Anavex Life Sciences Corporation (AVXL) Quote

I am pleased to hear Dr. Gabelle say that the Anavex drugs autophagy target extends to ALL neurodegenerative diseases. This would include Alzheimer's. Parkinson's, Huntington's, ALS etc. What about neuro DEVELOPMENTAL diseases? I ask chatGPT to list the top ten and Blarcamesine is already in preclinical or clinical trials with several!
"Neurodevelopmental disorders are conditions that affect brain development and can impact cognition, behavior, motor function, and social skills. Here are ten significant neurodevelopmental disorders:

1.Autism Spectrum Disorder (ASD)
2.Attention-Deficit/Hyperactivity Disorder .(ADHD)
3.Intellectual Disability (ID)
4.Fragile X Syndrome
5.Rett Syndrome
6.Cerebral Palsy
7.Tourette Syndrome
8.Down Syndrome
9.Fetal Alcohol Spectrum Disorders (FASD)
10.Specific Learning Disorders (SLDs) – Includes dyslexia, dyscalculia, and dysgraphia, impacting reading, math, and writing skills."

I’m away this morning & you are probably right, but my thinking has been expecting news to come earlier! Yes, Missling has said he’s going for full approval which is 210 days after the clock starts up again & questions are answered! We wait just like always 🤗

For the schizo trial: Notably, we haven't gotten an LPLV announcement for Part B yet. This is something to watch for. This is a very small, single site trial, so database lock and analysis should not take long after.

As for AD, I thought the company was still guiding "end of year" for EMA decision.

The 70% occurrences of 'clock stop two' based on oncology stats is much more likely to be close to CNS indications than the 10-15% Boi came up with from ChatGPT. One challenge of course is that there aren't many MAA filings for AD to base stats on.

Even Missling has said that he expects a decision on the Anavex AD MAA in Q1 2026, so what is all this irrational in the summer of 2025 approval talk about?

boi568
That response seems pretty thorough to me, acknowledging that Frrol is totally more informed than I am, but 10-15% seems reasonable based on the history they provided.

Citrati

I did a little research on the tax situation for hedge funds considering "wash sales" specifically and it seems they can be classified either as investor or trader....so if they are considered an "investor" they have to operate under the same rules as a retail person using the 30 day holding period ruling to avoid tax problems.

I believe most operate as "traders" and therefore have the advantage of doing this under IRC Section 475 (f) and use mark to mark accounting using tax attorneys and tax accountants and complex journals to be completed at year end for tax purposes....matching up the buys and sales for a net bottom line gain or loss.

I would think that most of those hedge funds in $AVXL are traders.

Surely the market makers operate as a business....ha ha

Yes lifestyle changes early enough will beat any current AD drug and likely future ones too.

Even light exercise could help slow cognitive decline in people at risk of Alzheimer's.
https://www.sciencedaily.com/releases/2025/04/250424120851.htm

You still dreaming about FDA filing? What is the relevance of it anyway to the EMA process — you think CM would feel encouraged by the Qs, or that AVXL has been or will be too busy with answering the EMA Qs to file for FDA? Neither makes much sense.

It is not an unknown, but it takes a bit of work to find out - more than for example Hoskuld apparently has put in to state a categoric unsupported opinion.

Did you read my post? I listed several reasons I think that AD could be different from the oncology clock stop data.How then do you think the Clock Stop Stats fall out in CNS and how different are they to those we can see for Oncology?

The data on CNS diseases clock stop durations is not available as far as I could find, which I pointed out in my post.

This is an unknown as far as I am concerned. So it will be what it will be and I am comfortable waiting for the result. Odds of approval are immaterial at this point. It is a binary event.

Very much like a quantum mechanics field equation. It is in many states simultaneously. Till the observation is made all outcomes are possible. Only when the observation is made will the field equation collapse and we will have the result. I hope that Schrodinger's cat is alive.

35 years old EE, do some simple math.

And my head fits in every room I enter!

I have a great diet and I do avoid motorcycles and all of that try hard stuff.

Why do choose to missinform about institutional interest and short positioning?

Why do you keep wrongfully implying you know the short cost basis and obligations?

YOU DONT KNOW!

Neurodevelopmental disorders are conditions that affect brain development and can impact cognition, behavior, motor function, and social skills. Here are ten significant neurodevelopmental disorders:

Autism Spectrum Disorder (ASD) – A spectrum of conditions characterized by social communication challenges, repetitive behaviors, and sensory sensitivities.

