Anavex Life Sciences Corporation (AVXL) News

Mayomobile has a relatively brief post up on his site describing a trade newsletter's report on comments the FDA has received on its draft AD guidance we have been discussing here. The newsletter quotes comments from Johnson & Johnson as well as SOTC.

The comment period has now closed. I have looked over the docketed comments on the most recent draft; there were only four commenters on the draft, of which J&J and SOTC were the most notable. Significantly, none of the commenters opposed the direction taken in the draft guidance, but in general provided suggestions that would refine this new approach.

The legal significance of all this is that the administrative record that will underlie a final guidance is now complete. Given the lack of any public controversy over the proposal to drop the ADL co-primary endpoint, any final guidance is extremely likely to remain favorable to Anavex's chances with a future NDA, and a legal challenge to the guidance would be hard pressed to succeed. In fact, the lack of critical public comments signal that a serious challenge is unlikely.

Tomorrow fireside chat will be one of the best ever CC from Misleading, he will be rolling out of his bed and presenting same old hand dandy PPT.

Hope there is a fire under his arse, that will be miracle...LOL

Live by the sword, die by the sword.

Do you really expect them to admit failure after decades of force feeding the public?

Doc328...would love to hear your comment(s) on the conference call transcript below - especially the first Q & A by Soumit Roy.

Soumit Roy

Yeah. Hey, congratulations on all the progress and a few questions on the FDA guidance. It’s oftentimes a bit qualitative and trying to understand, read through the line, when they’re saying strong biomarker and strong statistical data to support the clinical outcome on the cognition front. How do you really interpret that? When you’re looking at amyloid 42 over 40 ratio, the error bars when you compare with the company is just because of the cohort size is a little larger. How many patients was there and do you see these to be considered strong or FDA would ask for a larger trial? Just curious about your thoughts.

Dr. Christopher Missling

So the key background is that for the biomarker of Aß changes in placebo versus active arm, we have to be reminded that the mechanism of our drug is not an antibody removing Aß drug, but it’s an orally available, once daily, easy-to-administer and scalable drug and has for that a lot of convenience features, which the antibodies don’t have, in addition to the fact that they are having challenges with the black box warning, which they have been given. So there’s also a challenge from safety and repeated safety measures on MRI are required.

Regarding the biomarker data of the Aß, we were intrigued, but on the other hand, not surprised that we saw a reduction of Aß in the brain measured by the plasma Aß42/40 ratio, which is the analogy of measuring a PET Aß level in the brain, which is intuitively easy -- easier to understand, because you are showing a decline in the brain. But the Aß42/40 ratio, which again is representative of this fact of reduction of Aß in the brain is then measured in the plasma and shows as an increase of this ratio, favorably showing a decrease in the brain. So if the ratio goes up, that means Aß in the brain goes down.

So since we don’t target Aß directly with our drug, but have a more upstream mechanism of action, again, we were intrigued and surprised to see in all patients, there was no sub analysis in this analysis of the Aß ratio showing a significant decline. So now it’s a question of dialogue with the agency, how this will be interpretable as a biomarker.

But I’d like to also point out we have a second strong biomarker, which probably even is stronger, specifically from a p-value perspective, which is the changes in the atrophy of the brain. So in the pathology of the Alzheimer’s disease, there is a very well understood feature of shrinking of the brain over time. And this is intuitive, if the brain is shrinking is less active, it cannot have as good memory or activities of execution and function as the brain was not shrinking.

And we noticed in our trial, a significant stopping of the shrinking of the brain with ANAVEX2-73 blarcamesine in the active arm, compared to placebo. So the placebo arm continues to shrink the brain in the patients, while they are on placebo, which is standard-of-care, by the way, it’s not placebo itself, it’s including donepezil, memantine. So all the data is always on top of standard-of-care, which is today approved, includes approved drugs.

And however, the active arm on blarcamesine or ANAVEX2-73 shows a significant separation from the placebo by not shrinking the brain any further or delaying the shrinking of the brain in many regions of the of the brain and this exact data will be part of the publication, which we’re expecting.

