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Sure. The only voice that I care about is the FDA’s. Let’s wait to hear what it has to say about the trial design.
My guess is that if the results are as good as advertised, A273 will be approved for Rett and it’ll be the last we hear from Adam F for a while. These type of clowns love to make a lot of noise from the tree tops, and then fly away silently when everyone stops listening.
Part of me hopes one of these class action cases goes to trial. It would allow Anavex to really get a good look at Adam Feuerstein in the discovery phase. Depositions, access to email records, etc…
Martin Shkreli is in jail because of the attention he brought in himself. Adam F uses terms like “likely” to cover his ass, but that may not be enough to save him — for the same reason a prostitute can’t sell someone a pencil and claim the monetary transaction was related to the pencil only…
I am struggling to understand the anger and animosity. When the smoke clears — to use a fire analogy — the fire didn’t burn anything down of significant value.
Could Dr. Missling have done a better job of communicating the endpoint change in advance and made it clear that the FDA requested it? Sure. But I doubt that would have stopped Adam Feuerstein from finding something else to criticize.
Remember back in the day when he criticized the science as a fraud? He’s changed his tune as more evidence mounts that the S1R activation has a noted effect on various CNS conditions.
Nothing has changed for the worse. Anavex has plenty of cash so it’s not like a short-term depressed share price means we’ll suffer additionally unnecessary dilution. And Adam F isn’t on the FDA advisory panel, so it doesn’t really matter what he thinks. If the FDA is okay with the revised endpoints, that’s all that matters.
Those complaining are doing so for one of three reasons: 1) they were hoping to cash out ASAP, 2) they are buying into Adam F’s narrative that A273 doesn’t work, or 3) they’re panicking because of the unrealized losses in their account.
But we’ve been through this song and dance several times since 2015 and survived, and we’ll survive again this time.
Not everyone has been in AVXL since 2015, some may have bought their shares this summer at the all-time highs and it’s natural for them to feel the same unease that we did many years back.
I’ll say it again — the only opinion about A273 that matters is the FDA’s, and so far I’ve heard nothing from the FDA to indicate that they are concerned with the trial setup. If the FDA isn’t concerned, why should I be?
Why bother? He said it in the conference call, from what I can tell anyway. No need to repeat himself just because a few traders are trying to distort news for their own gain.
Who is still scared at this point? Everyone knows the risks are all-or-nothing.
I guess I’m confused because hasn’t AF been attacking Anavex for years. Why should anyone be afraid of this one?
Does it matter what anyone thinks of the data other than the FDA?
I’m interested to hear the Rett Foundation’s position. Will it support FDA approval? If so I think odds are decent the FDA will concur.
I wouldn’t rely too heavily on BIIB’s $20B drop in market cap. Biogen has a manufacturing and marketing and distribution platform set up. Anavex doesn’t.
Those costs will have to be factored into AVXL’s value.
Sorry to hear about your dad. Memory loss runs in my family too. Hopefully Anavex or another company has the cure for this awful disease
Yes. My opinion of him has changed over the last 2.5 years.
I don’t know if he’s the right person for the job if and when A273 gets to market, but in recent years I’ve agreed with most of his decisions…and dare I say, I was wrong about my initial assessment of his performance.
To Fireman, et al, who I think will appreciate this:
It feels like lately we’re having the wrong conversation. The debate shouldn’t be whether Dr. Missling is doing a good job, it should be whether the A273 works.
Does anyone remember back in 2015, 2016, when people like Martin Shkreli, Jean Fonteneau, Adam Feuerstein used to attack the science? This was easy to do then because there was so little data, but these days those who do not believe Anavex will succeed are going after the company’s leadership. Again, we don’t have much of a track record for how Dr. Missling will perform — he may be the best CEO to bring the drug to market but the wrong person for the job to market it successfully. We’ll see.
