Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
The first thing I would say is that you used the word "fair". My considered opinion is the market is not fair.
I tried to make the distinction between long term and short term. The current share price is based on the short term view as I see it. That means, by definition, that projections you are making are not holding sway.
It is frequently said that the market looks out about 6 months in the future. almost none of the factors you list are likely to occur in the next 6 months. So to my way of thinking they don't really apply to the current SP.
As far as using the current share price to calculate the chance of the drug being approved goes, I just don't think that is considered by most of the market. Those of us the think it will be approved have already acquired out positions so there is not much buying pressure there. It will take new eyeballs for retail to start buying and generating upward pressure on the SP and that will require significant positive news.
The institutes do seem to be slowly increasing their positions but are doing so in a slow controlled manner that doesn't move the SP. There is no reason for them to buy in a volume that would move the SP up since there is no news on the immediate horizon.
As far as my sense of the likelihood of approval in 2025, I'd go with a 90% likelihood. As to why that is not moving the SP higher, see my earlier comments about the 6 month horizon.
I see you have no idea about what I think.
He said that they started the process in Europe because their process takes longer.
Starting the MAA process gave the company 7 months to work on the MAA once the LOI was submitted. In the US the process starts with the NDA submission.
The MAA and the NDA should both be ready for submission at about the same time or fairly close to the same time. The MAA process provides for meetings with the RA during the 7 months prior to obtain feedback and discuss potential issues before submission of the MAA. That feedback can be incorporated in to the NDA , improving it before submission to the FDA.
It appears that the EMA got to look at some of the data in making the centralized authorization procedure and the LOI acceptance decision. According to Missling, they liked what they saw and encouraged the company to proceed.
I understand your argument. On the other side there is this calculation.
99% of AD drugs fail. 2-73 is a completely new approach to treating ANY disease. AD has shown itself to be remarkably resistant to the "best" approaches that current medicine can develop. 2-73 recently failed a drug trial in Rett. That was its first test that could lead to validation of the MOA. You can argue about the Rett trial results meaning, but no matter how you slice it the trial results did not lead to an NDA. There is a class action lawsuit in the system. The promised peer reviewed paper has still not been published. Additional trials are slow in coming for 2-73.
Those are reasons for the share price to be at its current level. Notice I didn't mention shorts once.
Your discussion is a longer term view of the future. The things I list are mostly a short term view of the future.
As the items in the list above are removed by trials results, peer review paper being published, and RA filings your long term view will become the more prevalent view. Till then, the SP is in the doldrums and is subject to easy manipulation or the whims of the market depending on how you view the situation.
If you held shares based on George's cheerleading you are a First Class Dufus.
But as they say, "There's a sucker born every minute".
Oh Wait, your post was sarcasm. Which shows you don't believe anyone pays attention to George's predictions. LOL.
Rave on, Dufus.
He is no longer the Chair of the BOD. So that goes a long way to weakening his position in the BOD.
Because they know more than you do? That would be my guess.
How is this CEO not fired by the board of directors by now?
That response almost has meaning. Would you care to try again?
Kinda like your situation. You have been here for close to 8 years. I don't know what you vacay benies are but you have been on somebody's dime all the time. Kudos.
How can that be? We keep getting told that is imaginary.
You were pretty selective in quoting from Investopedia about poison pills.
Because many shares come with ownership and voting rights, it is possible to own enough to purchase a controlling amount of shares with voting rights. So, if one entity owns the right amount of shares, their votes weigh more than those with fewer shares.
To prevent this, the potential target creates a provision that prevents hostile takeovers by establishing a share ownership limit. This provision may specify that if a single entity or person acquires a stake of 15% or more, the company implements a share issuance or other measure that makes the hostile action ineffective or undesirable. Because many shares come with ownership and voting rights, it is possible to own enough to purchase a controlling amount of shares with voting rights. So, if one entity owns the right amount of shares, their votes weigh more than those with fewer shares.
