Anavex Life Sciences Corporation (AVXL) Quote

He's no different than most CEO's in that way, most quarterlies are scheduled on or near the last day they're supposed to report. I live in L.A., decades ago most quarterly and other presentations were scheduled about a half hour after the market closed. Suddenly I found most companies switching to an hour or so before the open. I asked my broker what was going on and the explanation was simple, nearly all the Analysts are on the East Coast and nearly all come in well before the bell to get up to date on the news. They complained that when the day ended they wanted to leave, not wait around for nearly two hours to first read the financial, then listen to the quarterly report which followed the release.

While I'm interested, I don't get up at 5 a.m. to see the release, or 5:30 to hear the call, and only rarely am up when the market opens at 6:30 my time. I may use the bathroom about then, so I'll take a glance, but unless I find a big move in one or more of my stocks I just go back to bed until I normally wake up, 1 to 3 hours later. One of these days, if I miss the open, when I do wake up I'll learn I'm half a million or more dollars richer, from NWBO news, I don't own enough AVXL to make that sort of gain, at least not yet.

Gary

Missling is sloppy with his timing. He doesn’t think when he picks dates for CCs. Several times he had CCs on strange dates like before holidays and weird times like switching to an 8am on a Monday, not thinking investors read into these moves.

They all have been a nothing burger, while we all got excited expecting something since he telegraphed.

I hope there’s something here this time.

Or maybe he was just like, oh crap, we got to do the ASM. Shiit, I knew I should have never fired my secretary.

Powerwalker, clearly they'll be speaking with a quarterly in the next two weeks, but how much they can reveal above and beyond a normal quarterly may be in others hands. If no material or data that's never been peer reviewed is released, they're limited about what they can say. On the other hand, if they're in control of an issue, like filing with a regulator, they can certainly update about that.

I know that when they discuss million page filings there are companies that specialize in getting them out, just the announcement that such a company has been engaged would be positive news rather than trying to do it all themselves. I'm frankly unsure if even the BP's do it themselves. If they were to announce an intention to file somewhere no later than say the end of the third quarter, it would be greeted positively.

If you're right about discussions with one or more BP's, it would be big news to indicate they're in a quiet period, so it's cannot be discussed. Sometimes the best news available is that we're not free to discuss anything. During such periods they're still required to issue financials, but the failure to say certain things in the financials may be telling a story by itself.

I do suspect that sooner, or later, a BP will either partner, or look to buy the company. Personally I would like the price much higher before it happens, but that can only happen with one or more approvals. Offers very rarely pay more than double the current price, I would hope the company's trading in at least low double digits before considering any offer. Under confidentiality agreements, a potential partner, or buyer, would gain access to all the data we're being denied until it's peer reviewed. That's information that could lead to a much higher offering price, but only after the stock price reflects the news that's not yet been released to investors.

I for one believe that when we get the full story on RETT's we may see a possible path to approval without further trials, but that's purely my opinion. On more than one occasion the regulators have agreed that more than specific goals in a trial should be considered if a product has some benefit where nothing else exists.

Gary

True and been in it over12 years so I know what your saying!

Your insights are invaluable.

P.S. I am wondering, after the Rett January numbers, which were better by ~ 3x than those of Acadia's, whether Dr. Missling, his staff, the lawyers, et al realized that Anavex was batting against Sandy Koufax with a whiffle ball bat and its strategy needed to be altered.

BP has many different ways to "influence" a trial and it wouldn't surprised me if it did here ... with the results, Dr. M understood that fact and is looking to bring in some heavy muscle, e.g., Merck, Takeda among others. Just a thought ...

Alas, it's not done till it's done. LOL... WGT want to wait till share price slides to $0.01 and wipes out all their capital.

Gary, this is not a NWBO scenario. Anavex will need to be forthcoming in the next two weeks as to its current situation. If not, it will need to be specific as to why no data is being revealed. If Anavex were still ambiguous, there will be more lawsuits directed at the withholding of material evidence, which might be easier to prove than the ambulance chasers as there are dates when data is known and whether it were disclosed or not.

Hopefully, in the next 7-10 days, this will all be clarified.

It's biotech. It always has had significant risk.

Contrary to popular whining, I think the overall level of risk has been reduced considerably.

Alas, it's not done till it's done.

Only if it's another Rett scenario. And if it is Missling will be sued into his grave.

This has really turned into a crap shoot!

Powerwalker, I'm sure you're right about the company doing the quarterly webcast in a timely way, and yes, they certainly speak with investors whereas NWBO doesn't do such webcasts, so all you get is the written text. As for the Annual Meeting, if Missling gives investors a reason he'd prefer to wait, I believe investors would support it.

