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  6. Anavex Life Sciences Corporation (AVXL)

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Anavex Life Sciences Corporation

Anavex Life Sciences Corporation (AVXL)

NASDAQ
8.475
0.23
(2.85%)
Closed 21 November 8:00AM
Delayed by 15 minutes
8.59
0.115
( 1.36% )
Pre Market: 12:00AM
Delayed by 15 minutes

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AVXL News

Official News Only

Form 10-Q - Quarterly report [Sections 13 or 15(d)]
Edgar (US Regulatory)
07 August 2024
AVXL (2.85%)

Form 8-K - Current report
Edgar (US Regulatory)
31 July 2024
AVXL (2.85%)

Form S-3 - Registration statement under Securities Act of 1933
Edgar (US Regulatory)
30 July 2024
AVXL (2.85%)

Form 4 - Statement of changes in beneficial ownership of securities
Edgar (US Regulatory)
17 June 2024
AVXL (2.85%)

AVXL Discussion

View Posts
ignatiusrielly35 ignatiusrielly35 46 seconds ago
Yes I can. I already did. An artificial deadline is one that has no penalty if it is crossed. Such as an EMA filing by x date. A real deadline would be a statute of limitations, for example. 
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Hoskuld Hoskuld 5 minutes ago
To not spend what was needed on a program is not criminal but it is close to it. You sell people on the idea that you DO believe in the program and you ARE doing what you need to do to get it to market. Then, afterwards, you say you didn't know it would work and so you didn't spend enough money? I have a real problem with that because I believed it would work and I believed what they said about setting their programs up for success. I was so embarrassed about believing them that I didn't post here for a year after the Rett failure - I thought it was a gimme, and it should have been.

Agree that we should all hope that 2-73 is approved for AD soon. But, my point is that had the programs been run properly, like nearly any life sciences company would have done, then we wouldn't have to hope. Look at Cassava with its (probably) ineffective simufilam: they are running 2 separate P3 trials in parallel with ~2,000 total patients. Had Anavex done the same - or immediately started a 2nd P3 after the 1st one ended - then hope would not be a part of this discussion and the share price of Anavex would be 3x higher right now.
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Hosai Hosai 8 minutes ago
Daniel Klamer is doing a 30 min presentation at the 4th Mitochondrial Dysfunction Drug Development Summit in Boston today with this title - "Uncovering Mitochondrial & Related Pathways for Parkinson’s Disease & Dementia to Discover Biomarkers".

Then just after he's in a 45 min fireside chat - "Adopting an Integrated Approach to Measuring Mitochondrial Activity for
Validating Biomarkers".

Yesterday was day 1 which he chaired - https://www.linkedin.com/feed/update/urn:li:activity:7265132981608955904/
👍️0
sab63090 sab63090 9 minutes ago
Powerwalker, here's what I found for you on "Gemini" since many here like these AI findings:

No, a company's market cap dropping during the year does not automatically change their SEC filing status. The SEC determines a company's filing status based on their public float (the number of publicly traded shares) at the end of their fiscal year.

However, if the company's public float drops below the threshold for their current filing status, they may become subject to different filing deadlines in the following year.
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powerwalker powerwalker 45 minutes ago
William, I was thinking that once a company are in that group of large accelerated filers, it never leaves. Why should investors be watching a pogo stick, as to whether a company files in 60 days one year, 90 in the second and back to 60 in the third. The SEC, along with investors, like consistency and allowing a company to vary such filings from year-to-year is ridiculous.

But, stranger things have happened ...
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ExtremelyBullishZig ExtremelyBullishZig 1 hour ago
Great! Your wife says hello!
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ExtremelyBullishZig ExtremelyBullishZig 1 hour ago
Too bad that no one followed up to see that the story was false. Where is Ern today?
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ExtremelyBullishZig ExtremelyBullishZig 1 hour ago
It looks like it could maybe possibly work better than what is currently out there...it is what it is. Only a large properly planned trials would prove what you claim.
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ExtremelyBullishZig ExtremelyBullishZig 1 hour ago
The lost of people who look at things correctly. Stop taking psychedelics and you will see what is going on at Anavex.
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ExtremelyBullishZig ExtremelyBullishZig 1 hour ago
That isn't the point. If a company gives 10 "artificial timelines" annually, andaybe delivers on one of them, they cannot be trusted toanage properly...it means they don't know how to manage projects...it is a problem.