Attention-Deficit/Hyperactivity Disorder (ADHD) – A disorder affecting focus, impulse control, and hyperactivity.

Intellectual Disability (ID) – Characterized by limitations in intellectual functioning and adaptive behavior.

Fragile X Syndrome – A genetic disorder leading to intellectual disability, anxiety, hyperactivity, and social difficulties.

Rett Syndrome – A rare genetic disorder primarily affecting females, leading to loss of motor skills and speech.

Cerebral Palsy – A group of disorders affecting movement, muscle tone, and posture due to brain injury or malformation.

Tourette Syndrome – A condition characterized by repetitive, involuntary movements and vocal tics.

Down Syndrome – A genetic disorder caused by an extra chromosome 21, affecting cognitive function and physical development.

Fetal Alcohol Spectrum Disorders (FASD) – A group of conditions resulting from prenatal alcohol exposure, affecting cognitive and behavioral functions.

Specific Learning Disorders (SLDs) – Includes dyslexia, dyscalculia, and dysgraphia, impacting reading, math, and writing skills.

First, I am reporting the AI answer with a degree of skepticism, i.e., "FWIW." I view ChatGTP as an unreliable research assistant.

That said, here's the edited background (I had collateral questions) to the query:

I began with the question, "How often in an MAA review by the EMA is there a second clock stop?" Keeping this simple, the answer was ". . . a second clock stop isn't common, but it also isn't rare. . . . According to public EMA data and regulatory specialists, second clock stops happen in maybe 15-25% of cases, depending on the therapeutic area and complexity of the application . . . . Advanced therapies . . . and neurodegenerative disease drugs tend to have more frequent clock stops."

"How many second clock stops are triggered by safety concerns?" "Most second clock stops are triggered by CMC issues (Chemistry, Manufacturing, and Controls) -- like problems with production, stability, or quality control data -- not safety. . . . Safety concerns (clinical safety data issues) trigger second clock stops in about 10-15% of cases where a second clock stop occurs."

"Are CMC issues common or uncommon for small molecule drugs?" "CMC issues . . . are fairly uncommon for small molecule drugs -- especially compared to biologics. . . . When they happen, they are easily fixable, not deal-breakers."

"What are the odds of a second clock stop for a small molecule drug without known safety issues?" "If a small molecule drug has no known safety issues . . . and assuming it's reasonably well prepared (good manufacturing data, no sloppy CMC gaps) then the odds of a second clock stop are very low -- probably around 10-15%. . . . Small molecules are significantly simpler on the CMC side."

"What is your basis for stating that most second clock stops are triggered by CMC issues?" "I'm basing it on a few things: 1. EMA procedural guidelines and internal reports. . . . In [EMA annual reports or cluster reports] CMC issues (manufacturing, stability, impurities) are consistently cited as the leading cause of delays during the second review phase. For example, a 2017 EMA document on review timelines stated that the post-120 issues were 'frequently related to quality (CMC) questions rather than clinical data.' 2. Analysis of Public Assessment Reports. . . .[Y]ou'll often find comments like: 'The applicant was requested to provide additional manufacturing data.' Or 'Issues relating to the comparability of drug substance batches required additional clock stop.' Less frequently do they mention clinical (safety) concerns triggering second clock stops, unless for very high risk areas (oncology, advanced therapies). 3. Expert regulatory sources. Regulatory consulting firms (like Parexel, NDA Group, McKinsey pharma regulatory briefs) have published findings saying: CMC issues are the 'predominant cause' of extended EMA reviews. Safety issues do cause second clock stops but less often -- and when they do, they are bigger red flags. I'm also pulling from whitepapers aimed at pharma applicants preparing MAAs."

I do concede that I posed my questions based on small molecule/safety, rather than neurodegenerative/non-neurodegenerative, having kept in mind that my categories will be broader (hence more statistical stability) and that blarcamesine is unlike other neurodegenerative drugs by being a small molecule with no known safety concerns.

Where do you get your conclusions of ANYONE’s opinion about Market participation?
Certainly not from anything I have posted.
You would benefit from a proofreader as likely peer review of your comments not available.
The Pope died, but I doubt he passed his infallibility to you.

I find you tedious and uninformed.
You have made your bruised ego contempt apparent. Why not give the MB a break and return to the Cheetos and Red Bull.

