Anavex Life Sciences Corporation (AVXL) Options

Anavex didn't have a successful P3.

AVXL certainly is pretending like it did!

I'm not sure why this buffoon is sponsoring CTAD when he's presenting the same old, crappy data from a two-year-old trial. No company holds onto full data for this long and still claims success.

- We have apparently not applied for conditional approval. So we would not get AA via that route.
- If after their full evaluation the CHMP has concerns, they can: (1) recommend not approving our MAA, or (2) they could recommend a conditional approval. Note that #2 is after the evaluation, so there would be no AA in such a case (it's too late, the evaluation is done, there is nothing to accelerate).
- AA is a possibility, independent of conditional approval. If the CHMP were quickly impressed from their initial evaluation of our MAA, they could grant AA. Possible, not likely.

Interesting. Thanks.

A slightly different ChatGPT answer when asking specific to neurological drugs.

Q - In reference to EMA neurological drug MAA pre-submission and final MAA approval rates. What percentage of applicants that initiate the pre-submission process actually have an MAA application approved by the EMA allowing the sale of their drug to the public?

A - In the context of EMA approvals for neurological drugs, approximately 80% of applicants who initiate the pre-submission process typically receive approval for their Marketing Authorization Applications (MAAs), allowing for the sale of their drugs to the public. This statistic highlights the effectiveness of the pre-submission consultations in addressing regulatory concerns and enhancing the likelihood of approval.

For the most accurate and up-to-date data, it’s advisable to consult the latest EMA reports or publications specifically focusing on drug approval statistics. If you have any further questions or need additional details, feel free to ask!

I added the underlining.

LOL...70% is a low number to you? That is almost everyone who thinks they have a chance. Nothing to do with anything. The EMA did not beg 70% of companies to apply. They told them all, yes, you are welcome to pay us to look at your data and application. And 70% said okay.

Trust me...Playboy Playmate wives are overrated...

.

Also, Anavex didn't have a successful P3.

It requires proof that it works. That hasn't been provided.

Chat GPT estimates around 70% of potential applicants decide to still apply following the EMA pre-submission meetings, so clearly not all of them are being encouraged "for the fees".
Following this about 80% then make it though the eligibility to submit an application stage.

Both are agencies that take applications. They don't tell companies to move forward. Anavex most likely led the questions and the EMA said sure...we will take your payment and look at the data. They would do the same to any applicant that begged for someone to look at their data.

The market is pricing in no submission; approval is seen as the next step. If there was even an iota of a submission, the share price would be over $10

Finally someone with some sense. I have been thinking and saying this regarding your first paragraph since Missling first claimed that the EMA "said to apply". No way they begged them to apply. They will happily take the fees.

If that's how you view things isn't it the same for Cassava? The market is pricing in low chance of an eventual approval and according to you the market is always right.

That's exactly how I view both companies. The market valuation is what it is until it changes. Both AVXL and SAVA have been very disappointing investments for me--so far.

Just sent that to your wife.

Blarcamesine should have a $15B market value….and I should have a Playboy Playmate for my wife.

Wishful thinking does’t make it a reality.

If that's how you view things isn't it the same for Cassava? The market is pricing in low chance of an eventual approval and according to you the market is always right.

He has created value and potentially a lot of value.

To put a $ figure on your "value" created, I note the current value of AVXL is $461 million. No way to spin that top.

Blarcamesine should have a $15 Billion Market Cap

Other companies that have successfully completed AD Phase 3 trials have been awarded market caps exceeding $15 billion prior to regulatory approval. Guess what? AVXL's value today is $461 million. It seems your opinion doesn't carry any water. Let us know when you gain an understanding of that market valuation disconnect.

I have 6000 shares . Just in case . Perhaps lightning will strike .

So, frrol, please see if I am interpreting you correctly. Since Anavex went in requesting full approval, it is not open to them to change this during the initial (pre-submission) rapporteur process, and therefore Accelerated Assessment would not typically be open to them. However, if I read you correctly, the CHMP could still grant conditional approval after the normal assessment process, even if the MAA submission was for full approval?