So I think once this data comes out, I think that we can re-discuss the impact of that biomarker in combination with the Aß biomarker. And again, with the Aß biomarker, I’d like to remind again, we did not target with our drug directly Aß. So it must be a downstream effect of the upstream feature of the sigma one receptor, showing also the impact on the entire population in our trial.

Soumit Roy

These are truly encouraging data. You have quite a few catalysts coming up in the next probably three months. I’m trying to understand what would be the strategy when you go to FDA, would you wait for the open-label extension on trial data to come out along with the publication and completion of the European filing and then approach to FDA with the totality of data with biomarker and the long-term, or would you do before that, meet with FDA before the long-term extension on trial data?

Dr. Christopher Missling

Yeah. So we really want to have the best impact, I would say. And you don’t have a second chance for first impression, as they say. And certainly having data of the open-label study, which is 96 weeks, probably, would be favorable. However, we have not decided how to proceed on the timing exactly, but definitely this year. But also we can do, since it’s an open-label, interim cuts. So there’s a way to expedite the analysis of the open label study.

Soumit Roy

That is truly helpful. The last question on if you can provide any guidance on the timeline around completion of the European filing?

Dr. Christopher Missling

Yeah. So we definitely want to expedite this and the teams are working really over time to put together the modules, which are many pages, a significant package, we talk about a lot of documents and they all have to be completely ready. Usually this takes time and other companies are going through the same process need the same time. So we’re not in a different situation like that. But we said we want to submit this year and we are well on track to do that. So we will provide updated timing when we get closer to the filing time. But we have very good on time with that. So stay tuned.

Soumit Roy

Thank you and congratulations on all the progress.

Dr. Christopher Missling

Yeah. Thank you.

Operator

Our next call is coming from Ram at H.C. Wainwright. Ram, you should be live.

Ram Selvaraju

Okay. With respect to the regulatory process with the European authorities, can you give us a sense of A, when you expect the MAA filing to be completed, and B, how you anticipate the process to evolve with respect to the CHMP review, how and when they are likely to become involved in the review of the application and what do you understand to be the principal criteria they are going to use to evaluate the suitability of blarcamesine for approval in the European Union? Thank you.

Dr. Christopher Missling

So we stated that just a minute ago that we are filing as soon as possible, definitely this year and the team is really working overtime to put together a package which has to be done in one submission. There’s also interactions taking place with the EMA to be aligned on the technicalities, so that precedes this submission. We also are, sorry, what was the second question?

Ram Selvaraju

The involvement of the CHMP, that review committee that typically looks at drug candidates that are subjected -- submitted to the EMA for approval and renders a positive or a negative opinion prior to an approval decision being taken. Just wanted to know when you expect the CHMP to get involved in the review of the blarcamesine MAA and what criteria you expect them to use to determine what their opinion should be.

Dr. Christopher Missling

Right. Thank you for reminding. So the procedure of the submission involves a review of the package before it gets submitted and it’s a very healthy procedure because it allows exactly this intelligence to, feedback to be received. So we expect this to take place.

To give you a sense of the level of interest, we noted before that the reason we submitted to the EMA was not because we thought it would be a good idea, but because we shared the majority of the data with the EMA beforehand, and asked for their input and their feedback, and their response was unambiguous to request to immediately file a submission.

So we of course hope that this initial feedback will continue to be the case down the road and right now we have no belief why it wouldn’t, but that is of course up to the review. So we are coming in here, not that we push, but we were pulled into the submission, given probably the unmet need in Europe and also the fact that the European Union has not MRI or PET centers in all places in the countries of the European Union, like in certain countries, for example, like Hungary or Poland or Romania, there are not enough MRI centers, which would probably be needed for an antibody given its safety profile. So that’s the best we can say at this point.