Then add the same for the US then the rest of the world.
Then add Schizophrenia, Parkinson’s , etc etc.

That AI query was poor. Try again, but with specificity. Keep in mind that you're seeking response relevance.

A little mathematics for this spring weekend:

There are over 7 million people in the EU with Alzheimer's or dementia

Suppose Anavex Life Sciences is able to treat half oof those people that would be 3.5 million

Suppose the cost that Anavex would charge is $10.00 per share. That would be $3652.50 per year

Suppose that Anavex's profit margin for blarcamesine would be conservatively 80% or 0.80

Suppose that AVXL's price to earning's PE ratio is conservatively 25

Then the price per share of AVXL would be conservatively

(3,500,000* 3652.50 /100,000,000)*.80*25= $2556.75 per share for AVXL based on conservatively 100,000,000 shares outstanding at the time.

Yes that is an estimate of $2556.75 per share for AVXL based on conservatively 100,000,000 shares outstanding at the time.

Good luck and GOD bless,

You are correct when it comes to retail investors and long-short hedge funds. I agree in principle to your thoughts relative to retail trading. The issue is the private brokerages retail customers have no access to that are not transparent. In a sense it is similar dark web activity. Only in this case the SEC knows the trading exists but tolerates/turns a blind eye to what is behind the curtain.

How is it GS could earn $200million dollars illegally years ago and only pay a small fine? SEC doesn't close the process with stricter rules and oversight.

The clock stops allow 60 to 90 days, but they can answer the RFI faster, so even 150 plus 60 may be required. I don't know how often they've achieved the 6 months the FDA sets as it's goal for priority review, but it should be achievable.

I've often criticized the FDA, but most of the times they meet their PDUFA dates, and when they don't, they reschedule, so everyone isn't in the dark. I do prefer that to the way Europe and the UK are operating. Those following NWBO know we're about 16 months since our filing was initially validated. It's not really stated if the clock starts on initial validation, the final was a couple month later. My point is, no one seems to know when the count really should begin.

I'm uncertain what that day should be here? I do believe w e'll know by Fall, but of course I thought we'd have the approval by that time last year for DCVax-L. This should be an easier decision, but you never know.

Gary

Steady T

Thanks for your very clear view! Since I have had cancer and my blood cancer is incurable, I've suffered with various and multiple "side effects" and much information has been coming to point out some of the negative protein spikes etc that I have witnessed. Yet, I am still in remission and getting older and closer to the exit, so I am happy that I'm still around.

OK, it's pretty tough doing multiple transactions and not having a way to handle the IRS and have a good factual account of those transactions!....I think Leo and I agree that most of these people do not sell short and hold that position for a long time, rather they short, cover, and do this often until they have reduced the position or hedged with options assuming there is a lot of open interest in the option series.

Investor:

OK, I'll accept your opinion as being worth considering....for me, with what I've read I'm sticking to my impression which accepts the peer review and OLE results as affording a quicker approval.

Did you ask ChatGPT to include references to the specific information used to come up that percentage and then read them yourself to determine if the answer might have been relevant and correct?

So you don't actually believe the broad stroke conflated >83% chance of approval for an accepted MAA applies to Anavex and CNS?

How then do you think the Clock Stop Stats fall out in CNS and how different are they to those we can see for Oncology?

Hoskuld provided the link I had used apparently believing he had the proof against what I posted - lol! What heck are guys talking about here as if experts catching me out.

tred----" The latest SAB addition is"---could not agree more--this recent SAB addition==huge stamp of approval from someone who really counts -on top of those involved in our "peer review" !!!! Ms.Gabelle would not have come on board unless she was convinced WGT !!!

FWIW, I asked ChatGTP what the odds were of a second clock stop for a small molecule drug with no known safety issues, and the response was ten to fifteen percent.

Not an interpretation rather an applicability question. Oncology is different from AD. Toxicity is an issue in most cancer treatments. Administration is not an oral pill in many cases. Safety is much more in question compared to 2-73. Many cancer treatments are very specific and require genetic testing to determine applicability to a specific cancer.

So the oncology stats for clock stop times may not apply to 2-73. Having said that I couldn't find any other clock stop data to set expectations either.

No amount of “maybe’s” or spin here on our MOA or ultimate value by holding will cloud my vision.

