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I always enjoy reading your posts because I never know what I am going to get. Sometimes you're bullish, sometimes you're bearish, on both the market and Anavex itself, which is funny because Dr. Missling has been remarkably consistent over the past decade. I'll never understand the trader's flippant mentality, but I do admit it can lead to some nice profits if your intuition is correct.
But 2023 United States is nothing like 1920s Germany. For as much printing money and taking on debt as our politicians like to do because it allows them to pour money into unnecessary projects they can tout during re-election season, America's debt is moot assuming the GDP can grow at an equal or greater rate. It's the equivalent of increasing a credit limit after receiving a job promotion. Debt to income is what matters to the individual; debt to GDP is what matters to national economies.
Fortunately for Anavex investors, we are somewhat insulated from global macroeconomics assuming Blarcamesine is the real deal. The inflation rate could reach Weimar levels and there will still be demand. You don't think there are 6 million wealthy people in the world each willing to pay $10k for Blarcamesine if it works better than having to take a jab with one of the -mab drugs? Do the math on the share price assuming a 20% net income and a conservative 13x P/E. If Blarcamesine works -- and that's the only qualifier for now -- the drug will sell itself no matter the economy. Tesla may have an issue though...
As long as Dr. Missling prices his drug less than the competition, insurance companies will have no incentive not to make Blarcamesine the new standard of care. Without insurance coverage, Blarcamesine will be a drug for the wealthy -- a base that, under your scenario, should increase exponentially. We all know who ends up benefitting the most after any natural disaster or recession. So even if there is a recession, I fail to see how this significantly impacts Anavex over the long term. Key words: long term. Those words aren't appealing to some, but it's the key to making fortunes that triumph over what any trader or short-seller can amass in a lifetime.
My current favorite stock right now is Achieve Life Sciences. Anavex is a close second. From a pure risk/reward perspective, Anavex offers more upside. But Achieve has an almost slam-dunk case for FDA approval, and it owns the exclusive rights to a soon-to-be blockbuster drug on par with Blarcamesine in terms of global reach and demand. It's also got a market cap of $110mm. Only problem is that the company won't be able to charge $5000+ for treatment, so revenues are severely capped. Still, it's most likely going to be a 5-10x return in the next 12 months. Super transparent CEO. And if I am lucky, Anavex stock will still be trading low enough that it makes sense to roll some Achieve profits into AVXL.
I remember the days before internet stock message boards existed. Or maybe they existed but they certainly weren't accessible to mainstream retail investors with limited tech skills. Back then, investors went long on a stock and periodically evaluated it on their own. Due diligence was proprietary because it was your own, unless you subscribed to a newsletter or something. Investors did not let people named "50 Percent Haircut" or "Bonerman94" influence their investing decisions. A timeframe of 5-10 years wasn't considered insanely crazy to hold a growth stock.
Sometimes when you have conviction about something, the best thing to do is step away and invest like it's 1992. I have yet to hear a convincing argument for why I should sell my shares. Maybe I'm alone on this island but I don't mind the leisurely pace or the mistakes. Mistakes mean decisions are being made, and the slow pace gives me more time to accumulate shares, sell calls, whatever. I've got other investments to look at besides this one, lots of other ways to occupy my time so I don't really think about Anavex for more than maybe the 10-15 minutes I'm on this board every few days.
I expect the stock price to double or even triple upon Rett approval. From that point, Alzheimer's could add another few billion to the market cap with an even greater ceiling 3-5 years from now when there's enough long-term efficacy and safety evidence to deem it a winner against the competition, and perhaps A371 is available to treat other diseases.
That would be nice but I think it's likely going to take longer based on Dr. Missling's track record. I am guessing the Rett Excellence readout happens in mid-December. Investors will be selling shares of all sorts of companies for tax loss season and the market will be flush with cash on the sidelines. Maybe some of that money flows into Anavex with a well-timed PR or peer-review journal.
Getting approved for Rett will pave the way for Alzheimer's, but we'll probably need another 12-18 months before we see any movement there.
We'll see. I don't think it sounds silly. I'm not going to think my investment is screwed just because Anavex doesn't present at CTAD. The next milestone that matters to me is peer review, because that takes away the biggest criticism that the trial design isn't acceptable.
