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Thanks for sharing. I think this seems overly optimistic and falls into the pump and dump category. We should expect a lot of volatility with traders entering and exiting over the next few weeks — and of course we know there will be detractors no matter what. Dr. Missling could announce that he’s donating a kidney to a child who needs it and people like Adam Feuerstein will still write something negative.
I like Anavex as an investment but realistically there is almost zero chance a $10k wager turns into $300k in 8 weeks. These types of pipe dreams rope in novices, just as it did in November 2015 at our first CTAD.
What makes you think Missling and the lead researchers would have attended CTAD if not they're not presenting in some manner? And you're inference that Anavex will raise more cash is also just an opinionated guess at this point.
There are certainly some here who wear rose-colored glasses. Fortunately I don't see most of their posts because I've put them on ignore along with the ones who continually try to disparage the company without supporting evidence or facts. But from a purely objective perspective, presenting top-line data in a late-breaking oral presentation at CTAD is going to be seen by the investment community as a net positive. If Anavex weren't presenting, people would be inferring that the data must be bad and that too would be a fair and logical assumption.
I don't think Anavex will be raising cash at these price levels. We'll see...
I stopped listening to the $1000+ share price posters way back in 2015 and I continue to ignore them today. Nobody has any idea what the top line data will be except for those involved with the trial. We can infer the data is positive from the fact Avanvex is presenting at CTAD, the lead researcher is flying across the globe to present the data, and that they're having the data peer-reviewed and published -- but just how good the data will be remains a mystery to all of us and predictions are simply a parlor game to pass the time until 12/1.
Nothing is for certain. The best anyone can say with regards to A273 is “we’ll see.”
Most likely there will be a slight run-up prior to CTAD and then the stock will fade down in classic "sell the news" fashion. Even with positive P3 data, there's still an enormous amount of time between releasing the top line report and meeting with the FDA and with a shaky market sentiment, I can easily see the share price dropping until the FDA makes a decision. The intrinsic value we're all banking on won't be realized until the company becomes profitable and we're still a few years away from that happening. The good news is that with a positive showing at CTAD, the 7+ years investment many longs have endured will finally become significantly de-risked and we'll start to see money that's been on the sidelines flowing into this former printing company.
I'd expect a few hit pieces as well to trickle out after CTAD, dampening some of the excitement surrounding positive data. This is just a speed bump but experienced investors and institutions who were too risk averse to invest early will want to acquire shares as cheaply as possible.
I'm still holding some shares in a shoebox in my closet. The next few months will be interesting but I don't think the weeks immediately after December 1st will result in the share price appreciation many here are talking about. In my opinion, we're looking at late 2023 / early 2024 for Anavex stock to make its big move.
Did CRTX announce its tepid data at a major conference?
Good find. I would imagine if they're reporting top line P2B data at CTAD it's probably positive news. I don't see Dr. Missling and Dr. Macfarlane traveling all the way to San Francisco to serve a sh*t sandwich to the investment community.
Patents provide value. Without patent protection, the value is significantly decreased. On the tv show Shark Tank, one of the first questions about any product is whether there's a patent.
The cost to protect the IP is minimal. It's possible nothing ever comes of it but in the event that Anavex is considered an acquisition target, any buyer or partner will want to know that the pipeline its acquiring has patent protection in place.
Got this email from Alzheimer’s association. My only fear is that the FDA won’t want to approve too many drugs at the same time for the same disease, and Anavex may lack the clout at the FDA that its competition has.
———————
We have an exciting major development about the potential for a new treatment for Alzheimer’s disease, and we wanted to share the positive results with you as quickly as possible.
Tonight, initial clinical trial results were announced for a drug called lecanamab which was tested in individuals living with mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s dementia. Results from the clinical trial found that this treatment significantly reduces clinical decline from the disease.
These are the most encouraging results in clinical trials treating the underlying causes of Alzheimer’s to date. These results indicate lecanamab may give people more time at or near their full abilities to participate in daily life, remain independent and make future health care decisions.
