Anavex Life Sciences Corporation (AVXL) Quote

And you are kidding yourself if you think he doesn’t have significant input!

You are kidding yourself if you think Dr. Jin is in charge of trial design. That is not in his job title or list of responsibilities. He contributes as a member of the team, no doubt, but he is not in charge. It is clear that you have never worked in biopharm and that is OK - but your musings are not accurate.

Ken:
We recently learned that my wife who never has had ANY medical problems has just been prescribed some drops which I have to put in every day for her since they see glaucoma developing and is scheduled to see our ophthalmologist on 9/24...she was referred to someone who handles both glaucoma and cataract surgery....I had both eyes done last year for cataracts and don't require glasses for distance, just reading....give me advice if you have something I should consider.....no macular degeneration nor a vitreous hemorrhage was mentioned, this is her 3rd doctor in the office, mine said she needed to see someone else, then the new doctor referred her to this one (all in the same practice)....best, Steve

Tom:
Maybe it holds, so let's see how the next 2 days help to establish a potential inflections level! I'm just standing pat for now.

Steve

I have glaucoma, macular degeneration and a vitreous hemorrhage currently so may not be seeing clearly.

Maybe your moving avg. support line has a chance to hold now? We'll see soon enough. Price movements are not staying tight in technical trading. It's more volatile with larger moves. Up 50cents, down 50 cents.... but the whole playing field is 1 dollar (5 to 6) small, small steps, but the price is climbing and tumbling 2 and 3 steps at a time. In this range.

Anyone who didn’t doesn’t deserve an opinion.
As with my original .72 entry.
Never existed as NASDAQ listing.
Therefore.....1:4

Both the $IBB and $XBI both look better to me! ha ha.....so let's expect $AVXL to catch up....😃

Actually just realized they did a phase 2a too, though also fairly small with 48 patients.

XBI is at resistance as well. 103 has been tested several times and is a real barrier. The most advertised rate cut in history has not as yet been the catalyst so many expected. Momentum is waning in the sector but volume is not lacking.
AVXL would be considered a special situation if peer review or EMA submission were to occur. Absent any news this should go the way of XBI.

"This is a news driven stock" True - it goes down on ANY news.

That is always the question, how do macro economics affect the micro economics.
AVXL exists in a bubble right now.

The SP is controlled by the big players.

This is a news driven stock, till that changes, the players control.

Also on a practical level can't see the EMA loving the storage/transport and infusion aspect of the Longeveron drug:

"Cell-based therapies like Lomecel-B, which use live mesenchymal stem cells (MSCs), are generally sensitive to temperature fluctuations. To maintain cell viability, they often need to be stored and transported at ultra-low temperatures, typically in the range of -80°C to -196°C (cryopreservation in liquid nitrogen).

Maintaining these low temperatures is crucial because exposure to non-ideal conditions can reduce the cells' viability and therapeutic efficacy. Special cryogenic transport systems would likely be used for this purpose, similar to what is done with other cellular therapies like CAR-T cell treatments.

Hospitals and infusion centers administering Lomecel-B would need proper storage facilities, such as cryogenic freezers, and trained staff for handling and thawing cells before administration."

I see we were up 20 cents at one point - that's the AUTOMATIC SELL signal. It NEVER fails. The stock remains a total POS.

Lacey, Falconer, Nidan, its positive that this cite allows us to share medical and curbside knowledge that sometimes comes from little trial "n". Meanwhile millions suffer and die while formal drug development follows the slow gathering of statistics and presentation before world agencies! We understand the need for safety and efficacy, but those with approval authority are by in large state salaried bureaucrats who are not prone to "reach for the stars". I fully appreciate operating within safe guidelines being an Air Force Flight Safety Officer for many years, but I also knew that lives depended on rapid mission accomplishment in "life or death" contingencies. So what I am leading to is, with millions ww facing disease degradation and death, the medical establishment and drug approval authorities need to go to war with the enemy and not rely on job safety and commercial politics. We as a country lose more of our children, parents and grandparent each year than in all the military conflicts on the horizon. If we forced all of our defense industry in time of conflict to operate at peacetime development speed, we would not be a free nation today. The medical drug industry is at war every day and countless are falling each day ........sound the bugle!!

Gundlach Interview on CNBC: this is one very smart person and I think he's correct...looking at Commodity Prices kind of points to a weaker economy....look at Energy Prices with Crude Prices hanging near their lows! Refreshing to hear his points.