To prevent this, the potential target creates a provision that prevents hostile takeovers by establishing a share ownership limit. This provision may specify that if a single entity or person acquires a stake of 15% or more, the company implements a share issuance or other measure that makes the hostile action ineffective or undesirable.
Many drugs have serious and long term side effects and in some cases lethal side effects. If Xena chooses to call long term serious side effects of a drug she was prescribed a poison, that doesn't seem like much of a stretch to me.
What would you call a lethal side effect?
Joe, say it's not so. LOL.
You're right. Trial designs and MAAs write themselves.
Then again, I do wonder what these 40 employees are even doing when news and progress is few and far between.
I also will believe it when I see it. Till then I'll just wait and see how this play turns out.
And maybe buy a few more shares with discretionary funds, or maybe not. I have a position in Anavex that I am quite comfortable with. There is not much reason to increase it.
I did buy some NVDA today, also with discretionary funds.
Ummm. Missling doesn't post here but there are still a lot of negative vibes. Several posters don't miss any opportunity to spin anything to as negative as they can think of. Facts and reason be damned.
Have you looked at the anti takeover provisions Anavex has to prevent a hostile takeover?
I have little doubt that some BP have made overtures to Anavex. The board and Missling know what Anavex is ultimately worth and are in a position to demand a high price for the company.
My sentiment is that Missling is asking for more than BP is willing to pay at this point. We shall see if that is the case or not in the future.
As has been pointed out on the board several times, most deals are much less than 10X the current share price and I seriously doubt that the BOD would consider a $40/sh buyout.
With AD approval AVXL will be worth more than $100/sh. At the current SP that is 25X. Do you think any BP would be willing to pay 25X the current SP?
Generally when one has expectations there are reasons for those expectations. I was asking why George had those expectations i.e. what reasons, if any, to support such expectations.
Seems like a reasonable question to ask.
So you reply to one person, who made a specific statement, based on what "nonsense" other people have said.
Are you sure you weren't just trying to find an excuse to spin some negative vibes on the board?
Pretty lame.
What part of "discretionary funds" are you not grasping?
Thanks. W Munny
If the Rett trial had come out as expected 2023 might have been the year of approval an revenues. Sometimes ca ca occurs.
Why?
Expect GREAT NEWS either Monday or Tuesday next week!!!
Do you have link to this rapporteur appointment procedure? I haven't run across that.
I hadn't seen anything that indicated the submitting company had to request the rapporteur appointment.
Maybe we are not talking about the same thing. Are you discussing how the CHMP rapporteur process works internally?
Thanks.
I don't understand what the Jan 10th submission deadline. Would you elaborate on that please?
My understanding of the process is The request for centralized marketing authorization. Letter of Intent can be submitted at the same time but is not a requirement.
The Letter of Intent (LOI) specifies an expected date for the submission of the MAA package. It must be at least 7 months post LOI submission date. Submission of the LOI starts the Rapporteurs appointment process. What has not been mentioned is that the EMA encourages meetings during the process, starting even before the LOI submission and afterwards.
On the proposed submission date the MAA package is submitted and that starts the 210 day or 150 day accelerated timeline for MAA approval if accepted. There are two possible clock stops in the regular approval process. The first one can be up to 90 days and the second one can be up to 30 days. For accelerated assessment there will be one clock stop of up to 90 days.
The Anavex PR says the CHMP declared blarcamesine eligible for centralized regulatory review. That was Dec 19 2023. The eligibility request can be submitted 18 to 7 months before the LOI. So that really doesn't set the LOI timeline start date.
The Zacks PR quoted below says that Anavex start the process in November 2023. I couldn't find anything to confirm that information but it makes sense since the CHMP eligibility process can take a few weeks to over a month depending on when CHMP meetings are scheduled and when the request was submitted to the meeting cycle.
So far Anavex has not confirmed LOI submission and it appears they won't based on my conversations with IR. My guess is the LOI was submitted with the eligibility request. If that is true then that starts the 7 month clock.
