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Don't poke the bear.
We'll see. I don't think the cost is going to be a significant factor -- Medicare should ante up and pay, if the drug works well enough to help some who take it. I'm looking at the hassle of infusions -- nobody wants to inject if they can avoid it. There have been countless attempts at finding an alternative delivery method for insulin because who wants to go through unnecessary jabs? If Anavex is available in pill form, and it works, and it's safe, it'll be approved.
We've come a long way since the days when our biggest concern was being delisted from Nasdaq post reverse-split.
There's no way Lecanemab isn't going to be approved. It works just well enough and is just safe enough and has the backing of influential people. It's a superior treatment and most who take it will be okay. Brain bleeding is a big risk but Alzheimer's is 100% fatal and that's why there are so many influential people rallying around Lecanemab. Compared to the current standard of care, it deserves to be approved for now.
For now.
If all Anavex has to do is match Lecanemab in efficacy but offer an easier, safer and cheaper alternative, I don't think approval is going to be too difficult to achieve. So I am excited for Lecanemab's imminent approval. It makes the bar for our own approval that much easier.
I don't think nor do I expect to receive any data prior to the JPM conference. If we do, great! But it's not a harbinger of bad news if there's no big announcement and the conference passes without fanfare.
There'll be the inevitable sell-off during and after the conference by the impatient and the speculators. And only time will tell if they were correct in their willingness to part with those shares.
Do you follow college football? TCU was unranked in the pre-season. Now it's playing for a national championship. Go back 12-18 months and you'd see that the foundation for success was being laid when it hired its new coach, signed some big time recruits and effectively utilized the transfer portal. But the season still had to play out before the rewards of those efforts could be seen. Nobody awarded TCU an opportunity when the big time news was being released last year.
The same is true with Anavex. You're looking at CTAD with the idea that it would be some sort of instant catalyst for the share price to go parabolic. Go back and read my old posts and you'll understand why that didn't happen.
What did happen, however, was another milestone accomplished in Anavex's quest to gain regulatory approval. That is progress. The share price will go up with regulatory approval, and that takes time just as making it to the college football playoffs takes time.
Don't conflate share price with success. Anavex's data may not have been air tight but it was certainly good enough to move company up in the standings.
Google the XBI chart and put it side by side AVXL's chart over the past year. They basically mirror each other. The market in general has been in a slide over the past year, so that trend isn't too worrisome to me.
I'm giving it two more years. That will have made it a ten-year investment, which officially counts as long term in my book. Time goes by fast so an extra 2 years is whatever to me. My gut tells me that everything will happen slowly, then suddenly. And I'd hate to sell my shares only to see it skyrocket a few months later.
The way I see it, we essentially lost 18 months to Covid. It's unfortunate but that's life. As long as I see progress, however incremental, the upside is too great for me to give way to emotional impulses to sell before the data tells me to.
I am not part of the WGT or God Bless crowds, but I will say that my optimism has increased significantly over the past 7 years. I originally gave Anavex about a 5% chance of approval, which at the time was a lot considering the 99% failure rate.
I think the odds of approval for any one indication are now greater than 80%, and the odds of approval for multiple indications are slightly better than 50/50. If the 50 mg cohort is observably improved over the 30 mg and placebo, I'd say we're looking at closer to 95% approval for Alzheimer's.
My critical faculties see a disease without a cure, one that the current treatment isn't adequate, and the alternatives either have safety risks or are not far enough along in their trials to pose an immediate threat. There is an evident need and if Blarcamesine can play even a small role in fulfilling this need by helping a subset of the Alzheimer's population, it will be approved. If another trial is needed, Anavex has the funds to run it without dilution.
I thought it was understood that I was referring to a 33% improvement vs. the placebo. I should have been clearer.
I tell my kids all the time all they have to do is hit the ball 3 times out of 10 and they'll go into the Hall of Fame. Baseball is a game of failure.
