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Somebody has to be first to validate this potential endpoint, correct? Maybe that is where we come in and the FDA accepts what we have to offer.
Remi gone. Sava dead.
On the pipeline slide # 16, Dr. Missling states that the company is in Phase 4 for Alzheimer's. My question " is the term Phase 4 an FDA approved term or just being used loosely by the company?" I wonder if any conversation with the FDA allowed them to use this term.
The term Phase 4 is not an FDA-approved term in the sense that it does not refer to a specific stage of drug development that requires formal approval by the U.S. Food and Drug Administration (FDA). Instead, Phase 4 refers to a post-marketing surveillance phase that occurs after a drug has already been approved for use in the general population following rigorous testing in Phase 1, 2, and 3 clinical trials12.
During Phase 4, the main objectives are to:
Monitor the drug’s performance in real-life scenarios.
Study long-term risks and benefits of using the drug.
Discover any rare side effects that may not have been apparent during earlier trials.
If safety concerns arise during Phase 4, regulatory authorities may take action, including withdrawing the drug from the market. Notably, some drugs have shown harmful effects only during Phase 4 trials, leading to subsequent bans
This new corporate presentation has to be the best one they have put out ever. There is new data in here that along with the enthusiasm the entire slide deck shows is a tribute to the progress that the company is making. The presentation at HC Wainwright that just took place was very very good. I suggest everyone listen to it.
https://www.anavex.com/_files/ugd/79bcf7_f15cabd7a94a46f6a6d06d35cd807c54.pdf
Another new stats person. http://linkedin.com/in/yunfan-li-23a14a1a
They probably should have hired these people two years ago but I am sure they will be very busy with all the new trials coming.
The big question where is all this money coming from to do all these trials? Partnership.
Continuation:
9. Why do you need a golden parachute which is up for vote? If you have a product that works you will be sufficiently rewarded with the shares you have.
10. One of the jobs of the CEO is to create shareholder value. Right now the company is closer to a 3 year low ( $3.41 ) than its 3 year high ( $31 ). How come the company takes no active role in changing this. The company does not seem to be shareholder friendly. I base this on the lack of news driven events that would be market moving. I do not see any real insider purchases of its stock by its executive staff and the company only has a few analysts from the institutions. The analysts that the company has are predominately B and C players in the industry. No real biotech funds are in the stock. Why?? HC Wainwright has been predicting a $40 share price for about 5 years now. Are they right or is the street right? Where do you believe, Dr. Missling, our fair value should be. BTW, when an analyst continues to pump the stock price for 5 years and we are closer to all time lows , I think there is a problem with the analyst and/or the company who is feeding them info.
11. The last company presentation shows that there are 40 people in the company. It has been in this range for years. To me, increasing headcount is a sign of a healthy company. Why no growth and there seems to be a fair amount of turnover in the company at all levels.
12. Dr. Missling said approximately 6 months ago that he wanted to surprise the market with our data? Have we had this surprise yet?
13. Index funds have moved up to about 40% of the outstanding shares but at the same time short interest is at its highest levels. Something is wrong with this picture. Why hasn't more been done to combat the shorts?
14. How come with all the positive news about PDD we still have not seen the "next" trial begin. This has been going on for years.
15. Why so secretive about the undisclosed indication? This has been going on for years.
My questions for whomever might be attending next Tuesday. Sorry but I cannot attend.
1. Peer review what happened? Back in Dec/Jan time frame we were told that the peer review was very close to coming out. Why doesn't the company have a better handle on this other than some day it will be released?
2. How come we have no updates on FDA/EMA? Yes I know the company is telling us that they are submitting the necessary paperwork. But... in what time frame? Sorry ASAP is not a valid response. Doesn't the company have a better handle on this other than some day?
3. We know more about what is happening with the EMA than the FDA. Why can't we get straight answers to the questions we have? Where Exactly are we in the process with both agencies? Did the FDA tell us to submit or give approval to do so like the EMA did? So much speculation as to the process and where we are in that process. Shouldn't we know? I don't need to know the exact date. I will accept a month or quarter for submission. The company should know this. I see no evidence that the company is as far along with the FDA as it is with the EMA.
4. Top line Alzheimer's results have been out for over 1 1/2 years and we have not seen the full results. Why? The company has a history of doing this with all the data? Blaming the "peer review" is not acceptable for Alzheimer's data. Now I am being told that the we may get the results before the peer review? So the story changes again. What are we waiting for? Either you have good results or you don't. Again, we were told 18 months ago that we met our primary and secondary endpoints and we haven't submitted yet.
5. Why does Wall Street hate this company so much? Is trust an issue with Dr. Missling?
6. Rett results have been out for 6 months now. We have been told that the company knows what the issues are and will be doing another trial to combat the Placebo Effect. Why haven't we had an update in 6 months on the new trial.