My point is that whether Dr. Missling is doing a good job is not the conversation that we should be having. Let’s get back to discussing the science. I want to hear from those with knowledge why A273 will work, or won’t. There are a few posters here who continue to do that, but I miss the likes of Dadofmarcmax and others who were able to contribute to meaningful debate — not whether Dr. Missling should be tarred and feathered because he’s a few months behind reporting data.
Louis CK has a brilliant comedy bit about how everything is wonderful and nobody’s happy. He used the example of the WiFi on an airplane not working — forgetting the fact you’re in a metal tube flying 500 mph across the country when just 125 years ago the same journey meant forging the river and hoping your family won’t die of dysentery.
How many people complaining about Rett delays invested in AVXL because of Rett Syndrome? How many investors here had even heard of Rett before they invested in AVXL?
Dr. Missing is setting this up to give the best chance for success. It’s much easier to convince the FDA to approve a rare pediatric disease than to approve a novel Alzheimer’s drug. If/when A273 is approved for Rett, Anavex will be submitting its other trials with a drug that’s already been approved, and it will have the priority voucher to further accelerate the review process.
I’d rather take my time with this plan than doing “sneak peaks” or trying to rush everything through just to meet an arbitrary deadline. Going forward I’d be surprised if Dr. Missling offers any timeline at all, and I’ll bet he gets attacked for that.
Dr. Missling isn’t perfect and I’ve called his motives into question in the past — I don’t like the idea of blank check preferred shares because the downside to poison pill protection means that it’s harder for shareholders to replace the CEO should we want to down the road.
But to criticize Dr. Missling because he’s late on his estimated timeline — during a pandemic when everything came to a sudden halt — and to do so just three weeks into Q1 is absurd. Impatient traders are the only ones who want to cash out ASAP, and I’m grateful that Dr. Missling isn’t pandering to them.
Those who say they care about those suffering — we all do. How many could also say with a straight face that they’d be okay with a competitor beating AVXL to market if that’s what it took to end suffering quickly?
Sorry for the long rant — but this will be my last post here for a while, until the conversation is steered back toward the science and odds for success, because ultimately that’s the only thing that matters right now.
Best of luck and stay safe!
Well said!
OMAD, or one meal a day, is a more extreme version of intermittent fasting.
Beginners are recommended to start a 12/12 cycle and gradually move to a 16 hour fast and 8 hour eating window. Advanced fasting can go 20/4, but OMAD is typically the most extreme with one or fewer hours of eating a large meal.
As long as you’re having nutritious foods, eating enough calories (minimum of 8x body weight), taking a daily multivitamin to supplement any deficiencies, and drinking plenty of water throughout the day, OMAD is generally safe and effective.
A less extreme version of OMAD is the warrior diet; eat fruit, raw veggies and nuts in very small quantities throughout the day and have one large protein-based meal before bedtime.
Many studies have shown that intermittent fasting produces benefits that Fireman mentioned, including shedding dead or dying cells. Of course, there’s no money for the pharmaceutical companies with fasting or improving health through diet and exercise.
Technical Analysis can be helpful in the short term to determine if a stock is trading outside of its traditional price channel, but long term investors are better off relying on fundamentals such as balance sheets, sector analysis, and competent management histories.
I use fundamental analysis to decide whether a company is worth buying and technical analysis to help me decide when to buy. As for selling, I generally wait for a seismic shift — a big news event, a stellar earnings report that’s unlikely to be replicated or a similar black swan moment — that renders both fundamental and technical analysis temporarily useless. Sometimes this is a good thing and I’ll sell high, sometimes it’s a negative event and I decide to cut my losses.
Both methods have value. The trouble with TA is that everyone has different metrics and ideas about how to use it.
The people who ads complaining because we are 13 days past when data was expected are probably the same ones who still complain when their pizza isn’t delivered in less than 30 minutes.
As long as the Rett data arrives in the next 3-6 months, what’s the big hurry?
The secret of life is enjoying the passage of time.
How’s the performance been over the last year? 5 years?
The performance of the stock price doesn’t bother me too much. That’s shortsighted. Neither does Dr. Missling’s competence, for now. The only concern I have is whether Anavex can get A273 to market within the next 24 months. I believe it can if the data is well received.
