Anavex Life Sciences Corporation (AVXL) Options

Yeah but once ADL is sensitive enough to be a reliable measure it means that the patient's AD status got worse.

1/3rd of the participants in the Phase 2b/3 trial were receiving a placebo

1/3rd of the participants in the Phase 2b/3 trial were targeted to receive just 30 mg/day of Anavex’s blarcamesine

1/3rd of the participants in the Phase 2b/3 trial were targeted to receive 50 mg/day of Anavex’s blarcamesine. However, some of these participants were down titrated to 30 mg/day due to inadequate titration (too quick and not using an intermediate 40 mg/day dose prior to the targeted 50 mg/day dose).

Also approximately 20 of all of these participants did not have a natural wild type of sigma-1 receptor.

So, yes some of these patient progressed to mild to moderate Alzheimer’s disease prior to starting the OLE study using a target dose of 50 mg/day or the highest tolerable dose identified during the in adequate titration process.

GOD bless,

Very few OLE participants still are classified as having MCI and/or early Alzheimer’s disease so ADL can be an appropriate primary end point.

So did most of the patients on A273 progress from MCI to mild AD in just 1 year

or

As I've posted multiple times, most of the patients were already stage 3 or 4 at study entry

Which is it?

Wow! Even George is saying “ that’s seems wildly optimistic “.
Pumpers & bashers on the fringe are quite annoying.

J&J stock price is the same today as it was 5 years ago. It trades in a range between $150 & $170 for the most part. A lot of that is due to the unknown outcome of the talc settlements which weighs down the stock.
If you are looking for a dividend then J&J is about as safe as you can get, but stock appreciation is not their core competency.
Add to that the turmoil coming up with a new CEO being needed due to age limits and the spin out of MedTech, I’ll take the cash that is offered and sell the Jnj stock if it is part of the deal.
BTW, J&J has plenty of cash to purchase companies, they rarely use their own stock for acquisitions.
All in all, good problems to eventually have.

Is a size 13.5 big enough?

George told him in a dream!!!!

I do believe that the ADL endpoint achieved statistical significance during the OLE study, since all of the people in the OLE study received a target dose of 50 mg/day of.blarcamesine compared to only 33% of those from the Phase 2/3 trial. And they were farther along in their Alzheimer’s progression.

GOD bless,

So you don't believe that apparently ADL improved stat sig during the OLE between early and late starters?

I don't think you see and understand the conundrum in that.

The difference is the time frame for changes in ADL to show up.

You don’t understand.

This is personalized medicine. Each patient response differently and some respond quicker than others. For example those either that natural sigma-1 receptor respond stronger and faster than those with a sigma-1 receptor variant.

GOD bless,

He needs a rectoencephalectomy.

Hang on - but Anavex did treat the patients early, which is why you claim ADL is irrelevant, and so why wouldn't the P2b/3 AD patients be doing just as well now as good old Ern Heaven?

Your argument doesn't add up - no surprise there!

Misleading is excited for next week, and so is his squeeze and sidekick. He will be making additional $5M+ for doing a lousy job over the past 10 years. What a great reward! Only Anavex rewards a CEO this much for delivering zero value to shareholders.

BDR10 is mocking georgejjl, who says such things every week.

You are wrong again.

I do believe that Anavex’s blarcamesine can stabilize and even reverse the course of Alzheimer ‘s disease if treated early enough and with the proper dosing. However, each person is different stabilizing and/or reversing the course of Alzheimer’s disease may take longer in some people than in other people.

Early treatment and at the proper dose is the key to treating Alzheimer’s disease successfully with Anavex’s blarcamesine,

GOD bless,

I see, so you don't actually believe that A2-73 stabilise and halt AD.
Very few OLE participants still are classified as having MCI and/or early Alzheimer’s disease so ADL can be an appropriate primary end point.
Probably the only honest post from you in a long time.

Good to see!

You are wrong

Very few OLE participants still are classified as having MCI and/or early Alzheimer’s disease so ADL can be an appropriate primary end point.

GOD bless,

Can you elaborate as to why you think there will be great news this week and a BO the following week?

Anavex however reports on ADL from the OLE, so can't be quite as irrelevant to them as it is to you.

Expect great news this week and the short squeeze to begin along with a possible buyout in the following week....but beware of the bashers shorters and fudsters who will PAINT THE TAPE

Wrong!!!

