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I think you're overanalyzing this and making another wild assumption that Anavex doesn't have dosage-arm data. You seem to believe that Anavex should release this data immediately. I can think of a few reasons why it's not in Anavex's best interest to do so, even if it has the data in hand.
I'm waiting to let the process play out, just as you are. The difference is that I realize I have zero control and b*tching and moaning on a message board about the CEO's integrity or competency isn't going to make a lick of difference in the outcome.
Why was Kun hired? Because he strengthens Anavex's management team. It was a solid hire regardless of where Anavex is at with its pipeline.
And 3 months is not a long time, at least not to deep value investors and those who understand how biotech works. Check back in 18 months and let's see where Anavex is at. My guess is the share price will reflect rapid growth if Blarcamesine were to be approved.
I don't see how Nell's modeling career has any impact on her ability to perform her job well at Anavex. From what I've read, she studied neurobiology at Tulane. This hardly qualifies her as an expert scientist but her education and experience at Anavex should make her more than capable of holding her own when discussing Blarcamesine.
But let's dive deeper into the more misogynistic element of your post -- that because she's attractive she cannot also be intelligent? The two are not mutually exclusive. She was a college student who is offered a modeling job and it grew into something much bigger than a one-off assignment. Congratulations to her, she found success in a highly competitive industry.
I have a degree from a top-15 university. I also had a job after college that many would consider "beneath" someone who spent 4 years in college. I didn't care what others thought because I loved what I did until I inevitably aged out and had to put my degree to use.
Brian May was the lead guitarist for the biggest band in the world. He's also a respected astrophysicist. David Solomon, aka DJ D-Sol, spins EDM to thousands of ravers at giant club parties across the world, but he also runs Goldman Sachs. The list goes on and on...
There's a reason why being attractive and gregarious is sort of an unspoken requirement for pharmaceutical sales reps. Business development is all about developing relationships -- if anything, Nell's modeling background is interesting and differentiates her from all the other biotech business development executives working for competing companies.
I agree, Kevin. I also believe there will be multiple approaches, just as there are several different drug options to treat a headache (Tylenol, Advil, aspirin, etc). I am more interested in Sigma-1 in the broader context, if this is a new approach to treating illness and Anavex is the pioneer it will bode well for the long-term share price.
I think Billy Dunn is a pariah at the FDA now and many of the decision-makers there aren't going to want to be seen or associated with him.
Resigned effective immediately to pursue other opportunities = forced out by someone with more influence than he had.
I hope not. Billy Dunn's credibility is permanently compromised and Anavex shouldn't be associated with anyone whose background isn't beyond reproach.
Besides, Anavex has plenty of people with FDA experience or connections already on its payroll. If anything, Billy Dunn leaving means the FDA will be less easily influenced from here on out, which bodes well for smaller companies like Anavex that previously had to compete against Big Pharma lobbying.
There will still be lobbying, no doubt, but their influence is diminished thanks to Billy Dunn putting the FDA under a public microscope.
Does the data have to be good? Even mediocre results in a safe and convenient delivery method is better than what is currently available.
Anavex has $100mm in cash in the bank. My feeling is that if the data were pure garbage, they'd shift focus to A371 or one of the other drugs in the development pipeline.
Go back and read the post I responded to. An intelligent poster whose posts I always try to read commented that Anavex is a lock and we're now just a waiting game. While I'm inclined to agree, I'd say the entire cult of Anavex crowd truly believes this to be a guaranteed millionaire-maker. I don't agree much with what the likes of Investor, Doc, etc post, but on this I think they're spot on.
Haha thanks for the correction. I was actually listening to Willie while posting and that's what made me type his name. Funny comment though!
Not exactly. I don't have any control over the share price. Nobody in this forum does, so what good would trying to scare people into selling their shares do even if that were my goal? If I want shares I can afford to pay full price for them.