Yes but based on a phase 1 study with 33 patients.
It was for 26 weeks and the Hippocampal finding was with completed (n) of 7 placebo, 9 low dose and 8 high dose. Obv also was exploratory endpoint, high dose spikes at 13 weeks but is falling back closer to placebo at 26 weeks.
Also in terms of the ADAS COG they didn't find stat significance which slightly goes against what he was saying but maybe that's why he seemed to be arguaing ADAS COG wasn't the best measure at one point.
https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.12651

3 Days dancing around the 200 day sma and the price level seems ok to me, so I'll probably get hit on "Terrible Thursday"....I kind of like where the price is albeit without conviction with price and volume!

Not far away from breaking the down slant line @ around $6.20 to $6.25 so I should expect an effort by the mm's (and their buddies, the hedge fund guys) to put a big effort to stop the push up from happening, if not we might just surprise.

that makes sense, boi568

I sense that the people who are borrowing money, I.e. using their credit cards to pay ongoing bills will have a big effect eventually with minimum payments so the banks will be reducing access and the borrowers will be overwhelmed and will stop "buying things"....not sure when but I think it will stop the consumer from spending.

Very nice link, ty. Dr. Missling did very well amongst his peers.

Interesting to note: at minute 46 the Longeveron rep says his company did just that in their small POC trial: they detected and publicly showed a potential correlation of brain (hippocampal) volume improvement of their drug to cognitive benefit (MOCA and MMSE).

Fed cuts interest rates by a half-point

https://www.washingtonpost.com/business/2024/09/18/fed-meeting-interest-rate-cut-decision-live-fomc/

That is GREAT NEWS for the US and world economies and GREAT NEWS for AVXL stock.

Good luck and GOD bless,

Multiply that .17 x 4!

When you're five months into a year to live, one will gamble on what one is learning is real and works. Lots of crap papers out there...

I “put it in” to hopefully afvantange the yin/yang of the absolutists.

.17 2013
and
5.30 2024

Is the oft cited clairvoyance.
IF you accept that…does it fit YOUR results?

He will probably PR the filing upon the EMA accepting it.

Yes I thought in general he spoke quite well even though obv nothing new revealed.
Annovis' plan seems overly optimistic but if FDA were receptive it would be a good sign in how flexible they were becoming.
I believe Annovis are planning to do an 18 month phase 3 trial but after 6 months plan to apply to FDA with an NDA based on the 6 months for symtopmatic treament and then will expand it to disease modifying after 18 months data. I don't see how they unblind the 6 months data to make this application without interfering with the 18 month trial however.

I wonder if Missling will PR the MAA filing or just the acceptance of it.

I’m hoping he does both of course.

Thanks for posting. 9 minutes in, Missling points out that correlation of AB reduction to cognition response has not yet been "described" (studied and disclosed), saying that it may be because there is none.

We too, however, have not provided cognition correlations for our brain volume,mAB ratio, etc biomarker results (this will cause whining from who don't read). This is one of several things the paper needs to "describe", along with S1 status correlation. Missling is implying saying here that they will be for our trial, and reviewed in future scientific talks. Let's see, looking forward to them.

Abe:

I agree that Dr. Jin was hired to be involved actively and not passively!

His purpose is to add strength to what is hoped to be a good drug in order to obtain FDA approval, but I think Missling has decided that the EMA will enhance eventual approval in the USA, so let's see if an actual EMA filing takes place.

The world approval process would be best if every country made an effort to work together on major medical diseases which are draining world wide monies!

God bless you and good work on alternative treatment!
Never give up, never give in.

Do you all realize that u spend hours and hours a week saying the same thing talking to the same 10 people over and over and nothing anybody says good or bad is changing a damn thing.
It is amazing that these same comments over and over don’t get old to the ones saying it.
Missling could care less about George, or that whinny little Kung dude.
He is running this show !!
He ain’t going anywhere . This is His drug !!!
Put ur money in , or take it out . Don’t matter to him.

Thanks for interesting info. Please send your info to some American Diabetes Association(ADA) literature sites dealing with Chronic Kidney Disease and Risk Management—Screening and Treatment. Some links:

1). Kidney Disease: Improving Global Outcomes (KDIGO).
Diabetes Care 2022;45:3075-3090
2). Clin Diabetes 2024;42:212-213 (doi:10.2337/cd24-a011)
3). http://diabetesjournals.org/clinical/article-pdf/42/2/212756314/diaclincd24a011.pdf

IF, as does George, you believe 50 basis points is coming tomorrow because
it will empower the Economy to "zoom".....

Then buy AVXL today and benefit from the risk on attitude you see returning.

