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  6. Anavex Life Sciences Corporation (AVXL)

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Anavex Life Sciences Corporation

Anavex Life Sciences Corporation (AVXL)

NASDAQ
3.44
0.05
(1.47%)
Closed April 27 4:00PM
Delayed by 15 minutes
3.44
0.00
(0.00%)
After Hours: 7:48PM
Delayed by 15 minutes

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AVXL News

Official News Only

Form 4 - Statement of changes in beneficial ownership of securities
Edgar (US Regulatory)
February 23 2024
AVXL (1.47%)

AVXL Discussion

View Posts
frrol frrol 4 minutes ago
Yes. It's a decent response, just gets stumped because the 7 month clock starts with our Rapporteur Appointment request, which we have not announced. Though no idea how it came up with April (and May).

Keep in mind that these AIs often give flawed responses. (Gemini warns you of that several times when you first use it.) Most people are pasting AI responses without examining them, which is careless. They also blame AIs as the new Manipulator boogieman, also careless.
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Investor2014 Investor2014 53 minutes ago
There is precious little of what you post that is a must see, most is a best ignore!
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frrol frrol 1 hour ago
I think he means "getting" as "in the process of getting".
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Steady_T Steady_T 5 hours ago
Any relationship between your post and reality is an unusual occurrence.
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Steady_T Steady_T 5 hours ago
How do you know that they are getting rapporteur comments in early March?

I must have missed that.
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kund kund 6 hours ago
This is form 3 year and still no sign of starting that trial. She moved on to different drug, no one has time like clown, who goes on Europe vacation every year with his model.
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tredenwater2 tredenwater2 6 hours ago
So Annovis just inked a deal to raise funds right before a release of ph 3 data and the soars? Normally dilution causes a stock to tank.

I hope they have solid data and the manipulators transferring wealth are not given an opportunity to crash the stock….for any reason.
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tredenwater2 tredenwater2 6 hours ago
Whats the skinny George? No need to download another site to tell us much of what we already know.
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go avxl go avxl 6 hours ago
2021 Video won't give you 2024 NDA

george style BS
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frrol frrol 6 hours ago
Great post. You're pretty familiar with the guidelines and dates. So asking for eligibility is first step, submitting LOI second step, and CHMP appointment of the rapporteurs third step, which Missling said we're waiting on. You're saying it's the "second gating factor" but I think it's the third. From Missling it sounds like we've submitted our LOI, and the CHMP was still appointing our rapporteur(s) back in March.

https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/obtaining-eu-marketing-authorisation-step-step

I hear what you're saying about the rapps, because the guideline below says "The (co-)rapporteurs appointment procedure takes one month...". But it's after the LOI submission, because the LOI is an annex to the pre-submission request for rapporteur appointments according to Section 2.4.1.1:

https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/pre-authorisation-guidance

But the link above is a little confusing, because it says "This notification is also called the 'letter of intent'."

So yes our LOI filing is probably after the Dec 19th PR. I think from all the above, it's safe to say that around Sept MAA submission is likely.
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georgejjl georgejjl 7 hours ago
A MUST SEE regarding AVXL!!!

Watch and listen to Dr. Randi J. Hagerman MD regarding Anavex 2-73

Watch starting at 38 minutes and 21 seconds and again at 1 hour and 16 for the Q & A including many questions and answers regarding Anavex 2-73



https://health.ucdavlis.edu/mindinstitute/videos/images/dls/hagerman-2021-dls.pdf

Good luck and GOD bless,
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kund kund 7 hours ago
Good, at least you know clown has not even submitted LOI, he is still counting millions and millions of pages.
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kund kund 7 hours ago
Another useless post. First get the trial started, fully enrolled, then complete it and report data as per protocol end points, whole thing is like 10year from now or may be never.
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georgejjl georgejjl 7 hours ago
From prodigy2023 on ST

https://www.pharmaceutical-technology.com/data-insights/blarcamesine-hydrochloride-anavex-life-sciences-fragile-x-syndrome-likelihood-of-approval/