" Alzheimer's Society News" Blarcamesine among the "Three promising drugs for treating Alzheimer's disease bring fresh hope".

Blarcamesine should have a $15 Billion Market Cap. imo

The drug is also being tested for other conditions, including Parkinson’s disease dementia

https://www.alzheimers.org.uk/blog/three-promising-drugs-for-treating-alzheimers-disease-bring-fresh-hope

Plain and simple, he has been a horrendous leader and communicator. The fact that he is allowed to continue as our CEO with BOD approval says all you need to know about this pathetic excuse for a company.

What value has he created? The share price is the same price after 10 years, but he has increased the market cap 4x through dilution. Most trials have failed, there is no clear path , timeline and direction.

The CHUMP engages in juvenile assaults on Anavex investors, is a purveyor of endless childish sarcasm and inhales chocolate laced herring like a trained seal.

The CHMP is involved in an eligibility request in so far as it appoints a sponsor. Just as it appoints the rapporteurs. The EMA makes sure the assessment is very independent, even the eligibility.

Just accept that there won't be any EMA filing and peer review paper. CEO just dragging this till his retirement.

Yes but. Companies are encouraged to request conditional approval, and we have not indicated that we have; AA would not be in the cards in this case (ie, the conditional approval would come after normal CHMP assessment).

This isn't quite true, the CHMP are part of the cursory review at the earlier stage where they decide if a company is eligible to submit an application.

Section 2.2 here (CHMP mentioned often) -
https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/pre-authorisation-guidance

"The eligibility will be evaluated on a case-by-case basis by the EMA/CHMP. The applicant will, in all cases, be informed of the CHMP opinion, the week following the CHMP meeting where the discussion took place.

NB: Review of eligibility applications made under Article 3(2)b will take place over 2 consequent CHMP meetings because of the need to appoint a sponsor(s) to assess the request.

The eligibility to the centralised procedure under optional scope is accepted for a period of 3 years from the time of CHMP adoption. It is the responsibility of the applicant to monitor the lapse of the acceptance period. If an extension is intended, the applicant should submit a new eligibility request under optional scope, and review of eligibility application will take place over 2 consequent CHMP meetings.

As eligibility requests are accepted at the earliest 18 months before submission of the initial marketing authorisation application (MAA), applicants should notice that any application to the centralised procedure previously accepted under Article 3(2)b must be submitted within 18 months from the date of CHMP adoption. Once this time has elapsed and no submission of the initial MAA has taken place, the applicant will be requested to submit a request for re-confirmation of eligibility under Article 3(2)b upon discussion with EMA. In exceptional cases, a maximum period of 3 years from the time of CHMP adoption might be accepted following appropriate justification from the applicant."

To summarize what Anavex has said.
Anavex released a PR (November 20, 2023) that said they had met with the EMA, discussed AD and their data, and initiated the process of submitting an MAA. Goldberger said they look forward to working with the EMA and Missling said there was an urgent need.
It's now >10 months later and they have said initiating the process for submitting "is underway" (PR August 6, 2024). Anavex also said at this time that "full regulatory submission of blarcamesine expected in Q4 2024".
Note this commitment seems to say EMA submission, not necessarily acceptance. We should know if any of this is true in the next 3 months.
https://www.anavex.com/post/anavex-initiates-regulatory-submission-of-oral-blarcamesine-for-alzheimer-s-disease-to-european
https://www.anavex.com/post/anavex-life-sciences-reports-fiscal-2024-third-quarter-financial-results-and-provides-business-updat

He has created value and potentially a lot of value. We will see to what degree it is fulfilled over the next 3 years.

You mean EMA. Everyone needs to keep in mind: the EMA itself doesn't evaluate a drug; the CHMP and its rapporteurs do. (The EMA makes a decision from that evaluation.) The CHMP has not had any interaction with Anavex; it didn't invite or advise or guide or agree for them to do anything.