The point that you evidently missed is that despite all the good news, there's never a sure thing with this company's future. Sometimes, the unexpected happens. It's the same way nobody is 100% comfortable on an airplane because in the back of our minds we all know there's always that 1-in-1M chance something could happen. Or put another way, there's a reason even the most bullish of investors here aren't taking out second mortgages to buy Anavex stock.
I'll take Willie Nelson's advice and count my money when the dealing's done. That isn't stoking fear. It's common sense.
No, the point is that there are lots of unexpected things that can happen outside of Anavex's control. See: the pandemic as just one black swan event nobody saw coming. The law professor had full trust in the window's strength just as you have full trust in the Anavex trials. It was something else that caused the issues. And it's these factors that always make me wary when I hear that an experimental drug is a sure thing. I like the odds but I also need to leave some allowance for doubt.
I'm expecting Rett approval within 12 months. Alzheimer's approval within 24 months.
Several years ago there was a Canadian law professor who was showing off to some students the strength of the industrial safety windows in his skyscraper office. He would run full speed and jump into the window, bouncing off each time. It was a party trick that entertained and delighted all who saw it, so he kept doing it. With each success he felt more secure, and more emboldened.
It worked every time, until it didn't. He went flying through the window and fell to his untimely death. To the manufacturer's credit, the window itself remained completely intact even after it hit the ground. What happened was the window pane detached from the casing that surrounded it and he fell through that way.
You're plenty smart to understand the moral. I like Anavex's odds more now than I did three months ago, but there's never "no doubt" until the first dollar of revenue is secured.
I don't think anyone thanked you because, and I say this with no disrespect, your bearish prognosis isn't exactly unique. Almost everyone knows that the economy is hot on the surface but cool to the core, and that a bubble was due to burst. This is the cost of Covid and shutting down. Whether saving lives is worth an economic recession is an ethical question I'm unqualified to answer.
November/December 2024. 21 months from now, the Anavex case will be closed. Blarcamesine either works or it doesn't, and Anavex will either launch a successful marketing campaign or there'll be no commercial interest. It's all binary and it's coming to a head soon.
21 months in the grand scheme of things is not that long to wait. It takes on average a decade to bring a drug to market -- and that's without having to navigate the pitfalls of being a startup biotech, trying to operate during a global shutdown. Figuring that 2015 is when the ball started rolling, I'd say that Dr. Missling deserves another 2 years, minimum, to get Blarcamesine across the goal line. The pandemic caused delays at the FDA that rippled down to affect every single drug company not working on Covid.
Delays happen. Not a big deal in the long run.
I have no reason to believe Doc328 isn't a doctor, nor do I think that he's shorting Anavex. His posts indicate that he's knowledgeable and at one point was very bullish on Anavex. People's opinions change. At one point I had Anavex pegged at about a 5% chance of approval. I wasn't short, I was just skeptical. And as we inch closer to the zero-sum outcome, I'd expect a lot of other longs to begin wondering if they should play it safe and take some profits.
That said, confirmation bias is real and I do think it's possible that Doc, having become discouraged and/or skeptical, is now looking for reasons to justify his bearish opinion. This is good, hearing contrary views makes for better discussion and gives longs something to consider. There's a big difference between a quality bearish post and someone who parrots the same BS every day (and that goes for pumpers, too).
If I am not mistaken, Doc reduced his position significantly and also sells covered calls. So it's in his interest to keep the stock price down -- collect the premium and keeping his shares is the ideal outcome, short-term. This doesn't mean he is short selling, which is sort of foolish to do at this stage in the game with a max $10 upside, when there are so many better stocks to short with less risk and greater reward. But shorts also provide liquidity -- trading would be nearly impossible without shorts existing to make the market.
And it takes only a brief look at Doc's post history to see that he's not correct all the time. At the end of the day we're all placing our bets and waiting to see who bet correctly. My money is still on Anavex, because it doesn't have to have blow-out numbers to be approved. If it's convenient to administer and works as well as Lecanemab, it should be approved without much discussion, for the same reason nicotine chewing gum was approved as an alternative to the patch.