ADL was and is the wrong primary end point for any trial for participants that have MCI or early stage Alzheimer’s disease.

GOD bless,

Molleone, have you looked into rapamycin as a preventative for Alzheimer's until Blarcamesine becomes available? Both have similar docking sites and there is reason to believe that rapamycin is particularly effective for APOE4 carriers. The website rapamycintherapy.com provides quite a bit of information. Dr Green is no longer with us, but other doctors are providing scripts for the rapamycin protocol...you would have to search for one that would meet your needs if interested.

Tax consequence depends on vehicle.
MY AVXL (and other) is tax exempt Federal.

Been a few years since I last owned shares. Got out due to the unknown
time line. Fast forward, just listened to their latest conference call, see they
have an EMA for the EU. And just heard the Q&A expose that here in the US,
'discussions with the FDA' is something 'down the road'.

So if I got my update right, they are going for approval in the EU first,
maybe at best, some comms with the fda already in progress re: an NDA
submission here in the US.

And the EMA review submitted Nov/Dec with a 200+ day review means
nothing till 3rd/4th qtr this year??

This about sum up whats going on in their AD development??
Disclaimer: Own no shares,curious again. And check out TNXP
which has a 15 Aug decision date at he FDA..

Yes, the EMA made an effort to revise their MAA process. That effort was ongoing in late 2024, so is not directly relevant to our submission. For ours, hopefully we have used specific expertise both in-house and third-party. Having consultants who know what a thorough regulatory submission requires saves some time and is worth the money.

Any gain is eventually given back - usually in the same day. You should pay attention.

Guzzi, I didn't write that both failed - only one failed - but they would have hit both had they had the proper number of patients in the trial.

100% agree Tschussman. I only wish Anavex had believed in themselves as much as we did. Now they know and should be less conservative with our money. The admission at the AGM last Spring that they had underspent on Rett and planned on a fully-sized Rett trial was heartening. The fact that they never ran it is extremely frustrating but at least they seemed to agree that trial size and design need to trump reluctance to spend.

If Missing f.... up, thats the only place he, the management and BOD are welcome. I never trusted him, in with a lot of money because of greed, and a APOE4 something running in my veins.

In the current context and considering Missling is from Europe, where approval is sought from EMA. Anavex have run only one tiny adult Rett trial in the U.S., all other trials have been run in countries collaborating with Europe. Considering all this - the Anavex HQ may not be in NYC or anywhere close and any partnership could be with a European entity - just saying for a friend...who btw. says that an Anavex HQ in Greenland would still be too cold.

You misunderstood Hoskuld’s sentence, go back, read and think.

I want this stock to go UP. It just never does.

But you said it went up 31 cents this week!

please explain

getting J&J shares is much better from a tax perspective.

if you dont want to keep them, you can always sell them.

Plus Blarcamasine slows AD associated brain atrophy to a rate of a normally aging brain, in contrast to the approved MABs that accelerate brain atrophy!

Both endpoints failed, and the second one required subtle medical evaluations over Zoom during the pandemic. It was therefore doomed from the start, and increasing the number of participants would very likely not have helped. To add insult to injury, this second endpoint was only added after Anavex consulted with the FDA over the trial design. I do not blame Missling for this one; it's like blaming him for the pandemic and FDA feedback.

He does get blame for the overly compassionate trial design (even though we've been informed he's a sociopath) that put two thirds of the trial participants on the dosed arm -- which may have underpowered the placebo arm and likely influenced the placebo parents to mistakenly believe their daughters were on the drug.

It's at least an oversimplification, and perhaps an error, to say the trial design failed for lack of enrollees. We can at least agree that the Rett trial did not disqualify blarcamesine as a potential Rett therapy.

Once they have an approval I believe that off label use in Rett's is very probable.  The key is having sufficient anecdotal evidence for insurance to pay for the drug.  In time another trial, that isn't flawed, will gain full approval in Rett's IMHO.
Gary

Blarcamesine is the safest Alzheimer's drug with over nine years of proven drug trial result in the CNS space. Mabs kill people and the FDA is on record approving these drugs currently in use to this day. No brain bleeding here. That is everything you need to know. Imo

Hoskuld, I also would have preferred that the Rett trial was successful and approved to help with this disease. I had invested with this as my expected outcome, so both financial and in support of Anavex providing help for those cursed with Rett. There was enough positive results with the trial, as small as it was, that it did lead me to feel that A 2-73 was of benefit. This, combined with what was known at the time for A 2-73 for Alzheimer's and with my experience with rapamycin, was enough for me to continue investing as the stock price dropped. Not that I was completely comfortable...but confident enough with what I understood on the science to make the investment.

