Anavex Life Sciences Corp (AVXL)

[ignatiusrielly35]

That is the only basis for an insider trading restriction that can think of in this situation. Having material inside information of whatever nature.

[tredenwater2]

Ty SBSS. Great presentation imo. Great expectations of approval still hanging with in the next year.

[Doc328]

Most MAD studies do a 3 + 3 design. Enroll three at lowest (first) Dose then move to next dose if 0 patients have toxicity. If one has toxicity do three more patients and move to next dose if none of these have toxicity. Each dose is a cohort so each cohort has either 3 or 6

[Doc328]

Most MAD studies do a 3 + 3 design. Enroll three at lowest (first) Dose then move to next dose if 0 patients have toxicity. If one has toxicity do three more patients and move to next dose if none of these have toxicity. Each dose is a cohort so each cohort has either 3 or 6

[Steady_T]

Are the same subjects being used in both part A and part B or are they two different sets of subjects?

[k9uwa]

Interesting watching the close today. Different from the last several days. Volume the last couple minutes showed some trades of around 10K shares all still at 3.88 3.88.5 with the total shares at 769,000 and in the last instant today additional 170,000 shares traded and price stayed the same 3.88 And then around 4:04PM an additional 61,000 shares traded. Price stayed the same at 3.88 with a total traded today of 1,000,000 shares. The big difference today... no large quick selling DOWN at end of day.

John k9uwa

[sumbuysumsell]

Missling clearly stated that at this time the window for insiders to buy is closed!

Can anyone comment on why insider trading would be 'closed' beyond Rule 10b-5 and Directors, etal having recently obtained confidential non-public insider information?

[Steady_T]

Is that a good thing or a bad thing?

[Steady_T]

I am corrected. I didn't look it up for that post. I used the last 10K number.
I haven't read the PR or listened to the call yet.

Having the AC worked on and shoveled 1 cubic yard of soil before the rain this afternoon so I didn't take the time to check the most current number.

[kund]

Don't count cash on hand, Misleading counts possible LPC dilution as cash, his cash and cash equivalence never goes down, it is same quarter after quarter.

Cash and cash equivalents of $139.4 million at March 31, 2024

[LakeshoreLeo1953]

Not sure even the harshest critics should place $30M as
the cost to liquidate..

[kund]

I meant to say that the worth of this company is below $100 million, not its current valuation.

[LakeshoreLeo1953]

$175M may be an accurate valuation of IP.
Then again one would hope not.
I am guessing the office furniture is leased.

[georgejjl]

The estimated total enrollment is 40 men and women total

The 40 total is separated in to separate cohorts
Part A cohort 1 would be the 30 mg every 8 hours
Part A cohort 2 would be the 60 mg every 8 hours
and there would also include a placebo cohort for each

Part B cohort would be a TBD chosen from the above doses taken every 8 hours
and and there would also include a placebo cohort

The total of all these would add up to an estimate of 40 men and women total

Good luck and GOD bless,

[LakeshoreLeo1953]

Perhaps should have emphasized rhetorical question.
I certainly understand exchange rate effect(s), but WHY
if retaining cash from previous "dilution" would you hold
ANY overseas in this environment.
Seemingly Q to Q there is something abroad that devalued.

Now going forward may be a different matter....particularly given November.

[ignatiusrielly35]

So it took about six weeks to enroll Part A, which started around March 15. Assuming the same amount of time for Part B enrollment, this trial should easily complete by end of summer. Depending how long it takes in between Part A and Part B.

[123tom]

Price was jolted at the open, to hit the current targets of support(3.60 step) which held so far around 3.75 area, a higher high... so far, and resistance at 3.90 area, not hard to see on the chart. 3.80 is set as the balance line now, and today's small bounce , after holding support, has a chance to become a bullish rally follow up , to target 4.00 and climb higher steps 4.10/20/30/4.40 target zone, in a mathematical "finish" target. Simplest view is to call it a 1 dollar rally from the 3.25-3.40 "Bottom ". But the current battle isn't resolved yet, here at the key balance point 3.75/3.80... could still roll over, if they want it to.
In the larger chart view of the past month, the developing upwave looks to me like 3.25 Bottom , up 1 dollar, to target 4.25 top. And the downwave pattern would be the 3.90 resistance rollover area, down 1 dollar to target 2.90. In the middle is the key shoulder around 3.60

[sage4]

Was it a peer review article if it was in Nature?
I see sp reaction is kind of lukewarm. Was it positive article? Thanks.