You and I are sitting in the same boat. Assuming the trial data (both efficacy and safety profile) holds up under the scrutiny of the EU authorities, I see no path for Blarcamesine other than regulatory approval, whether that be sooner or later. That approval could be attached to a concurrent requirement for a larger confirmatory trial--which is just fine. From a broad perspective, Blarcamesine should be a layup for regulatory approval compared to the remaining currently approved drugs. It's just a matter of time. but my bet is that the EU authorities are going to advance Blarcamesine into commercialization with AVXL's current MAA. I see no downside to timely action by the EU--the evidence is already in and this medicine should be made available ASAP to Alzheimer's patients.

This would indicate that maybe the big traders assume that there is now a lot more money to be made pumping AVXL up to over $100 than dragging it from $9 to $5.

I for one am not selling on big moves much to the dismay of experienced nickel and dime makers here. I am more of an event seeker like AD approval, partnership PR with details, or further basket trial PR. No amount of “maybe’s” or spin here on our MOA or ultimate value by holding will cloud my vision. If this turns out even 25%-50% of what I believe to be true then in 5-7 years my grandchildren, yet to be born, will thank me immensely.

We are closing in and Dr. Missling is rock solid and firing on all cylinders imo. The latest SAB addition is yet another valuable addition and speaks volumes in this regard.

Tred

Guy all of that to say you DO NOT KNOW!

24M short shares SAY YOU ARE WRONG!!

Your claim of the shorting bulk at 20$ is as DUMB as that bike trip you took then!!

Find a post in which I deny shorts exist.
I actually applaud their participation in the Market.
Perhaps your emoji throng can help.
Better odds for me than WGT.

I do question the "use" of MOC, but seemingly you find
subtleties of investing incomprehensible.
At the very least improve your own reading comprehension.

As to taxes, I gather it escapes you that HOLDING from $20
has different consequences than in and out (perhaps many executions) since that time.
Then again, have YOUR taxes ever involved such treatment?

In the meantime, perhaps just allow for the fact that there are
many investment strategies, numerous Market tools, and
perhaps your knowledge of any is less than stellar.

I am sure you must have noticed that is the document I referred and linked to in my post.

Do you have an alternative interpretation of the data in that paper?

https://www.ispor.org/docs/default-source/euro2024/isporeurope24cervelobouzohpr86poster144868-pdf.pdf?sfvrsn=ebd2a543_0

You are in a perpetual state of no institution is accumulating and shorts do not exist on this stock.

Reality is institutions are accumulating and shorts like you are stuck like chuck!!

What is the tax consequences of trying to manipulate a narrative??

I'm just here to expose you.

Trust me the board sees right thru the ugly bikes!!

Yes, the majority work as long-short businesses. There are some that don't. They operate as in the example given. They thrive on low market cap emerging public companies because they have far more control over price. The amount of capital to influence price is vastly reduced. Because companies that take a long time to get to market, receive approvals etc, generally struggle, have exploitable weakness real or made up, they are the potential targets.

Not going to take the time and space to dive in depth on this. There is info on the internet if one wants to go find it. It is getting more difficult to access though because AI and the first info that comes up in a search doesn't show the down and gritty information. 10 years ago and earlier stories, stocks that were being taken advantage of could easily be found.

One way may be to do a search on all the companies AF has written hit pieces on.

The accounting on no buy to close a short position is accurate. Just like no sell produces no gain even though your account is up considerably. The difference is that because you get cash up front with a short the capital is free to use with no tax until you cover with a buy. Only then do you spend capital. Up front the shorter receives capital that is not taxable. This is why naked shorts are so destructive.

Just like computer programs have back doors, there are back doors for shorters that the SEC refuses to close.

Have a great weekend. All AVXL needs is an approval to stop the majority of the nonsense.

Yes.
Cancer seems to me to be urgent and complex whereas Alzheimer's Disease is not urgent but is complex
That is why the risk vs. benefit equation can and should be different by indication taking in to account unmet need and critical timing patients are facing.

The sentiment many feel is right regarding proactive and faster approval paths for A2-73 in AD etc. is understandable, but it just isn't so far how complex clinical trials in large indications are handled. Instead there is the accelerated approval pathway or the full evaluation, Anavex has been guided down the latter path by EMA. Will that change mid-way through to an accelerated approval path - maybe but probably not, especially because Missling's answer when asked directly was full PRIME approval process!

I prefer to base my investment view on what is known and has precedence, unless there is very clear is evidence of something different happening that breaks convention - there isn't as far I can tell regardless of how much we might call for that on this mb.

