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What is the recourse for suing a company with assets that either are not valuable because they don't work, or unknown assets that will require hundreds of millions of dollars to test in various trials? The default reaction in America is to file a lawsuit, but I don't know of too many attorneys who will take the case on contingency unless the goal is to secure the $120mm in cash, which after the attorneys take their 35% fee, will provide about $1/share at best.
And that is assuming Anavex loses the lawsuit. Most shareholder lawsuits do not end well for the petitioners.
We as shareholders must decide whether Dr. Missling is credible. I believe he is. I've seen firsthand what terrible, lying CEOs look and sound like -- and Dr. Missling is not cut from their cloth.
And I hope that Dr. Missling responds, "We'll see where the data leads when it's available."
Attrition is a slow process, and even the most patient eventually find their breaking point.
Wow I didn't realize he had accrued so many shares over the years. Then again, I stopped reading the 10K about three years ago. Thanks for the updated info!
Everything in this world is for sale if the offer is large enough. But to answer your question specifically, I don't think selling outright the rights to Blarcamesine is going to happen. More likely, it'll either be an outright acquisition of the entire pipeline or licensing Blarcamesine to a larger company, either for specific indications or for all diseases.
It all depends on what is Dr. Missling's end game. Does he want a quick exit so he can retire to the islands with tens of millions of dollars? Does he want to try to turn Anavex into the next Pfizer or Biogen? Does he want Anavex to continue to be something akin to a minor league baseball team that develops assets for bigger organizations?
From what I can tell, it sounds like he is bullish on A371's potential. But it would be a huge risk to accept a lump sum cash for a proven asset without any sort of assurance that the rest of the pipeline is going to pan out. Now, if a company wrote him a check tomorrow for $25 billion, he might be tempted to sell the company's assets piece meal. But I wouldn't bet on it...
Almost. There is another outcome: Anavex fails the trial, and pursues an over-the-counter route, and in a few years becomes the next Herbalife. Cristiano Ronaldo will wear Anavex on his soccer jersey just like David Beckham promoted Herbalife when he played for the LA Galaxy. Anavex becomes a household name, and nobody cares that the FDA rejected it. It's not like half the country isn't suspicious of Dr. Fauci and the FDA and would see rejection as a badge of honor. Blarcamesine would be available in every CVS, Walgreens, Kroger, and Amazon. Or the company could go the MLM route instead...
Honestly, getting approval just seems easier. I'm fairly certain that's the path of least resistance, assuming all continues to go well with the FDA trials. I am thankful that Dr. Missling is smart and experienced enough to ignore the message board arm chair quarterbacks. There are plenty of instances where criticism is warranted. I just don't see it here, if delays are the biggest shareholder gripe. That seems more like a shareholder's problem to me.
User MayoMobile appears to have a deep understanding of neurobiology despite a lack of formal training. My brain isn't wired to understand any of the science so I try to digest the big nuggets of information as best as possible, hoping that this amateur biotech researcher isn't a silver-tongued charlatan. All due respect to Mayo, of course, because I believe he has good intentions -- but without an MD or PhD confirming his understanding of neuroanatomy is correct, I'll always remain slightly skeptical of anything not officially provided by Anavex.
With regard to the Dr. Grimmer interview, I think we all know what he's going to say with about 75% accuracy. He believes in the company's future, the results have been extraordinary to date, there still remain some challenges ahead and he wants to be a part of the team to try and get this into the FDA's end zone several times for several diseases.
And as long as the meeting took place at MayoMobile's expense, I appreciate him sharing his insights. I'm particularly interested in the non-verbal cues, the real stuff that tells whether Dr. Grimmer believes what he says.
Looking forward to hearing what Dr. Grimmer says even if he is restricted by all sorts of confidentiality agreements and SEC regulations.
I don't even remember where I heard about AVXL for the first time. I've always had a riverboat gambler's mentality when it comes to the stock market, but AVXL circa-2015 wasn't a well-known stock and I wish I could remember how I discovered it.