So if that is when the LOI was submitted the MAA submission date could be late June or July. Note the the LOI must set a submission date AT LEAST 7 months in the future. As I read the rules that date can be more than 7 months in the future. Given Missling's statement about submitting early as possible I would use the 7 month minimum as a target date for MAA submission.
At least seven months before submission, applicants should notify the European Medicines Agency of their intention to submit a MAA and provide the intended date of submission. This should be done by using the Pre-submission request form Pre-submission request form (Intent to submit MA), selecting as a scope of request: Centralised Procedure-Intent to submit a MAA; this should be sent by raising a ticket via EMA Service Desk, selecting the tab “Business Services”, category “Human Regulatory”. The subcategory to be selected is “Pre-Submission Phase - Human”, followed by the sub-option: “Letter of Intent Request”. The appointment procedure for (Co-)Rapporteurs will be initiated 7 months prior to the Marketing Authorisation Application intended submission date (see question "What is the procedure for appointment of CHMP Rapporteur/Co-Rapporteur and their assessment teams?").
NEW YORK – December 19, 2023
Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, announced today that the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) agreed that oral blarcamesine for Alzheimer’s disease is eligible for submission of an application for a Union Marketing Authorisation in the EU under the European Medicines Agency’s centralised procedure.
Zacks Equity Research for Zacks ->
Anavex Life Sciences Corp. AVXL announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) considers its pipeline candidate, oral blarcamesine, eligible for a centralized regulatory review in the EU.
This indicates that Anavex may file a single marketing application to the European Medicines Agency. The company initiated the regulatory submission of blarcamesine for the treatment of Alzheimer’s disease to the EMA in November 2023.
Being in the rapporteur application process to me means that the 7 month waiting period has started. The fact that Missling said on March 4th that they were in that process doesn't indicate when that 7 month process started.
I hope your interpretation of the available information is correct. That is not the way I interpret it.
I am confused by your last sentence in light of what you said earlier in your post.
Looks to me like mid/late August or the first week of September. Hope all this was reasonably clear and helpful.
Did you get a rent payment yet? lol.
That would be the up and down part.
I guess you are ignoring the period where the SP was in the low $20s.
AD OLE completion date is 7-31-24.
The 7 month period post LOI for the EMA filing would be pretty close to that. Within 30 days or so.
So waiting, if there is in fact a wait, would not be much of a delay. If the OLE data is supportive of an approval why wouldn't waiting for that information make sense? And there is that 90% or so rollover into the OLE trial to indicate that the people in the trial think it is worthwhile.
To be more specific. If your shares are loaned out, you can not vote those shares. Whomever bought the loaned out shares gets to vote them.
A target is where it is going, not where it is.
It's a long trip to get to the destination, full of ups and downs. Yeah, the current share price sucks. Anavex continues to move forward. Rett was an unexpected set back. However it was not lethal and it did slow the journey down. The forward momentum continues.
Unreal how many freeloading idiots are here. Nwbo cornered the market on paid bashers. They must have the BP discount rate.
Glad to see you figured it out.
...there's only three things that will move this stock and that is approval partnership or buyout nothing else matters
I love the attack. By the way, who do I see about getting a check?
Seems that anything that isn't an attack on the company must be from paid pumpers.
It fascinates me how many negative posters there are on this board and how frequently they post. Seems odd that a company that has, according to them, so little chance of surviving let alone bring a treatment to market would attract so much attention.
One of life's little mysteries.
Sounds like LG was doing his job.
I have made 5 posts out of the last 100 and you have made 18 out of the last 100. Who's "spewing"?
Given the number of posts made on this board that are personal attacks my posts are pretty tame. But, if they annoy you that is a plus.
Since the issue is in the proxy and it has significant financial impact on the company, yeah, the company has something to say about it and is contacting the shareholders on the issue since they are the ones that will be most impacted. You do realize that the company is not well financed and big hit to the cash position is a very serious issue.
I don't recall posting to you or you being involved in the conversation I was having with pepeoil.
Hoskuld hasn't posted on Ihub since 1-2-24.
I thought the whole world would like to see the quality of your writing.