If your wife constantly told you that she would be home from work by a certain time and was frequently an hour late without being promoted for working so hard...you may want to get a PI to find out who in the office she is "working on so hard". It has to do with trust.
🚽 1 ❌️ 1
ExtremelyBullishZig ExtremelyBullishZig 2 hours ago
Same thing every year since they changed their company from a photo print shop to a drug company.

They always lost ten items and possibly complete one withing the year that they list the catalyst.
🚽 1 ❌️ 1
Investor2014 Investor2014 2 hours ago
As there is a lot talk about and use of LMMs like ChatGPT to 'help' understand e.g. the chance of approval for Anavex in AD. This talk gives an easy to follow and in depth understanding of the capabilities and limitations of this type of AI.

👍️ 1
Investor2014 Investor2014 2 hours ago
Many here do indeed need to think much more as an investors in a speculative stock.

Biotech is not for everyone.
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Investor2014 Investor2014 2 hours ago
How is it going with that other biotech you have been pumping and the Investment Group?
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Investor2014 Investor2014 2 hours ago
A blatant pumper and Missling apologist has been in plain sight for quite some time.
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Investor2014 Investor2014 2 hours ago
Can you define "Artificial deadlines" and mention a handful of companies that successfully sell products and services grounded in setting artificial deadline?
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Steady_T Steady_T 8 hours ago
How's that rent collection going? 🤣
👍️ 2
georgejjl georgejjl 8 hours ago
When discussing "muscarinic M1" in relation to schizophrenia and PANSS, it refers to the potential therapeutic role of activating the M1 subtype of muscarinic acetylcholine receptors as a novel treatment strategy for schizophrenia, where improvements in symptoms can be measured using the Positive and Negative Syndrome Scale (PANSS), with research showing that targeting M1 receptors may lead to significant reductions in PANSS scores, indicating symptom improvement in patients with schizophrenia.

Anavex 3-71 for the treatment of schizophrenia.

Good luck and GOD bless,
🧠 1
ExtremelyBullishZig ExtremelyBullishZig 9 hours ago
You believe George after the crap he pulls on a daily basis?
👎️ 2 👺 1
georgejjl georgejjl 9 hours ago
I will predict that AVXL should exceed the $1 Billion market capitalization next week.

Good luck and GOD bless,
👍️0
boi568 boi568 9 hours ago
You are thinking more like a manager than an investor in a speculative stock.
👍️ 5
kund kund 9 hours ago
Pumper Mayo pumping JPM news, which clown CEO posted on linkedin and X 3 month in advance, as if that is any indication. He pumped model picture with Elon's mom sometime back.
👎️ 1 👺 1
kund kund 9 hours ago
You didn't get the memo? New video has surfaced, most probably from that tiny phase 2a trial, super responders.

https://vimeo.com/1023753471
👎️ 1 👺 1
georgejjl georgejjl 9 hours ago
An Australian TV news interview of Ern Heaven and his wife. Ern had Alzheimer's for over 2 years and was declining when he joined the Anavex phase 2a trial of Anavex 2-73. Over a period of a year on the drug, he first stabilized, and then improved. No other drug has ever helped an Alzheimer's patient improve.

According to the 1 year trial results, 6 patients out of the initial 32 had "strong" reactions and showed improvements in one or more tests.