I do remember spending several days debating whether to buy AVXL, led by some unknown German PhD/MBA, or Axovant (AXON), led by some Wall Street wunderkind who had just ushered in the largest biotech IPO in corporate history.
I have a policy of never investing in anything trading on AMEX, even with the recent name change designed to give it more credibility. I remember back in the 80s when Amex was always the inferior exchange to NYSE, so much to the point that my newspaper would often neglect to even print the previous day's quotes.
Anavex is in a good place. Yes, there is still manipulation when hit pieces are published but it's nothing compared to what's happening to other stocks on less prestigious exchanges.
The 80-person target trial size should already take into account there will be some dropouts. More likely, Dr. Missling didn't want to tell some girls with Rett syndrome that they'd have to wait another year or longer for the FDA to review the trial data before she's eligible to take Blarcamesine.
My point is that it's ridiculous for some to assume that participant demand doesn't exist when the trial exceeded the target goal. Completion could have just as easily taken longer because Anavex is running three concurrent trials and has maybe 35 employees.
Hahaha. There’s an issue finding patients in a trial that exceeded enrollment expectations. Life is too short to get into debates with people who lack common sense or intellectual capacity. You’d have been better off trying to argue the trial will be a failure than claiming there is no demand to take part in it.
They’re not a secret to the FDA
Sorry Zig but your comments are more ridiculous with each post. You should have quit while you’re ahead. Enrollment exceeded expectations because the Rett community is tight-knit and word has spread about the excellent results to date. Anavex could have capped the trial at a smaller N but that would have been cruel to those kids who would then have to wait.
Ask yourself this… if Blarcamesine is a joke why would people be banging at the door to get into the trial, especially when ANVS appears to be on track for an FDA review soon?
But I think you already know the answer…
Sure, that's where the range comes in. But we have to remember that whoever acquires Anavex will want to make a substantial profit and won't be willing to pay the fair market value.
I read somewhere that Biogen's market cap increased $20B on positive Alzheimer's data. That's probably the upper range for Blarcamesine, unless it also gets approved for PDD and other diseases. This is why I'd prefer to see a partnership where Anavex retains certain rights and ownership. From what I've heard, A371 has the potential to be the real game-changer. I see Blarcamesine as more of a stepping stone that paves the way for something bigger within the company's S1R platform.
Yeah. Good catch. Thanks!
As Vin Diesel once said in the classic action film Fast and the Furious, “it doesn’t matter if you win by an inch or a mile. Winning is winning.”
So whether the data is just slightly better than Blarcamesine or a lot better is irrelevant. If it’s better, it gets approved and that’s what matters. The quality of the data only has to surpass the current threshold.
Re: voucher, I don’t think Anavex sees any money from it. Instead it’ll use the voucher to get a faster review for Alzheimer’s. And having the drug already available should make it easier to get approved because safety will not be a factor (not that there’s any indication it’s unsafe but it’s one more thing the FDA will consider for Rett).
Agreed. Rett is going to be the first points scored in the game. After that, we'll see what happens with the rest of the pipeline.
My point was more that an Alzheimer's approval should put the company in the range of a $10-$15B buyout offer. Data is irrelevant. If the drug is approved and works as well as Lecanemab or Aricept, it'll become the new standard of care. Whether it barely squeaks past them or the data far exceeds what those other drugs can do is irrelevant. Consumers will want to take the most convenient drug available, all else being equal.
Rett approval should make it easier/faster for Alzheimer's approval to happen if Dr. Missling decides to use the rare pediatric voucher to speed up the review process.
Thanks for the kind words. I try to call it like I see it, the good and the bad.
I get where Anshu is deriving his $1-$2 billion valuation from -- he's basically looking at this from a Rett-only perspective and I'd agree that's probably an accurate estimate for the rare disease. But I also believe that it's disingenuous to completely devalue the current results for Alzheimer's, Parkinson's and a bunch of other diseases Blarcamesine may be able to treat.
