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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.
Well he is still alive.
https://en.m.wikipedia.org/wiki/Barrie_Pittock
Good chance he is still on our drug since over 93% of the people on it remained on it after the trial ended.
What is to counter?? When there is something to say they will say it. Until then they will not feed the beast which are the shorts, lawyers, trolls etc. My guess is that we still have 60-90 days until they give us something great. That being and I’m speculating here, a fantastic peer review, submission of our application to the EMA, FDA guidance on Alzheimer’s which could include accelerated approval and potential partnership. I believe that we will see a recovery of the share price until we see news and hopefully be in the $6-$8 range within the next 30-45 days. If we hit a few of the things mentioned above we can be back in the 20’s in a heartbeat. Especially with the huge short positions. If we get everything mentioned above we will be in the 40’s. I also wonder if the FDA guidance on Alzheimer’s and the peer review process has been hindered by the new FDA guidelines. I guess the EMA is ahead of the curve with Alzheimer’s guidelines.
Never saw this guy before. Dir of Analytical Analysis out of Canada.
https://www.linkedin.com/in/janusz-debowski?utm_source=share&utm_campaign=share_via&utm_content=profile&utm_medium=ios_app
They are going for the FDA approval based on the fact that the FDA will be changing the rules for submitting an NDA. Why would you want to waste your time, money and resources on Australia when you have much larger fish to fry. Go EMA and go FDA.
So not knowing the corporate response to your question, but I would suggest that it is such a small market that they’re better off going first to EMA and FDA, and then head to some of the outlying countries. Why spend their valuable resources on something that won’t net them nearly as much as Europe or the US will. Also, I wouldn’t be surprised if Australia excepts FDA and EMA approvals.
Cres, if you truly believe that 2-73 is dead then why are we wasting time and money on approval in Europe?? I think your theory is wrong.
Doc what say you regarding the new guidelines from the FDA.
BS. It means validation from a top medical publication. It also probably means a 10 point pop in the stock as Wall Street does not believe that they have the goods. With a positive peer review that will prove we have the goods. It is not meaningless.
Looks like to me it is a tax bill he has to pay.
Ignatious, but what about Rett syndrome? It seems to me that the FDA knows all about placebo effect, and Anavex seems to have great real world data so I would assume either we get a conditional approval or they want to see another trial I would like to hope we get conditional approval, obviously with a phase 4 based on the totality of the data and the real world data. Certainly the fact that the drug seems very safe is comforting for the conditional approval. This is where I wish Dr. Missling would be communicating better with us.
I would think the peer review will tell the tale of this drug. If it is very positive, I hope the company at that point in time shout it from the mountain top with a marketing program. And at that point in time it kicks off buying from the biotech funds that we have been waiting for to jump on board. Ignatius, why do you think the biotech funds have not given us the time of day? They seem to take chances on other biotech who are in similar situations as us. Or is our technology just way too advanced for them to understand where we truly are. Thank you once again for your input.
Ignatious, can you please simply tell us in layman terms how Wall Street is manipulating our stock. Who is actually doing what? Is there coordination between firms/ funds/ individuals who are taking orders from the Adam Feurstein’s of the world who is taking orders from the big pharma? What is the current trading suggest to you? Accumulation? Continuing downtrend?
Yes the company has made some mistakes but it still seems like the technology is still solid, and we will move forward with approvals first for Alzheimer’s in Europe, then move to Alzheimer’s with the FDA, and along with it, still going for approval based on the totality of the data in Rett. Do you see it this way and that the powers whomever control Anavex sees things positively and is this stock being manipulated for accumulation or is it manipulated for continued downtrend. I have one of my smaller accounts in the stock loan program, and my shares were returned to me yesterday. That suggest to me either it is a rinse wash and repeat kind of thing for the powers that be or it is now time to let the stock run back up, because now Wall Street is expecting a positive peer review along with positive happenings with Alzheimer’s. I think I’m pretty solid with what the company strategy is although Dr. Missling could be much more forthcoming with us but the trading action puzzles me. It has been this way for the last nine years for me. Just when I think things are going great for the company Things turned bleak, but the company remains positive. All the little tricks of the trade lawsuits, Adam, Fierstein, etc. thanks for your feedback I appreciate it.
I think this is total BS. First off they are going forward with Rett syndrome and looking for approval based on the totality of the data. Just call and ask and they will tell you that. Secondly, A.D. results will come out via the peer review. We will at that point in time know how strong the data really is.from what I hear the results are still as we thought, coming out of phase 2, and that was very very good and better than any standard of care out there. So I’m not sure where you’re coming from to save the company is in Dire Straits as you portray.
Does anyone have what the short interest is with ANVS? Or what the stock loan interest rates are at. I bet they dwarf us.