Arbitrary deadlines set by message board hustles don't interest me much.
No Kool-Aid for me. I still leave open the possibility that the short thesis could be correct. I don't think it's likely, but I'm not in the WGT camp either.
My sentiment skewed bullish last December when we reported the top-line data. At that point my investment thesis boiled down to one simple question: is Dr. Missling truthful?
And all the evidence I've seen to date indicates that Anavex is marching slowly toward its goals. If investors want to be fed up with the glacial speed of progress that's on them. In all the investments that have returned the most money, they also took the longest time. It's all relative, anyway. The person who bought an initial position today may think this is the fastest moving stock ever if/when things take off toward the end of the year. I've been here for 8 years, but I figured it would take about 10 and that was before the pandemic shut everything down.
I am relieved the odds have shifted to the point where my only decision is deciding whether I believe in Dr. Missling's character and integrity. The scientific posters confuse me. If Dr. Missling says the full results will be available by the end of the year, I'll wait to hear what he says because I believe him. If I didn't, I'd probably be eagerly shorting the company too. I'm sure there will be some people who find ways to attack the science, the trial design, etc which is why I am waiting for a trusted peer-review before I'll enter the WGT camp. In the meantime, I trust that Dr. Missling has been in communication with the FDA and is pursuing the best path toward approval. Time will tell if my bet is correct.
You are a trader. You have a trader's mentality. I don't suspect you'd understand how or why someone like me doesn't view 9 months as a long period of time for certain investments. If I send my kid to to the corner bodega to buy a couple of grocery items and I give him a $100 and 9 months later he brings me the change, sure, I'll acknowledge that's a long time to wait. But it takes 10+ years to bring a drug to market. By this standard, we're still on track.
As a former air traffic controller, I'd expect you of all people to understand that delays happen but a delayed flight doesn't mean the plane is going to crash or the pilots are incompetent.
Your timeline and expectations clearly do not align with mine. That's okay. If we all agreed on the same thing it would be impossible to ever make a functioning market.
I guess to me, six months isn't a long time. Neither is two more years, if that's what it takes. If five years from now this turns out to have been a waste of time, so be it. Most of us are playing with house money at this point. I'll judge Dr. Missling according to averages. It takes about 10 years to bring a drug to market so that gives him until around the end of 2013, but he gets an extra year or two because of the pandemic and the FDA devoting all its resources toward the vaccine.
If you think February is a long time to wait, I feel bad for you. The secret of life is enjoying the passage of time, but your life seems rushed.
I don't believe we'll be presenting at CTAD in October. And that's not a bad thing. Dr. Missling isn't going to turn into a pumpkin this October, so why use CTAD as some arbitrary date where if we don't get more updates, it's time to panic?
I'll use the timeline provided by Dr. Missling himself. He said expect results by the end of 2023. I'll give an extra 45 days grace period because of the holidays and all that, plus the time it can take to have attorneys review press releases, etc. So by mid-February, or 5-6 more months. If by then there's still radio silence for Rett or Alzheimer's I'll begin to have some questions to ask at the next shareholder meeting.
What I do believe is that Dr. Missling is holding out for a journal publication. That's when he will publicly reveal the data everyone wants. No matter what he says before JAMA or some other entity peer-reviews the Alzheimer's trial, there will be those who call him a liar and use any opportunity to write more hit pieces attacking his character and credibility, the trial design and the efficacy results. When Dr. Missling said he wants to take the market by surprise, I think that was a targeted comment aimed directly at those who have been betting against him.
For what it's worth, I also do not expect a big-time partnership announcement. I think if anything we'll see an agreement that gives away just a fraction of the profits for a short duration and is limited in scope, such as handling manufacturing or distribution. My gut feeling tells me that Dr. Missling isn't looking to retire the day after the FDA makes a decision. He wants to build this company into something big if the trials continue to show potential for multiple CNS diseases. My feeling is that we'll end up partnering with a smaller company, or perhaps even someone like Dr. Reddy's.