Ram Selvaraju

And with respect to 3-71, just wanted to A, get a sense of how you expect to monitor the efficacy profile of this compound in schizophrenia. If you regard, for example, certain domains of the PANSS to be the most appropriate efficacy measures, as well as the extent to which you expect 3-71 to be differentiated from existing anti-schizophrenic medications and what you expect the principal areas of differentiation to be. For example, is it safety and tolerability, or so then the efficacy, or do you expect on both the safety, as well as the efficacy fronts, this drug candidate to demonstrate the differentiated profile versus currently marketed, for example, atypical antipsychotic medications?

Dr. Christopher Missling

Yeah. I think it’s exactly as you stated, it could be really both. And if you look at the landscape of drug approvals, you want to always be better than what is out there on the market. So if you’re able to show that the safety has a better feature, a better profile and also translate into stronger, more meaningful efficacy, both on the positive, as well as the negative domains of schizophrenia, then this would be extremely valuable and helpful.

We also want to point out in this study, we are focusing on EG/ERP as a considered surrogate biomarker of schizophrenia. So we are excited about finding out how the drug interacts in that regard and it’s a very elegant non-invasive methodology to identify that.

But we also have included the standard PANSS score in addition to this EG/ERP. So we might learn something about the effect of our drug in the study in those regard, which would then allow us to decide how to proceed with this drug in schizophrenia.

Ram Selvaraju

And then the last question is sort of a combination of a strategic and financial query. Let’s say hypothetically that the EMA agrees that blarcamesine is approvable for treatment of Alzheimer’s disease in the European Union. At that juncture, strategically, what do you expect your preferred strategy to be in terms of whether or not you elect to undertake independent self-commercialization activities in Europe or whether you at that point would look to identify a partner? And does your cash burn guidance of runway for the next four years take into account any pre-launch activity related expenses related to blarcamesine for treatment of Alzheimer’s disease in Europe or are you assuming that if you get an MAA approval that you will look to identify a partner with which to launch the drug in Europe? Thank you.

Dr. Christopher Missling

Thank you for the question. So what we try to decide when it comes to that point is what creates most value for shareholders. So if the most value is created by finding a partner and who has the expertise and the bandwidth and the strength of executing and maximizing sales of the drug blarcamesine for Alzheimer’s with giving us the appropriate incentive to do so with the upfront payment, with milestone payments and royalties, that would be probably the choice.

If, however, it is not the case, then there are certain combinations of such features where we could also consider a split ability to market the drug, which could also actually be beneficial for the company and shareholders because we might retain more upside down the road. So this is really a decision made at the point in time when we are there to maximize shareholder value.

On the other point, you asked about the cash utilization rate. Right now, we are not including any marketing expenses and it’s also not necessary because if it comes to approval, you would have the ability to raise funds, non-dilutive fund with debt funding and financing and these sort of, which would not dilute current shareholders.

So you would not need to have that money in equity available if you would come to the point that you need to pay expenses for marketing entry for that reason. So we would be in a position to leverage the balance sheet without diluting existing shareholders.

Ram Selvaraju

Thank you for all the clarity and congrats again on all the progress.

Dr. Christopher Missling

Thank you.

Operator

Thank you, Ram. Next question comes from Tom Bishop at BI Research. Tom, you should be live. I think you’re muted, Tom.

Tom Bishop

Okay. I wasn’t clear about this comment about the first cohort of schizophrenia being fully enrolled. And is this a 30-day trial? So would data presumably be forthcoming in H2 at least?

Dr. Christopher Missling

So we have to finish the trial. So it consists of several cohorts and several parts. So this was the first cohort in the first part. And again, I want to point out this is a testament of the execution of the team, which has done this so quickly. And again, we are ahead of time because we are anticipating starting the trial actually in this quarter and we ended up starting the trial in the previous quarter and now already have enrolled the first cohort. So it’s very encouraging. I would leave the analysis and when the study is finished, when we get closer to that point to announce that, but we are very encouraged so far about the speed and the process of the study.

Tom Bishop

What are these different cohorts, what are they targeting and how long does the trial last in terms of dosing?