What exactly are you waiting for? The company is going for approval with the EMA first then the FDA. The company is waiting for the peer review which is coming soon. I bet it is a top tier publication but we will see. The company has stated that they will be going for approval for Rett. Hopefully soon. The company has stated that they will do a partnership probably after the peer review comes out. They need to be partnered up before EMA or FDA approval. I wouldn’t be surprised if FDA approval comes first since the EMA takes sooo long. Missling has made some mistakes but they are not fatal. The only thing that sucks here is the stock price. We could all wait thru the delays if the stock was stuck between 10-15 but we are here due to the mistakes. It does not change the science. We got this it will just take a lot longer than expected.
Xena, can you please tell us what that means. Thanks
Is this a new position being hired for at AVXL https://www.anavex.com/headofrandd
Has anyone joined in on the class action or a waste of time. I know , pennies on the dollar. Just wondering. Whomever has a large # of shares (MrPalmer) are you in or still looking for the EMA/FDA/Peer Review saving us all. Thanks.
https://www.sotcanalytics.com/home
I think this is a new write up by Jesse.
That was done last quarter. If you click on the 9/30/23 quarter end you will see that on 11/14/23 they reported that sale. Keep in mind they still have 3.6M shares and Blackrock added during this past Q4 quarter end.
Anyone willing to share the contact info for Missling, Chairman Ma and the board? Emails, phone #'s, etc. I know the process is for a written document to be sent to the corporate address to address the board but it seems to me that if we all put a bit of pressure on them we might force some change. Change in the way the company communicates and change in being a credible partner with its shareholders. I still believe that we have the science but not the right leader to deliver us to the promised land. Or at worst case bring on an Executive that has Wall St cred and has brought a few drugs to market. I do believe that the team is good but the $5 stock price says wall st does not believe them just yet. And the larger question is Why doesn't Missling care about the stock price? Why should he? He is not selling stock at this level. He probably believes that the price will recover when the peer review is out so why do something that could be seen as panic like buying some shares on the open market. That would send Feurstein off to the races. Also, not that it means much but most of our stock peers are in the same boat we are, down and down big. Maybe not avxl big but big. And they are not going up today either. Look at acad, anvs, dnli and sava ( slightly higher ). We need the industry to turn to the upside then we go. Or better yet, we are the ones who make the sector turn.
OK did we fill the gap? Or close enough at 4.95 ? Can we go up now please!!
Well if you find them tough to understand then block me. Just because you don't get any answers maybe it's you that is the problem. I have no trouble getting what I need, although I don't like some of the timeframes but over time I pick up a few useful messages.
I don't know about this Mr. P. Yes the stock is looking like something bad is about to happen but.... Everything that I have heard is that the Peer Review could be in its final stages and could be released at any time. Now this is coming from the same people that has been telling us all great things as the stock is about ready to hit a 52 week low. What I keep hearing is that the peer review will be nothing short of very good and might be the best peer review ever seen for Alzheimer's. So that really is not much as we only have a few drugs approved and we know that they suck. So having a peer review that is better than any other drug out there should be huge news and could be the springboard for the stock to turn around rapidly. When that happens who knows but when I asked IR this question about 10 days ago, they said that it could happen soon with the caveat that they are not in control of the release date. Also, I think that if it is really the best Alz peer review, it must be in a top tier publication. We have seen all the results that are public and I think that we all agree that even with some level of failure within the trial we are still head and shoulders above all others. That tells me we have a great peer review coming and it should be in a very influential publication. So once that happens lets say in the next 1-4 months, doesn't that open us up to a positive ema and fda review and very possibly increased partner activity. I would think that we get information in this order : first peer review, then we have the marketing of the peer review ( whatever that might be ), FDA guidance on Alz and Rett, submission of the EMA Application in about 4 months, submission of the alz FDA NDA in approx 5-6 months, Rett approval by the FDA early 4th qtr., FDA acceptance of Alz NDA and PDUFA date given of April 1, 2025. I think 2024 q3 and q4 will be our huge move timeframes but also peer review and FDA guidance will be huge as well. Just a few more month of pain or $4.90 whichever comes first.
Another new hire, Yanning Liu, PhD MS
She is the new Sr. Dir of Biostatistics.
Guys, it really comes down to the work involved with submitting the applications not how large or small the country is. And quite frankly, if the FDA approves it, Australia will approve it based on that as well. So do the large potentials first, and let the smaller ones come behind. You don’t need your top-tier talent who is chartered with getting the applications completed, and the drug approved wasting their time on smaller potentials upfront.
Are you serious? You don’t think Missling would take a $10 billion buyout which would be about $121 per share. Multiply that by the 8 million shares that he owns and that would be about $1 billion payoff. I don’t think he’d worry about his cushy job for that kind of money.
This is the press release that we are waiting for. When this happens we rocket to new highs.
https://www.cymabay.com/investors-media/news-events/press-releases/detail/592/cymabay-announces-fda-acceptance-of-nda-and-priority-review
Great stuff and now I understand much better as to what is going on potentially. This is from rowdyboy on stocktwits.
https://medium.com/@irwinbooks/new-alzheimers-treatments-how-to-play-the-odds-for-blarcamesine-and-lecanemab-our-hope-and-c35eafbab366