The economy has been in a bubble for nearly a year. When the bubble pops, do most funds want their money parked in a risky non-revenue producing asset? We’re seeing a run for the hills. Maybe it’s the right move for those who can’t stomach the risk, the wait, or who wish to protect profits.
I’ll add one more thing:
In the 35+ years that I’ve owned stocks and more recently since the internet message boards became a popular place to discuss them, I’ve noticed there are a certain group of people who like to try to trash stocks online — presumably for the “benefit” of others.
What’s funny is that in the real world, I rarely encounter these benevolent and altruistic strangers. They must all be at home, online, helping random strangers by providing free and unsolicited investment advice.
I have seen people who owned a stock, gotten impatient, sold it, and later on regretted doing so. Sometimes they stick around and bash the stock because misery loves company, or they want back in at a lower price.
I don’t believe in conspiracy theories or cabals or investment funds hiring paid internet bashers — maybe back in the day, but not anymore — just like the mafia no longer runs Vegas. It’s all corporate now and they are more likely to play by the rules.
I think it’s wonderful that some people who previously liked Anavex changed their minds. Critical thinking is always a good thing and in order for my bet on Anavex to win, someone else unfortunately will have to be on the losing side of the wager. Generally speaking, when I change my mind about a stock and decide to sell, I don’t continue to stick around and talk about the stock on message boards.
My thoughts:
1. Dr. Missling sounded confident that the adult Rett data would be released soon. Whether its released Q4 2021 or Q1 2022 is irrelevant to the long term investors. Traders may be annoyed, but I doubt Dr. Missling cares too much about them.
2. When the analyst asked if the data would be released by end of Q1, Dr. Missling laughed. It sounded more like a confident incredulous laugh than a nervous, “I’ve just been busted” laugh.
3. This summer’s stock price to $30 may have been the worst case scenario for long-term, impatient investors — especially those who have a lot of Anavex and it’s now one of the largest monetary positions in the brokerage account. Nobody likes to see paper profits evaporate, but stock prices this year across the board have been overly inflated. Is GameStop worth $15B? Tesla worth $4000/pre-split? Of course not. Anavex got caught up in an exploding market, it has a cool story, and people wanted in believing that news was imminent. Probably the same people who bought at $10 in November 2015…
4. Anavex is trading exactly where it should be right now. It has no revenue and no guaranteed revenue, and it’s worth more than a billion dollars. If/when it gets a revenue-producing drug in its pipeline, the market cap will rise to the the intrinsic value in a matter of weeks.
5. Dr. Missling may be waiting until the last minute he can to release data, and additional stock options may be his motivation. Is it unethical? Yes. At the end of the day though, it has no bearing on whether the drug works and little bearing overall in the future market cap. If he can successfully bring a game-changing drug to market, I’ll happily accept a bit of dilution for his personal benefit.
6. Dr. Missling is unlikely to do anything that could send him to jail. Things like, “he’s hiding bad news” is ridiculous. There is a legal obligation to report material information in a timely manner. If you really believe he’s delaying or hiding bad news, collect the evidence and file an SEC complaint.
7. Dr. Missling probably doesn’t know much more than we do if the trials were double-blinded. He may have a more accurate hunch from little things he can glean here or there — but there is a reason he hasn’t done a sneak-peek as some impatient traders here insist that he do. There’s no reason to jeopardize the integrity of the trials this late in the game.
8. If nothing else, hiring new staff and speaking at investor conferences is a sign of confidence. If he knew that he’s holding a bad hand, he’s not going on roadshows —for the record, I wish he’d stop going to these. They’re irrelevant by now, he’s presenting to the same people every year.
9. Dr. Missling does not have any role in whether this drug molecule can successfully treat CNS disease. His competence becomes more important after FDA approval. For now, he’s made all the right regulatory moves. Talking about post-approval plans today is putting the cart ahead of the horse.
ALS is a terrible disease. I hope that Anavex has the cure, or at least the ability to slow its progression.