Good luck and GOD bless,
👍️ 1
La Flaca La Flaca 9 hours ago
We all stumbled onto this drug and didn’t really appreciate its value - starting with the Greek doctor and Missling. We all hung around because we hoped and prayed that it would work. Earlier and better execution would have been great but it is what it is. Looks like it works - better than anything that’s out there. Let’s hope it gets approved soon for the sake of the families afflicted with early alz. The money will come.
🎯 1 👍️ 9
crescentmotor crescentmotor 9 hours ago
to have submitted something 4 months later than it nominally should have while moving the ball forward on none of the other programs is shameful.

Dr. Missling is a proven underperformer. It's even worse than that as he has mislead AVXL's shareholders for a number of years with shameful shareholder guidance. I don't see how anyone with a properly functioning brain could argue that fact. It is nothing but horrible performance that the AD OLE data has not been released, not to mention the MAA. The word "slow" comes to mind that doesn't seem adequate. I will be very pleased if the MAA is filed and moves forward. After that, a partnership/buyout could occur and Dr. Missling would most likely be put out to pasture.
👍️ 2 👎️ 1 👺 4
bas2020 bas2020 10 hours ago
You're absolutely correct. I saw through that masquerade for quite a while. Another to add to the list.
👍️ 6 👎️ 1
georgejjl georgejjl 10 hours ago
I predict that the dosing of all trial participants in the Phase 2 schizophrenia trial will be completed during or prior to December 2024.

https://www.anavex.com/post/anavex-life-sciences-announces-encouraging-preliminary-biomarker-results-from-ongoing-phase-2-study#:~:text=NEW%20YORK%20–%20October%2017%2C%202024&text=Part%20A%20of%20the%20Phase,mg%20daily%20for%2010%20days.

Good luck and GOD bless,
🎯 1 👍️ 2
ignatiusrielly35 ignatiusrielly35 11 hours ago
An extremely subtle fudster has revealed himself or herself. 
👍️ 7 👎️ 1
Hoskuld Hoskuld 11 hours ago
Yes - to have submitted something 4 months later than it nominally should have while moving the ball forward on none of the other programs is shameful. It is a win - but is severe underperformance. For a pumper like yourself, everything is perfect, I get that.
👍️ 4 👎️ 3 👺 6 ❌️ 2
Hosai Hosai 11 hours ago
"As you wrote, they will either submit the MAA or they won't...but submitting it by YE is a hollow win".

An AD MAA for Europe where only a handful of AD drugs have been approved in decades, which has high approval rates due to a lot of discussions and vetting pre-submission and for which approval would likely mean massive revenues and subsequant share price increase equals "a hollow win"?
👍️ 11
ignatiusrielly35 ignatiusrielly35 12 hours ago
Artificial deadlines are only important if they have some substantive consequence. In which case they would not be artificial. But I digress. 

I would feel so much better, if I was short or wrote covered calls, if the EMA filing doesn't occur by x date that would necessarily mean that the data suddenly suck and/or the filing will not occur within y weeks of x date, or ever. Load the short boat. 

If my wife doesn't come home from work as predicted that means she's likely dead from a car accident. 
👍️ 1 👎️ 1 👺 1
WilliamMunny WilliamMunny 12 hours ago
Actually, power, Anavex has 90 days to file its 10-K this year. Unlike 2022 and 2023, the company's public float was under $700 million on the last day of FQ2, so it is no longer a "large accelerated filer," at least as I read it. Therefore the 10-K (and PR/conference call) in December is no problem for the SEC, whether it is the first business day of Advent or Christmas Eve. Particularly since Thanksgiving is late in the month and would interfere with the PR and conference call, I can't imagine a 10-K filing in November.
👍️ 5
Hoskuld Hoskuld 12 hours ago
LF, they have inexplicably abandoned every other initiative they initially said they would make progress on this year: no PD, no secret indication, no Rett, no [fill in the blank]... They have inexplicably poured everything into this one document and they have not finished it yet and have maybe 15 business days left to do so. IMO, they have wasted another whole year with the exception of schizophrenia program - whose p2 is so tiny that I don't think even tremendous success will lift the share price and create value...