The Market on the run up to the announcement does not seem to feel the same way.

Meanwhile currency loss of the dollar seems to be outpacing any interest rate reduction.
THAT WILL continue despite the size of the cut.

RELAX LOONGS our day will come.JUST HOLD ON TIGHT LOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOONGS

Not misleading at all. You have your opinion...and I have mine. My opinion is based on my interpretation of Dr. Kun Jin's resume.

You've been ranting for some time that Dr. Missling needs to learn his lesson about crafting a proper trial...and now that he has hired a big gun like Dr. Kun Jin, all you do is minimize his experience as just another biostatistician. Really? That's absurd when you read his resume. Anyone with an open mind can see that he is loaded with firsthand experience in all kinds of trials.

BTW, do you still claim that Dr. Kun Jin is not an expert on AD trials after reading this part of his resume? (See below in bold)

"Prior to joining Anavex, Dr. Jin had a distinguished career of more than 27 years at the FDA. During his tenure at the agency, Dr. Jin has contributed extensively to statistical review issues and trial designs surrounding the regulatory approval of drugs for the treatment of neurological diseases including Alzheimer’s disease, Parkinson’s disease, migraine, epilepsy, and multiple sclerosis, as well as rare diseases, such as ALS and DMD. Dr. Jin was the lead author in top theoretical statistics, biostatistics, and molecular genetics journals. He was also a winner in a worldwide innovation competition on clinical cardiology data processing (Predicting Acute Hypotensive Episodes).

Dr. Jin has extensive research experience in Alzheimer’s clinical trials. He has been an invited speaker and has authored publications on topics in Alzheimer’s disease endpoints and trial designs. He conducted FDA/CDER The Oak Ridge Institute for Science and Education (ORISE) Summer Fellowship projects, built the Integrative Alzheimer’s Trial Database, FDA/CDER Regulatory Science and Review (RSR) Project and the results have been communicated at Accelerate Cures/Treatments for All Dementias (ACT-AD), Drug Information Association (DIA), and Joint Statistical Meetings (JSM). Before joining the FDA, Dr. Jin was Assistant Professor at the Division of Biostatistics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania. Dr. Jin received his Ph.D. in Statistics from the University of California at Berkeley, California."

falconer66a, thanks for relating your your story about Stage 4 CKD and how you fought back.

That was seven and a half years ago. I continue to have no indications of needing a transplant or dialysis. An utterly effective treatment of my otherwise lethal CKD. I'm at peace with my Creator and have the salvation of His Son....May your blessings continue .

Whenever I see/hear about stories like yours I reflex to question how does a true story like yours find it's way back into medical school training of future or current students-inspectors and in method/manner-context how does such knowledge get passed around, CAPA for example. I have lots of respect for the FDA and for the hard working agents-inspectors and field people doing their daily jobs. How does such information-knowledge get passed back and who is responsible to ensure some closed loop problem solving feedback system is at work.??? As an x FDA contract (3rd party) auditor and field inspector I would want to know..."Then what happens?" .

A well known problem solver and WW Quality System consultant-leader, Dr. W. Edwards Deming has noted , "The first step in solving a problem is recognizing that one exist ". . What comm/feedback systems does the FDA have to capture and act on knowledge like that shared here by falconer 66a??? Such steps exist as basic engineering 101 problem solving and in fact any effective FDA/ISO corrective action follow up should (is required to) do the same.

Here's the study.
falconer, will you please post a link to that study here?
I just tried to find the study in PubMed, but accessing it was too complicated. But here is the URL for the study in the Indian medical journal. Just click this URL and the paper should come up as a PDF.

https://mail.innovareacademics.in/journals/index.php/ajpcr/article/view/9994/4038

Here's the abstract of the paper:
ABSTRACT
Objective: To evaluate efficacy and safety of add-on therapy of Nigella sativa oil in patients of stage 3 and 4 of chronic kidney disease (CKD).
Materials and Methods: The study was conducted in a tertiary care center of north India in stage 3 and 4 patients of CKD. It was a prospective, comparative, and open label study. Patients were randomly divided into two interventional groups. Group I (Control) received conservative management of CKD while Group II (Test) received conservative management along with N. sativa oil (2.5 mL, per orally, once daily) for 12 weeks.
Hemogram and renal function tests were done, and adverse events were recorded at 0, 6, and 12 weeks of treatment.
Results: After 12 weeks of treatment, there was a progressive improvement in clinical features and biochemical parameters in both the groups, but it was more marked in the test group compared to control group. Both groups showed gradual improvement in the biochemical parameters as compared to their pre-treated values which were more marked in N. sativa oil supplemented group. There was a reduction in blood glucose, blood urea, serum creatinine, and 24-hr total urine protein. There was an increase in hemoglobin, 24-hr total urine volume, and glomerular filtration rate.
Conclusion: N. sativa oil supplementation along with conservative management is efficacious and safe in averting the progression of disease in stage 3 and 4 patients of CKD.

falconer, will you please post a link to that study here? I would like to send to a nephrologist friend in case it can help other people.