Both end points failed in the AD trial? That new to me, I am sure it's only one that failed?

Out of curiosity, was the 30 day approval a totally new drug approval, or were they approving a drug which was previously approved by someone, like the FDA.

I'm guessing it will take till mid year at the earliest, but I'd be thrilled to have it happen sooner.

Gary

We can say "with some confidence" that none of us know when EMA will approve blarcamesine. If in the past the longest approval took 581 days and the shortest approval took only 30 days then the blarcamesine approval could come any day! Blarcamesine is not an "average" drug. It is an unusually safe and effective drug for a poorly treated disease that can bankrupt health care systems around the world! Patients need it, their families need it and the health care system needs it! It is superior in every way to the Mabs which have already been approved!

tschussman, you just need to hope that they don't go light again. They admitted last year that they should have run a trial EXACTLY LIKE TROFINETIDE. That is crazy, right? I mean they literally knew the trofinetide trial design before they ran their own trial. And they decided they were not sure whether 2-73 would work so they ran one that was 1/3 the size.

It is good that you were able to buy more cheaply after the stock cratered - but I would have preferred Rett was successful. I bet Rett patients' families also would have preferred that. And AD patients would have preferred that Anavex took a crowbar to its wallet and enrolled another 200 patients. Approvals would have already happened and patients would have been better off - and so would investors.

BL, I don't think that is the right take. They simply did not run trials that were large enough. You think that this is because they were being cautious - and if so then basically we invested based on the story they told us that they did not fully believe in. That is almost criminal, if true. I bought it because I thought this would work - but they didn't test it fully so we couldn't prove it.

This is a public company. We invested money that we expect them to spend to be successful. There is not other purpose for our investing. If I wanted cautious then I would have bought government bonds.

Thrift has cost us big time But Misleading made millions....he will be making another 5+milion in just 2 weeks.

Misleading don't care about stock price, he is here to make money for himself and his college buddies.

The longest clock stop time has been 371 days on top of the 210 active EMA process days. The median clock stop is 81 days.
The shortest time the EMA has ever taken to grant a marketing authorization is 30 days.
So with some confidence we can say that if A2-73 is approved it will in somewhere between 291 and 581 days, but highly unlikely to be 30 days as by now we would have heard about that.

I cannot argue the impact of the small sample size for the control in Rett; it likely was the reason for lack of statistical significance. The non-stat significant metric for Alzheimer's possibly would have still failed with a larger sample size, as it has been postulated not to be a good measure of effectiveness for early Alzheimer's treatments. Perhaps the only reason for inclusion was the FDA requirements of the time.
What I expect to result in a favorable outcome for me is that I was able to acquire the majority of my position post Rett data reveal. Need one of: EMA approval for A 2-73, or demonstrated effectiveness for A 3-71 on Schizophrenia. I believe the odds are in our favor.

That’s all true, but it also assumes a successful outcome. It’s possible that Anavex would have been unlucky with its patient cohort or there’s a pandemic or whatever that results in failure, even with a large and expensive trial and then Anavex is trading around $0,40/share. Hindsight is 20:20.

I’d take a few additional years of waiting and accumulating shares, gathering data to inform future trials, then blowing it all on one turn of pitch and toss. As is there’s no guarantee for Blarcamesine with the EMA so I’m grateful we have 4 years of runway just in case we need to turn attention to 371.

Spending more may have produced better results but it’s way to be aggressive with other people’s money. If Dr M spent hundreds of millions and the trial still failed, people wouldn’t be happy either. The hope was low spend with a passing trial but that didn’t happen. Rett was just a placeholder while the mAb drugs proved to the world they’re not the answer,

Thrift has cost us big time - Rett trial failure was due to thrift and the failure to hit both primary endpoints in the AD trial was due to the same thrift. Had Anavex spent the money the share price would be at least several times higher than today's price.

I’m not suggesting that is what they do, I was questioning whether Anavex will be able to operate as they are as a major CNS company. Low head count, no brick and mortar facility etc.

Is there any other mid to large pharmas that contracts out all of there activities?

Dr Missling seems to be very thrifty with the way he operates so who knows?