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K9, and that is why I do not trade the stock. Always the fear of missing out on the big run. I’ve been saying that for the last 10 years. Ha ha. 😂
George, what is your best guess as to the news that will come out that will help propel this much higher?
Are there any dates with respect to the EMA/MAA submission that we should be looking forward to? I googled EMA procedures and came up with this. If you click on the “view” on the first one labeled:
Timetable: Initial (full) marketing authorisation application accelerated assessment timetables. It will take you to a spreadsheet labeled assessment of initial submission. 120 day timetable. If you go down to lines 28, 29 and 30, it shows the upcoming dates for deadline for submission. The first date is September 16, the second is October 14 and the third date is November 11. It looks like these are specific dates when you can actually submit. those being the next one in line. September 16 is coming up in 6 days but I doubt they will hit that date. That is just because of Dr. Missling‘s comments about before the end of the year. November seems more likely than October based on that same comment. Not sure if I am understanding this correctly. Can someone please confirm. Thanks.
https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/submission-dates/procedural-timetables
Well I hope a peer review does more for our stock price than it did for nwbo.
Trust is waning. I will take a buyout right now at $40pps.
This is a BS response. Sorry try again. They split it into 2 weeks. Lame!! You are a phony.
Doc how come you ignore being called out on your predictions as some kind of expert per below. You are obviously on line and responding to everything else. My take away from this is you probably only scared a few shares away from the weak and not accomplish what you hoped to have happened with your doomsday scenario.
How come you don’t respond to your predictions about July 28th.
I forgot about his big prediction of massive volume on July 28 and the short interest going down to 11m shares and the stock price much lower. What happened there doc. Care to explain??
How come you don’t respond to your predictions about July 28th.
I forgot about his big prediction of massive volume on July 28 and the short interest going down to 11m shares and the stock price much lower. What happened there doc. Care to explain??
I forgot about his big prediction of massive volume on July 28 and the short interest going down to 11m shares and the stock price much lower. What happened there doc. Care to explain??
When did he say before September for the peer review? I do not recall hearing that in the past. Thanks
I believe they wanted to go with someone who would actually help them. Not like I believe it was Canter Fitzgerald, who has done absolutely nothing for them.
Personally, I think they’ve defocused on Rett. I think the focus now is clearly Alzheimer’s, Parkinson’s and schizophrenia along with fragile x. I think Rett is way down on the list right now.
Or maybe he is working on the long awaited partnership and the sale of our shares will be going to the partner. Just thinking out loud.
To me, it’s amazing. We have the great news and up about 4% right now and Sava with all their issues is up 18% today. What is wrong with this picture. I hope it is just short covering and they are allowing them to do that over the next couple of days and then we can takeoff. I hope it’s not a scenario where we are only going to get to fair value once we have either a partnership or approval.
I will take the advice from renowned Dr. Marwan Noel Sabbagh, MD, Professor of Neurology at Barrow Neurological Institute and Chairman of the Scientific Advisory Board than a pretend doctor on an internet chat board.
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