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Anyone closing out or rolling their Jan 10’s 2024 now that most are probably in n the money or close to it?
So how long have you been working on team Feurstein?
Joe the good stuff is in the peer review. This will be the biggest de-risk that will propel the stock price. If this paper comes out and is as we expect it is a rocket ship. Especially if it shows up in one of the big publishers. If we get key opinion leaders giving it credence it will be tremendous validation.
Yes of course you are right…but egg on their face is Anavex has the goods and they don’t publish it. Personally I’m hoping for NEJM
Their last issue was released on November 15th. Maybe, if our peer review is released in AA we might only have a few days to wait.
https://alz-journals.onlinelibrary.wiley.com/toc/15525279/current
https://www.linkedin.com/in/jeffrey-edwards-07b0844a
Another new position. Dir of Pharmacology
Maybe this is where we present our p3 data to the world after the release of the peer review article. I hope we will be invited this year.
https://2024.jpmhealthcareconference.org/?gclid=CjwKCAiAvdCrBhBREiwAX6-6Ujk7nTeGfyWLruyttg4aGMnWw-x_cGLmKyDDoXE3z0-e9n7-7gu-uBoC2RQQAvD_BwE
Well, we know the stock is undervalued, but maybe there is a method to his madness. If you want to attract some of the high-level talent that he has been bringing in recently, he wants them to get shares at the lowest possible price so he holds on data. Maybe once we get the peer review and the Rett data that will signal the end of senior management hiring, and the rest of the hires will get the stock at 20 30, 40 bucks per share. Is that the right way to do it? Not from my liking because I think the stock should be at 40 today and let the new hires get it at 40 and ride it to 200.
Joe we feel your pain. Since we are so close to the big readout via the peer review maybe it is time to start a grassroots effort to make the FDA evaluate blarcamisine now. This is what happened with Serapta and with the help of patient advocates they won approval. Does anyone on the board have the skill set to help organize this push. We are so close.
So the p2 b/3 trial ended I think last June and we got the top line data in December. We now have the ole which is scheduled to end on 7/31/24. Data readings maybe 3-6 months then submit an nda. That is a long time if you ask me. They could have submitted the nda some time between say April 2023 and now. The FDA could have done something to speed this up based on the totality of the data. From what I see we will not have this approval before mid 2025 after getting full data months after the end of the trial on 7/31/24. That is where I get my timetable. Thanks. But the good news is Rett should be approved much sooner.
It is road blocking if it takes an additional 18 months to get this drug to market.
Yes, but did the FDA ask them to do the OLE and make it part of their submission? That is the FDA putting roadblocks in the way. If that is true.
Jeffery Edwards VP of Clinical Pharmacology Anavex. Another new hire. On board 2 months and worked with the Sr VP that people were speaking about yesterday.
Here is another new heavy hitter added to the Anavex team. Terrie Burrell Kellmeyer, PhD. Look her up on LinkedIn. New Senior VP Of Clinical Development. On board 1 month.
The only reason the stock was down Today is because two minutes after the call started, Adam Fierstein put out his tweet that sent his minions off into short and distort mode. Another coordinated attack as soon as the market opened. Nothing more nothing less.
Speaking of the peer review journal, does anyone know how and when they publish these types of articles? Meaning is there a set timeline for when they publish , ie for example does the New England Journal of Medicine publish each month on the first day of the month. Does the online version come out before the print edition? Do we think that the company will put out a press release based on the release of the article or just let the data and the authors speak for themselves?
George wouldn’t that be a pretty expensive insomnia treatment? If Rett goes for about $200,000 to $400,000 per I don’t think anyone will be prescribing that off label for insomnia, and insurance will not pay that obviously.
Today the bat signal was sent out by Feurstein to have his minions to start shorting the stock and keep the price under control and low. POS.
I believe we will get the Rett data, the Alzheimer’s full dataset, and the peer review article all before the end of the year. I also believe that the data will be so positive that we will also see a wild run during this time frame. How far over and above the high of 31 it goes that is to be seen by the momentum crowd. Maybe we get somewhere between 35 and 40 and then a pull back by the shorts may be back to 20-25 where they will load up And then watch this thing go to triple digits over the next few years. I can dream.
So why would the company say that they are starting the trials and not share the strategy of repurposing? If that is truly the reason it is great but with some of the mistakes made along the way I’m not sure. Why wouldn’t they tell us that is the reason? By not telling us it makes them look like they are not hitting their milestones and certainly investor confidence is shaken. I hope you are right.