Investors want to hear more about the data, until that data's been presented for peer review, the company shouldn't do it. Wouldn't you rather have a Journal out, or peer reviewed presentation first, then have open discussion of the data, or have the meeting and be told that the data won't be discussed until it's been peer reviewed.

I don't believe Missling will delay more than a few months, but I'd rather have a meaningful Annual Meeting in perhaps August or September than a meaningless one in May, June or July.

Another possibility does exist, but only after peer reviewed data's out. Hold a Science Day. It's really just a few hours, but allow the scientists to do far more of the presentation. I don't know them, but hopefully among them there are better presenters than Missling. I know other companies have done Science Days so when the time's right, why not AVXL.

Gary

Not really...we expect after 5 years from trial end that we can at least get a drop of data. So you must not have dug deep enough..

Gary, I don't know about the NWBO activities that you mentioned or its responsibilities to report, though several NWBO posters have been here in the past and have brought their complaints and/or optimism.

What I do know is that Anavex has a date of May 10th for Q2 numbers plus a CC and if it weren't released/conducted with some news on the ASM, our NYC shareholders would set up a date to meet in Manhattan and storm the Anavex offices. [My wife and I might join them from NW Indiana.] If a delay were announced and no valid reason provided, the stock gets hammered to pre-RS levels as it is easier to FUD then defend when that happens.

Therefore, Dr. Missling, give us something to hang our hats on in the next two weeks.

Were any of the CEOs you advised members of the upper echelons of biotech investors?

Your posts reveal that you were quite the consultant. Forgive my incredulity.

Bio4, if any of that were true as to your career, you would NOT be trolling any message board with your "best intentions." You would be long gone into a wealthy retirement and there would be no need to be here ...

Unless, you were a lousy management consultant and were not able to ID the right guy more often than not. Actually, given your posts over time on the Anavex board, that is probably the case ... and, you are missing again.

I pity your poor sign ... No, you probably don't have any one tied to you ... each one saw you for the loser you are!

Really? FYI, I spent my entire career working as a management consultant to senior executives and coaching management teams on organizational issues. I’ve seen my share of good CEOs, mediocre CEOs, and bad CEOs. There’s plenty of mediocrity out there but there are some great CEOs and some terrible CEOs. It doesn’t take me very long to size them up.

I completely agree with you Chris. Any CEO would prefer to have their Annual Meeting after some good news, rather than when under fire for nothing new happening. On the Nasdaq a CEO probably doesn't have the freedom an OTC stock does, in NWBO's case they didn't have a meeting in 2023 after holding the meeting for 2022 on the last business day of the year, but I suspect that Missling can delay a couple months without a serious penalty. I believe if shareholders wish to force the issue 13 months after the last meeting they can sue, which will take time, but ultimately they can force the meeting, If I were Missling and I expected a Journal publication at any time, I'd wait until I had it unless I had something even bigger to announce, like actually filing for approval.

As for Missling's ability to be CEO, some will deem him a failure right up to the day the company gets it's first approval, then everyone becomes a hero. I believe that CEO's are given entirely too much credit, or blame for what most companies do. If they put together a good mix of the right people, it's all of them that are doing the job. Ultimately it's the science that determines if a product is really approvable, I don't know Missling at all, but I doubt if he contributed much to the science that's produced the company's products.

Sadly, in at least a few companies I've seen good science fail because companies tried to gain approval quickly by using pancreatic cancer as the target for products that worked far better against cancers that took much longer to kill. The company didn't have the funds to do the additional trials so the products were abandoned and the company went belly up. Missling has the company well positioned financially, now the science must prove worthy of approval, I believe that's happening.

Gary

And you are uniquely unqualified to evaluate the CEO.

Missling is uniquely unqualified to be a CEO. I urge you to take some time and look at his career track record prior to joining Anavex. As CEO of Anavex, his performance has been dismal. It’s been one fumble and stumble after another. It’s not the fault of investors that the stock has collapsed, nor is it the fault of Adam F or hedge funds. Missling alone is responsible for the destruction of shareholder value. I know it’s a lot of work but do yourself a favor and study his performance over the course of his career and tenure at Anavex before coming to any conclusions.

You are 100% right on with your views. I would add a couple of other points. The companies silence along with the shareholders meeting, not being announced yet lead me to believe something larger else is going on. Maybe it’s the preview being released maybe it’s a partnership, maybe it’s guidance from the FDA or submission to the EMA. But clearly somethings gotta give one way or the other and I suspect it will be positive for the longs. Stay tuned.

