Anavex Life Sciences Corporation (AVXL) 銘柄情報

Expect a press release tomorrow that will announce that there will be a conference call next week to review financial results for the first fiscal quarter of 2025 and provide an update on the execution of the Company’s growth strategy. Following management’s remarks, there will be a question-and-answer session.

Good luck and GOD bless,

Sorry you missed the run to 14 while waiting for your gap fill.

This is from ST TTTav66 Maxim Group “Institutional Group Dinner” with Dr. Missling on Thursday evening in Miami Beach Misleading has found another avenue to showcase his presentation skills. Previously, he used to attend neighborhood Rotary Club dinners, but now he has elevated himself to the investment banking level.

Tomorrow's earnings meeting held the support...look out after the meeting.

There already is another gap at $5.85. see you down there.

LOL...not good...means no one there is currently good at that job and everything to this point might all have been incorrectly reported... ouch.

Are you being honest about this one?

About the job

Summary of Position

Anavex Life Sciences Corp. is seeking a talented and highly motivated statistician to join our team. This position will have full responsibility for the methodological and statistical considerations in the design, implementation and conduct of clinical studies as part of the development program team. He/She/They will provide technical expertise necessary for leadership and guidance on statistical matters interfacing with key internal and external stakeholders to support company initiatives that will improve the quality and content of all clinical programs to deliver our portfolio.

Key Responsibilities

Support the clinical development program in designing clinical trials.
Develop the statistical analysis plan (SAP), programing specifications, SAS programming for derived datasets, review and validate TFLs.
Facilitate the implementation of statistical analyses, provide statistical input to the clinical study report and scientific presentations/manuscripts.
Perform statistical functions for submission related activities and serve as an internal statistical expert for the program.
Interface with therapeutic area members including Clinical Development, Data Management, Clinical Operations, Translational Science, Regulatory Affairs and Publication Teams.
Participate in managing vendors to ensure quality of all deliverables and adherence to requirements/timeline.
Participate in process improvement, training, SOP development, enhancing statistical technical expertise and mentoring junior statisticians as a senior member of biostatistics department.

Position will be filled at level commensurate with experience.

Requirements

Ph.D in statistics or biostatistics with at least 5 (Associate Director), 8-10 (Director), or 13 (Senior Director) years of experience in the biotechnology/pharmaceutical industry. Exceptional MS/MA candidates will also be considered.
Deep understanding of statistical designs and methods for early and late development programs.
Solid understanding of regulatory guidelines on drug development, regulatory submissions, and statistical practice.
Experience in applying quantitative decision-making methods to support internal Go/No-Go decisions.
Significant prior experience interaction with health authority agencies such as FDA and EMA.
Demonstrated track record of successful project management (6+ years) and evidence of leading role as biostatistician in progressing assets from early development to marketing applications.
Outstanding ability and skills to effectively represent Biometrics and Data Management in interaction with senior management or cross-functional teams.
Proficient in SAS, S-Plus/R, sample size calculation software and statistical programming (SDTM/AdaM).

Remote position; intermittently required to work on-site in New York City; occasional travel.

https://www.linkedin.com/jobs/view/4143665894/

So they want more biostatistician—for what? More data mining?

Dr. Kun Jin PhD appears to be hiring again.

Check out his Linkedin page.

Good luck and GOD bless,

You are clearly Olympic-caliber in pointless blabbering. The irony seems lost on you. 

CC's are very informative for real investors. ...so you can hear more lies and pointless blabbering.

CC's are very informative for real investors.

There is no press release, but he could just issue a statement with his usual stale update. What is the point of a conference call? Only one analyst joins, who doesn't even know how to use a computer. Instead of having a shit show, it’s better if TGD doesn’t speak. Maybe he learned his lesson and decided to just issue an earnings statement.

I don't think that data are out there. However, it would be very odd for an applicant to withdraw the MAA in the absence of a clock stop, so I think an approval in that case would be near, if not at, 100 percent.

Is Anavex earnings date tomorrow?

Of the 15% of MAAs that don't have a clock stop, what % are approved?