7. We haven't had a deep dive into the technology for over 2 years now. https://www.anavex.com/vnrjune2022 WHY? It looks like this update was a one time affair. WHY?
8. Why has there been such a disconnect between all the positive news that the company is telling us and the stock price? The company tells us that we have a much better product than the MAB'S from Biogen and Lilly but Wall Street does not believe. Why? Why is it taking the KOL's so long to get the message. When they get the phone calls from the institutional investor's technology people they can tell them that yes, Anavex has the goods. Yes I know the peer review will help that but "Where is the peer review?" We are getting jerked around.
Are you sure you researched Steffan Thomas correctly. He has plenty of experience in the corporate world. This is from the Anavex website. Even though they went to school together he has plenty of experience. I'm sure if you look at most boards in the Fortune 2000 you will probably find many examples of friends, classmates, etc on the respective boards. This guy has the experience. His expertise fits nicely with what Anavex has needed.
https://www.anavex.com/press-releases/anavex-strengthens-board-of-directors
Steffen Thomas, PhD, a director of Anavex®, has over 15 years of experience as a European patent attorney and is currently practicing at Epping Hermann Fischer, a major intellectual property law firm in Europe. Previously, he worked for Japan-based Takeda Pharmaceutical Company, the largest pharmaceutical company in Asia and a top firm worldwide, as an in-house patent attorney. Prior to that, he worked for Nycomed Pharma, acquired by Takeda in 2011 for approximately USD $10 billion. Dr. Thomas’ legal practice covers drafting of patent applications, prosecuting patent applications before national and international patent offices, defending and challenging patents in opposition, appeal, and nullity proceedings, enforcing patents before the infringement courts, and preparing opinions on patentability and infringement in the technical field of chemistry. Dr. Thomas has particular expertise in small molecule pharmaceuticals. He holds MS and PhD degrees in Chemistry from the University of Munich.
Funny how that happens the day before the shareholders meeting. It would certainly be more meaningful if it was Missling buying some shares but I guess I'm looking a gift horse in the mouth. Now it is also funny that the shareholders meeting falls on the same day that the ASCEND 2024 Rett Syndrome National Summit begins. https://www.rettsyndrome.org/ascend/ . Maybe we get some Rett news tomorrow to continue to soften the blow of a crappy share price. Maybe they announce that the new trial is starting.
One more question for anyone attending the shareholders meeting. Has the company been approached in the last 12 months from any pharmaceutical company where they have officially offered to buy Anavex. Officially meaning a formal and legally bound offer? I am trying to gauge Dr. Missling’s answer to this pointed question. If someone has made an offer I don’t think he can out and out lie to us. He might try and talk his way around the question.
I have been here for 9 years as well but I still believe that we will succeed. I am not happy about the length of time and the fact that Missling is not very forthcoming with the complete story. But I still feel confident in approval. I hope a few in attendance next week can ask the tough questions in addition to the ones that I laid out.
Continuation:
9. Why do you need a golden parachute which is up for vote? If you have a product that works you will be sufficiently rewarded with the shares you have.
10. One of the jobs of the CEO is to create shareholder value. Right now the company is closer to a 3 year low ( $3.41 ) than its 3 year high ( $31 ). How come the company takes no active role in changing this. The company does not seem to be shareholder friendly. I base this on the lack of news driven events that would be market moving. I do not see any real insider purchases of its stock by its executive staff and the company only has a few analysts from the institutions. The analysts that the company has are predominately B and C players in the industry. No real biotech funds are in the stock. Why?? HC Wainwright has been predicting a $40 share price for about 5 years now. Are they right or is the street right? Where do you believe, Dr. Missling, our fair value should be. BTW, when an analyst continues to pump the stock price for 5 years and we are closer to all time lows , I think there is a problem with the analyst and/or the company who is feeding them info.
11. The last company presentation shows that there are 40 people in the company. It has been in this range for years. To me, increasing headcount is a sign of a healthy company. Why no growth and there seems to be a fair amount of turnover in the company at all levels.
12. Dr. Missling said approximately 6 months ago that he wanted to surprise the market with our data? Have we had this surprise yet?
13. Index funds have moved up to about 40% of the outstanding shares but at the same time short interest is at its highest levels. Something is wrong with this picture. Why hasn't more been done to combat the shorts?
14. How come with all the positive news about PDD we still have not seen the "next" trial begin. This has been going on for years.
15. Why so secretive about the undisclosed indication? This has been going on for years.
My questions for whomever might be attending next Tuesday. Sorry but I cannot attend.
1. Peer review what happened? Back in Dec/Jan time frame we were told that the peer review was very close to coming out. Why doesn't the company have a better handle on this other than some day it will be released?