[k9uwa]

Cohort divide (people) into groups with shared characteristics. And since there are only 2 Cohorts pretty good chance they are equal in quantity. Something I saw someplace that ALL of the patients in this test were Inpatients of the same facility? First part is 10 days and results will determine what quantity of 3-71 should be given to patients. 2nd 28 days all will get the same quantity.

John k9uwa

[skitahoe]

Approval in the UK should end this argument, once that occurs the other regulators should fall in line, but it may wait for the EDEN unit to be accepted for commercial production. People who criticize the the trial fail to realize how much was learned, and how much the regulators became involved in redesigning it to look at OS and ignore the PFS goals flawed by pseudoprogression.

Gary

[georgejjl]

Anavex 3-71 schizophrenia trial
Part A is 10 days
Part B is 28 days

Good luck and GOD bless,

[Steady_T]

Thanks. I hope that is the case. If so, that trial is moving along smartly.

[boi568]

I think that post qualifies you as a fact checker.

[IhidfromtheX]

I thought I saw 139M left...

[boi568]

I think the cohort is 40.

If Part A enrollment is complete, the cohort's finishing the 10 day course of treatment can't be far off.

[Steady_T]

Now that is an outright lie.

82 million shares X $3.83 current share price = $314 million valuation.

$150 million in cash.

Who's the liar?

This company value is in sub $100million,...

[kund]

And still NWBO is in penny land....peer review is just another tactics this scam artist CEO using to delay eventuality. For market what matters is execution, timely publishing of unambiguous data and management reputation.

[ignatiusrielly35]

I’m having difficulty interpreting the Schizo trial description in the PRs. It seems vague to me. Part A will be a 28-day dose determination leg? Part B will then be a 28-day POC leg based on the dosage determined from Part A?

Will both Part A and Part B have cohorts that receive either 10 days or 28 days of dosing?

[Steady_T]

I wonder what a cohort is in terms of the overall enrollment.

[williamssc]

He's too busy typing for a cookie

[nidan7500]

Nice thought and good work on this. It is beginning to look and feel like AVXL are beginning to move the ball down the field. Lots of big and important things happening...NICE TO SEE.

Thx georgejjl

The first cohort of Part A of the phase 2 Anavex 3-71 schizophrenia has completed enrollment. I believe that the second cohort of Part A of the phase 2 Anavex 3-71 schizophrenia will be completed by or before summer 2024 and that the entire phase 2 Anavex 3-71 schizophrenia trial will be completed before the end of summer 2024.

https://classic.clinicaltrials.gov/ct2/show/NCT06245213

[georgejjl]

The first cohort of Part A of the phase 2 Anavex 3-71 schizophrenia has completed enrollment. I believe that the second cohort of Part A of the phase 2 Anavex 3-71 schizophrenia will be completed by or before summer 2024 and that the entire phase 2 Anavex 3-71 schizophrenia trial will be completed before the end of summer 2024.

https://classic.clinicaltrials.gov/ct2/show/NCT06245213

Good luck and GOD bless,

[Steady_T]

In psychology that is called projection.

Once again, your desperation is on full display.

[skitahoe]

Just yesterday, Nature published an article on NWBO's DCVax-L and Poly-ICLC, which had been seen in draft form about 8 months earlier. If you figure it took several months to create, you should understand that Journal articles that are peer reviewed can easily take over a year.

Gary

[Steady_T]

Wow. You are working hard today. Give yourself a cookie.

