Anavex Life Sciences Corporation (AVXL) News

That makes total sense. A good strategic plan.

Now you are talking

Steady_T is a "soft" basher in AVXL stock

Good luck and GOD bless,

-Presentations with some new info on several fronts
-MAA filing and peer review
-OLE data
-While waiting for EMA decision. Start with FDA meetings about NDA
-Schizophrenia results coming after

None of this is coming in 2024. TGD said mid-2024 AD RNA data and the Rett trial would be announced, but we have already passed that point with no sign of a PR. The CEO lies through his teeth; the guy has no morals when he puts out those timelines.

The accurate quote is "might be complimentary to the Mabs". Acknowledging this, re-read your post.

-Presentations with some new info on several fronts
-MAA filing and peer review
-OLE data
-While waiting for EMA decision. Start with FDA meetings about NDA
-Schizophrenia results coming after

Seems like we could have a good run coming.

Just don’t Fuk it up!

Why should I be worried? Buzzword Misleading keeps coming up with different word salads. Buzzwords aren't going to get the drug approved; it requires properly designed trials with solid data. Misleading and the company are making lofty claims without producing any data. Why hide the data if things are so rosy? Let the world know what you have. It's been 18 months since the AD trial, and still no full data, not even dose-dependent data.

Seem worried Kund.

The company is creating an illusion with claims of autophagy and brain shrinkage without providing any supporting data. Anyway, the market doesn't give a damn about such talk.

Doc328: Do you believe that the following is in general true or false???
Alzheimer's disease is easier to treat at the earliest stage possible. See the image below to understand why this is true.

The above is especially true if you are targeting upstream MOA with precision medicine.



The Anavex Blarcamesine Phase 2b/3 trial is for early stage Alzheimer's disease with baseline MMSE scores of 20 to 28 inclusive

Prevention of Alzheimer's disease via Blarcamesine or Anavex 3-71 would be the earliest stage possible.

Good luck and GOD bless, 🇺🇲🇺🇦

Yes I normally phrase it as approval from existing clinical trial results.

To be clear, my 1% chance is for approval by the EMA or FDA based on the current phase 2b/3 trial (i.e submission in 2024 and approval in 2025). As I stated in my posts from 2/2/2024 and 2/3/24, I feel the chance would be higher if there is a successful Phase 3 (especially if larger and 1 1/2 years)

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173762987

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173768692

They are quite a respected site they don't just put anything out, from gemini:

Industry Recognition: ReachMD won the "Best Healthcare Professional Media Brand" award in the 2020 MM&M Awards [5]. This suggests industry recognition for the quality of their content.
Partnerships: They have partnerships with over 25 medical societies and medical centers [4]. This indicates trust and collaboration with established institutions.
Content Focus: Their content is curated by editors and medical staff [1]. This implies some level of editorial oversight.

Not to mention Sabbagh himself has a very high reputation in the field I'd imagine he wants to maintain.

Some posters have complained about Anavex not getting its name and drug publicized. That seems to me to be a false narrative and this is another fine example of why that is a bogus complaint.

I missed that. That is good news. Glad the company is doing some educational marketing.

This activity is supported by an independent educational grant from Anavex Life Sciences Corp.
I know too well how such independent educational grants work...

Do you have some trouble understanding the word possible?

It doesn't really matter what our opinions are on the approval possibilities. That decision is in the hands of the regulators.

It only matters to an individual investor in how they choose to position their portfolio.

This is not an Anavex presentation. It is a medical education and networking website. Videos by MDs for MDs.

abew: therefore Dr. Missling has figured out a way to appease BP

Agree, and (similarly) the EU thrust w/expanded AVXL scope is a well timed (some say synchronous) regulatory move. BRILLIANT...

" I think that this talking point is more political than clinical. It subtly affirms that blarcamesine works differently than the monoclonal antibodies and it also positions Anavex as a less threatening actor."

Another claim again, ‘complimentary to the Mabs’ without any clinical data to support it. A theoretical idea that probably came up after a German beer, in addition to ‘precision medicine’. They probably didn’t think it through and never tested the concept. Such claims without supporting evidence are unfounded, not necessary, distracting and will lead to discussions that make regulators and KOLs suspicious of all other claims. There is no need to be afraid for big pharma, they should be concerned about the scarcity of their clinical data and not make additional claims that would even need more proof. Missling plays the genius again, but should focus on delivering the basic work.