I'm not in the $1249 camp -- not yet, anyway -- because to get to those numbers probably requires trials showing preventative benefit. My guess is that an initial buyout offer would probably be in the $10B-$15B range (company is worth more but nobody pays full price in a buyout) and the number goes up as Anavex's cash flow increases. I'd like to see a partnership with up-front money to fund A371 development.
But to say that Anavex has already reached 80-90% of its buyout potential is just silly.
You could go short AVXL and buy some out of the money call options as a hedge. That's the simplest way, but there are others.
If you are in the profit zone and you choose not to sell despite having reservations about management, the blame is entirely on you and not Dr. Missling. You say "hope to reduce my position" as if there's some force preventing you from doing so right now other than your own greed.
If there is a buyout, it's going to be for a lot more than $2 billion and it'll probably be years away after Anavex has gotten FDA approval. I suspect you and the rest of your ilk will be long gone by the time that happens.
I hadn't noticed, but I have some guesses as to why...
1. We're in a holding pattern. Without news, there isn't much to discuss or post. We can pass the time by talking about the hypotheticals and what-ifs, discuss other companies' trial results, and speculate about when the FDA will review Blarcamesine but it's all for show without actual news or data.
2. The quality of this message board has devolved significantly from its early years, particularly before iHub when many of us posted on the old Yahoo finance chat. It's the same 8-10 posters here, day after day, either repeating the same banal criticisms or cheerleading from the sidelines with broken-clock predictions.
3. He's sold and moved on. I do not believe this to be the case -- I think Fireman and I are alike in that neither of us feel 6-12 months in early stage biotech is a significant amount of time to wait -- but one thing many here lack is patience to see this through. I get it...5-7 years is a long time for someone to hold an investment, but in biotech it can take 10-12 years or sometimes even longer to begin seeing revenue and share price appreciation based on cash flow rather than potential. Not everyone wants to wait that long, and lately the message board has become a place for people to voice their criticisms. Nothing wrong with venting, but I can understand why many of the more respected posters no longer bother to spend much time here.
Figure when all is said and done, we'll be at around 100 million shares outstanding. I'd guess maybe 20% of them will be held by insiders. I can live with that. If more shares are needed, there's an authorization allowing the company to issue another 100 million which could be useful to thwart a potential takeover, or to raise more cash to fund some of the trials lower in the pipeline (pain, cancer, etc).
Revenue is probably 24-36 months away. Assuming it takes between 8-12 years to get a drug to market, everything is on still on track for a successful Blarcamesine launch in 2024 for Rett, if the pediatric trial is a success.
The new hire has FDA experience. Dr. Missling is assembling a quality team of executives who understand how the FDA works. This is what we want to be seeing from our CEO.
Who cares if another P3 trial is necessary for Alzheimer's? Rett data is coming in soon and that is more than enough revenue to keep the company afloat without dilution until the next P3 trial finishes up. Of course, it's a massive assumption that Anavex will need another trial but the point remains that if that's the worst case scenario, who cares? The impatient can sell and move on. The patient can remain and hopefully profit.
I look at the new hire with 20+ years of FDA experience and ask myself, "Why is he working for Anavex in the twilight years of his career?" It's most likely for the money but it's not like this guy couldn't have gone to work for any other number of companies. Why did he choose Anavex? Most people with successful careers don't risk it all on some scam company just to earn a few extra bucks. Sure it happens from time to time, like Frank Thomas "The Big Hurt" endorsing questionable testosterone pills, but to convince several FDA scientists to jump ship? That's not easy to do unless they believe in the product's potential. Most likely all three were attracted to the potential value of the employee stock options.
Little things like this make me feel better about this investment. It's not entirely de-risked, but I've noticed that even the bears aren't questioning the science nearly as much as their questioning Dr. Missling's character. I can wait another 10 years if I need to, easy.
Probably December 2023, + or - a few months.
You guys should all know by now who the pumpers are. They sell into the pump while encouraging others to buy. Been doing it since 2015.