Good point. The caveat I’ll add though is that the stock has increased nearly 20x without any fundamental changes other than perception of the odds of success. We’re still a zero-revenue, zero-product startup that is one failed trial away from going back to $1.25. On the other hand, we’re one positive trial away from exponential gains.
Just the other day, there was a stock that performed well in P2 trials but failed its P3. The stock price dropped from $80 to $10 overnight. So, we aren’t out of the woods yet — in fact, I’d argue we are in the thickest part of the woods because to date we really haven’t received the thorough scrutiny of an FDA review.
The stock has been a money maker to those who have traded in and out, like yourself. Others, however, are still assuming a lot of risk by not selling. The trade off, of course, is that they will enjoy long-term capital gain benefits on the greatest amount of price appreciation vs. those who sold and reset the clock.
Thanks as always for your insight over the years. Stay safe and enjoy the holidays!
The secret of life is enjoying the passage of time. Any fool can do it.
Everyone is talking about accelerated approval. I don’t see that happening for the same reasons that Doc328 mentioned in an earlier post.
I think it’s more realistic to believe Dr. Missling will seek accelerated review, not accelerated approval, using the voucher if we can get Rett across the goal line.
This way Dr. Missling can provide more robust data but still get approval in roughly the same timeframe as accelerated review using a surrogate endpoint.
I was on my way to meet a friend for dinner tonight, but it was raining. I told him I’d be there at 7 pm, I didn’t arrive until closer to 7:15.
I felt bad, but I didn’t lie. I expected to be there by 7 and left my house at a time I thought was reasonable.
Same thing with Dr. Missling’s expectation of 2H 2021. I’m sure at the time based on the info he had that was a reasonable expectation. Just because he may not meet that goal doesn’t necessarily mean anything nefarious is happening behind the scenes or that he’s withholding data.
I agree with your assessment that early 2022 is reasonable. It will be here soon.
This is what I think too. I also believe the goal is to get a priority review voucher that will accelerate the approval for Alzheimer’s if the data is positive.
Question for the board: at some point Anavex will lose patent rights for A273. Generics will hit the market when the FDA allows competition. Assuming the clock for Rett begins ticking in 2022 or 2023, would each subsequent NDA for A273 extend the protection, or doesn’t it matter once the drug is approved the first time?
Today marked the first time that Dr. Missling seemed confident. In the past he used terms like “cautiously optmistic.” Today, he used the word “excited.”
Make of it what you will.
Easy come, easy go when it comes to the share price movement.
It takes on average 10-12 years to get an experimental drug to market in the United States. For startups, it’s usually toward the longer end of the spectrum.
At the current 5.5 years you’ve waited, that’s not anywhere close to the national average. I’d expect this to be approved or rejected within the next 18 months so there still well under the average.
Perhaps the issue isn’t so much the length of time it’s taking but rather impatience from investors? I’m sure Dr. Missling with his 1 million shares or whatever has a more vested interest than any of us in seeing data results, unless you believe it’s an intentional delay to continue milking a salary?
Your frustration ought to be with the FDA. They’re the ones responsible for bottlenecks and drug approval holdups, but most people prefer well-tested drugs rather than quick approvals to satiate a few impatient investors.
5.5 years is a long time to wait. It seems that those who got in a year ago sub-$2 were the ones who timed this perfectly. You and I, not so much…
They ought to open up the trials and allow more people to enroll.
The goal should be looking beyond approval. More data for a longer duration means less resistance from insurance companies. None of them are going to be excited about the prospect of reimbursing an expensive blockbuster drug that millions of people will begin taking all at once.
If we’re really concerned about the masses who are suffering though, it seems logical that Anavex should waive its patent rights and allow generics to hit the market ASAP particularly in developing nations, similar to what they’re trying to do with Covid-19 drugs. That would end the most suffering in the shortest period of time, no?
That would be fantastic. 1000 days isn’t all that long to wait for potentially life-changing news.