2. How come we have no updates on FDA/EMA? Yes I know the company is telling us that they are submitting the necessary paperwork. But... in what time frame? Sorry ASAP is not a valid response. Doesn't the company have a better handle on this other than some day?
3. We know more about what is happening with the EMA than the FDA. Why can't we get straight answers to the questions we have? Where Exactly are we in the process with both agencies? Did the FDA tell us to submit or give approval to do so like the EMA did? So much speculation as to the process and where we are in that process. Shouldn't we know? I don't need to know the exact date. I will accept a month or quarter for submission. The company should know this. I see no evidence that the company is as far along with the FDA as it is with the EMA.
4. Top line Alzheimer's results have been out for over 1 1/2 years and we have not seen the full results. Why? The company has a history of doing this with all the data? Blaming the "peer review" is not acceptable for Alzheimer's data. Now I am being told that the we may get the results before the peer review? So the story changes again. What are we waiting for? Either you have good results or you don't. Again, we were told 18 months ago that we met our primary and secondary endpoints and we haven't submitted yet.
5. Why does Wall Street hate this company so much? Is trust an issue with Dr. Missling?
6. Rett results have been out for 6 months now. We have been told that the company knows what the issues are and will be doing another trial to combat the Placebo Effect. Why haven't we had an update in 6 months on the new trial.
7. We haven't had a deep dive into the technology for over 2 years now. https://www.anavex.com/vnrjune2022 WHY? It looks like this update was a one time affair. WHY?
8. Why has there been such a disconnect between all the positive news that the company is telling us and the stock price? The company tells us that we have a much better product than the MAB'S from Biogen and Lilly but Wall Street does not believe. Why? Why is it taking the KOL's so long to get the message. When they get the phone calls from the institutional investor's technology people they can tell them that yes, Anavex has the goods. Yes I know the peer review will help that but "Where is the peer review?" We are getting jerked around.
No actually a great time to announce an acquisition or partnership would be at AAIC which runs from July 28-August 1. Or at least the peer review. Will it surprise the shorts? I hope they have something planned for us and not the same old tired presentation.
Nidan with all due respect why lately do you care so much about pre market. Anavex shares are being acquired by smart money and this will continue until you wake up one day and we are $10 higher. Probably on no news. Leaks happen. Then on news, hopefully at AAIC we run hard on peer review. Which will be hopefully released at the same time as AAIC. That is when we make the big run. Hopefully we also announce at the same time submission to EMA and FDA. Maybe we get accelerated approval from both as well.
George, I think you are off on the low end. If we submit an application for approval to the EMA based on them telling us to do it I would think we go much higher. BIIB would go up $20B in market cap just off of their BS press releases. I would have to think that $30 - $48 is more in line. That would be a $2.5B market cap to $4.0B. Much more in line as to where we should be. Now if we get some news on the FDA then much higher.
What do you think if we get a partner along with the submission? I would up my prediction if that happens to a $3.5B to $6B market cap. Time will tell. If we don't get news by the end of June I would suggest that they will wait for AAIC in Philly starting on July 28th - August 1. Maybe the peer review, maybe submission to EMA.
This is not a triple witching day. Anyone have any thoughts as to why the huge spike at the end of the day.
Nidan what I have found over the years is that when a company is really this quiet and we know that there is pent-up news, and things happening behind the scenes, I’m thinking a partnership is brewing or something that will be so conclusive that we rocket ahead. Be the peer review or EMA submission or partnership or all three something is up. Think about this for a second if we are almost ready to submit to the EMA we need to be ready to deliver to the millions of customers around Europe. The EMA wants to see that things are in place before they approve. I believe we are going in parallel with the EMA and a partnership And everything will be rolled out in the coming months. Dr. Missling said today submission this year I think it’ll be before October. I also think partnership soon after submission, but maybe even before submission.
It looks like she was brought into the company by Terrie Kellmeyer who joined the company just 7 months ago as Sr. VP of Clinical Development and who she worked with at Acer. Great people hang with great people. Anavex continues to make some great hires.
Ok this to me is a great addition to the team.
http://linkedin.com/in/kim-tharaldsen
She looks to be filling a huge patient advocacy type need and by the looks of the people wishing her success she seems to be well liked by all.
Some welcome news. A very small amount but still ok. Lets see some more of the executives join in.
https://archive.fast-edgar.com/20240517/AB2ZLG2CX222OZO2222P2ZE299RTZ2229I62/
Holy cow, state street adds 100% to their holdings and are now up to 7.299 M shares and is now the largest holder of Anavex. Institutional Holdings is now up to 38% https://fintel.io/so/us/avxl?d=2024-03-31
So Doc, thanks for the explanation below as to what may be happening with the shorts and why the stock price is stuck where it is. So if June 28 is a big day and that is when the shorts will be covering, what happens if Anavex produces some big news in the same timeframe? Lets say some of this happens: peer review that is very positive and is in a premier publication, EMA submission for AD, FDA guidance or submission as well, potential accelerated approval from both EMA and FDA, partnership ( less likely but not out of the question ), PDD trial start, etc. You get the idea. There is a ton of pent up news that is just waiting for release. Could the company be planning to release all this news like the shorts have planned for the Russell selling to cover. Could this be a major short squeeze like George has been touting? Or is that just wishful thinking? How does the layman plan for what could happen. Thanks in advance.