Yes it seems . Missling has created zero value in 9 years .. has not run a single trial powered to industry standards . I would shed no tears if he walked . The market has created a couple trading opportunities perpetuated by the epidemic and that’s it . He’ gets a D —

This is one horrible friggin' stock.

No one suggest that that the EMA got down on its knees AFAIK.

My point, which seems to be at odds with your view, is that it seems quite possible that in the discussions that Anavex had with the EMA (CHMP people) that they liked the data that Anavex showed them. They expressed a positive view.

Even if they did say please submit, the CHMP will go through the full submission file which will contain much more information that was shown in the discussions. The CHMP will make its recommendations based on the full submission file and whatever was said in those previous meetings will be a distant memory and have little to do with what the CHMP decides.

I'm not reading much into the tea leaves.

Range pattern seems developing. 5.00 to 5.80,and down again. 5.00 area seems like the beginning of fair bargains to me. Patient waiting, for the whole year.
Roll over tumbles in the pattern, 50 cent movements, 5.80 peak hits 5.30 , would it bounce to 5.60, roll over and tumble to 5.10, etc, etc.
Would we see the one that rolls over at 5.30 and tumbles to 4.80 . Bargain shopping. 🎱
This week started with an upward looking short time frame pattern, that needed to hold support at the 5.40/5.50 area and begin climbing toward 6.00, maintaining the bullish pattern. But instead... this week has already tumbled down, below bullish support, broke the little upward pattern, and now looks to me, more downward, once again. Rolling over at 5.80/70/60 and testing 5.30, it broke the upward look, and now I'm watching to see if resistance at 5.55/5.60 rolls over and reestablishes the downward bleeding game. Those downwave targets are 5.00/4.90/80/4.70 Have a nice week. Have a nice October. 🫣
5.00 could bounce again, and that's your Range pattern.

You are the helpiest - thanks again.

It only matters if you are investing based on likelihood of success. One might think outright approval is a lock if the MAA got down on its knees and begged Anavex to file for approval...or might think the chances and outcomes are more nuanced if the interaction with the MAA is more normal. If you are not really interested in building a discount factor into your investment model or handicapping outcomes some other way then, yes, it wouldn't matter to you.

Its just some's Missling bs threshold is higher than other's.

True, but that is not the point that was being discussed.

It really doesn't matter exactly what was said. Anavex still has to make the MAA submission no matter what was said.

I think it's more likely that the EMA staff advised Anavex it was already in a position to go forward with a full application, but did not actually request a submission. I also suspect this was a pleasant surprise to Missling, who (1) believed he needed to await the OLE results at that point and/or (2) expected the EMA would only accept a conditional application.

Glad to help.

Hey Georgejll, do you think there is a good chance $AVXL will close near the high of the day today too?

Good to get an opinion from someone with zero experience with either agency. Thanks for that.

The FDA is not the EMA.
As we have seen by the rejection of the mabs.

The EMA has a different problem than the FDA. The FDA approved the mabs so there are drugs on the market for AD
The Ema rejected the mabs so the EU needs an AD treatment that it can afford and make available to all EU countries that don't have the infrastructure to support the mabs.

I don't doubt that the EMA looked at the data that Anavex presented and said, that looks good, please submit so we can take a deeper look.

So you're denying your own existence? 👺🐀

If, as you suggest, the company could yet be steered toward an application for conditional approval, the EMA guidelines indicate that an Accelerated Assessment application may also likely be appropriate.

We were "setting up nicely" but then came....
the war scare.....damn the luck! My observations over various such events is that the market will eventually just shake if off even climbing a "Wall of Worry"....

Oh yeah, we are at the 11th day of trying to bust higher yet at the 200 day sma....AGAIN! Time for golf, Mike
🤣

No such thing as a paid FUDster, so your post is null.