Goof luck and GOD bless,
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123tom 123tom 8 hours ago
I agree with your thoughts, John. We're buying core shares down here. But I have some trading shares I bought too soon in a different cycle, I'll need to sell when the right time comes. And yes, let's hope for a good medicine to eradicate ALZ. I still believe in Anavex science, but the FDA corruption is a bit concerning. Look what they've been doing with the big phrma and vaxx operations, and the revolving door for executive employment. Conflict of interest much? Anyway, have a good weekend.
.................................
Price action today.... no rocket ship bounce from the 3.25 Low.... could we see that as a bearish clue? Don't the computer algos see 3.25 as a great place to buy? Today fluttered a small step but stayed capped around 3.46.... I was seeing 3.45 ,3.50, 3.60 area as Resistance to watch.... gotta keep watching it for the roll over and tumble. Not much else to say about today's lack of movement in either direction. The computer bots are waiting for the next trigger, whatever it will be. 3.40 could develop into a support shoulder... IF we see another rally climb to 4 dollars. > And pullback to retest a 3.40/3.50 shoulder. There's a pattern chance to see how 3.25 would develop as a finished bottom.
But, my money is still waiting for 3.00 target zone, 2.90/2.80 maybe even 2.70. The resistance overhead around 3.50 is still the next thing I'm watching.
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kund kund 9 hours ago
sometime between April and June 2024. April is gone, Clown has no plan to submit to any regulatory body, he is buried under millions and millions of pages. This is a scam, no drug, all hogwash with tiny trials and made up end points.
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Hosai Hosai 9 hours ago
When the second paragraph from the PR is added with the "early as possible in 2024" line it seems to sway it to saying "Given the focus on speed in the December PR and some lead time, it's reasonable to guess they might submit the application sometime between April and June 2024. However, the rapporteur details mentioned in March could cause a slight delay"
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Hosai Hosai 10 hours ago
For what its worth when I copied into google gemini the December 2023 PR opening paragraph plus the fact that the company had 40 employees and the CEOs currently getting rappatour comments in early March it guesses a submission date between June and September 2024.
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bas2020 bas2020 10 hours ago
The FUDster 👺 made it up. The company had not stated when the LOI was submitted.
Be careful of anonymous posters pretending to be experts.
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Steady_T Steady_T 10 hours ago
Where did you find the information that the company filed it's LOI in mid December?
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WilliamMunny WilliamMunny 12 hours ago
My understanding is that the second gating factor is when the company files for the rapporteurs. It won't get worked on until 7 months before the targeted MAA date. The EMA also advises against filing for the rapporteurs much later than 7 months prior. If the company also filed that in early/mid-December, then it would have met the January 10th submission deadline for the rapporteur process. It means that when Missling said on March 4th that he hadn't been notified yet on the rapporteur(s), the EMA had waited more than 6 or 7 business days after the published selection days to advise him of the outcome. Certainly possible, but it could also be that the company filed prior to the February 7th deadline (and they would have then been in the process, as Missling said, but were not going to be notified until after March 21st.) So, it seems to me, depending on our interpretation of Missling's comment, that the 7 month minimum until filing for the MAA would mean early/mid July to early September (at the very latest) for the MAA target given to the EMA, assuming the company does prepare it expeditiously, as you say. While mid-June is not inconceivable, I suppose, it seems quite unlikely with only three months left to work with the rapporteurs. I just prefer to expect Q3, leaning toward the first two months.
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ignatiusrielly35 ignatiusrielly35 12 hours ago
I accept that answer. Others would, however, find a new primary griping point.
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sab63090 sab63090 13 hours ago
BioChecker4
I just checked in after a busy day....

I did not say that other reasons might not be used, but I have had enough litigation issues that I have participated in with the understanding that it is a "legitimate excuse" for a delay in filing.

Investor2014 mentioned May 13th deadline for getting a lead person to file with the several law firms out there hoping to catch a live one. An intelligent thing to do is wait for a couple of weeks....Well, on the good side I have a granddaughter graduating from college and I will be out of town to celebrate with our whole family including our twin granddaughters who attend the same university who will complete their freshman year....😊
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Investor2014 Investor2014 13 hours ago
Missling opened up for the possibility that the P2b/3 full data presentation could happen prior to and independent of a published peer reviewed article. One interpretation of that could be that a journal is taking an indefinite time process the peer review and publishing, or it has been declined. Another could be that the data presentation is coinciding with something yet to be revealed e.g. MAA submission, a scientific conference or any other wonderfulness.
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CashMoney75 CashMoney75 13 hours ago
But can crash from $26 to $3 right? Loser
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BIOChecker4 BIOChecker4 13 hours ago
That would be a good move. I like that!
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BIOChecker4 BIOChecker4 13 hours ago
Are you a securities lawyer offering a professional opinion or just a guy making something up because it sounds plausible to him or fits a comforting narrative? I think I know the answer but I’m asking anyway.
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BIOChecker4 BIOChecker4 13 hours ago
“On another issue, if he were to leave what would be the new primary fudster talking point?”

Well, I don’t consider myself a FUDster since all I’m doing is expressing my opinions of our CEO’s performance and that of the board of directors in coddling him. I’ve NEVER said or even implied that anyone should sell and I don’t care what anybody does with their money except to behave in a financially responsible manner. However, to answer your accusatory question, I personally would have nothing negative to say. If a competent CEO were hired and that person had a track record of success in drug development, business development, regulatory affairs, and commercialization leading to enhanced shareholder value, I would 1) Add to my position, and 2) Sit back and give it additional time.
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Foodman1291 Foodman1291 14 hours ago
So now his FUD style makes sense to me. Thanks for the insight Williamssc. Some people have a perverted need to impress
others but only display cleverness by half.
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ignatiusrielly35 ignatiusrielly35 14 hours ago
If you want to engage in other baseless speculations about the delay in the ASM it could be that a proposed merger or buyout needs to be on the proxy.