Dr. Christopher Missling

So there are two cohorts in two parts. The first part is just identifying the doses of what is the best dose for the schizophrenia patients. So it’s an ascending dose escalation part. And the second part is then at the optimal dose, if you like, a longer study of almost 30 days. So that is the second part. So we are right now in the first part.

Tom Bishop

Okay. And it’s good to hear about the phase three Rett trial. What can you tell us about the timing and the number of patients? And I guess it’s to be 50-50 this time with placebo. Can you tell us more about the trial?

Dr. Christopher Missling

Right. So we really think that with Rett syndrome, we have really a good chance of what we refer to learn our lessons from the previous trial, where we really were only impacted by a very high placebo effect and that was contributed among others, as you pointed out, to the 2-to-1 randomization, which gave the sense of a participating family to think that, so 2-to-1 means that two chances are higher to be on active arm and randomizing only a small portion, one-third, to placebo. So 60 patients ended up in the active arm and 30 in placebo. But because of that, people thought or had the impression or certainly the aspiration to have a higher chance of being in the active arm.

And that leads for those who are on placebo and are completely blinded, so don’t know if they get the placebo or the active arm, to suspect or hope that they are in the active arm psychologically. So that’s what is this bias most likely. So to avoid this, we would have a 50-50 randomization, 1-to-1, so that there is no anticipated ability to expect that to be in the active arm and triggering a placebo effect in the placebo arm. So that would be one thing.

The other part is there are also features to reduce placebo response by features of the trial, which are specific to technicalities. And then we also would do a larger study, it turned out that indeed the measurements are volatile and only a few participants in the placebo arm could basically noise -- cause noise of the signal to be not significant and that’s what we observed. So there was a very good trend in directional improvement, but we have to now make sure that the signal is strong enough to be significant and that’s the ability to do that.

And the timing is, we will provide update when we get closer, but the community is receptive to this. We are engaging with the community as we speak and also we mentioned that we are presenting at the conference in June in Colorado, as a matter of fact, to connect with the community about the next steps of this trial.

Tom Bishop

And you don’t quite yet know the number in the trial, which would affect how long it takes to go on?

Dr. Christopher Missling

So the good news is that it’s a relatively short trial. It’s 12 weeks, so it’s not too long. It can be done relatively timely, because the matter of fact is it’s a not long trial to begin with. And if there is, again, ability to scale this up and there’s strong interest in an alternative marketed drug to Rett syndrome patients, this could help actually accelerate this trial to start and to kick off. Again, we will provide update as we know more.

Tom Bishop

Okay. Can you remind us of the Fragile X data to-date? Is it just Phase 1 kind of safety data or in food data or is it -- or do I forget kind of some trial results we’ve gotten that you’re considering moving to Phase 2b/3 trial?

Dr. Christopher Missling

Which indication? Sorry, I missed that.

Tom Bishop

Fragile X.

Dr. Christopher Missling

Yeah. So this is very intriguing data. It’s a biomarker, which is measurable both in patients, in humans, as well as in animals. And it’s correlating very clearly, it has been published to the pathology of Fragile X or to showing a reduction of the pathology of Fragile X.

And this will be presented for the first time at the conference in July and we’re very excited about it, because it strengthens the, first of all, the evidence that Fragile X is an extremely good indication for blarcamesine for ANAVEX2-73, but also it would give us in a clinical trial, a biomarker, which is so important in CNS, which is hard to find biomarkers of a pathology. So these are the two reasons why we’re very excited about this presentation coming up.

Tom Bishop

So you could move into a potentially pivotal Phase 2b/3 trial, just based on your biomarker data to date, is it?

Dr. Christopher Missling

Yeah. So that biomarker data we presented will also -- we also -- yeah, we have to also appreciate that there are physicians, patients, advocates group who want to learn why would you -- why want to be part of a trial? And this information would give somebody that information to say, to be excited about being part of a trial because of the fact that it would define the chances of being beneficial to a Fragile X patient in real world and that’s what this biomarker data will -- would be to get the excitement in the community to also then have a smooth enrollment and trial execution, which is important.