You don’t say in a formal press release that you will be delivering your full peer reviewed data set in a “major publication “ unless that has already been lined up. I would suggest that the company has already submitted and has been accepted for the publication, we just need to wait for the specific publication date. Will it be December, January or February, that is the only question. Also as far as the Major Publications go, will it be NEJM, JAMA or Nature??? They are all major publications but my guess it will be the NEJM for one reason. It is the most recognized publication in the world and it will have immediate attention from all players in the Alzheimer’s game. When I say it will have immediate attention from all players in the game, I mean your average person on the street as well. Which tells me the groundswell will begin once this publication is released, and the news sources start to talk about their results. The millions of people around the world will start demanding that the FDA, EMA and other regulatory agencies approve the drug. Get ready.
Does anyone know what the surprise is going to be? Is the surprise great Rett syndrome data without telling us exactly when it’s coming out? Is the surprise the peer review and how good it is going to be. Or totally something else?? Partnership? Accelerated Approval? FDA or European guidance.
But but….what if the peer review is over the top great ? What if it covers every bullshit thing that Adam F or any other manipulator has said about Anavex and is over the top positive. What if the most respected kol’s in the world start talking about what we already know, how great the drug has worked and a few of them are quoted in the peer review. I would have to think that would be worth at least a $4B market cap when the peer review comes out. Approximately a $50pps. Oh and add another $20 pps for Rett.
Or it is a way of purchasing avxl shares at a discount. Sell a put to open. Say a $6 nov 10 strike and you collect.40c. So you’re buying the stock for $5.60 if it gets put to you. At the point of purchase, the big hedge fund start driving the price down they get their stock put to them and then they drive it back up. That’s how they accumulate shares without moving the market too much. They have been doing this for months now.
So if I am reading this correctly, the Rett pediatric phase 2/3 top line data is more than the top line read out but less than the full data set. So somewhere in the middle. Is that correct. If that is accurate, that is great news as the company is obviously very excited to share more information than they typically would with just the top line read out. That is what I was expecting. It could be a great end of year after all, if they can get the peer review, completed before the end of the year as well. But I know that is out of their hands.
Anyone think that the big surprise might be that we get the peer review p2/p3 Alzheimer’s results before the Rett p3 pediatric top line data. Maybe in Nov? I say that because what else would constitute a surprise on Missling’s schedule? Everyone is now thinking Rett comes first so the surprise is Alzheimer’s peer review comes first and it is spectacular with at least 2-4 kol’s name on the document. Then follow up with spectacular Rett results with accelerated approval. That could add to the big surprise the market theory. Talk about a $50 pps before the end of the year.
Maybe, just maybe the BIG SURPRISE will be the unambiguous peer review which will have our new Chairman of the Scientific Advisory Board name all over it along with several other BIG names in the industry. From my perspective, we have been fed good to great data over the years regarding Blarcamasine. We have never put together a comprehensive package that lays out all of the data in a clear, clean method. With Kun Jin doing the stat work and Dr. Marwan Sabbagh, MD from our SAB along with other KOL's that should be part of the peer review this could be the final package that goes to the FDA, Australia, Canada and Europe. So back to the surprise. The peer review comes out and we let the world know that we have submitted our NDA package to all regulatory agencies listed above. That would set the stock on fire I would think and keep AF's mouth closed. Anyone else think this is a possibility ?
So Mr. B. Langostino. If the FDA wanted Anavex to complete another P3 or confirmatory why not tell us?? Isn't that material? I don't think they have had THE meeting with the FDA just yet because they are still working through the data. If it is for some strategic reason that they are not telling us what is going on, I just don't understand the strategy. Is the strategy to not tell your competition that you are required to do another trial? Why is that even a thing. It is coming out sooner or later. If it is coming out later as part of a strategy it backfired. The stock is down 80%. If they are going to tell us in a month from now that they have good data but need to do another trial how does that help when we are at $5 pps. Ok so we have good data we announce that the fda wants another trial and if can duplicate the results from the P2/3 we get approval. And the stock runs to 10-15 based on the fact the FDA has now told us what we need to do for approval. I'm more in the camp of a partnership of some sorts. Maybe a Far East partner before anything. That gets the ball rolling in that section of the world. Then after approval do big Alz partnership for the ROW. Maybe Esai for the far east and let them do those trials. Harold Hampel?? Then come in with some great Rett data that gets us to some level of fair value. Who know what is happening behind the scenes but whatever it is it better be big to compensate for this level of double secret probation.