This is all just random guessing at this point.
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ignatiusrielly35 ignatiusrielly35 14 hours ago
Anyone can direct the ASM. If they wanted to they could just have the CFO or Ma herself run it. Or even an attorney (shudder).

Technically, the only absolutely necessary task is to document the shareholder votes.
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powerwalker powerwalker 14 hours ago
mrp, you do not know the strategic plan ... the Board does ... and it apparently approves of the plan as it has not let TGD go as of today.

They know the process and time line: Board, TGD and the officers/workers of Anavex. It appears no one important is jumping ship.

The plan is in incubation ... let it hatch.
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Foodman1291 Foodman1291 14 hours ago
Hi Hosai

I can assure you Tom Bishop was not confused. However, he did appear somewhat rattled when he experienced mic feedback (technical difficulties) as he began to ask questions of Dr Missling. I’ll give you that.
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ChrisMissing ChrisMissing 14 hours ago
All you guys who think Missling is gone are dreaming. It is his company to see 273 through to completion and a buyout if the price is right. That to me is anywhere between $10-$20 billion. I personally think that the delay is associated with either a partnership or FDA guidance. If partnership then George might be right with his multi billion $ change in market cap. If great FDA guidance like accelerated approval is given that would be huge as well. Or the same for the EMA. I hope George is right this time. Personally I am giving this until the end of the year. If we are still in the same boat I will be moving on.
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attilathehunt attilathehunt 14 hours ago
But replacing a CEO would not be a reason to delay the ASM.


Unless, they haven't decided on a new CEO and the Board doesn't want the current CEO to open his mouth anymore.
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XenaLives XenaLives 14 hours ago
There are parameters defining that requirement...

Cite chapter and verse and the nature of the alleged violation if you want to be taken seriously.
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Lacey1 Lacey1 15 hours ago
Grand Slam
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JoeBear906 JoeBear906 15 hours ago
Gosh, what a day we have rocketed up 1.5% for some giant coin! Jimmy has a nickel!
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williamssc williamssc 15 hours ago
That one is is a sava bull. A-273 scares the heck out of that bunch.
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JoeBear906 JoeBear906 15 hours ago
SEC reporting is required, specifically, the law “require(s) that investors receive financial and other significant information concerning securities being offered for public sale, and prohibit(s) deceit, misrepresentations, and other fraud in the sale of securities.
Even if you have a bushy hairdo and a mid-European accent.
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ignatiusrielly35 ignatiusrielly35 15 hours ago
Unlikely, in my opinion but who knows? Doesn’t matter to me either way.

But replacing a CEO would not be a reason to delay the ASM.
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attilathehunt attilathehunt 15 hours ago
Expect Ma to be named interim CEO...This should stabilize the price.
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Hosai Hosai 15 hours ago
Maybe Bishop is confusing it with the peer review which Missling said "this year"? Bishop did seem a bit confused last time he was on a call.
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skitahoe skitahoe 15 hours ago
If I were the company and expected something positive, like a Journal or regulatory filing in the near future, I would not call an Annual Meeting until I knew that it had happened or was about to. It should be within 13 months of the last meeting, but the regulators really don't seem to care, so if shareholders don't force the issue by suing, they can do what they wish.

Gary
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ignatiusrielly35 ignatiusrielly35 15 hours ago
The only reason the ASM might be delayed by the unlikely event of Missling leaving would be his board seat. The proposed replacement would have to be on the proxy.

On another issue, if he were to leave what would be the new primary fudster talking point?
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frrol frrol 16 hours ago
The company filled its LOI to the EMA in mid December. My understanding is that we'll be submitting our MAA around mid-June to July, assuming we prepare it expeditiously. That meets the 6-7 month target that follows the EMA guidelines.
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BIOChecker4 BIOChecker4 16 hours ago
I honestly don’t see why the ongoing litigation would be a reason to delay the ASM. The litigation could go on for quite a while. Also, most public companies are in litigation for one thing or another all the time. It doesn’t prevent them from holding an annual meeting.

Maybe I’m guilty of wishful thinking but I still can’t think of a better explanation for the delay. However, since I’m not a securities lawyer and I’m not familiar with the rules for public companies incorporated in Nevada, I admit I could be missing important information.

If there is a securities lawyer reading this board, it sure would be interesting to get your a professional opinion.
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mrplmer mrplmer 16 hours ago
The board has to be looking at replacing this goofball
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mrplmer mrplmer 16 hours ago
would you want to face the shareholders? He'll say he was waiting on peer review.
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Investor2014 Investor2014 16 hours ago
Yes wait until just after 13th May that little problem might not consume to whole ASM.
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