They're going to submit the pediatric trial results first (assuming they're positive) or maybe both children and adult trials at the same time. Nothing to update until the Excellence trial results are in.
I don't know, Doc. Different diseases may require different dosages. I fail to see how AD and PD dosages are related?
Also, to be fair none of us have any idea what's happened for the last 3 months. I think it's safe to assume that Dr. Missling hasn't just been sitting in his office playing Candy Crush all day. Things are moving forward, new information is being gleaned. The lack of clarity may only be on our side, no? Something like a dosage update is not material information that would require immediate disclosure to investors and the SEC.
Many of us are older and retired.
I get what you're saying, my point was more that Anavex is basically a 5 year old company and most companies, even the great ones, aren't going to show massive shareholder returns or exponential revenue growth. Particularly in a zero-revenue startup phase with biotech.
Anavex isn't worth that much because it's still a half-baked cake. Whether Dr. Missling could have sped up the process is another issue -- I am inclined to give him some slack because he had to deal with a pandemic and now the FDA's egg on its face with the botched "Adu" approval.
Let's take a look at these rockstar companies and compare their first 5 years with Anavex's most recent 5 year low ($1.41 back in December 2018).
Current AVXL PPS: $10.60, or a 7.5x gain from the December 2018
MCD: Went public in 1970 at .19/share, 5 years later it was .44/share (2.31x)
HD: Went public in 1981 at .02, five years later it was .23 (11.5x)
COST: Went public in 1986 at $6.2, five years later it was $8.35 (1.34x)
TSLA: Went public in 2010 at $1.07; five years later it was $17.33 (16.2x)
The average return for the 4 superstar companies that you mentioned in their first 5 years is 8.12x. Anavex is at 7.5x.
I don't think Anavex's performance has been as bad as you think. The Anavex story didn't really get started until around 2017/2018 so that's where I start to judge Dr. Missling's performance. It was at that point he decided to go at it alone and started running multiple trials for several diseases.
It will take a lot longer than 5 years for it to reach its max value. Dr. Missling can't control how long it takes to run a trial, particularly during a pandemic. It also took Home Depot, McDonalds, Costco and Tesla more than 5 years to become what they are today.
Who cares about the specific p-value? It was good enough to achieve statistical significance. The focus now should be on Rett and getting that across the finish line.
Rett --> Voucher ---> Accelerated Alzheimer's Review --> Approval --> Commercialization.
I figure it'll take another 9 months for Rett to be submitted to the FDA. Figure 24 months for Alzheimer's data to be submitted. By February 2027, Blarcamesine should have a year's worth of revenue for multiple diseases, and the projected cash flows will lead to financial models that launch the price toward its true market value.
For the sake of argument, February 2019 wasn't all that long ago. I can wait.
Not sure if this was posted earlier:
"Pfizer has set a goal of adding $25 billion in revenue by 2030 from business-development moves including acquisitions."
https://www.wsj.com/articles/pfizer-novartis-merck-executives-say-they-are-hunting-for-deals-again-11675907783?st=udhmyx54x4r1vt3
Peer review = validation. It drives the value up, gives Anavex more negotiating leverage and many biotech CEOs want to see peer review and third-party validation before committing billions of dollars. The FDA definitely wants to see that data validated. It's the difference between an eBay auction and a Sotheby's auction. You can buy a Babe Ruth autograph on either, but you're willing to pay a whole lot more for one than the other.
People act like Dr. Missling is just winging it. It's easy to criticize when you're not privy to everything going on behind the scenes. Maybe I'm more empathetic and patient of Dr. Missling because I've been in a similar situation where I've had a lot of shareholders upset with me and I wanted so desperately to tell them the insider information I knew to be true but couldn't due to NDAs and securities laws. It was a 2.5 year process where I fielded angry emails every week, but those who were patient were ultimately rewarded with 5000% gains.