My guess is we get an update mid-December. I’m basing this on the FDA wanting to get a lot of its administrative housekeeping finished before 2022.
I don’t expect any news to include an Alzheimer’s sneak peek at the data. That would be a terrible long-term strategy.
My gut is that we see Rett approval in late 2022 and use the priority review voucher to accelerate an FDA decision right around the time the Alzheimer’s data should become available.
I agree. My fear is that we experience another overall market crash similar to December 2018. The stock market and underlying economic conditions have been diverging for a while. The only thing holding the stock market up have been bailouts and the fact there’s nowhere else to really right now invest other than real estate (illiquid) and Bitcoin (too volatile).
I don’t know how old you are but this seems eerily similar to the dot com crash. I know people who made millions reading during lunch breaks, I see the Reddit meme crowd as the same bunch. Right now they’re trading cohesively.
$30 represents a 25% appreciation from Anavex’s current stock price. My gut tells me that it will act as a level of resistance until there’s news. We were recently told 2H 2021.
I hope that nobody is 100% all-in anything, from t-bills to individual stocks.
For decades Bernie Madoff was as close to a sure thing as anyone could find. Look how that turned out.
Diversification and patience are the pathway to wealth.
Suppose you’re the CEO of a company and agreed to sell X number of shares on a certain day in the future. In this scenario, you’ve got a temporary price imbalance and the market is not correct.
Suppose there are allegations of fraud and hedge funds are required to sell their entire positions at once to avoid being sued by their investors. The fire sale price does not reflect the fair market value.
There are lots of instances where two parties agree to a transaction, and one side gets it wrong completely. Astute investors have made billions on arbitrage situations precisely because the market is wrong.
You are correct though that over the long-the long-term, the market is always correct. A day’s snapshot though often paints an incomplete picture, the same way a baseball player who goes 4-for-4 in a game isn’t a 1.000 hitter, despite what the box score says.
If the price can hold $23 for the next few days, it may be setting a new floor prior to its next move up. All dependent on positive data of course.
I personally believe any company with a promising but unapproved drug and zero revenue shouldn’t be worth more than $500 million market cap, but everything is overinflated in the current market.
$30 looks like it may happen in the next few weeks if there’s a good Rett update.
What’s the best guess for the rare undisclosed disease Anavex plans to test?
The market is overdue for a collapse. Problem is where else is there to invest? Property is overpriced too, Bitcoin is too speculative for most rationally conservative investors, gold has lost its luster because of bitcoin, and bond yields aren’t spectacular with artificially low interest rates the past decade.
It’s going to be really ugly when the rug gets pulled, especially for these younger investors who have never been through a prolonged downturn.
The good news is that biotech should be relatively immune over the long run. If blarcamesine works it doesn’t matter what’s happening anywhere else, the stock will go up on that news. And blarcamesine’s success isn’t dependent on bond defaults in China or the Afghanistan withdrawal or anything else that may spook the market into an avalanche.
But yes, you are correct that we are overdue for a correction. Today is just a blip when that happens.
It's unfortunate that Blarcamesine can't treat impatience or short-sightedness.
Actually, I think this is a good sign for Anavex. The more methods of action that are disproved, the more eyes will turn to Sigma-1 as a potential treatment.
My gut feeling odds of success are 60% for Alzheimer's. That's up significantly from the odds I gave Anavex when I bought my first shares in 2015.
Why do they have to figure out a way to get it done faster?
Slow is smooth and smooth is fast. Trying to rush through the process is a surefire way to make a mistake along the way.
Professional sports is littered with athletes who left college too soon and never realized their potential.
Dr. Missling has a lot more incentive to get this to market quickly than anyone posting in this forum. I'm sure he's going as quickly as he can while being sure that everything is done correctly, because a lot of times you only get one chance.
We've had this conversation before. I wouldn't hold my breath for approval for any disease until 2022 at the soonest, and you're probably correct we won't see Alzheimer's approval until 2023 at the earliest.
The future will become the present soon enough.
I'd rather see 12. Good buying opportunity at February's range.