We will know more at the end of November when the data behind these initial results will be public. We look forward to learning more at that time about participant safety and representation in the trials. It’s also important to manage our own expectations that this treatment is not yet Food and Drug Administration (FDA) approved and is not yet available in doctors’ offices.
This is a major milestone for Alzheimer’s disease treatments. It is a significant gain for people with the disease and their families and it further positions us to advance our mission in new and exciting ways.
We have never been more hopeful, and we hope you share our excitement. Even with the success announced today, we must redouble efforts to discover new targets and test new and more effective treatments for Alzheimer’s and all other dementia.
Thank you for all that you have done, all you are doing, and all you will do to make this a reality.
As they say, bulls and bears make money. Pigs get slaughtered.
I would guess that you and I are among the few who own AVXL in our Roth accounts.
Haha, perhaps. But that's the kind of confidence I want to see with Dr. Missling. I still think it's a coin toss whether the FDA approves Blarcamesine, with or without another P3 or P4 trial. Rett will be the canary in the coal mine but I just don't know what the company will do with all that cash but I hate that it'll be sitting there.
Again, if 273 doesn't pan out they can invest $500 million in A371 and most investors won't want to touch the stock with a 10 foot pole because confidence in Sigma-1 will have been drastically eroded.
Good summary. To be honest I don't care about the share price because I'm done trying to trade any shares. I've got my core position and now it's approaching time for everyone to show their hand and see who the winners are. I don't know how it will play out but I know the stock will be nowhere near today's share price two years from now, one way or the other.
I just think it's a prudent investment decision. That cash is earning maybe 5% interest sitting there, and if Dr. Missling believes that Blarcamesine is the real deal the cash can earn a lot more than 5% if it's re-invested in the company.
I'd love to see Dr. Missling's bargaining position (if this gets approved) be one where he can dictate the terms of a partnership. If they don't give him an offer he deems acceptable, simply re-issue the shares Anavex purchased for $5-$7 for 10-20x that and use the money to go at manufacturing and distribution alone.
Using even $60 million in cash at say $6/share if it drops that low gives Anavex 10 million shares it can sell later. If Blarcamesine is a blockbuster and shares end up trading for $100, those 10 million shares are now worth $1B which is more than enough to purchase a manufacturing facility, hire a sales team, and still have plenty left over to develop the rest of the pipeline.
When Warren Buffett feels Berkshire is undervalued and he can't find other good investments, he buys back his stock. It seems to be working for him pretty well.
Agreed. The $1249 crowd has suckered in so many investors with hopes of riches and I hate to think about inexperienced investors who have unrealistic short-term expectations.
Most of them will fall by the wayside -- look at that Sparks guy as an example of someone who came in, stirred up a lot of fear about a cabal, and then vanished with his so-called "investment group" taking profits at others expense.
There are also those who trade in and out completely and they're risking not owning any shares if this ends up going parabolic. That's a possibility, too. I think it all boils down to how many shares did someone buy initially? The person who only invested $1500 may be more inclined to let it ride than the person who risked $30k.
All good points. I'm a big fan of riding free shares, particularly when you only need to sell 10-20% of your stake to get there.
A 6600% windfall is certainly more deserving than "nice job" but I've learned excessive celebration tends to annoy the stock gods. Remember what happened with that "millionaire's club" last summer? That chorus is a whole lot quieter today so I'll keep my praises modest just to be safe.
I've sold shares. I don't trade shares though because I know at any moment there could be a PR and the stock price goes parabolic. I'm willing to accept the alternative and I lose everything instantly. I've never been very good at musical chairs and I don't want to be caught on the outside looking in. That to me is just as big of a gamble as holding everything from 2018 to now.
Depending on the size of a person's holdings, the short-term capital gains can pose a real threat. I don't like paying 20% but it sure beats the alternative, year after year.
I thought about that. Ideally any partnerships and/or revenue generated would be strong enough to offset the increased operating costs.
I want to see Dr. Missling put his money where his mouth is. If he's not going to use his own money to buy shares, use corporate money if the stock is truly trading at a discount to market value and/or if the expected future cash flows make the current price a buy.