The truth is only Schizophrenia Topline, Partnership, and EMA Approval (knock on wood) matter. Pretty much everything else has zero revenue-zero price moving effect.
But the myriad of worry walls whip us about until then.
Not even Adam F or Martin S can move our price much now.

Cancer seems to me to be urgent and complex whereas Alzheimer's Disease is not urgent but is complex.....with that in mind, Alzheimer's Disease can be treated with something, anything that is safe but requires further verification to help the patient in dealing with this.

Investor, OK I'll consider that you know this stuff better than I do, but I can't get away from the thought that the stock has performed pretty well from the very recent & quick reversal on the daily below $8 to now and is holding up.

My sense is that the quiet trading is indicative of the bears not quite as confident as they have been and are also waiting for some indication of what is happening or developing.

I'm fairly bullish, but also waiting for a price and volume confirmation of that in the coming days, something over $10.50 with vigor would put my target back up to the $14 to $14.50 area.

More time will tell!

BioSpace - Massive Investment in US Manufacturing Triggers Wave of Career Opportunities
April 24, 2025 | 6 min read | Angela Gabriel

Anavex - Drug line made in America by BP. imo

2025 U.S. Manufacturing Investments
So far in 2025, Eli Lilly, Johnson & Johnson, Novartis, Regeneron and Roche have announced increased investment in their U.S. manufacturing operations. Eli Lilly made the first move, on Feb. 26, while Roche and Regeneron shared their plans most recently, on April 22.

https://www.biospace.com/job-trends/massive-investment-in-us-manufacturing-triggers-wave-of-career-opportunities

“Tell me this - has Anavex over the years given us any reason at all to assume the most optimistic interpretation of their statements and actions?”

Anavex is comprised of a different blend of personnel than it was a few years ago so it’s a bit disingenuous to assume same old same old. But can always expect you to queue up the worst prospects.

The average is always the starting point. You then adjust it on rationales. Considering our circumstances - big indication (AD), relatively small trial, etc. - we will likely be over the average. Our PRIME status may mitigate these somewhat if it gets us expedited review of LoQ responses.

On what data do you base this statement?
Clock Stop 2 doesn't happen at all in the case of many applications.
Can you provide references?

Here is the one I find clear, although it is concerned with Oncology Indications:
Frequency and Variation of Clock-Stop During EMA Assessment



I haven't got similar for CNS, but a good guess is that it would not be shorter than those related to oncology on risk vs. benefit equation and life expectancy. Many CNS indications incl. AD of course are not nice but still the risk vs. benefit equation and life expectancy. Hence I don't the stats I am showing would indicate faster approvals stats in CNS.

Clock Stop 2 doesn't happen at all in the case of many applications. In terms of what we should expect, I think that from a purely investment point of view that we should assume the whole process will take 14 months after acceptance (the average) and if it takes less then be pleased.

‘‘Tis better to be thought a fool than open one’s mouth and remove all doubt.”

Far from what I said or obviously your understanding of tax consequences.

Perhaps revisit the original poster’s premise.

Chair in the corner for you. Cap optional.

We don't know how long Anavex will take to answer clock stop one, but I am not assuming the median response time or less. Then if that goes well there is clock stop two, which in the majority applications also will have a LoQ to answer. We don't know how quickly Anavex can respond satisfactorily to that either. So I conclude Feb'ish rather than the most optimistic WGT view on these things.

Tell me this - has Anavex over the years given us any reason at all to assume the most optimistic interpretation of their statements and actions?

Investor
I must be missing something...we have reached Clock Stop One, so the average time to answer questions is normally 1 to 3 months....using the average, that would be end of MAY or end of JULY; and if no further questions....I would assume an approval before year end, not February 2026.

My assumption is the clock stops are done and we get approval along with a conditional confirmation trial, Phase 4, not Phase 3.

I take it you are assuming it's more complex and would take to the end of November 2025. with approval or failure several months later....

Citrati

I'm not quite sure about that....As far as I know, hedge funds work as a business and part of the reason they do shorting and covering is because of the advantages of this being their on going business....I am not an accountant, but I believe they can buy and sell with specific advantages in combining all of these transactions during the taxable year.....I.e. profits and loses.

I lean towards Leo's idea of selling short at 20, covering and doing this at multiple times during the year or years...

Maybe someone here is an accountant or familiar with this?