If provides solid support to existing claims and / or new ones, then yes chances can be updated/adjusted.
It’d be fun to see the updated view when that peer review finally does get released.
As always it will be key not to get carried away and to spent time thoroughly reviewing the data and reading the limitations, like these from the P2a peer reviewed paper:
There are some limitations in this study:
• Small sample size, with 32 patients entering the study and
21 patients having available genomic data, which limited the power
of the study.
• Lack of adjustment for multiple comparisons in the analyses of relations
between markers and therapeutic response.
• Genomic analysis results reported for only a subset panel of
243 genes; however, an analysis of 39,974 DNA variants (Table S5
in supporting information) showed SIGMAR1 p.Gln2Pro and COMT
p.Leu146fs in the top 0.2% association rules linked to outcome.
• Standard of care measure of change in MMSE and change in ADCSADL
for calculating effect size were obtained from the literature at
48, 52, and 82 weeks61-64 and extrapolated to 57 weeks, which was
the time point used in this study.
• RNA analysis was limited due to collection time (103 to 135 weeks)
and lack of baseline transcriptome data for comparison. Nonetheless,
an exploratory analysis did find that high SIGMAR1 expression
was associated with better therapeutic response (Table S6 in supporting
information).
• Newly identified patient selection biomarkers were longitudinally
confirmed for change in ADCS-ADL, but not for change in MMSE,
over 148 weeks. This result may be due to a higher variability in
MMSE scores.

It’d be fun to see the updated view when that peer review finally does get released.

Given our results and recent changes in regulatory views, I think it's better than 50% in Europe, and (currently) a bit less in US.

Therefore Dr. Missling has figured out a way to appease BP by emphasizing a combination therapy...and thus, the FDA will be open to approving our drug. LOL...Misleading has no strategy; he just makes up stuff as he goes. Check all the conference call transcripts, and it becomes evident. He answers the same question differently in different calls. Without data, no one is going to approve this. They talk a lot but haven't provided any supporting data from clinical trials so far.

Quote: "I think that this talking point is more political than clinical. It subtly affirms that blarcamesine works differently than the monoclonal antibodies and it also positions Anavex as a less threatening actor."

Yes. Exactly. We must remember that BP owns the mabs...and the mabs have been approved by the FDA. Therefore Dr. Missling has figured out a way to appease BP by emphasizing a combination therapy...and thus, the FDA will be open to approving our drug.

Kudos to Dr. Missling for this strategy!

Masterfully done!

You and all your friends can Bone up on better tactics. Have fun, you'll need them

Thanks for your consideration.

No-one appears to have asked your chances of EMA approval for A2-73 in AD, where are you in the spectrum of Doc's 1% and the 83%+ of some?

Sorry. No pumpers / WGTers allowed.

Good point, I forgot about how many exclusions there were.

Yes, Dr Sabbagh interestingly makes that remark saying activating the sigma1 receptor triggers Neuroprotection, which may be complimentary to the monoclonal antibody treatment. So taking A-273 for it's Neurprotection while receiving MaB treatments? Both together could get pretty costly.

This company seems to be stuck in the mice model and proof of concept (POC) stage. There's a lot of talk but no supporting data. Misleading claims Anavex is in the regulatory filing stage, with millions and millions of pages supposedly being worked on by his IG model team.

“ Blarcamesine can compliment a MAB treatment by reducing or stopping brain atrophy and shrinkage”

I agree and it appears to me that you might only need a mab in severe cases of plaque buildup, after you jump through all the other “exclusions” for the mabs.

The mabs do not work symbiotically with the body, hence the ARIAs, and our drug does so I agree, Dr Sabbagh he might be throwing them a bone until we gain approval knowing once we do, their prescriptions will be collecting dust on the shelf.

YES! Foundational science being laid/shared and by highly respectable Dr’s in the field. Peer reviewed paper, AAIC, biomarker for Fragile X, bring on AF. I almost hate mentioning him because he nothing more than a sad little wet puppy carrying out the wishes for those trying to gain control of our company’s IP. We are trying to bring major symptomatic relief for so many with so many different diseases, how does he look himself in the mirror daily?

Onward and upward has not always included MC, obviously, but again foundational science being laid WILL lead to approval which will take care of MC!

I would love to go - do you have a free pass you could share?

I agree that the utility and opportunity for a blarcamesine/MAB Alzheimer's treatment regime would be minimal over blarcamesine alone. It is, of course, true that the MOAs of the drugs are distinct and should allow for combination.