[k9uwa]

"option grants which are almost 10% of outstanding share count" Then he has about 8 MILLION reasons for wanting the shareprice of Anavex to go UP UP and UP.
John k9uwa

[georgejjl]

Michael Weiner, MD, is a Professor Emeritus in Radiology and Biomedical Imaging, Medicine, Psychiatry, and Neurology at the University of California, San Francisco. He is Principal Investigator of the Alzheimer's Disease Neuroimaging Initiative, which is the largest observational study in the world concerning Alzheimer's Disease. He is the former Director of the Center for Imaging of Neurodegenerative Diseases (CIND) at the San Francisco Veterans Affairs Medical Center. After graduating from the Johns Hopkins University in 1961, he obtained his M.D, from SUNY Upstate Medical Center in Syracuse, New York in 1965, and he completed his internship and residency in Medicine from Mt. Sinai Hospital in 1967. From 1967-1968, Dr. Weiner completed a residency and clinical fellowship in Metabolism from Yale-New Haven Medical Center. From 1960-70 he was a research fellow in Nephrology at Yale. From 1970-71 he was a postdoctoral fellow in biochemistry at the University of Wisconsin Institute for Enzyme Research. In 1972, he became an Assistant Professor in the Department of Medicine, Renal Section from the University of Wisconsin Institute and from 1971-1973 he was a Research Associate of the Veterans Administration. In 1973 he was awarded a Clinical Investigatorship of the Veterans Administration. In 1974 he became an Assistant Professor of Medicine (Nephrology) at Stanford University. In 1976 he was a visiting scientist in the laboratory of Sir Hans Krebs in Oxford, England. In 1980 he became an Associate Professor of Medicine (Nephrology) at UCSF. In 1983, he established the Magnetic Resonance Unit at the San Francisco VA Medical Center, which became the Center for Imaging of Neurodegenerative Diseases in 2000. In 1990, he became a Professor of Radiology, Medicine, Psychiatry and Neurology at UCSF.

Dr. Weiner’s research activities involve the development and utilization of MRI and PET for investigating and diagnosing neurodegenerative diseases. In 1980, he was one of the first to perform MRS on an intact animal, and subsequently pursued his goal to develop MRI/S as a clinical tool. In 1988, his group used MRS to show that the amino acid N acetyl aspartate (NAA), a marker of healthy nerve cells, is reduced in the epileptic focus in the brain. In 2004, Dr. Weiner's group reported that reduced NAA predicts development of Alzheimer's disease in mildly impaired elderly subjects. During the past 30 years he has worked to develop and optimize the use of MRI, PET, and blood-based biomarker methods to diagnose Alzheimer’s disease and other neurodegenerative disorders. Also, Dr. Weiner’s research focuses on monitoring effects of treatment to slow progressions in Alzheimer’s disease, and detecting Alzheimer’s disease early in patients who are not demented, but risk subsequent development of dementia. He is the Principal Investigator of the Alzheimer's Disease Neuroimaging Initiative, a 19-year national longitudinal study of over 2,200 subjects which is aimed at validating biomarkers for Alzheimer’s disease at 60 sites across the USA and Canada for cognitive testing, MRI, PET, and lumbar puncture. He also launched the BrainHealthRegistry.org which is an internet-based registry with the overall goal of accelerating development of effective treatments for brain diseases. This website registry recruits, screens, and longitudinally monitors brain function on more than 100,000 participants. His overall research goals are to participate in the development of effective treatments and methods for early detection of Alzheimer's disease and other brain disorders. Recently he has focused on developing inexpensive, scalable, tools to identify normal elders at risk for cognitive decline and dementia. Dr. Weiner has mentored over 150 postdoctoral fellows, has authored 960 peer reviewed research papers and 71 book chapters. He has received numerous honors including the Young Investigator Award of the American College of Cardiology in 1976, and more recently, the Nancy and Ronald Reagan Award from the Alzheimer’s Association, the Potamkin Prize of the American Academy of Neurology, a Docteur Honoris Causa Degree from Paul Sabatier University, Toulouse, France in 2019, and the Henry Wisniewski Lifetime Achievement Award in Alzheimer's Disease Research, from the Alzheimer's Association in 2021.