What do you expect? This miracle drug is known only to WGT and "Clown," while the rest of the world remains in the dark. According to WGT, they want to teach a lesson to the cabal. However, the biggest cabal member is Misleading, who is reaping millions for doing nothing and vacationing 364 days a year.

Big pharma still doubling down amyloid based on cnn

Based on what we've seen so far, don't spend too much time worrying about the Rett-based complaints. Filing a complaint is easy and doesn't on its own mean much.boi568

Thanks for reply. I get that response /credibility, etc. it's just irritating to make such claims and then to have a claim that the clock has expired (('M OK if that is true-valid) I just want to verify the status of what could be important to some. TIA.

We are encouraged by the very recently issued FDA guidance for Early Alzheimer’s disease, which states that one cognitive measurement alone, like ADAS-Cog13, could be a sufficient primary endpoint for early Alzheimer’s disease. I believe he is encouraged because he found another excuse to kick the can down the road

Millions and millions of pages....keep counting

Based on what we've seen so far, don't spend too much time worrying about the Rett-based complaints. Filing a complaint is easy and doesn't on its own mean much.

Can anyone produce a PR or text msg/any evidence on the status of the legal action/suite dropped (reportedly ) due to lack of timely response from legal complaint.....PLEASE.

TIA , is threat of that law suite still hanging out over AVXL or or not???

Well sure, if they wish to do so. But they could probably not do so directly. They would have to go through a market maker at the prevailing market price.

Can't the Russell funds also just transfer the shares to a more speculatively geared fund of their own?

Hope your employer is working on your FUDster list, it is a slow process for a guy who spends 364 days on vacation. He might need new option grants as motivation. These could be vested once he contacts the first person from your list.

No sense trying to reason with nonsense paid bashers... it's pointless.
Just accept their FUD posts as what they are... JUNK!

Zig
How can u say what patents are needed now versus those not needed?
And isn't waiting for approval a risky proposition?

And ultimately, of course, the Russell funds will have to rebuy the shares, and then some.

Agreed, Kevin.

While the index tracking ETF's are bound to follow the rules in their prospectus, actively managed money is where the next market moving demand will come from.

I'll be looking forward to updates highlighting the increases in non-indexed institutional holdings.

The point is that Missling has gone after way more patents that are needed

No--you and Kund have not made a valid point at all. Up until the time of regulatory approval/commercialization biotech companies build basic patent protection. That consists primarily of breakthrough knowledge relating to the drug's method of action, potential disease applications, and any unique methods of manufacture. etc. Unneeded patents in the drug industry are alleged to be pursued after commercialization in the big pharma practice called "strategic patenting" or "blanket patenting". The amount of resources AVXL has devoted to basic patent production are minute compared to the overall research and development of Blarcamesine. If you want to continue to play this game, then you must compile a list of what you consider to be frivolous Blarcamsine patents that have extended the protection period beyond that of Blarcamesine's basic patent protection. I'm waiting for your list--I don't believe any such patent extensions exist for Blarcamesine. In addition, you will need to furnish documentation that proves that AVXL has put more effort into patent development than it has into Blarcamesine's research and development. As to drug approval, AVXL has just started the process of submitting for regulatory approval so those efforts have nothing to do with resources previously devoted to obtaining basic patent protection. Your post was total hogwash.

It wouldn’t have mattered. I would not have included #6.

Only you call him the Messiah! He lives in your head no?

It's called box!

Same here. # 6 ruined my win, exacta, trifecta and superfecta, which I picked correctly following Seize the Grey. Oh well.

No, the world is not against Missling. It’s about crooked hedge funds and mm’s trying to make money.

Thanks, I certainly have had serious long term bad effects from Cipro from years ago (when I took it for 2 months with terrible ill effects at that time for a prostate problem...but trusted my urologist at that time who has since retired)....damn my luck!