As you wrote, they will either submit the MAA or they won't...but submitting it by YE is a hollow win: the value of the asset is worn away by yet another year. This is just not done in biopharma - executives work their tails off to maximize the most important asset: time.
👍️ 6 👏 1 👺 1
Hoskuld Hoskuld 12 hours ago
If they had submitted then they would announce. This is a company that has never met a self-imposed timeline and had a terrible failure with Rett program. It was supposed to do so much this year and has done nothing. If they had anything even resembling a win they would PR it immediately.
👍️ 6 👺 1
Investor2014 Investor2014 13 hours ago
Yes and otherwise we are into Feb'ish.
👎️ 1 👺 1
La Flaca La Flaca 13 hours ago
Just trying to piece everything together. AVXL has an opportunity to announce either the start date of 11/28 (which means the MAA was filed and accepted) or the filing of the MAA 11/25, in Dec. and they’d meet their commitment / deadline to file inQ4.
👍️ 4
Investor2014 Investor2014 13 hours ago
The chance of that being true is even better than the rumour of a tea pot orbiting Mars, which could be true. Alas as yet we just can't prove or disprove it.
👍️ 1 👎️ 1 👺 1
Hoskuld Hoskuld 13 hours ago
Maybe it was approved and they are secretly selling 2-73 in Lichtenstein right now. We don't know that is not happening, right?
👎️ 1 👺 3 😁 1
La Flaca La Flaca 14 hours ago
I should clarify that I don't know for a fact that they haven't filed. Maybe they have and will PR the start date of 11/28 referenced by Hosai. 🤨
👋 1 👍️ 1
La Flaca La Flaca 14 hours ago
I'm optimistic. They will either make or miss the deadline for what appears to be the last date of submission with EMA in 2024.

👍️ 2 🤔 1
CkFacts CkFacts 15 hours ago
CHMP is a committee of the EMA , and is responsible for the scientific evaluation of the application dossier . After thorough review of the data the CHMP issues it opinion ( positive or negative ) to the EMA . If review is positive the EMA sends recommendation for approval to European Commission.
👋 2 👍️ 3
Hoskuld Hoskuld 15 hours ago
PW you are spot on. The hype in the post, too, is silly: a report needs to be made and it will be made - there is no promise of anything more than the necessary report.
👍️ 1
kund kund 15 hours ago
Anavex has 75 days to file 10k, company market cap was less than $700mil at the end of fiscal year. ST poster is correct, but there is nothing much to read into it, buffoon want to delay everything as much as possible.
👺 1 ❌️ 1
powerwalker powerwalker 15 hours ago
You trust him why? He is full of s**t ... He did NOT speak to IR. As george noted, it is a 10-K being filed, not the Q, and I believe Anavex has to file within 60 days, which is November 29th. If they don't, they need to file with SEC and explain why.
👍️ 5
Hosai Hosai 15 hours ago
The CHMP meetings are just where they discuss applications that have already been accepted as MAAs as far as I understand.
I don't believe the CHMP is involved in the 2-3 week period when a submission is processed and 'accepted' and given a start date. It's a more basic administrative checklist exercise. There is no scientific evaluation here.
CHMP were involved in the eligiblity to submit an application stage which AVXL already passed obv.
👍️ 7
CkFacts CkFacts 15 hours ago
Next CHMP meetings Dec 9-12 ,2024 , Jan 27-30 2025
👋 1 👍️ 2
ExtremelyBullishZig ExtremelyBullishZig 16 hours ago
LOL
👎️ 1 👺 1
Hosai Hosai 17 hours ago
I believe the last 2 start dates of this year will be around Nov 28th and Dec 27th going from previous MAA start dates recently and in prior years in that ongoing CHMP apps tracker s/s. Usually the acceptance PR is on the day of the start date or a few days after it.
👍️ 5
Investor2014 Investor2014 18 hours ago
It would make sense for Anavex to announce an accepted MAA, which might be doable in December provided of course the company has actually filed one.
👍️ 2 👎️ 1 👺 1

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