Actually, All Is Well
Rest assured, we will all eventually be joining bennyboy...some of us sooner than the rest. ... May God's peace be with you falconer!
Thank you. I'm at peace with my Creator and have the salvation of His Son.

But my phrase "I'm Gonna Die" was actually sarcastic, in this regard --- relating to the safety and efficacy of the multitude of vitamins, minerals, and supplements I take. I'll briefly describe just one of my otherwise lethal ailments --- which has been utterly reversed by an unapproved supplement I take.

Seven years ago, from a severe urinary tract infection (actually caused by antibiotics I was prescribed, which selected drug-resistant bacteria) I nearly died from sepsis. In the ICU my kidneys were found to be in Stage 4 Chronic Kidney Disease. I was told I would have to have a transplant or start kidney dialysis promptly.

But I checked the world's literature on Stage 4 CKD and found a study by nephrologists in northern India that showed that the taking of 2ml of black seed oil, from the plant Nigella sativa, twice a day, in most cases, stopped and even reversed Stage 4 CKD. I bought some black seed oil and began to swallow 2ml each morning, and 2ml each evening.

In two weeks the nephrologist, arranging for dialysis, checked my most recent blood and urine tests. "They got the wrong samples. These can't be your data. You've got Stage 4 CKD. These are for someone with Stage 3 CKD."

The good doctor knew nothing of the Indian study (available in PubMed). I gave him a copy; he read just the abstract, and said, "Well, this looks pretty good. Keep taking this stuff and let's see what happens."

That was seven and a half years ago. I continue to have no indications of needing a transplant or dialysis. An utterly effective treatment of my otherwise lethal CKD.

Here's how it works. Black seed oil has a number of healthful chemical constituents, the most significant is thymoquinone. Among many other things thymoquinone chemically disables the Interleukin-6 cytokine, which in my CKD creates the inflammation that slowly destroys the kidney,

With this over the counter supplement, unapproved by the FDA, and unrecognized by American nephrologists (they need to talk to their Indian counterparts) my kidneys continue to function at a continuing ample baseline. There is no indication that it will fail. Most likely, in a good number of years, I'll die of some other cause.

Again, no. Dr. Jin is a member of the team who offers input but he is not the one responsible for "crafting" any trial. This narrative seems deliberately misleading.

Why is he closes his eyes while talking? He keeps highlighting the negative points of MABs but doesn't emphasize his own drug much. It seems like the EMA never pulled them, another lie

Bravo, Steve!

Anyone have an informed update on EMA-AVXL plans or Pubs? TIA

The panel talk Missling was a part of is here - https://journey.ct.events/view/b72fd686-0547-49f0-ab66-b1e4959753a1

OT When I was given a year...failed Chemo (only made three treatments) throwing blood clots...Developed covid in the hospital treating the clots...Told no more Chemo for me...Stay home for three months and do nothing...I studied my rear off creating my own chemo so to speak...Study Astragulus Root...Sea Cucumber...Apigenin...Bai Hui She She Cao...I was lucky...maybe you will be too! Never give up...Pray!

Looks like we're going to give back the rest of that big gain from Monday today. What a POS. It NEVER changes.

Lacey1

Best wishes to you and I agree that supplements are helpful.

Your journey was and has been so much more difficult than mine and it had really sent me into a deep depression at that time when I had been healthy my whole life until I was shocked with the news of having a Stage IV diagnosis with blood cancer, but I have survived for more than 10 years now.

Both of my adult daughters in their 50's also had breast cancer and are doing well, too, after a tough time.

Life is full of bad happenings and is a reason why Family is always good to have, so we hang on to each other and remain very close!

Hope you continue to do well!

Falconer...I just want to extend my appreciation for all of the great posts that you've made. Your contributions have been very instrumental in understanding how everything works in layman's terms!

Rest assured, we will all eventually be joining bennyboy...some of us sooner than the rest. But eventually we will all be there!

The difference is that some of us have taken the time to know our creator...and are quite comfortable passing on to the next life.

May God's peace be with you falconer!