No, that's not an issue as can be seen by the ~15 percent of MAAs that don't have the clock stop. You can be sure that the reviewers are providing reports to their managers on the MAA and their take on it. That demonstrates their diligence.

It's just a dream. I used to have that one too.

It looks like Oldmystic was right about the $8.50 gap that needed to fill. I’m hoping for no more gaps, just a nice, orderly rise to $25 and then partnership announcement or EMA approval, then BAM, gap up big and never look back. It’s nice to dream😂

All one needs to know is the indication / type of treatment and whether approved, withdrawn/rejected - all public information only. It is not that hard to get a handle on - but of course it is easier to draw a lazy and incorrect conclusion and then stick with it and argue it no matter what like say a lawyer would.

and the EMA staff have to show proper due diligence.

Questions have to be asked to show they read it.

Given the stats, expect a clock stop but don't be alarmed by it. It's a voluminous application.

Fear is a stronger emotion than greed.

The key here is that the mabs specifically screens with PET scan for amyloid plaque load as that is the target MoA addressed.

Not sure what you are trying to achieve with your screening comparison?

For the next confirmatory trial(s) even after a possible EMA approval, there will likely be additional biomarker screening of A2-73 trial participants to hone in on responders.

boi568
I've been on the same side as you!

I do remember you mentioning that it would be normal for questions to be asked and that we should expect some questions at Stop Clock One.

Prior to now, I had thought that there would be no need for any serious questions and actually thought we would be approved without any necessary questions and I have accepted that I was probably wrong on that.

My disappointment is that the price does not agree with a logical bullish outlook, hence I've been wrong 2x recently thinking that prior support levels would hold; they didn't.

"Conversely, IF shorts and sellers attack here"--like I've been saying since last October--"heads I win--tails you lose"

Exactly!

Font choice? give me a break
get a new script

Did you happen to notice the poor choice of font in the peer reviewed article? Was that amateurish or what?

Another unbelievable unforced error.

Yes I did note this, though 48.6% screening for Blarca is still less than the 70% screened out from enrollment into randomisation in Lecanumab and 79% for Donnanemab.
If we use ITT as you suggest then it was 71% screening exclusions for Lecanumab and 80.6% exclusions for Donnanemab. Blarca using ITT would be 53.3% exclusions.

Watching the latest waves, from 10.80 to 8.40, back up to 9.10, pulling back to Hold at 8.60, which was, to me, the critical support to hold, and so far holding ... now a bounce today, and holding around 8.80, looks poised to jump higher now... it would feel bullish to see tomorrow rally upward. Target 9.60/9.80/10.00 area.
9.60 represents a 50% Fib retrace of the downwave, so it's not a great recovery, but a start... from where the next pullback could retest 9 dollars... And Holding, could generate the upwave pattern of higher lows/higher highs. So future target steps to watch for.... centered around 9.60. Let's see if the technical pattern gives us a good jump tomorrow.
Conversely, IF shorts and sellers attack here... 8.80 drops, bleeds and tumbles back to 8.40 bounces to 8.60 as resistance, and tumbles to target 8.00 continuing the bleeding down game.

And let’s not forget how much better looking the Mab trial patients were on average compared to the Anavex group. The Anavex group will undoubtably stop the CHMP clock, and how many additional years will that extend the potential investment payoff?

Simply not worth waiting around for that to play out, or certainly should cause one to trim their investment.

From the peer reviewed paper:
Of 988 participants screened, 508 were enrolled and randomized, and among 462 randomized participants in the ITT population (mean age, 73.7 years; 225 [48.7%] women), 338 (73.2%) completed the trial. 338 were assigned to receive blarcamesine and 170 were assigned to receive placebo (Fig. 1). Baseline characteristics of the ITT population are summarized by blarcamesine group (n = 298), assigned to 30 mg group (n = 154), assigned to 50 mg group (n = 144), and placebo (n = 164) group (Table 1).
I make that about 50% of participants not making it through screening, worse if we use the 462 participants that made up the ITT population.

If you've been paying attention, you will have noticed that the Mab trials were highly screened, but our AD trial only required minimal screening.

Have you noticed that the volume is always much lighter on up positive days compared to the down days where the volume is much heavier?