The impatient, hyper-critical ones here have probably never been in Dr. Missling's shoes. There is so much going on behind-the-scenes that none of us are aware of. Dr. Missling isn't just sitting around hitting refresh on iHub while he's waiting for data results to arrive. An American company circumventing the FDA with a potential blockbuster drug is not a good look for the FDA. And considering that Anavex needs a good long-term relationship with the FDA, it wouldn't be wise to do anything to embarrass it right out of the gate. Approval will be FDA #1, Australia/EMA #2/3. So we wait...
Wall Street will ultimately judge Dr. Missling based on two simple criteria: is he able to bring Blarcamesine to market, and is he able to sell it in a highly competitive market? We'll see.
Pfizer, Merck and Novartis CEOs are actively looking to increase the number of acquisitions this year and next. It's rare that everything times up perfectly but Anavex, if Blarcamesine is approved by the FDA, will be hitting the open market as a free agent at a time when payouts are near all-time highs because of so much money sitting on the sidelines the last few years.
It would be rather ironic if the delays everyone's complaining about end up positioning Anavex to receive a better offer, simply because of good timing. There are hundreds of professional athletes in the prime of their careers wishing they'd held off just one or two more years before signing the massive contract extension. Sometimes being patient is worth the wait.
It all hinges on FDA approval. If Blarcamesine has to go up against other competitors first, so be it -- at some point word will spread and quickly in the medical community and the best drug will win market share. Based on what I've seen from the competition, I'd still put my money on Blarcamesine being the most favored drug when the dust settles in 2-4 years.
All speculative. Nobody has any idea who is interested in partnering, what discussions have taken place, or what the future holds. Right now, there's not even a drug that can be sold to patients.
I wish iHub would permanently block the guy who keeps saying Roche is guaranteed to buy the stock. The truth is nobody has any idea what will happen. We can speculate all we want but it's wait and see for now.
I didn't realize the WGT crowd were to be taken seriously. The people shouting $1249 are probably just as wrong as the ones insisting the stock will become worthless. So I ask again, who cares what they think or what they were certain of?
I don't claim to know the first thing about investing, but I do know that investing based on the whims of an internet message board is a dumb strategy.
Let LPC sell. It's short-term volatility. I can see how it may upset traders who mistimed their entry before the offering announcement, but long-term investors shouldn't care about how long LPC holds. Someone is buying those shares, what is their holding strategy?
It doesn't matter if the stock trades at $1 or $100. At some point in the not so distant future, the FDA will decide whether to approve Blarcamesine for Rett syndrome. If that happens, actual cash flow models will be created and speculative volatility will disappear, as will those who want to day trade the stock.
The market would have dropped the stock no matter who financed the deal. Anytime there is a possibility of dilution, some people will panic and sell their shares and it provides an opportunity for others to take short positions.
Dr. Missling made it clear that there is currently 4 years of cash runway available. He's planning for the future to ensure he always has access to cash. What's so bad about that? The deal itself seems favorable and on par with Cantor Fitzgerald's.
Let me ask the board this question: if a blue chip investment bank offered the same $150mm financing, but at worse terms than LPC, which would you prefer Dr. Missling choose? Money is money, and fortunately this money isn't even needed right now. But Dr. Missling is in a far better position to negotiate a deal now with $140mm cash in the bank than he would be when the cash starts to dry up. If anyone wants to know how toxic death spiral financing works, it usually begins with a company that is strapped for cash making disadvantageous, highly-dilutive deals with vulture firms out of necessity. I applaud Dr. Missling for not letting Anavex get to that point.
Maybe the naysayers are correct. The drug is a bust, the FDA is corrupt, whatever the case may be, it's important to always leave some room for doubt. And if one is so easily talked into all the reasons to walk away now, Anavex probably is too high-risk or that person has too much invested. As a purely speculative, high-risk/high-reward gamble, however, I don't know of too many opportunities that are better than what we're facing today.