As a reasonably new investor in AVXL I've seen a great deal of criticism of the CEO, but honestly it's nothing that I haven't seen in other biotechs, and in most cases it's been for the same reasons. In most cases it's because investors believe that once a trial end, they're entitled to in depth trial data. In reality, the company does give Top Line Data, but that's just a paragraph or two summarizing what's seen in the trial, after that, once data's been peer reviewed and presented, then they can talk about it.

Sadly, companies want the peer review to be done by organizations deemed to be highly respected, and they'll wait for them rather than finding the first conference or Journal willing to permit a presentation. I'm much more familiar with Oncological products, and there conferences like ASCO are where they want to be. I'm sure much the same applies here, though I don't really know the key conferences, or publications they're working to get into. My point is, it often takes many months, sometimes in excess of a year to get the data presented in the manner they wish it to be, and until that happens they simply would be violating proper protocol to discuss them beyond what's in that TLD statement.

When a peer reviewed presentation is made it won't be just the positives, it will be a review that has positives, negatives, questions, etc. seen in the trial, it's rare that nothing negative can be found. Peer review will cite both good and bad, that's what it's all about. Competitors, who fear approval of a competing products may have their own "experts" develop presentations that counter the good as well, money will buy almost anything, and some lessor publications or conferences will accept what's provided and consider it peer reviewed by their staff.

Finally there are the geniuses like AdamF, with his degree in PoliSci, as I remember it, that work in support of shorts to put down companies who put their spin on the results, and sadly many people do follow them, as well as the hedge funds that no doubt employ them.

In time, all of this becomes meaningless if the company applies for approval with the regulators, and gets it. When revenue builds, that's something that can't be denied, but until that happens, one minute the CEO's terrible, the next he's brilliant, it's all dependent on the current stock price.

Gary

Misleading and his shenanigan continues, he is been doing this for last 20+year, he is pro in scamming retailer with slogans. Lately, he has been using social media platforms like Facebook, Twitter, etc., to pump the stock price with the aim of enriching himself. It's important to recognize this pattern, which has been evident since December 2022.

MF has not invested single penny to buy the stock in the open market.

Barons doesn’t know more than the rest of us. Based their 12 months $AVXL forecast the MAA filing and validation feels like $40 in their analysis, which would be fine.

Will it happen? We wait to see…

https://www.barrons.com/market-data/stocks/avxl?mod=quotes

Now what? Looks positive...suggests multiple positive AVXL PR's in near term? Let's hope it is just not more parasite bait.

ANVS secured non-diluting funds for future trials. Class act their CEO which has invested her own money into the company total opposite of “TGD” which has diluted the shit out of Shareholders with no approvals on sight this year or 2025.

I'm certainly no expert, but I suspect that many of those pages are generated as a product works its way from preclinical development through clinical trials. They essentially provide the backup to significantly fewer pages that are the real guts of the filing. On the 1.7 million pages in the NWBO filing almost everyone I discussed it with agreed that less than 10% will probably see the light of day.

Gary

Power the Anvs board has the filings. They appear to be favorable towards the company and the timing of the data release is a primer. I pray they do not have any hiccups in their data.

He said MILLIONS of pages for EMA approval and 40 person staff won’t be able to produce.

Also, summer break is literally “around the corner” (not Missling time quantum) so he’ll PR more useless Patents.

Ugly model BTW.

When is AGM for this year? Looks like Misleading trying to avoid facing Burbon and Household...or something (both poster are not much active anymore). These posters where upbeat when they heard slogan "You will appreciate what we did and the way we did it"

MF Misleading blabbers in every CC, guy makes up stuff, has no strategy, spends entire year tapping model

I wondered the same thing earlier. Per the link that follows: "For each application for a new medicine, two committee members - known as rapporteur and co-rapporteur - from different countries are appointed to lead the assessment (for generics only one rapporteur is appointed). They are appointed according to objective criteria to make best use of the available expertise in the EU.

The role of the rapporteur and co-rapporteur is to conduct the scientific evaluation of the medicine independently from each other. They each form an assessment team with assessors from their national agency and sometimes from other national agencies.

In their assessment reports, each team summarises the data from the application, presents its judgments of the medicine’s effects and its views on any uncertainties and limitations of the data. They also identify questions that will have to be answered by the applicant. The two separate assessments take into account regulatory requirements, relevant scientific guidelines and experience in the evaluation of similar medicines.

In addition to the rapporteur and co-rapporteur, the CHMP also appoints one or more peer reviewers from amongst the CHMP members. Their role is to look at the way the two assessments are performed and ensure that the scientific argumentation is sound, clear and robust."

https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines/how-ema-evaluates-medicines-human-use

I liked this part also:

"Did you know..?