So if we end up presenting at CTAD next month, awesome. But if not, whatever. Let the stock price do what it'll do. Dr. Missling said the end of 2023 so I'll give him until early 2024. Until then, there's not really much else that needs to be said absent more news on the Rett front.
This is the type of objective research I'd like to see more of on this board. Much better than trying to attack Dr. Missling's credibility. Questioning the science is a good thing because there is always the possibility that messing around with receptors may have harmful side effects. More research is clearly needed.
That said, people have been taking Blarcamesine in clinical trials for 7+ years now. We would know if Blarcamesine caused cancer or at least if a large enough sample size developed cancer where its safety could be questioned. To my knowledge, the side effects for Blarcamesine have been minimal and trial participants are subject to periodic health screenings.
Everything these days may cause cancer, from the cell phones we place next to our brains to the chemicals in our water supply to the rays of sunshine that seep through the ozone layer. I read a study that found 99% of us have plastic by-products in our blood.
At the age when most people develop Alzheimer's or Parkinson's, a slow-spreading cancer is probably a better alternative to slow-developing dementia. I think most people if given a choice would prefer to be able to spend their final years being able to interact and socialize with others. The current standard of care for some cancers for some people above the age of 75 is just to let it kill you (i.e. prostate cancer).
I'm not too concerned but I do think S1-related cancer is something to continue to investigate. It could also be that over-activation of the receptor causes cancer, but for those who already have malfunctioning S1 receptors, Blarcamesine restores things to normal. It's the difference between turning on a light switch (no damage) or repeatedly switching the light on and off hundreds of times per minute.
For now, I'll rely on the fact that cancer has not been a concern to the Anavex researchers or we'd have heard about it by now and the trials would have most likely been suspended until further review.
A burger place opened up two weeks ago down the street from me, one of these new gourmet chains everyone seems to love. There was giant signage that said "Coming Soon."
Two months ago the sign disappeared. Twice a day I'd drive by and see people inside so the other night I pulled into the drive through. It took me about 5 minutes before I realized they were construction workers and contractors.
Why did the signage go away? Who knows. It wasn't replaced with any new information about the grand opening. The few people I asked didn't know anything, either. Maybe a storm blew it away. Maybe it was placed on a city-owned easement. I have no idea. But the removal of the signage and lack of the communication from corporate didn't mean the restaurant wasn't still on track for its grand opening. The drive through line is pretty much packed 24/7 right now.
The same holds true for Anavex. If the best evidence for failure that you have is that an incomplete PR was removed from the website, it seems like a lot of risk for shorts to take when the max gain is only $9/share and there are so many other companies out there with worse balance sheets and zero potential trading at insanely high premiums (see: most AI, EV, crypto and semiconductor-adjacent stocks).
I still haven't tried one of their burgers. I don't eat much red meat these days. But when I do, I'll let you know if it's worth the hype. Perhaps @MauiSmart can try one for lunch if it is.
I believe there is a coordinated effort, at times, to bring down the share price. The timing of the price drops and hit pieces over the years is beyond circumstantial. And I wouldn't be surprised to see a few more attorneys pop out of the woodwork, though I'd bet most by now realize there's no meat on the AVXL bones when it comes to fraudulent litigation, aka legal extortion. Every now and then one of these investigations may yield something illicit but the success rate is not very high. I'd research it as it's all public info but who has time for that...
I do not believe there are members of the "cabal" posting on these Internet forums. Back in the day when that Cramer video came out about the manipulation tactics, internet stock trading was pretty new and it was the Wild West back then. Times have changed, tactics have changed, but motives have not. Those who post one-sided data or misinformation here are lone wolves, simple retails looking to pick up the crumbs. They make money some days, they lose money same days. Over the last 10 years, anyone who's held a long-term short position is down big. How come nobody likes to ever mention that?
I know an enforcement attorney for the SEC. If anyone has firm evidence of anything illegal, send it to me and I'll pass it along. The problem is the "cabal" most likely isn't doing anything illegal. Feuerstein can write whatever he wants, and institutions are free to sell when they want to sell as long as they don't have material information not yet made public. Proving they're coordinating requires more than just seeing the price drop big. Find a smoking gun email and Feuerstein goes to jail. But that won't happen and it's why he keeps doing what he's doing. It's legal but immoral just like many other things in life.