Hey George, hope all is well. Quick question for you. Why does it matter if we trade 1M shares or 600k or 1.5M shares. I can see if we spiked up to 2M -4M shares but over a million, why does this matter to you so much. Unless we get really active on a continual basis, not just a one off day of 3M shares then I really don't see why we should hear about the volume between 500K and 1.5M. Thanks
Yes but if Missling did something like buying some shares, or nominal share buyback and get the stock back to say $10 then come out with great news maybe we can go to $30. If we come out with great news when the stock is sitting at $4-$5 maybe we go to $15. Right now I would love to see $15 again. But I wish they would go on the offensive instead of burying their heads in the sand and allowing the stock to get hammered.
Wrong, he can do something. He can put out a PR like saying that the company is on track to release data by the end of the year. There is no reason for the stock plunging. He can go on the open market an buy 10K shares along with the rest of the executive staff. He can do a nominal share buyback of say $5M or 1M shares. All token things that can settle the market for Anavex stock. He can also put out some data or start a trial that was promised a year ago. Do something. He does nothing but take it.
George I’ve been in this for 9 years now. I have accumulated more shares than I really want right now and with this latest downturn I am now under water. Yes I expect the company to be further along. Too many self inflicted wounds by Missling. His primary role is to create shareholder value. This is accomplished by providing the market with clear unambiguous results that cannot be refuted by the likes of the short crowd. We should be a $3b - $5b market cap company today. The doctor gets great grades for funding the company and delivering the results of the trials. At least the headline results. He gets an F for taking soooo long getting something into the end zone, an F for not managing the short attacks better and C for not hiring the high level talent quicker. He also gets an F for not managing Wall Street better. If I could give him a Z for a grade I would on this part.
Cross your fingers that this isn’t the day that they release news after hours. Only bad things happen Friday after hours. Contact the company and demand that they address the stock price.
George people are buying. Over 1m shares bought today. :) Everyone should be contacting the company and let them hear it. This is bullshit.
So you and Mr Palmer have now announced February as the date for data. Hmmmm.. I wonder who you spoke with at the company. As you both probably know that person is not very reliable. They have been wrong about 85% of the time on everything.
Can you please explain why it’s nonsense?? Has he promised trial starts without delivering?? Wall Street watches. Has he produced data that has led to misinterpretations of the data? Wall Street watches. Has he brought on board a few biotech funds to buy a few shares to validate the technology? Wall Street watches.
It is not nonsense. He has not delivered and he has not been held accountable. He should have been bumped up to chairman and they should have brought in a known ceo who has brought a few drugs to market.
This has nothing to do with “this particular stock manipulation and takedown”. The stock price is due to Missling’s consistent strategy of promising a lot and delivering even less. His constant missteps as ceo include missed deadlines, bumbling of data releases, hiring mediocre cro’s, not hiring a great stats guy 2 years ago, not hiring enough staff to move pipeline along faster, not partnering soon enough to get the drug into patients hands sooner, not dealing with the short attacks or AF, not going for approval in Australia before fda,…. I can go on but you get the point.
Now the ceo goes into hiding for the last 6 months or so and we are all left in the dark with a depressed share price.
They will not be doing a buy back. If they have to do another p3 then there goes the$150m and they will never start the 3 other trials.
At what point does the company reward its employees with more stock for a job well done? I believe that they will do it before they release their data and any kind of run up in the pps. I also think that mr palmer might be right. News in January after the expiration of options. Too many options sitting out there. Watch for the company to plant that seed on the earnings call around November 8th.
I suggest that EVERYONE should pick up the phone and call Dr. Missling ( not IR or CT )and ask him what the issue is with 3 items:
1. Why the long delay in with getting the Alzheimer’s full results and Rett top line results.
2. Why hasn’t the company started the 3 trials that were to start before eoy 2022. That was promised mid 2022. As shareholders shouldn’t we know why there is a 12 month delay. After all some of us invest by what the company tells us. With no explanation investors fear the worst. Which for me after so many missed deadlines is management is becoming incompetent. I still have faith in the technology but faith in the leadership is waning.
3. Why has the company gone into stealth mode really since last December. Investor Relations has no useful information and when pressed they get a bit defensive. They are being hung out to dry like we are. Many times I don’t hear back from phone calls nor emails.
Now I don’t believe anyone of us will get an answer to our calls. but putting pressure on them will at least help to make sure that we get answers on the next earnings call. That should be mid November. Come on team, rise up. Be an activist investor. Demand to be heard.