The point is to calm any investor concern that they buy stock today and tomorrow he dilutes the pot. Dr. Missling is telling a group of financial experts that his company is financially stable. It's not bragging, it's material information that investors need to make informed decisions. Anavex has enough cash to last several years, it can easily afford to run another Alzheimer's trial, and it doesn't need to worry about taking on debt in these high-interest times we're living in.
If nothing else, Dr. Missling was smart to raise cash back when it was cheap to do so.
Because releasing the data won't have any effect on public opinion. Even the guy who wrote the Seeking Alpha article said the same -- only a peer-reviewed study of the trial design will be sufficient to quell any doubt about the integrity of the data. At this point it doesn't matter what Dr. Missling says or does -- many will believe him no matter what, some will try to discredit him and some like myself will just hold their shares and ride wave after wave until we either drown or reach dry land.
If the general public sentiment and market reaction will be tepid no matter how good the data may be, what's the benefit for releasing it now if he doesn't legally have to? The downside is that he subjects the company to more deceptive tweets from message board hacks. The upside is what exactly?
At this point Dr. Missling knows what he has and will wait for a journal to validate his claims. In the meantime, expect his focus to shift back to Rett and PDD. As it should...
Leverage.
Sounds good to me. I have no problem waiting even 15+ years. My grandkids will enjoy the benefits of my foresight to invest early.
Look at any biotech with a market cap over $30 billion. They all have the same 7-15 year runway where the stock is basically flat under $15 and then spikes exponentially once their first blockbuster hits market. I suspect the same will be the case for Anavex if Blarcamesine is approved, but it'll be closer to 12-36 months from now.
The $3 Jan 2025 calls look awfully tempting right now.
I don't think Dr. Missling wants the voucher so he can sell it to raise funds. I think it's more valuable as a tool that gives Anavex a competitive advantage when it comes to FDA access.
I agree that if Anavex wants to run A371 and other trials that look at Blarcamesine as a preventative drug, it'll require a lot more money. The strategy in place is to get Blarcamesine to market as quickly as possible for something (i.e. Rett or PDD), let Alzheimer's play out with a partnership, and use cash flow to fund future trials. I believe the days of massive dilution and toxic financing are more or less over. We may see an occasional small offering to take advantage of irrational markets but Dr. Missling appears confident that cash flow should not be a problem soon.
The only unchecked box that gives me a bit of pause is the lack of insider buying. I can explain away all the other actions but this is the one sticking point for me that reminds me the stock has been de-risked, but until the FDA grants approval anything can happen.
Companies like Anavex grow slowly, then suddenly.
It is exactly where it should be and needs to be at this point in time.
$100 million cash runway. No debt. Promising pipeline with potential for getting to market within the next 12 months for Rett syndrome. Credible scientific advisory board. Lots of money ready to be spent on biotech M&A.
I disagree. I think we'll see several PRs because peer review is months away, if not longer.
The purpose of these PRs will be as they've always been -- a means to communicate progress or setbacks, particularly with Rett, PDD, and A371. Blarcamesine for Alzheimer's is now in a holding pattern, waiting for landing.
Lakeshoreleo, you were an air traffic controller -- did you ever experience setbacks out of your control that required delaying or re-routing flight landings? It happens. I'd rather be stuck in a holding pattern than have a mistake that crashes the stock because our CEO is trying to appease a few impatient traders.
Most everyone here is sitting on a profit or had the opportunity to average down to break-even. That's what makes all the complaining all the more amusing. Dr. Missling is on the FDA's timeline, not ours.
But let's assume that he has the 50mg cohort data in hand. Why should he release it in a PR? It's not like it's going to change anyone's mind. Even if it's fantastic, some critics will find something to argue. There'll be talk of goal posts being moved, the integrity of the data, all sorts of reasons why we shouldn't trust the data and another trial is needed. And the WGT this crowd will continue to pump "GREAT NEWS TOMORROW!" and make $1000 proclamations.