In some cases, for example when a medicine is intended to treat a life-threatening disease for which there is no satisfactory treatment or if the disease targeted is very rare, EMA can recommend marketing authorisation on the basis of less complete or limited evidence on the medicine, provided that further data are provided at a later stage.

As for all marketing authorisations, it must still be demonstrated that the benefits of the medicine outweigh the risks."

Peace Powerwalker, All is Well. Or it will be Well once TGD announces the EMA has been filed.

John k9uwa

That looks like ancient history...delusional WGT keep following since 2015. 10 year still no progress, except Misleading got richer and he spends 364 days in Europe with model.

Share price is back to post split with pre split share count....way to go TGD

From Barron's

Stock Price Target
High $40.00
Low $25.00
Average $32.50
Current Price $3.3900

https://www.barrons.com/market-data/stocks/avxl/research-ratings?mod=quotes

Good luck and GOD bless,

The definition, from the horse's mouth, could use a little work IMO.
One of the two members of a committee or working party who leads the evaluation of an application.
https://www.ema.europa.eu/en/glossary/rapporteur

FRIENDS, what are rapporteurs in the EMA context??

John k9, a lot of people have been here since 2015 and we don't need to be reminded that you have been here since that year with every post you make ... nor that you are not leaving ... most of us from 2015 and before are not leaving either.

Peace,
powerwalker

I still believe in Anavex science, but the FDA corruption is a bit concerning. you are bullish on science which has not proved anything in last 10 year but keep blaming FDA for not approving drug. Have you seen FDA approving drug without filing NDA and data?

Clown knows something which he keep disclosing one snippet at a time, there is a reason why he is not filing to EMA and FDA; millions and millions of pages

Yes Tom totally agree. Interesting that today was rather light trading vs previous days... 949.97K shares traded. And it accelerated near the end of normal trade hours. A rather tight price range today. I too have some overpriced shares based on today's numbers. But will just hold all. Will see what Monday brings.

John k9uwa
Have been here since 2015 not likely to leave anytime soon.

Thanks for the clarification.

News is always on the way, and
News on the way ??
The longer you wait the sooner it will come.

Got it. That was helpful too, thanks.

plex, Q2 number should be issued by May 10th and usually a CC. As to whether that leads to real news, is anyone's guess.

A wrench might be thrown into this schedule since no ASM date has been announced nor proxy issued. If there were activities going on in the background, then Q2 numbers could be delayed, too.

OK, I was responding to a post about what I thought was your uncertainty on accelerated assessment at the EMA rather than the FDA.

Tred, do you have any of the details on the ANVS deal? Similar to Anavex's Lincoln Capital and their deal?

Thanks.

Actually, if you look at the dates to begin the rapporteur process month by month, the actual selection is actually closer to 6 weeks after the submission deadline. Presumably because of the holidays, there seems to no submission deadline (and therefore commencement of the process) in the month of December.

Thanks, yes I finally found that. See my last post.

The FDA response to Lily's post-phase 2 donanemab accelerated approval application and NDA was interesting, and no doubt frustrating to the company. Their phase 2 had 131 patients on drug (about same on placebo). The drug was so effective in decreasing AB levels, the key biomarker endpoint, that fewer than 100 needed to complete a year's worth of dosing, and were stopped. Their efficacy testing did not stop, and went on the full 76 weeks, well over a year. All per the trial protocol.

In the complete response (ie, rejection) letter to the AA application, the FDA requested that Lilly provide data from at least 100 patients who received a minimum of 12 months of continued treatment on donanemab. Which it couldn't without a new trial.

A couple notes on this:
- So what if an AD drug was designed for 3 to 12 months dosing, depending on a patient's biomarker progress? Dosing must be for a year? What if some drug were found to need only 6 months dosing? It's a bizarre objection.
- Shows BP doesn't get 'favored' treatment.
- If at least 100 patients or more getting a year's drug exposure is somehow a de facto FDA minimum, for AA or regular approval, our phase 2b/3 amply meets it. At least the FDA cannot justify pointing to our small trial size as an approval objection. (They may do so anyway, but would be controversial in light of their donanemab rejection.)

At the Noble conf, around 18 minutes in Missling said "stay tuned to hear more" on our FDA discussions for AD. This of course could mean next month or next few quarters. If discussions are particularly favorable, it may be that we get Fast Track. We are not eligible for AA (needed FT first), but that could follow.

FDA will probably release results of its advisory committee on donanemab's bigger phase 3 in the next few months. That too will be of interest. If they reject, it can't be for not having enough 12-month dosing data. Nor efficacy, since it was slightly superior to lecanemab. If would have to be on safety.