Minimal in the long-term. Pull out a 10 year chart because that's about how long he's been criticizing Anavex and it will show everyone just how much influence he has on the stock price.
Nobody likes seeing paper profits disappear but they'll return quickly. Feuerstein can only cry wolf so many times before the FDA decides it's okay if he gets eaten alive.
I don't disagree about that part. But I think even if he weren't being paid at this point, if he had his own personal blog, he would continue to write disparaging things about Anavex because now it's a source of pride for him. It's not about him being paid. It's about him not wanting to be wrong. He'll continue to double down until the FDA shuts him down, and then he will disappear.
Like I said, until he's willing to match the opposite side of the bet Dr. Missling recently took, I don't worry too much about what Adam thinks.
I disagree. I believe that some people sometimes find themselves married to a stock. It can lead to irrational decisions. I also think that sometimes, people can hate something or the idea of something so much that it prevents them from seeing clearly, too.
Adam writes as if thinks he's the smartest guy in the room. I think he gets off on the power trip, and takes delight that he doesn't even have a science background yet he's the self-proclaimed "most feared person in biotech", whatever that means?
For Adam, it's now personal. He truly wants to see Anavex fail and his recent posts look more like someone thrashing out in desperation. You know how a roach flips on its back and kicks around after it's sprayed with pesticide? Same thing here. It's a death gasp because he knows time is running out to sling mud at a company he's grown to despise.
And why does he despise Anavex so much? Because he went so hard against it years ago when the odds were on his side, and he has too much pride to admit now that he was wrong. That would mean having to admit he's not the smartest person (or the most powerful) in the room.
Adam Feuerstein is the perfect example of what I wrote about yesterday. His conviction just feels different than Dr. Missling's. As it should, because Dr. Missling has way more information, power and influence than this paid blogger. Dr. Missling knows what he holds. And that scares people like Adam. He just won't admit it.
If the FDA was okay with the changes, what's the issue?
There is a paywall. I'll admit that I am relieved because I'd have probably read his article and immediately wished I hadn't wasted my time. I've read some of his past work and it's all opinionated drivel. He's right every once in a while but I think he's going to be proven wrong with Anavex.
And ultimately, nothing will come from it. He's not going to admit that he's wrong. He'll just disappear. Of course, if it turns out Blarcamesine is a dud we'll hear nothing short of gloating from the rooftops, but that's the M.O. of insecure people -- they lack the fortitude to admit they were wrong. I can find lots of instances of all of his incorrect forecasts with a quick Google search, but no public mea culpas. What does that tell you?
As someone else posted here, he has a right to his (often incorrect) opinions and people have a right to trade based on his opinions. If they choose to do so at a coordinated time, it's no different than some Reddit groups trying to take down Melvin Capital through organized gamma squeezes. If it's legal it's fair game. Definitely not a game I am interested in playing because it's way too risky. It's easy for Adam to attack companies like Anavex because he gets paid by Stat News to write these articles. He doesn't have any personal exposure to Anavex. If he's right, he gets to gloat how smart he is. If he's wrong, he still makes money. The only cost is a hit to his already damaged reputation.
People like Adam Feuerstein create buying opportunities for people like me. His articles are like a fire ant bite. They're a bit uncomfortable for a few days or week but they don't do any lasting damage. He's been going at it since 2015, right? The stock was trading under a dollar back then. I say based on that alone, let him continue to attack the company for another 10+ years.
Dr. Missling could have cashed out 7 figures worth of options, but chose to take equity instead. Until Adam Feuerstein is willing to bet the same amount against Anavex, he'll remain irrelevant to me no matter his influence on the short-term stock price.
For what it's worth, that new diet drug just added $60 billion to Novo's MC when the data showed it could also prevent cardiovascular disease.
If heart health is worth $60 billion what is brain health worth?
Some thoughts on today's conference call.
1. This is by far the most confident Dr. Missling has ever been in a public meeting. I can't understand a single thing MayoMobile writes about the science, but I can spot a con artist a mile away. In my former career, I dealt with scumbags and fraudsters all the time. They're easy to spot if you know how because they all hide behind a veneer of confidence. Deep down they know there's a chance they'll be exposed and that creates a different sort of confidence than what I heard from Dr. Missling today. He spoke with conviction and authority.
