Anavex Life Sciences Corp (AVXL)

[Steady_T]

Where did you find the information that the company filed it's LOI in mid December?

[WilliamMunny]

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.

[ignatiusrielly35]

I accept that answer. Others would, however, find a new primary griping point.

[sab63090]

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....😊

[Investor2014]

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.

[CashMoney75]

But can crash from $26 to $3 right? Loser

[BIOChecker4]

That would be a good move. I like that!

[BIOChecker4]

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.

[BIOChecker4]

“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.

[Foodman1291]

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.

[ignatiusrielly35]

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.

[ignatiusrielly35]

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.

[powerwalker]

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.

[Foodman1291]

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.

[BAR123]

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.

[attilathehunt]

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.

[XenaLives]

There are parameters defining that requirement...

Cite chapter and verse and the nature of the alleged violation if you want to be taken seriously.

[Lacey1]

Grand Slam

[JoeBear906]

Gosh, what a day we have rocketed up 1.5% for some giant coin! Jimmy has a nickel!

[williamssc]

That one is is a sava bull. A-273 scares the heck out of that bunch.

[JoeBear906]

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.

[ignatiusrielly35]

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.

[attilathehunt]

Expect Ma to be named interim CEO...This should stabilize the price.

[Hosai]

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.

[skitahoe]

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

[ignatiusrielly35]

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?

[frrol]

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.

[BIOChecker4]

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.

[mrplmer]

The board has to be looking at replacing this goofball

[mrplmer]

would you want to face the shareholders? He'll say he was waiting on peer review.

[Investor2014]

Yes wait until just after 13th May that little problem might not consume to whole ASM.

[Investor2014]

85% chance.

EOY = Feb-ish 202*?

Imo!

[k9uwa]

Ummagumma Leo if a first pressing and the record and cover are in excellent condition ... worth some bucks it is.

John k9uwa
later gator

[sab63090]

BioChecker4
I really don't want to post any longer here, but I do read....the possibility of the ASM delay is certainly pointing to ongoing LITIGATION and is an acceptable reason for the delay....

My respect for the CEO of one of our competitors remains as can be seen by the price advance and offsets the recommendations I have read here in the past of how lousy that company is....name is ANVS....I always thought that RETT was a "lock" and bought into that speculation....I've been proven to be wrong! What else is new?

[Foodman1291]

Bar and grill

Took Misslings quote to mean before the end of 2024, which is this year. So I don’t know how you interpret his words to signal sometime after 2024. He did not use the term “fiscal” from what I can gather.

[JKS3]

Once fired from Anavex, ...

[WilliamMunny]

Baltimore, I have not heard of any new timeline given by the company on the MAA filing beyond the original "as early as possible in 2024." We do know, however, that when the company formally requested the appointment of rapporteurs on (or as much as 4 weeks before) February 7th, they had informed the EMA that the planned MAA submission date was prior to September 7, 2024. We know this because the company had to have an MAA submission date no more than 7 months later before the EMA would initiate the rapporteur selection process. On March 4 (at TD Cowen) Missling told us that he was awaiting notification of the rapporteurs and said that they were in the rapporteur selection process. The most recent filing deadline for the process at that time was February 7. I suppose since he said that they were awaiting notification, they could have met the January 10 deadline and that 6-7 business days after the selection process was theoretically over, the specific notification had not yet been given. I tend to go with February 7, but either way the target for submission was Q3 at that time.

[FooBarAndGrill]

EOY = Feb-ish 202*?

[BIOChecker4]

I’m being very honest about my belief that the proxy and annual meeting are delayed while the board and Missling negotiate the termination of his contract. I honestly cannot think of any other realistic reason for a delay like this. I don’t believe for a second that Missling is waiting for good news so that he can have something positive to discuss. I’ve never seen that happen.

Maybe I'm dreaming but there’s simply no other explanation I can think of that would make sense.

[Foodman1291]

Bulletman
Not exactly accurate. Here is the exact quote for our posters to review…

“Speaking of “later this year,” the Company has now gone on record saying it expects to complete its application to the EMA for the possible approval of blarcamesine for Alzheimer’s before the end of this year (rather than as soon as possible”

[jav0033]

ALL DELAYS AND MISSED TIMELINES HAVE MEANT BAD NEWS FOR SHAREHOLDERS.

History will repeat ITSELF.

[jav0033]

Oh god please.
Fire this lying scumbag. Have him rot in jail for his wrongdoings and then deported back to Deutchland.

“hope yuu are as excited as vee arr”

STFU!!!

[BIOChecker4]

My hope is that the proxy is late because the board is negotiating the termination of Missling’s contract and looking to bring on a new CEO before holding the annual meeting.

That’s the only reason I can think of for the delay. Surely it’s not because Missling is on vacation or waiting for some positive news.

[powerwalker]

sum, that is right … and I’m not sure Anavex has even filed a draft of it.

Something is cooking … I just don’t know if it is Dreamland ribs or stone soup!!

[tredenwater2]

“Increased statistical power of EEG/ERP biomarkers to help minimize trial size and cost • Streamlined regulatory process for trials leveraging the EEG/ERP biomarkers”

https://erpbiomarkers.org/

Seems to me this kind of consortium would help call the bluff of a company trying to stretch out its so called failures. Spending 2+ years in a co sortium figuring out specific disease characteristics and measuring metrics is advancing medicine not delaying. All this bei g said Im beginning to believe the Schizophrenia trial could advance to a new stage rather quickly with these new qualifying biomarker tools.

This company is a complete fraud or a grand slam, cant be both or any where in the middle imo and partnerships like this only add to the strength and integrity if you ask me. This is leading, not following the herd off the cliff thinking. Im sure all companies involved are keeping a close eye on trial design and results of our Schizophrenia trial. Our trials keep getting stronger and stronger with time.

[sumbuysumsell]

Going by last years timing the proxy is working on being 3 weeks overdue.

[LakeshoreLeo1953]

Just curious.
I'm sure a few here can answer.
Does click bait income cover the losses of owning one share of AVXL from 31 to 3.40?
Heck from 10 to 4?

[LakeshoreLeo1953]

Was having some fun with old vinyl and ran across this album cover
that may well define the infinite possibilities of TA.....

Ummagumma

[LakeshoreLeo1953]

ASSUMED

understanding and interpretation

Often IS

worthless.

Poster Child Emoji response(s) may prove the point.

[powerwalker]

Notice they haven't even announced the date of the shareholder meeting so I guess they plan on having no shareholders soon.

mike, I noted that last week that the proxy hasn't been filed. It is as if Anavex and TGD were waiting for something to happen ... I assume good since if it were bad, ASM would have been held by now, so the direct questions from shareholders would not have to be answered.

I think good news is coming soon ... even in The Chosen, the word "soon" is always under scrutiny! 😉

Peace, mike,
powerwalker