BTW, I had picked the 3 horses correctly picked following Seize the Gray, the winner, but failed by not even considering the winner...my bad...I had used the trifecta 3-5-7 and superfecta 3-5-7-9...all boxed....let's see how The Belmont goes for the 3rd leg of the triple crown

“Delusional long things entire world is against messiah Misleading.”

This is partially correct. What’s really at the heart of it is that the delusional retail longs think the entire world is against them.

Missling is merely their avatar.

The point is that Missling has gone after way more patents that are needed and has put much less effort into drug approval and keeping to timelines and promises.

The patents act as a fake catalyst to keep his salary going...getting 30 patents for a drug that doesn't gain approval is useless and a waste of time and dilution derived funds. Get the crucial ones now and get additional patents when the drug is approved.

You didn't answer my question.

And you believe he has started EMA filing? Guys is a liar, last Dec 23 he said rett data delayed due to safety and within 20days he said it failed...
Since 2020 he has been saying PDD data will be published in peer review paper, for AD he is saying same for last 4-5 CC, What kind of peer review papers he is using?

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.

His meaning of "underway" is misleading, similar to his claim that they have enough cash for the next four years. This claim never changes, even after spending $10-12 million per quarter. He talks about a non-dilutive raise, yet the outstanding share count keeps increasing.

For all the bitching you do, you seemed seem to have forgotten the EMA process has started.

I am curious, what did Missling do to you to give you such a hard on for Anavex and Missling? You post almost exclusively on AVXL and all of them are the most denigrating that you can think of.

Delusional long things entire world is against messiah Misleading. The stock is down because Misleading has failed to deliver, and there are no signs he is going to deliver. The biggest cabal for this stock is Misleading.

The market works on facts, and the facts are that there is no value in this drug based on what Misleading has shown to the world so far. Re-read last CC, there is no concrete timeline, it is all this year, next half, soon, stay tune etc...guys is kick the can expert.

They are waiting until the forced sale from the Russell ETFs. And jockeying for position to cover. Then those that are able to cover will probably go long. My prediction. The bandwagon short coattail riders will realize that the big fish they were riding on have lost their motive. The fudsters will continue their nonsense.

Shorts getting nervous as should

" index funds and retail only"

Many of the 193 listed "Funds" are anything but Index Funds. Everything from State Teachers Pension funds to Banks to Investment groups.
Click up this list and view them. You can sort the list by Any Column either high or low first. At the end of the day they now own 38% up from 31% end of 2023.

https://whalewisdom.com/stock/avxl
I own more shares than a bunch of them.
John k9uwa

Patents are useless until Misleading gets the drug approved and markets it.

More of Kund's chicken and egg gobbledygook. What is Missling supposed to do? Is he supposed to get the drug approved and only then seek a patent on the drug, thus loosing years of patent protection that won't start until years after the drug hits the market? That is the definition of a useless approach.

LOL. Impressive nonsense.

I know how patents work, but TGD is not here to get the drug to market. So far, he has proven to be incompetent. He can't get anything done on time, from starting trials and enrollment to completion and data release. His options are vested for trivial milestones, like 50% enrollment, he's just here to make easy money.

He dodged Bishop's question on the open market buy. He didn't show any interest and instead pushed it to other BOD members. He's gotten used to easy millions.

For someone bashing, how is this any different from any company working for approval of their first product. Patents on anything are worthless if no one wants to purchase what's patented. Meanwhile, people who look for a better way of doing something, and patent it, can make a great deal of money, that's how the Trinitron color picture tube was created. Of course it's worthless today as flat panels replaced tubes, but for many years it dominated that market.

Gary

Useless patent, another toilet paper. Patents are useless until Misleading gets the drug approved and markets it. He is not even close to filing an NDA and has been doing data analysis for the last two years; peer review and embargo....