I think that this talking point is more political than clinical. It subtly affirms that blarcamesine works differently than the monoclonal antibodies and it also positions Anavex as a less threatening actor.

Blarcamesine can compliment a MAB treatment by reducing or stopping brain atrophy and shrinkage.
The route of administration will remain oral, no "jabs" needed.

No jabs for me either!

I’m leaving tonight for a 3-day FUDster convention in Denver hosted by Citadel. There will be several prominent guest speakers and a series of panels and workshops showcasing new and old propaganda techniques for attacking small companies like Anavex by spreading misinformation and disinformation about their CEOs and products as well as new techniques to manipulate the markets without setting off alarm bells among market regulators. It’s sure to be one of the highlights of the summer season. I can’t wait!

Autophagy is a highly complex energy producing catabolic process that has evolved to balance the energy consuming anabolic biology.

It is in effect a highly skilled maintenance and recycling process. enabling cells to clear out any old, misfolded, and unwanted damaged constituents... !!!

Without autophagy, health would be an impossibility and imo, failure of autophagy (for various known reasons) is one of the key underlying causes of all chorionic diseases!!

I think the reference by Dr. Sabbagh that the AVXL drug is complementary is a bit of political one as he doesn't want to burn any bridges. And that is because imo, using monoclonal antibodies is a highly inefficient, "Autophagy Mimicking" way of targeting the intended "clean up"....

I got the same inclination when listening to it too JJ. He mentioned “compliments” at least two times. Maybe this is the “partnership” bait, solo distribution but also newly patented combo long term. Im not sure how you would combo our drug unless you were able to reduce the mab by like 90% and add ours to an injectable form…..which we did in our ph2a.

All good but no jabs 4 me please!

2-73 dislocates S1 from the MAM - hence "chaperone" protein. The hope is that it does this without effecting the S1's MOA, allowing it to fulfill its innate role. That's one of the key differences between mere S1 'agonist' (eg, donepezil) and 'potent agonist'. (There's also selectivity, etc.) Then there's the hope that potently agonizing S1 leads to therapeutic effects in the target indication - AD in this case. You need successful controlled clinical trials to show this. (Despite what knuckleheads claim to already know.)

The company is now making an argument that we have shown this, and has already gotten one major regulator to agree to evaluate our accumulated pre-clinical and clinical data. Folks like Sabbagh are on board, but he's 'on board' in both the figurative and literal sense; he is not an independent evaluator. The CHMP rapporteurs are. Having a peer-reviewed paper will be somewhat helpful, as that provides more validity and cover for what is a very big decision for the EMA. Luckily for the company, all regulators are hungry to approve a helpful, safe, convenient, and affordable AD therapy.

I suspect the company was hoping the paper would be published by now, in time for the summer conferences. It is certainly due now. Looking forward to the paper, and our completed MAA.

Ignore the conspiracies, pumping, and horoscopes. Be investors.

Sabbagh's presentation for some reason emphasizes 2-73 being "complimentary to" mab therapies when in fact, according to data, it is on-its-own more effective and far safer. It is an odd talking point - especially when uptake is incredibly small for those therapies. Also, it would be good if he would learn how to pronounce "autophagy". Neither point is a big deal: presumably 2-73 label won't be tied to the mabs and the Sabbagh will eventually learn how to pronounce the word.

WOW! LTB, thanks for finding this and the same to TTT.

Now, for the peer review paper to be published.

Part of the fudster manifesto is “try to undermine anyone who is positive about the stock.” There is intelligence and there is counterintelligence. The latter is why they all fixate on George. Citadel would prefer that you sell but they will settle for you not buying. So Georgie irks them.

2-73 We can be safer. Just for one day.👏

Relax, Georgie. These guys are way more full of shit than you. You are doing a great job of antagonizing them. Citadel probably sends out a memo to them saying “if you don’t negate this George guy, no paycheck.” They are terrified that you may induce someone to buy a share.

Well the good doctor talks to a slide that suggests that A2-73 could be used together with Mabs for their combined potentially beneficial effect.

It does make sense to remove the amassed neurotoxic effect of built up beta amyloid plaque, while A2-73 starts to prevent new forming by restoring autophagy.

The goal is to get blarcamesine to be FDA approved, then doctors can prescribe blarcamesne as a stand alone drug for many different stand alone indications including Alzheimer’s disease and/ or MCI etc.

Good luck and GOD bless,

I notice 2-73 was described as being potentially complementary to MAB approach to plaque removal, not as a stand alone.