Anavex Life Sciences Corporation (AVXL) Options

How's that rent collection going? 🤣

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,

You believe George after the crap he pulls on a daily basis?

I will predict that AVXL should exceed the $1 Billion market capitalization next week.

Good luck and GOD bless,

You are thinking more like a manager than an investor in a speculative stock.

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.

You didn't get the memo? New video has surfaced, most probably from that tiny phase 2a trial, super responders.

https://vimeo.com/1023753471

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,

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.

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.

You're absolutely correct. I saw through that masquerade for quite a while. Another to add to the list.

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,

An extremely subtle fudster has revealed himself or herself. 

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.

"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"?

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. 

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.

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.

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.

Yes and otherwise we are into Feb'ish.

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.

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.

Maybe it was approved and they are secretly selling 2-73 in Lichtenstein right now. We don't know that is not happening, right?

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. 🤨

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.

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.

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.

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.

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.

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.

Next CHMP meetings Dec 9-12 ,2024 , Jan 27-30 2025

LOL

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.

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.

La Flaca,

It is NOT a 10Q will be a 10K, since Anavex Life Sciences fiscal year ended on September 30, 2024.

Good luck and GOD bless,

Brian5220 from stocktwits:

"Okay... Just got off the phone with Anavex IR. They will give a weeks notice before the 10-Q release. IR states it will be in December. Not next week for the conference call or release of the 10-Q."

Cancel your sell limit. Don't say no one warned you. 🙏

Aren't we all here for the same reason there's no need to have all the fighting and arguing on the board can't we all just get along LOL

No. Trial size adequacy is NOT baked into the p values. (little p instead of big because it is lowercase rho that = stat sig.) So why is this not true? Answer: because for huge indications, like AD, you need a huge sample set to be sure of safety. It is possible that Anavex can overcome this with OLE data and safety data from Rett and other trials.

You could (easily) say the trial size was inadequate because ADL impact (one of only two primary endpoints) was not stat sig and adding even another 100 patients would have pushed it where it needed to be.

No one should have a bias where they think everything is honky dory with respect the Anavex and its trials designs and executions. We all want our stock investment to succeed but it doesn't do us any good to only see rainbows and unicorns whenever we examine Anavex's track record.

Anavex still hasn't done a damn thing. LFG Anavex - execute now please.

Very nice find, badger. Surprised it took 20+ days for us to see it, given the number of "all things Anavex" people who keep an eye out for publications. It would be good to know which trial these folks are from" P2a or P2b/3 or if it is a mix. More of these testimonials would be great to see.

"Isn't the trial size adequacy baked into the P values? Seems like form over substance to me. The fact that other companies with drugs having marginal effect chose to run two large pivotals is that important?"

Exactly...the 0.008 p value for ADAS COG in ITT means if you ran a trial on a sugar pill vs placebo 1,000 times you would only get a result as extreme as was found between Blarca and placebo 8 times out of that 1,000 trials.

Then there is p values for CDR SB - 0.01
CGI-I - 0.003
Grey matter retention - 0.0035
Whole brain - 0.0019
Lateral ventricles - 0.0015.
Plasma amyloid beta 42/40 - 0.048

Even the non-stat sig plasma findings had large effect sizes in Blarcamesines favour, but must have had huge variations between high and low in each cohort to mean not stat sig. They actually are on par with the effect size difference for grey matter vs placebo - 63.5%.

Plasma reductions vs placebo that were not stat-sig:
Nf-L - 67% reduction (p=0.28)
P-Tau 181 - 64% reduction (p=0.39)
P-Tau 231 - 92% reduction (p=0.44)

Not much new to read on this message board, same old biased viewpoints, so here's a couple of things to consider:

The price has definitely found some sort of support and I noticed that the MACD has corrected back to the black line to kiss that spot which is a noticeable "kiss" which often works as a short term "buy spot"....Kennedy from Elliott Wave has mentioned it often in the past. The RSI has certainly worked off the overbought level. I agree with Tom about short term resistance @ 8.35 to 8.40 and it seems to be challenging the down slope right now; looks potentially bullish if we are able to push up past it!

The OBV especially on the Weekly Chart looks good to me from that low at appx $3.50 to now...it's been going up consistently!

The sole negative, so far, is the lack of VOLUME and price push up!

That corner your painting yourself into is getting smaller

I just am replying to you as I just got back home and I try to answer any message I received first....seeing some things and will comment on in a few minutes!

This sure provided a ton of shareholder value. I am grateful for the news Anavex provided about the fireside chat presentations today.

Just got back home and I am seeing several interesting things which I will post on after I catch up on the board!

There always seems to be a pattern with this CEO—using various means to pump the stock before eventually revealing the drug's sucks. Until the company files for regulatory approval and the drug gets approved, there's little to no real value in this company.

So please do tell us: How many thousands of shares are you buying in anticipation of news between tomorrow and next week? Are you putting your money where your mouth is?

Perhaps a better question is: How many shares are you planning to sell once the stock runs up on anticipation of HUGE NEWS?

By the way, thank you for repeatedly reminding everyone of all the 2H events that are not going to happen.

Isn't the trial size adequacy baked into the P values? Seems like form over substance to me. The fact that other companies with drugs having marginal effect chose to run two large pivotals is that important?

Resistance now today around 8.40/8.30

The video was posted 24 day ago. 
So let's not worry. Lol