2. I don't think Dr. Missling ever forgot about or forgave the likes of Feuerstein, Fonteneau, Michaud, etc. They made his job far more stressful and difficult than it should have been, and I have a feeling his "take the market by surprise" could result in some max pain if he ends up on the winning side of the bet. The guy's got an MBA from Northwestern. He knows all the ways to maximize shareholder value at the expense of shorts. I'd much rather have someone like that than an MD who has zero years of professional financial experience or education.
3. We have 4 years of runway. That's insanely good cash management. While we don't know the terms of these partnerships, we do know that there isn't a significant cash outflow so he's striking financially prudent deals. My guess is there's no shortage of companies wanting to partner with Anavex, which leads me to the next comment...
4. Dr. Missling verbatim told us that he has received offers. These are easily verifiable claims if an investigation were to ever be launched. I have no reason not to believe him. There's been more M&A spending in 2023 than in previous years and there's still lots of money on the sidelines. This is the best possible time to have a marketable drug candidate.
5. Dr. Missling's suggestion that the extended trial could substitute for a P4 confirmatory was interesting, but it's not something that affects the calculus of my investment thesis. If it happens, great! But I've always believed we'll need another Alzheimer's trial and in the meantime, Rett will provide enough short-term revenue to prevent further dilution. The confirmatory trial is more or less pointless because everyone will know within a few months if Blarcamesine works once it becomes available, and there will be a direct comparison against those taking the -Mab treatments. Let the better drug win. If it takes another two years to get to market for Alzheimer's, that's just two more years of building demand for the product launch.
Sometimes in a poker game there's a point where it's no longer necessary to be secretive. I was pleased to see Dr. Missling finally reveal his hand when he spoke of offers received, releasing data within the next 4 months, and that he's firmly aware of current market forces and expects to counter them at the time of his choosing.
Also, thanks to all who sent private messages after I announced I'd be leaving this board. This site will not allow me to reply without paying a monthly fee. It's been a nice break from thinking about Anavex in general because at this point I feel like my money is parked and there's nothing anyone can say or do to influence the outcome. If I win I win big. If I lose I lose relatively small. That's how I look at it.
When this all finally plays out, there will be longs who made money and longs who lost money. Same with the shorts. But the musical chairs game is about to come to a screeching halt and I'm pretty confident I'll be able to find a place to sit when it does.
Good luck!
How is it going? They announced the partnership 3 weeks ago. Congratulations on penning the single dumbest post I've read in the years I've been participating in this forum.
Man, the quality of this board has really disintegrated. As such, this will be my final post. I'll be migrating over to the Facebook group, as much as I hate to use that platform.
The share price wouldn't have dropped too much had Dr. Missling sold his shares. Maybe .50-.75 or so, and most likely those shares would have been absorbed quickly and the stock price would rebound back to around current levels.
Anavex is trading exactly where it should. It's a pre-revenue biotech with an exciting drug that may re-activate the Sigma-1 receptor. If there is indeed medicinal benefit from targeting Sigma-1, Anavex will be sitting pretty as the industry leader with a whole bunch of valuable patents. But until the FDA decides whether Sigma-1 is the future, the company shouldn't be worth more than a few hundred million dollars which is right around $5-$8/share.
Put another way: the recent Powerball $1B jackpot paid out around $300mm after taxes. If someone gave me the choice of the single winning ticket or 100% of the shares of Anavex, I'm taking the guaranteed $300mm every time. It's a lot of money and most P3 companies ultimately aren't worth hundreds of millions because their drugs fail. Fingers crossed Blarcamesine keeps on truckin'.
Risk free is not exactly accurate. Dr. Missling didn't pay any cash out of pocket for those shares, but choosing to keep them rather than immediately selling them creates de facto exposure. If AVXL goes to 0 and he could have pocketed the cash, he loses nearly $1.8mm (correct the math if I am mistaken).
Granted, he's in the green until the stock falls under the $1.60 price he paid for each share but to say that he's without risk is to ignore that he could have sold and pocketed the cash but chose not to.