The study's outcome represents a noteworthy milestone, with blarcamesine being among the first drugs to exhibit efficacy on biomarkers of neurodegeneration. Michael Weiner, MD, professor of radiology, biomedical imaging, medicine, psychiatry, and neurology at the University of California, San Francisco, and principal investigator of the Alzheimer's Disease Neuroimaging Initiative, expressed enthusiasm over the study's results, particularly its ability to objectively slow markers of neurodegeneration.

https://www.sciencetimes.com/amp/articles/50071/20240508/anavex-life-sciences-alzheimers-treatment-brings-hope-to-millions.htm

[boi568]

And if, for example, the depreciated assets are held in Euros, they retain their buying power if spent in the European Union.

[kund]

Full data from the blarcamesine in Alzheimer’s disease Phase 2b/3 placebo-controlled clinical trial will be published in an upcoming peer-reviewed journal.

This is another forever catalyst list from clown CEO, how can he say this in every PR? even crooks has some dignity.

[georgejjl]

Alzheimer’s disease:

Full data from the blarcamesine in Alzheimer’s disease Phase 2b/3 placebo-controlled clinical trial will be published in an upcoming peer-reviewed journal.

The initiated process for submitting a Marketing Authorisation application to the European Medicines Agency (EMA) under the Centralised Procedure is underway. The Marketing Authorisation would allow direct market access throughout the European Union for oral blarcamesine for the treatment of Alzheimer’s disease. There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 2030, according to the European Brain Council.[2]

Analysis of RNA sequencing (RNA-seq) of the placebo-controlled Phase 2b/3 blarcamesine trial in early Alzheimer’s disease is underway. Interim data expected by mid 2024.

Ongoing ATTENTION-AD open-label extension 96-week trial. Interim data expected in the second half of 2024.

https://www.anavex.com/post/anavex-life-sciences-reports-fiscal-2024-second-quarter-financial-results-and-provides-businessd

Good luck and GOD bless,

[frrol]

The delay in FX trial is apparently mainly due to the building up of biomarker endpoints for the trial design. We published some a couple years ago but that was limited primarily to lymphocyte signals. We now have another biomarker candidate that will be presented in July. Trial planning is likely finally underway, as the company feels that we should be able to get community support in FX similar to what we got for our Rett trials.

In AD, EMA (Europe) has been the priority, and the company has not yet "proceeded" with the FDA (US). But it plans to do so "definitely this year". OLE data is not the cause of delay. (Delay possibly because company resources focused on EMA, or awaiting peer review paper to present to the FDA, or both.)

[kund]

Looks at the ANVS CEO, how she is putting out information, she want drug to succeed and shareholder to make money. She has invested her own money, unlike leecher Misleading, he has option grants which are almost 10% of outstanding share count.

[kund]

Full data from the blarcamesine in Alzheimer’s disease Phase 2b/3 placebo-controlled clinical trial will be published in an upcoming peer-reviewed journal.

This statement is there for last 4-5 earnings, what kind of journal he is working with? For other companies it takes 6-9month to get data published, but for Misleading it is always kick the can....

[meds4life]

QUESTION TO ANYONE:
Dr. M said "...we are doing an analysis of RNA sequencing" ( of the results of the 2b/3 AD trial data).
What is the purpose of analyzing RNA sequencing?
Is it to verify increase in SR1 receptors on brain tissue?

[Steady_T]

Why try to discredit the actual article on its facts when you can try to discredit its source.

No positive anything left unchallenged. But trying to discredit negative anything, that is unfair. LOL

[frrol]

Foreign assets depreciate (lose value) in domestic reporting currency terms when the reporting currency appreciates.

[sumbuysumsell]

https://video.wixstatic.com/video/79bcf7_9d2dd5a3c5d9411698c7a86b7f527eb5/720p/mp4/file.mp4

Its on their website

[kund]

This company value is in sub $100million, liar still has no definite answer and timeline for any of the milestones. He still says "soon", "very soon", this year, this quarter, H2.....

[longtermbeliever]

do they talking to a partner ? maybe that is why the insider buy window are close.JUST HOLD ON TIGHT LOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOO

[meds4life]

"pulled" is correct....this is good!