How is that any different than where we are right now? Dr. Missling provided the material information that P2B/3 met all endpoints. It's up to the individual to decide whether to believe him and invest accordingly.
On the other hand, if a peer-reviewed journal that is widely respected in the medical community publishes an article that says Blarcamesine is effective and the recent trial results are valid, the debate ends immediately.
Best advice: appreciate the holding pattern and find another interesting company to follow until there's an AVXL update. There will always be some who complain that they're stuck in a holding pattern instead of being amazed they're in a chair 30,000 feet in the sky. As Louis CK put it, "everything is incredible and nobody's happy."
My point was more that anyone who expected new data today was setting himself up for disappointment. Dr. Missling isn’t going to go into complex and novel scientific data to an audience that primarily cares about future cash flow, just as he’s not going to CTAD to talk about profit potential. Know your audience.
Anyone who is disappointed by today is free to sell shares to those who have the ability to be patient. All attention now should be turned to Rett, because that is the next data milestone to be announced.
I feel for anyone who bought in or planned to exit today for big profits. Lots of hype, but fortunately it doesn’t require a PhD to read the room. I suspect that Dr. Missling may have a surprise or two today, it just won’t be the big data reveal many hoped for, and that’s okay. Life goes on and Anavex may end up with a few more big institutional investors joining the party if they feel the investment has been de-risked over the last 3 months
How else does one sell their shares for profit pumping into the hype?
Tried telling you all that there wouldn’t be data today. The audience at JPM conference are people like me, those who can read a balance sheet but don’t know what the endoplasmic reticulum does. It’s not a science conference, so any new data would go over most of the attendees heads.
He’s going to use the existing data to hammer home the point that Anavex is getting closer and closer to becoming cash flow positive, which is the language these investor clients of JP Morgan speak. There is value in that, too, even if many here are disappointed that there’s no new data.
I hope that nobody bought in expecting GREAT NEWS today. Writing was on wall and by now everyone should realize that there are some pumpers who try to generate excitement to sell their shares, just as there are bashers who create fear to short the stock.
2H 2023 is when we see the next big announcement — pediatric Rett data, and that will be how Blarcamesine gets to market. Anavex is for now a Rett stock with a promising Alzheimer’s pipeline. There’s nothing wrong with that.
Buy the rumor and sell the news. Right now the rumor is that Anavex will release new data confirming the success of the 50mg cohort.
I'm not going to bet against it but I would be very surprised if there's a morning PR with new data. My guess is that we'll see something published in a journal with the full results but it may take a few months before that happens. In the meantime, Anavex will focus on completing the Rett trial and preparing an NDA submission for that disease.
You cannot be "absolutely certain" unless you're the CEO or similarly ranked C-level exec at Roche.
What you can be is confident, or hopeful, or optimistic based on recent comments that Roche is looking to expand its neurological pipeline. But for all we know maybe Roche wants to buy SAVA or another company that fits the bill.
My guess is that Dr. Missling has had conversations with most if not all of the big players at some point, if the report that he's meeting with investment banks is to be believed. But it's misleading to act like there is definitive interest when nothing has been publicly stated by anyone at Anavex or Roche.
Just trying to keep everything honest here.
Using your analogy, the fired coach recruited all the talent that took TCU to the championship game.
This message board used to be worthwhile but the quality has diminished as the most rational and intelligent posters migrated to other forums. There is a lot of cult-like group think, namely that SAVA or any other company cannot compare in any way. I believe 2023-2025 will see at least 3 drugs approved to treat Alzheimer’s, maybe more. There’s plenty of room for lots of Alzheimer’s treatments and let physicians decide which is best for their patients.
I don't think there will be much new info presented at this conference. It's an unpopular opinion but so was my post saying that CTAD wasn't going to send the stock price to $20+. I hope I am wrong.
I do agree that approval today bodes well for Blarcamesine but not via accelerated approval. Biogen has some clout and it won't want another drug competing right away.