And deep down I think the fact Dr Missling decided to keep those 232k "free" shares scares a lot of people who have significant unhedged short positions. Actions speak louder than words and at the end of the day $1.8mm cash in hand is a lot of money to defer to the future.
I think that's correct. The voucher is a valuable asset and one that Dr. Missling isn't going to (or at least shouldn't) throw away because Alzheimer's data happens to be ready a few months before Rett data. There's plenty of new information to glean from Alzheimer's to better inform future trials. There are probably more patent applications being reviewed. And a free $100 million adds an extra 15% to the market cap almost immediately.
Let the complainers complain. Dr. Missling buying more shares was all I needed to see.
November is your "needs to" date, and it's an arbitrary one at that.
It's not like Dr. Missling will turn into a pumpkin if there isn't an NDA filed before the holidays.
In all likelihood it'll be mid-2024 when something is filed. He's taking his time, gathering data, increasing patent protection, and focusing his limited attention on multiple trials. The NDA is just a small part of a much bigger picture. It will happen, but I'd be shocked if it happens in 2023.
Withholding the release of data means that the data must be terrible. The longer the data is withheld, the worse the data must be. I think that's the assumption that needs to be challenged so let's challenge it.
1. Suppose Dr. Missling released the data six months ago. Would it have made a difference? His critics aren't going to change. His integrity will still be attacked, and he can't defend himself. So why not wait until there's a third party to be the arbiter. Whether that's a scientific journal or the FDA itself, it's going to happen eventually.
2. Continuing that same line of thinking, if you only get one shot to release the "good news" PR and doing so without third party verification won't move the public opinion needle at all, why waste the shot on goal when waiting for the FDA or a science journal to validate Blarcamesine is a better long-term value creation strategy?
3. Perhaps the data simply isn't ready. 9 months seems like a long time but maybe Anavex is running a lot of tests. Technology is improving and precision medicine is still evolving. If the goal is to try and expedite approval based on current data, spending the time now to go over everything in as much detail is a worthwhile use of time if it increases the odds of approval + P4 vs a second P3 trial.
4. The cynical view could be that Anavex is focusing on Rett because it's the path of least resistance, most need and the $100mm priority review voucher is nothing to laugh at. Anavex is still a small company so if its attention is on Rett for the time being, Alzheimer's may not be as much of a priority now that the top-line data has been released for P2/3. Especially if another trial will be required.
I just fail to see the automatic connection that no news = bad news. Usually it's the other way around. Had Anavex realized a material misrepresentation occurred we'd have seen a filing with the SEC. It's highly unlikely that Dr. Missling is openly committing fraud -- even Bernie Madoff filed with the SEC when required to do so.
It's also unlikely that Dr. Missling chooses not to pocket nearly $2mm in cash, instead reinvesting that compensation into more Anavex shares, if he knew the data were horrible and the company was destined to crash and burn. That doesn't seem like a wise use of his options proceeds.
We already have the important data. Sure, everyone wants to see the granular stuff and that will be reported to the FDA, but Dr. Missling doesn't have to provide any more information. If someone chooses to sell their shares or not invest because of it, nobody's going to stop them and I doubt Dr. Missling cares either way. He has a long-term strategy he's executing and all obvious signs point to Blarcamesine working at least as well as the current available treatments, but safer.
It's like taking a test and seeing the grade posted on the wall. You didn't always get to see the actual exam and the specific questions you missed. And honestly, didn't everyone hate the kid who demanded to see the actual test questions? Those kids' whining and complaining was always so annoying, and we see here today that some things never change.
It takes about 10 years on average to bring a drug to market and the pandemic created a delay, so you can keep on sucking until 2025.
Waiting is only difficult when you've become attached to a stock. Rule #3: never become attached.
There are lots of ways to pass the time without feeling frustrated. For most people who aren't traders, a buy and forget mentality is probably healthier than checking every post every day of the week and scrutinizing all sorts of theories that may not even be correct. I'd suggest checking in once or twice a month and setting Google alerts or a price alert with your brokerage in case big news breaks.
All is well with Anavex, as far as we know, for now.
