Anavex Life Sciences Corporation (AVXL) Quote

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.

frrol, according to the most recent (monthly) list, donanemab was not granted accelerated accelerated assessment. Its evaluation started on 8/17/23.

Thanks, Hosai. Perhaps because I am also a Gemini?

Never, this company runs on slogans...

News on the way ?? Any opinions when we get some real news ??? Like from EMA-FDA--Parkinson's ?????? Don't want to hear about any Presentation or Conference calls !!!!

"Technical analysis is a windsock not a crystal ball." Carl Swenlin

In the chart posted below, notice that in the period labeled A, the 1.618 projection of the initial decline from 31.50 to 16.50 predicts the intermediate term bottom around 7.20. Applying the same logic to the periods labeled B and C predicts a low of 2.85. The trend channel suggests late May or early June.
AVXL Monthly Logarithmic: https://invst.ly/14kwmi

Yes probably more digestible and easy to comprehend a furlong at a time in less than a fortnight.

A MUST SEE for Fortnight George!!!

The past few years the EMA have had huge demand on their AD rapporteur roster. They're currently assessing lecanemab and donanemab, and they've been dragging on. Wouldn't be surprised if that was a factor in delay. Lecan is having procedural issues, and donan was being assessed for accelerated assessment last year (can't find out current status).

Probably not, but I would recommend this wonderful rendition of the story:

I wonder if fortnight was ever read the Boy Who Cried Wolf.

On the 4th March video conference in the q and a part he mentions in a slightly jargled way they are in the rapporteur process and awaiting being assigned a co rapporteur.

Yes. It's a decent response, just gets stumped because the 7 month clock starts with our Rapporteur Appointment request, which we have not announced. Though no idea how it came up with April (and May).

Keep in mind that these AIs often give flawed responses. (Gemini warns you of that several times when you first use it.) Most people are pasting AI responses without examining them, which is careless. They also blame AIs as the new Manipulator boogieman, also careless.

There is precious little of what you post that is a must see, most is a best ignore!

I think he means "getting" as "in the process of getting".

Any relationship between your post and reality is an unusual occurrence.

How do you know that they are getting rapporteur comments in early March?

I must have missed that.

This is form 3 year and still no sign of starting that trial. She moved on to different drug, no one has time like clown, who goes on Europe vacation every year with his model.

So Annovis just inked a deal to raise funds right before a release of ph 3 data and the soars? Normally dilution causes a stock to tank.

I hope they have solid data and the manipulators transferring wealth are not given an opportunity to crash the stock….for any reason.

Whats the skinny George? No need to download another site to tell us much of what we already know.

2021 Video won't give you 2024 NDA

george style BS

Great post. You're pretty familiar with the guidelines and dates. So asking for eligibility is first step, submitting LOI second step, and CHMP appointment of the rapporteurs third step, which Missling said we're waiting on. You're saying it's the "second gating factor" but I think it's the third. From Missling it sounds like we've submitted our LOI, and the CHMP was still appointing our rapporteur(s) back in March.

https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/obtaining-eu-marketing-authorisation-step-step

I hear what you're saying about the rapps, because the guideline below says "The (co-)rapporteurs appointment procedure takes one month...". But it's after the LOI submission, because the LOI is an annex to the pre-submission request for rapporteur appointments according to Section 2.4.1.1:

https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/pre-authorisation-guidance

But the link above is a little confusing, because it says "This notification is also called the 'letter of intent'."

So yes our LOI filing is probably after the Dec 19th PR. I think from all the above, it's safe to say that around Sept MAA submission is likely.

A MUST SEE regarding AVXL!!!

Watch and listen to Dr. Randi J. Hagerman MD regarding Anavex 2-73

Watch starting at 38 minutes and 21 seconds and again at 1 hour and 16 for the Q & A including many questions and answers regarding Anavex 2-73



https://health.ucdavlis.edu/mindinstitute/videos/images/dls/hagerman-2021-dls.pdf

Good luck and GOD bless,