Hosai:

You and Investor both make sense to me!

Therefore, we wait for some sort of clarification....apples to oranges, but overall including all types we get a statistical reference point for this....

I was beforehand in the mind frame that with no major side effects, cheaper cost to produce and need to reduce healthcare costs we were golden and would get approved fast.

Major problem: not too many people in the trial (low n) and probably very much screened; hence Clock Stop One.

Not only would Investor have to comb through every description of every MAA, but he would have to have all information, including confidential information, in the massive MAA as well as up to date information on the EMA (including the record of the assigned rapporteurs and internal practices). And even then he would be using an n of 1 to predict the outcome. He has none of this, of course.

We can only fall back to the most relevant available decisional stats for guidance. Anything beyond that introduces an enormous amount of inexpert personal opinion, and that becomes a worthless exercise in hubris.

But even if its approved, when you sell shares it takes time for your account to settle, and if you want to transfer all that money into another account you have to pick one. And then there's the IRS. And your wife wants some. You buy that new Lamborghini and you have to worry about someone wanting to scratch it.

Just sell now so you don't have to worry about that. You'll sleep much better.

You get the picture!

Oh, ok. LOL

Yes indeed.
You would need to comb through through every submission to declare Anavex' chances should be above or below the headline 89.8%.
And I did because that is the sort of thing I do.

Aside from the "NOT" that I believe is missing from "When I point out these stats I am (NOT) saying", I think we agree - as I said the chances are good, but they are NOT 89.8%.

For the record, I think the chances are better than 3% - 4% and less than 50%.

When I point out these stats I am saying these are the exact approval chances, they could be higher or lower. They just are the data we have.
As stated before, clearly an 89.8% overall approval rate is better than 29.8% would be.
Some will be cancers yes but also with bad side effects or absolute marginal efficacy.
Others will be for less serious indications that already have drugs and are trying to show theirs may be better based on debatable evidence. You would need to comb through through every submission to declare Anavex' chances should be above or below the headline 89.8%.

Those EMA stats are conflated across anything from diagnostics, surgical instruments, a whole range of more or less critical indications and with many being immediately critical and deadly cancers filling the stats, where the risk/benefit equation looks very different. Very few comparisons to draw from in CNS let alone AD/Dementia specific.

I don't quite understand why many here fail to understand that the top level conflated stats are not directly applicable to the Anavex MAA. The chances for Anavex are no doubt good, but they are not anything like 89.8%.

Regardless of these facts, I do hope Anavex will pass clock stop one! I'm just not in the near slam-dunk club.

You gave the reason why: Price goes up after we get past it !!! Missling is much smarter than most give him credit for. Yep like after EMA filing, peer review and JPM conference.

Check out Dr.Missling on his Linkedin account---reposting "nice things re:Blarecamesine"--good to see !

At his point in time, a partnership would indicate either
1) a lack of confidence by management
2) the gig is up, lets run

Neither is fun to contemplate, but certainly both are not bullish.

Memories...from my FB page

02/04/2021
Looks like Robinhood went after my Alzheimer's Biotech Company.
I left a LOT on the table, but this is stupid on no clinical news.
AVXL Anavex Life Sciences.

No we won't: We will most likely have a partner before clock stop one.

You gave the reason why: Price goes up after we get past it !!! Missling is much smarter than most give him credit for.

annual cost of MAB treatment of about $109,000 !!

versus $3650 - $10,000 for blacarsamine.

When govt health systems are going broke.

Yeah that might influence a decision.

Investor

I think you have for quite some time suggested that Clock Stop One is critical now and likely the nut to crack; my prior "guess" was that it would not be necessary at all or even not that long, so I now defer to you....120 days which Hosai just mentioned is not that far away from December and is also the time that Frrol has suggested (April 25th).

I assume all here are prepared to wait!

The latest I have from Walter Deemer, hope this shows, chart apparently illustrated on his post:

To fill this morning’s rather large gaps, $SPY would have to rally to 601.05 and $QQQ to 521.19. How quickly the gaps get filled -- if at all – gives us an idea of how strong the underlying trend is.