Much of the risk has evaporated over the last few years. Those attacking the science are slowly changing their tune to attack Dr. Missling because he's an easier target -- at some point the FDA will decide whether the science is valid but CEO criticisms are subjective and can last forever.
What happens if we reach March 1 and nothing happens? Nothing happens. What's so special about March 1 and who cares if the wolves begin to howl? Anavex doesn't have any debt due on March 1, it's just another day.
No. I only briefly scanned the terms but it appears LPC is receiving 750,000 shares now and another potential 750,000 shares depending on how many shares its required to purchase. Consider it a cheap insurance premium to secure up to $150mm in emergency funding.
LPC is going to make money in other ways too, but this seems to be a fair deal all around and comparable to the Cantor deal.
Who cares about the optics? Long-term, this is binary investment depending on how the FDA evaluates Blarcamesine. Retail investors' discretionary dollars are insignificant unless someone wants to average down or cash out.
LPC's money is just as valuable as anyone else's. If the terms are fair, that's all that matters short-term.
I agree. And this is where I think many shareholders will regret cheering on corporate stock buybacks when cash flow was rolling.
All the more reason to raise money now, if one suspects an economic collapse and the cost of borrowing to increase a few years from now.
Nobody was pleased with the decision to sell stock in 2021, but that turned out to be a prudent short-term move to shore up the balance sheet. It's much harder to acquire a financially healthy company for cheap than one that has the potential to become a money pit for the acquirer.
It's an insurance policy. Nothing more. It'll cost a small amount of capital to secure the right to raise money in the future, if it's needed.
I don't see what the big deal is. But for the sake of argument let's suppose that Dr. Missling taps into his 200mm authorized share limit and forces LPC to purchase the full $150mm worth of shares, at say $10/share. Anavex would then have $290mm in cash, no debt, and just over 100mm shares outstanding.
What's so bad about that situation? This is a non-issue. LPC funding was much scarier when the stock traded under $2.
There are 2 ways to read your question:
1. Will AVXL be selling Blarcamesine within 6 months, as in will the drug be available on the open market?
2. Will AVXL be selling Blarcamesine within 6 months, as in will the company license or sell the rights?
I think you were referencing #2, but the answer to both is most likely "no." I expect at this point Dr. Missling is confident enough to submit to the FDA without a partner, and if approved maximize the leverage he has entering negotiation. At worst, he'll be told to run another confirmatory P3 trial -- and he has the cash to do so with minimal dilution. More likely, he'll be asked to run a P4 trial -- and with the LPC deal he'll have the cash to continue advancing the rest of the pipeline.
Anavex doesn't need the money. But it's sending a clear signal that Dr. Missling getting his ducks in a row in case he doesn't receive any legitimate partnership offers. I don't think he wants to go at it alone but having access to cash is never a bad thing, because the cost of manufacturing and marketing will easily eat up all of the runway needed to get the other trials complete and further advance A371.
The market rose as Powell began speaking of an end in sight with the rampant inflation, and the markets faded just as quickly when it became clear the process was going to take a very long time. Overlay the AVXL chart with the DJIA chart and you can see exactly when the spike and drop occurred across the entire market.
The price action had very little to do with Dr. Missling or the company as whole. If anything, one analyst allegedly lowered his price target from $80 to $58.
Not bad. I bonds also look attractive, just not as much as last May when the rate was over 9%
As I've said before, if all fails the next step is to put Blacamesine for sale as a dietary supplement, which the FDA doesn't regulate. Make billions following the Herbalife model.
Or move on and spend the $140 million advancing A371 or developing new drugs for the pipeline and focus on Rett, where approval is much more likely given the adult results and lack of alternative treatments.
What does any of this have to do with the only thing that actually matters?
Is the FDA okay with the trial design? All indications point to yes.
Damn. When Mike.com is calling out others for being negative, what is the world coming to?
In all seriousness, it's grasping at straws. Lots of reasons to be critical or skeptical of the company's future, but minimal dilution isn't one of them.