I didn't say buy now. I said if there is a drastic decline where the S&P or XBI drops 20% or more, Anavex will most likely see its share price drop at a proportion that is out of whack with reality and an arbitrage situation exists. When systemic and intrinsic risk are out of sync, Anavex would have the opportunity to buy back shares at say $5-$7/share.
If Blarcamesine works, you don't think they'd be able to re-issue those shares a few years from now for $50? Maybe more? Seems like a good use of corporate funds. If they get approved we already know they're going to partner for Alzheimer's and the revenue will be more than sufficient to advance A371.
My suggestion has nothing to do with propping up the share price.
It's always been a holding game if you're an investor. If you truly believe in the company buy the dips. As much money as one can make trading -- and there's nothing wrong with taking profits at all-time highs -- there are some who are so convinced that AVXL will be the lotto ticket that produces the next blockbuster CNS drug and selling any shares under $50-$100 is premature.
If you sell 10000 shares at $30 that you bought at $3, you turned $30k into $300k. Nice job. That's quite the windfall. But if Anavex turns out to be a $20 billion company and those shares are worth $200 (diluted at 100mm float), the cost of financial security was $1.7 million. The question boils down to whether you think the lotto ticket you're holding also hits the multiplier number. I don't know enough about Anavex or CNS disease to make that assessment so I fall in the profit taking camp, too.
This kept me up late last night and the more I think about it, the more sense it makes.
Anavex has a 4+ year runway's worth of cash, but does it really need that many years in the coffers? If there's a recession (looking more likely) and Anavex is dragged down with the general market, which it will be, why not use that cash for a stock repurchase or a one-time special cash dividend with a DRIP option?
If the drug works, we'll know within 18 months if not sooner making the 4 year runway somewhat moot. If the drug fails, it's unlikely most of us will stick around to see how A371 fares so who cares if they're able to run a P2B trial there?
The bet is on A273 working. If it does, the reduced float will only help create more demand for shares when word spreads if Anavex gets approval.
Thank you for making my point, even if it was inadvertent. People are suspicious of the Covid vaccine partly because of how quickly it was rushed through the FDA approval process and the lack of long-term data collected.
I don't want to see Blarcamesine suffer the same fate where people like you refuse to take it because they don't trust Anavex, the FDA, etc. So as much as I'd like to be first to market, I'd rather produce a drug with more evidence-based safety and trial results even if it takes a little longer.
Even if it doesn't sway the public's opinion, more robust safety and efficacy data will sway insurance companies. And when patients are given a choice of paying out of pocket for one drug or being covered for taking a competing drug, I think I know what most doctors will end up prescribing.
Impatience is understandable but unwarranted. I used to have a coach who would tell us not to worry about what other team is doing. Execute our team's plan at our pace and we'll win the game. Most of the time this was good advice.
There are two good reasons why Dr. Missling is smart to take his time to execute his game plan: it improves the odds of FDA approval and it improves the odds of insurance providers paying for Blarcamesine.
Look at the Covid vaccine. It's proven effective and has saved lives and I'm 100% positive at least 30% of people reading this post will disagree. Humans are naturally skeptical (and rightly so) of anything new approved by the government. More trials = more data = more of a willingness to try something new.
Rett patients may be desperate for a cure, but not if that cure makes quality of life even worse for a patient. Is walking to school or saying a few words for the first time worth suffering from severe diarrhea? I don't know. What I do know is that Dr. Missling's goal is to ensure Blarcamesine gets approved and has enough irrefutable data that insurers have no choice but to cover it. Data collection takes time, and just because someone else is doing it faster doesn't mean they're doing it better.
Besides, being first to market is overrated if you have a superior product. Sony's Betamax was released in 1975, JVC's VHS was released in 1976. Ten years later, Blockbuster started a good run renting VHS tapes, until it was displaced by Netflix. Today, Netflix is being cannibalized by everyone from Apple to Amazon.
