data probably strongly supported earlier data making Phase 4 unnecessary.

Bods well for future NDA submission in the US if Europe approves.

I suspect the net margin will be a lot more than 20%.
Drug not expensive to make like mab’s and patients will be lining up to get it not requiring expensive sales network.

Actually the reduction in brain loss with an extremely low p value would make a great headline article in the retail press.
Very few people can follow trial details but everyone would pay attention to brain volume loss.

The apparent freeze on new trials bothers me.

I understand maybe the desire to save resources for a possible AD extension trial, however after making
specific plans for more trials in different significant indications the lack of follow through harms the companies credibility.

And the p value for 2-73
reducing/halting brain mass loss was extremely low.
Even a person not versed in AD science has to take note of that.