Huh? It’s a science conference not an investors conference. The vast majority of attendees are in the healthcare industry. There could be a dozen explanations as to why Anavex isn’t presenting but none of them have to do with being disinterested in further investment in the company
Sure there's a source. Look at every PR where's he's mentioned the word commercialization. And yeah, it sucks for some people who are suffering from dementia that they're probably too far past being helped. That's the raw deal of being born anywhere from 1930-1970. At least there's possibly hope on the horizon for future generations.
It was also unfortunate that people had to traverse the Oregon Trail with oxen while they were waiting for the railroads to be built. That's life.
So mock progress all you want. Without it, you wouldn't be typing on a computer and posting to a message board internet, you'd be writing a note with a pencil and throwing into a bottle in the ocean.
Dr. Missling has a finite amount of time and money. He's also in an impossible situation because if he spends time getting other trials started it'll slow down Rett and Alzheimer's and he'll be criticized for not getting those across the finish line ASAP.
Dr. Missling's attention appears to be shifting away from the science and more toward business strategy. He's heard shareholder demands for revenue immediately, recognized Rett is the best path forward (and we get a priority review voucher!), but that means a few other trials have to wait a bit longer in the queue.
It's really a first world problem if you think about it. Sigma-1 activation could play a role in so many different brain functions that we don't have the time or money to test them all simultaneously. Some indications will have to wait their turn. No big deal, as long as there's progress being made with Rett and Alzheimer's it's all good.
Correct. I am hardly part of the WGT crowd, although the evidence is looking better by the day. But if I were part of the WGT crowd, I'd be looking at not just multiple indications but also the potential for prophylactic use for all of those various diseases.
This is where I believe precision medicine + AI will help to cut down the time and cost it would ordinarily require to run such a prohibitive prophylactic trial. It just requires the FDA getting on board with data analytics and it appears that may finally be happening with the FDA/Ariana partnership.
For the sake of argument and mostly out of boredom, here is a fun parlor game with back of the napkin math:
Penetrate 2% of the global population and charge $1/day for Blarcamesine. That's around 150 million people x $1 x 365 days. $54 billion/year gross revenue.
Assuming 20% of that gross is profit, that's about $10 billion net earnings. At 100mm shares outstanding, EPS is around $100. Figure a conservative P/E of just under 12.5 and what do you know -- $1249.
Sounds like Axovant. Some of the old-timers here will remember AXON, which at the time had launched the largest biotech IPO and whose 30 year old wunderkind CEO was the pride of several hedge funds. Back then, some posters on the Yahoo message board wished that he was Anavex's CEO because he got things done, quickly.
His name was Vivek Ramaswamy, a former hedge fund manager. He's no longer in the Alzheimer's game. He's campaigning for president with Axovant shareholders' money.
I'll bet those shareholders wish that they had Dr. Missling instead. Maybe it's better to have a CEO with a science background who can see things like Sigma-1 activation potential, than some hedge fund hotshot who only saw short-term dollar signs for himself and his buddies?
Too many here on this board only see short-term dollar signs. They want speedy results even if it means not securing as many patents for long-term value, or peer-review to bulletproof the data from another short attack. If it takes another 3 years for this investment to materialize, so be it. Three years will be here in an instant anyway. This article was from 2015 and I remember those days like it was yesterday.
https://www.fiercebiotech.com/biotech/why-axovant-s-315m-ipo-bonanza-should-scare-hell-out-of-you
I've always believed that Blarcamesine's run time won't be as long as Aricept's because the rate at which drug development is speeding up. Years of Alzheimer's research is now manifesting in all sorts of potential treatments that show early-stage efficacy. The integration of precision medicine and AI will only make drug trial development easier, cheaper and faster. This is a good thing. A drug should not remain at the top of the mountain if there are better alternatives.
It's possible that beta amyloid is the correct path to pursue, but science hasn't yet figured it out. It's also possible and given the 99.6% failure rate more probable that there's more to Alzheimer's than removing plaque and unfolding proteins. This is why I invested in Anavex. It's attempting a new path and if successful will have first-mover advantage when it comes to Sigma-1 patents.