Let the Rett patients and parents have their go with Trofinetide. I figure six or twelve months of dealing with diarrhea will be sufficient for at least 21% of ACAD customers to try something new. Eventually word will spread about the superior treatment and the market will reward the victor as it always does.
You seem to want to take Sony's first to market approach. I am glad that Dr. Missling isn't trying to race to be first, nor is he scared about competing in the open market and letting the best drug win.
I know that I’m 2021 he and his CFO sold millions of dollars worth of shares. You can’t sell shares with insider knowledge either, so clearly there’s been opportunities for him to buy/sell legally and he chose sell.
My question is why?
Agreed.
So you’re saying that Dr Missling isn’t buying shares because it’s illegal to do so?
That isn’t correct and misinformation makes this board less credible.
You aren't answering my question. Why isn't Dr. Missling buying shares? There are certain times when he may not be allowed to make these purchases, but in a blinded trial he is certainly able to periodically, as all insiders are.
There are only three possible reasons why he hasn't bought any shares:
1. He feels that he has enough shares already -- not a good sign of confidence
2. He isn't willing to risk his own money -- again, not a good sign
3. He wants shares but doesn't have the money to buy them -- unlikely given his six-figure salary
The scary part is that we have seen several insider sales. I'm still bullish on AVXL but your response doesn't provide insight into why Dr. Missling hasn't bought shares.
Exactly. But as long as he refuses to put his own money up, questions will and should remain about his confidence.
Put another way if he’s not willing to buy why should we? Where is he putting his money that he feels is a better investment than his own company?
@Kund, I generally dismiss most of what you say because it's not supported by fact but you made an interesting point that's been on my mind for a long time: why no insider buying? If nothing else it shows conviction.
I don't have a good explanation for why Dr. Missling and other insiders aren't buying. It's not for lack of opportunity -- there hasn't been a major purchase in years, if ever -- and no insider is forever barred by SEC rules from purchasing stock on the open market. The best answer I have is that Missling simply gets enough free / cheap shares from the company which indicates mismanagement of fiduciary duties (perhaps), but excess dilution doesn't have any impact on whether Blarcamesine's effectiveness in these trials.
Still, it would be nice to see some insider buying at $10/share. I doubt it'll happen though.
Interesting move to shift into NWBO. They have no cash, the dilution is going to be painful and I expect that they'll need to dilute prior to the FDA approving its drug. That's one thing I like about AVXL -- a strong cash runway heading into P3 and beyond. Nice trade though, good luck in Northwest!
"Once we get the data, if bad i will sell in a heart beat."
Once we have the data, if it's bad it'll be too late to sell. The stock will be down 80-90%. The opposite is true too. Those waiting on the sideline will be on the outside looking in if the data is positive, although it's possible / likely there will be some attempts from Stat News and similar publications to distort positive data for a temporary price drop until markets have a chance to digest the data.
Go hit up WallStreetBets on Reddit and promote AVXL. Maybe someone will notice.
I don't expect anyone to know about Anavex. My guess is that it'll eventually be purchased by a larger entity and the parent company will take credit for Blarcamesine. Most people know about Pfizer's Lipitor. I'd be surprised if anyone on this message board remembers the name of the company Pfizer acquired to gain access to Lipitor.
This is mostly dead money until December. The stock price will ebb and flow with the XBI and other market forces.
I suspect Anavex will get a speaking role at CTAD in late November and this is where a big announcement will be made with definitive data. Stat News and similar sources may publish articles that try to curb the enthusiasm and that'll be the last we hear from them as they move their attention toward another early-stage startup with promising data.
If we see Anavex at CTAD, it's undoubtedly going to be something good. No CEO would ever stand in front of his peers to speak about a failed trial. I'll become worried about this investment if Anavex doesn't have a presentation ready by Thanksgiving.
Correct. Dr. Missling's job is to advance a drug through the arduous FDA approval process. Catering to the selfish whims of impatient traders doesn't benefit the company in any way other than perhaps reducing the cost of issuing new shares.