Australian patent for Anavex's blarcamesine for the treatment of high systolic blood pressure

AU2024202998 - SIGMA-1 RECEPTOR AGONIST SYSTOLIC BLOOD PRESSURE THERAPY

https://patentscope.wipo.int/search/en/detail.jsf?docId=AU429058526&_cid=P11-LWCUO5-16285-1

Good luck and GOD bless,

How many new patents have been assigned to Anavex since Misslings arrival? I remember all of the wailing and gnashing of teeth because there was no patent protection. Did Missling earn a little of that wealth?

Call them yourself, abe!

As Nike states, "Do it!"

More good info: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8450333/

More on L-serine. Quite promising!https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8450333/

Funny how same could be said about obesity as well, and here we are with the rich abusing the hell out of said pills.

I don't believe that what the medical profession labels "Alzheimer's" is a single disease with a root cause, so I don't believe there is a single solution. I also believe most doctors are clueless, as my physician insisted that I had to finish the Cipro script or get "antibiotic resistance" even after I told him I already had one toxic reaction to the drug. I no longer do anything a doctor says unless I can confirm the treatment with my own research.

Just because it worked for Cici doesn't mean it will work for everyone.

In “The Last Alzheimer’s Patient,” CNN chief medical correspondent follows Alzheimer’s patient Cici Zerbe who says her symptoms have been reversed after participating in Dr. Dean Ornish’s clinical trial on the effects of intensive lifestyle changes on the progression of mild cognitive impairment or early dementia due to Alzheimer’s Disease. That peer-reviewed study will be published in the journal “Alzheimer’s Research & Therapy” in June 2024. Dr. Ornish’s program includes a plant-based diet, regular exercise, group support, yoga or meditation.Watch the full documentary on CNN’s “The Whole Story” premiering on May 19th at 8p et/pt and streaming on MAX on June 18th.
https://www.yahoo.com/news/woman-claims-alzheimer-symptoms-were-202000196.html

I have dealt with both Fluoroquinolone (1997 & 2019) poisoning and COVID (2019 before it was known), both impair the body's attempt to produce taurine. After the bout of COVID things got pretty bad. I began a routine of supplements which helped, but until I upped the taurine my health continued to decline,

Abstract
Taurine is a sulfur-containing, semi-essential amino acid that occurs naturally in the body. It alternates between inflammation and oxidative stress-mediated injury in various disease models. As part of its limiting functions, taurine also modulates endoplasmic reticulum stress, Ca2+ homeostasis, and neuronal activity at the molecular level. Taurine effectively protects against a number of neurological disorders, including stroke, epilepsy, cerebral ischemia, memory dysfunction, and spinal cord injury. Although various therapies are available, effective management of these disorders remains a global challenge. Approximately 30 million people are affected worldwide. The design of taurine formation could lead to potential drugs/supplements for the health maintenance and treatment of central nervous system disorders. The general neuroprotective effects of taurine and the various possible underlying mechanisms are discussed in this review. This article is a good resource for understanding the general effects of taurine on various diseases. Given the strong evidence for the neuropharmacological efficacy of taurine in various experimental paradigms, it is concluded that this molecule should be considered and further investigated as a potential candidate for neurotherapeutics, with emphasis on mechanism and clinical studies to determine efficacy.

https://journals.lww.com/nrronline/fulltext/2024/01000/emergence_of_taurine_as_a_therapeutic_agent_for.10.aspx

This company is run by clowns... you are expecting too much. All those recent hires are just seat warmers. They all have big titles, so no one pays attention to the small things

I would think that too falls under the “longer we wait the sooner we get rich” banner.

Next time someone talks with IR, please inform them that their webpage for Therapeutic Candidates did not include Schizophrenia on the chart for 3-71. That webpage needs to be updated.

https://www.anavex.com/therapeutic-candidates

You are thinking too much, it doesn't take 2year to release full data. Misleading is just using peer review to cover his incompetency, for most companies peer review can be done in 6-9month, but for Misleading it takes ages, we are still waiting for PDD peer review since 2020.

All the recent hires are from another junk bio Acer, looks like he is collecting highly incompetent people to justify his delay.