I also think this is part of the reason for not releasing data yet. Dr. Missling is building a fortress around Sigma-1 research and I wouldn't be surprised if we hear about another patent approval soon (alongside peer-review). Of course I cannot prove my theory, but neither can those who claim the data release delay is due to specious data and corporate fraud.
And for the record, there's no delay. Dr. Missling never told us that more data will be available in H1'23. That was just the assumption a few message board posters assumed to be true. He's missed deadlines in the past before, but not this time. For all we know the only data we'll receive before an NDA is filed is what was released at CTAD, and that's perfectly fine with me. The top-line data was good enough to move forward with either approval or a P3 trial. That's called progress.
You keep saying that but you fail to provide any supporting arguments. Do you see the problem here?
The only argument remaining at this point is that he hasn't provided shareholders with every morsel of data. And somehow that means we must automatically assume that he's hiding something, that he lacks integrity, or that he's openly committing securities fraud?
Sorry, but I need more than that because I think he's doing an okay job all things considered. We already know Rett has solid data for adults and all indications are it will work well for children, too. We've also got solid overall topline Alzheimer's data, zero debt and about $100 million in the bank with minimal dilution.
You want to talk about Dr. Misssling's behavior? He could have pocketed over $1.5 million in cash last week but he chose to re-invest that money in the company. That seems pretty bullish to me.
I remember people here saying that Ariana is a scam, the partnership was a money grab that was like lipstick on a pig for AVXL, etc.
It seems to me that Anavex will have no trouble now convincing the FDA at the very least that its biomarker data is accurate and valid, and that Ariana knows what it's doing.
Just one more small step in a long journey but this sort of validation is not insignificant.
Correct. Many of the very people who demand answers now are the ones who plan to dump their shares the moment there's an NDA or approval, and Dr. Missling isn't interested in appeasing these shareholders when releasing the data now can only hurt the long-term value of the stock.
Release the data when there's a peer-review or when there's FDA approval. That way the data is shielded from criticism.
2026. That's when I will begin to question Dr. Missling's progress.
I figure he took over in late 2013 and needed about 18 months to patch things up to the point where the company had a viable future. 2015 is really when the ball started to get rolling (back when AXON was today's SAVA).
It takes on average about 10 years to bring a drug to market. So that brings us to 2024/2025. But given everything pretty much shut down for 2 years and the FDA had only one priority, I'll give Dr. Missling one additional year's grace period. So, 2026 is about when I'll begin to have questions.
I know this will trigger you but it is what it is. If something happens before then, great! But if not, no big deal for now. The lack of progress you speak of is entirely your opinion. I believe Anavex is making tremendous progress, and doing so in a way that presents as strong a case as possible to the FDA.
I'll bet there are some here who are probably critical of the FBI for not arresting the Gilgo Beach killer the moment they identified him as a prime suspect. Things take time when you're trying to gather evidence. Complain all you want on this message board if it makes you feel better, but we should all be grateful that Dr. Missling is operating at his own pace to ensure there aren't any cracks when he tries to convince the FDA that Sigma-1 is the new SOC for CNS disease.
Glad to see you're still hanging around.
Personally I feel that Dr. Missling has the data but he's intentionally choosing not to release it until he can accompany it with a peer-reviewed journal article. That's the only way short of FDA approval to keep his detractors from continuing to question his integrity, the trial design and the results. What good would it serve for him to release the data now? How would it change anything? The same people who don't believe the data we have today certainly won't accept new data coming only from the company's mouth. So we wait...
I can rattle off a dozen reasons why we haven't seen data yet, and none of them mean imminent doom for the company's future.
I agree.
In that context then you'd be correct.
I don't see it making one iota of difference. The data is going to be presented and reviewed. If the FDA likes the data it will approve Blarcamesine and if not, well, we know how that will turn out, too.
Again, people leave jobs all the time. I am about to resign from the Board of a local nonprofit for no other reason than there's another organization I want to assist. It has no bearing on how I feel toward the current one.
For Hampel, it may have been a money grab. Or maybe he just wanted to be a part of something that will get to market sooner. Or maybe he stopped believing in Sigma1, biomarkers, etc. But I doubt it.