I don't even know what more people want him to do to raise the share price. He's kept the float low. He raised money when the stock was in the $20s so there's no shortage of cash. There's minimal debt. He's hired an accomplished scientific advisory board. He got the stock uplisted to Nasdaq and has courted name-brand institutional investors. He's secured patent rights for the next two decades. He admits when things don't work out as expected (i.e., Anavex Plus). He's issued multiple PRs that give every indication things are moving forward nicely. What the market does with that information is out of his control, and so far the market underestimates the odds a small, unknown printing company-turned-biotech will revolutionize CNS research and treatment.
It would be like if your next door neighbor was building a space rocket in his back yard. What odds would you give him for a successful launch? Now imagine that next door neighbor is Elon Musk. Eventually you'd take him more seriously. Dr. Missling can either spend his time trying to convince people the rocket will work or he can spend his time building the rocket and showing people that it works.
I am glad he is choosing to pursue the latter.
"The FDA is not out to get Missling or Anavex - at least not any more than the TGA."
Correct. It's easy to lose sight of the fact that there are hundreds if not thousands of other drug candidates, and while Anavex investors believe that Blarcamesine is the most important one and thus ought to be prioritized, that same feeling is shared by other investors about their company's drug pipelines.
The FDA is a government agency. It's not going to move quickly -- there is already so much distrust about government, and the worst thing would be for the FDA to approve a drug that turns out to be ineffective or harmful. I am sure that Dr. Missling is trying to move ahead as quickly as possible, or at least that's what I want to believe because the cynical approach is that he's milking this for more salary, bonuses and stock options. Either way, I'd much rather have a CEO who is diligent and thorough than one who rushes to the finish line only to realize that mistakes were made along the way.
Yeah, I think it was upfront cash + milestone incentives.
This is where I think he's going to shine, and that Kellogg degree will become useful. He knows and understands the science behind Anevex's pipeline but I think he's far better when it comes to business strategy.
Yup. And I wish Anavex had been doing one. There's no way they'd have gotten $50m from retail shareholders, but I'd be willing to bet they'd secure at least a few million from the thousands of investors who believe in the company and would love to purchase at below market prices. Then go to LPC or any of the other funds to make up the difference. If I criticize Dr. Missling for anything it's that his initial financing decisions weren't as shareholder friendly as they could have been.
What does "non-dilutive" financing look like?
Dr. Missling mentioned that when its time to market Rett, he has plans for raising more money without further diluting the float.
Does he mean debt? With interest rates increasing, the days of cheap and accessible money are few and far between. While technically non-dilutive, debt financing without knowing exactly how much revenue or what the demand will be for Blarcamesine can be risky.
Does he mean that Rett Foundation and similar nonprofits will pick up the tab for marketing, or that he has access to grant money? This would be ideal.
One thing I wish is that Dr. Missling offered shareholders first crack at the various offerings over the years. So rather than go to Lincoln Park, ask the shareholders if they wish to purchase additional shares up to and equal to their current holdings before looking for outside money. Some shareholders may not participate, and will be diluted as a result, but at least it would allow most shareholders to
I know of at least one instance where a company submitted to the FDA first and got approval, but the rare pediatric voucher allowed another company with a competing drug to be the first to bring it to market.
It appears that Dr. Missling is playing the role of the tortoise in the race against the hare.
Agreed. Dr Missling wants that voucher, and I believe he will use it to expedite
Alzheimer’s to get to market ahead of anyone else.
“Data showed that sigma-1 receptor (S1R) agonists are effective in suppressing motor neuron degeneration and symptom progression in ALS animal models.”
From a March 10, 2014 press release that Blarcamesine may treat ALS.
My gut feeling is that this is the mystery indication it’s working on. I can see why the optics would be bad to announce an ALS trial while Alzheimer’s is still going on. People would assume the worst about bad data and a pivot.
If Blarcamesine works for Alzheimer’s, still a big unknown at this point, announcing an ALS trial will be received much more favorably and will boost the share price significantly. Smart strategy by Dr. Missling to save some of his PR ammo.