I don’t think that partnerships are based on approval but I do think that the FDA needs to be assured that all the boxes are checked off. That is probably one of the reasons why most small biotechs have partnerships early on. I guess avxl has decided that you get better value when partnering after results but before approval or at least I hope it is that way. I would hate to think that we will have to wait another 10 months for the stock to move.
Power, I think you are on the right track but I think partnership happens sooner rather than later. I think the FDA and EMA would want to see the partner in place as part of the submittal of the application. Which could take us to the June/July timeframe for partnership. Remember , the agencies want to see manufacturing and distribution plans as well. Sales and marketing are the easy parts. The question I have is do we have one partner or multiple?
I think the odds are above 80% that this will happen. I also believe that the FDA will not let the EMA approve the first real Alzheimer’s drug that actually works. I suspect that with the changes that the FDA are making for approval that we will go to the head of the line with of course our new global partnership. Look for approval NLT Q1 2025. It could be sooner. Merry Christmas!
George, I love your research but why would BMS want to partner or buy AVXL when they just spent $12B on Karuna Therapeutics. That could be seen as a huge overlap considering it could/would cost them about the same if they went after Anavex.
You are dead wrong The company has so much going on and their trials were not failures. They’ve already told us that they will move forward with the EMA. In order to handle that level of commitment if approved, they need a partner. I believe we will get a partner between now and the end of the year. I also think it could happen much sooner as this partner needs time to get up to speed. I predict EMA approval Q1 and some kind of FDA surprise along the way. Mr. George could be right and we could see much higher prices once some of this new starts breaking. Don’t forget peer review and new trial starts. Maybe we even get a sneak peek at 371 trial data before the end of the year. Remember, that is a very short trial and only 1 location to recruit from.
George from what I understand when using karuna’s drug for schizophrenia another drug has to be used to combat some bad side effects. Again from what I understand 371 with its part sigma 1 activation it handles this issue. So we have a much simpler drug to use. Let’s hope that the efficacy is just as good if not better than karuna. Sorry that is all the details I have on this. Any one else care to chime in?
You do know that will never happen. He brought her on as a director and she is probably still a bit of a puppet to him. I think there are bigger things at play here and I believe that when news breaks the games will stop and institutions will be in, large. With Toutain gone I’m hoping for a big name coo that will make Wall Street happy and our future partner/ owner. Peer review, partnership, FDA and EMA submission, etc. can all help light the fire. 🔥
The bigger question is who did they replace him with? Do we get a major upgrade knowing we will need a different skill set moving forward? If we are in the process of bringing this product to market we need a big pharma type COO who has the knowledge, contacts and skills to move products worldwide. Was Toutain the right guy, I guess not. I'm sure he leaves the company with at least a million shares. Hopefully he has the cash to purchase them and hold for the long term.
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.
All you guys who think Missling is gone are dreaming. It is his company to see 273 through to completion and a buyout if the price is right. That to me is anywhere between $10-$20 billion. I personally think that the delay is associated with either a partnership or FDA guidance. If partnership then George might be right with his multi billion $ change in market cap. If great FDA guidance like accelerated approval is given that would be huge as well. Or the same for the EMA. I hope George is right this time. Personally I am giving this until the end of the year. If we are still in the same boat I will be moving on.
They have already hired someone for this.
http://linkedin.com/in/david-goldberger-2439a14
He has all the EMA experience, knowledge and contacts Look at his role with Otsuka. He knows how to get this done.
Way too low George. The bar has been set already by Biogen at I believe is $26K per year. I m sure for the first few years we will be in the same ballpark, maybe slightly higher since our product actually works. We have 10 years of R & D to recover. It will be whatever insurance will bear. You will not see lower prices until the drug is used at lower levels for a preventative treatment like Lipitor. 1M patients x $26k=$26B minus partner cut and manufacturing.
I would suggest George that like most things the company does it’s hiring practices is in stealth mode and has to be going into a huge hiring mode. Partnership looming and EMA submission I suspect that we will need many more people. Like some of the other senior leaders we usually don’t find out until months later.
Very much so yesss. The company has made a few mistakes that slowed them down and I hope they fixed the issues that led them into these mistakes. But the drug works and I believe that we will see approval(s) before the end of Q2 CY25. The stock price will be much higher way before then as we get peer review, submission to EMA, submission to FDA, partnerships, etc. See you at $30-$40 by eoy.