Interestingly, so is Alzheimer's research. I'd suspect that if 1/3 of all Blarcamesine patients responded positively, it should be a lock for approval. As someone else wrote a few days ago, the big picture here is not whether Blarcamesine is a panacea, it's whether making it available will help even just a small fraction of people more than what's currently available. Anything above a 33% success rate will put it in the pharmaceutical Hall of Fame alongside other drugs like Lipitor, Viagra, and penicillin. The bar is not set very high for us, and that makes me feel a little better about this investment.
I think so too. There's probably more than meets the eye here. Dr. Missling gave us the bare minimum he needed to in order to meet the material disclosure requirements. That's smart. It's the same as in poker -- never reveal your hand too soon
Lecanemab will be approved because it is a more effective treatment than Aricept, and while there is a risk of developing some pretty horrific symptoms, for the most part those who take the drug seem to be okay. If Blarcamesine had the same safety profile, I have no doubt many here would be saying that the risk of significant adverse effects is so small that it's still worth approving.
The real question becomes whether the FDA is willing to approve multiple drugs at the same time and let the best one win in the free market. My guess is yes, it will, despite the objections from Biogen and Eisai who don't want to see their billion-dollar investment have to compete with anything other than Aricept.
Someone brought up the possibility that doctors won't prescribe Lecanemab because of malpractice risks. If the drug is approved and legally available, physicians will be safe from any lawsuits as long as they are acting in good faith. Obviously if someone is showing signs of brain damage and they keep renewing the prescription order that's a different issue, but it's not going to be easy for Anavex to compete against these larger companies that spend hundreds of millions of dollars hiring attractive sales reps to wine and dine doctors in fancy vacation spots across the world -- unless we get an equally powerful partner ourselves.
Keep an eye on AstraZeneca. Everyone is saying Roche, but our new CMO spent a considerable portion of his career there and with a $214B market cap, it has the ability to absorb Anavex and compete against Biogen/Eisai as well as anyone.
This is going to be another unpopular opinion, but I do not think that we are going to receive the data everyone is looking forward to prior to the upcoming JPM healthcare conference.
Instead, I think Dr. Missling uses his time to briefly go over the data across all the trials that have been run to date. My guess is that many attendees may have previously ignored or disregarded Anavex's presentations in the past, but they will be much more closely following the company post-CTAD.
The purpose of this conference is to connect institutional investors (i.e., JPM clients) with unique healthcare-related investment opportunities. We should have the 50 mg cohort data soon, but my gut tells me that it won't be coming next week. I said the same regarding CTAD -- that it wouldn't be the price catalyst everyone was expecting even thought the net result was overwhelmingly positive for the company's future.
Dr. Missling is operating at his own pace as he always has. I expect he's going to make the next data release as bulletproof as possible, and as long as his target audience remains the FDA and not the shareholders, all should be well for our investment 12-18 months from now.
My wife loves to complain about all the things I don't do. She often ignores / forgets everything I do. That's human nature. Some people just aren't able to see the bigger picture and give credit where it's due.
Dr. Missling isn't perfect but he's perfectly positioned Anavex for the long haul. It has plenty of cash, no debt, a direct line of communication with the FDA, the potential for a priority review voucher and at least three shots on goal for approval.
So yeah, I'll give him a pass if it means not getting everything accomplished. I'm sure in the next few months we'll start to see him ticking off some of those action items and I'm fine with waiting. Why aren't you?
Adding to your point, I believe we haven’t reached the part where Dr. Missling’s talent will shine. A lot of these science-minded biotech CEOs struggle when it comes to running a profitable business. The fact that Dr. Missling is running several concurrent trials for multiple diseases, with $100 million in the back, no debt, fewer than 100 million shares issued and a poison pill to thwart a takeover is all I need to see to know he’s going to be a good post-revenue CEO.
As for the missed deadlines, I’m sure that Dr. Missling would love for everything to be complete. Is it possible he’s trying to bleed the coffers? Sure. But it’s more likely there are delays because…delays happen. I am patient.
And I just don’t see Dr. Missling using smoke and mirror tactics to claim statistical significance. Too much risk to walk the fine line with the SEC, when he could easily just announce that another trial is needed or he’s pivoting to A371 and Rett.
Speaking of Rett, even if that’s all Anavex had in its pipeline it would still be undervalued at $9/share. Blarcamesine has very good odds of approval for Rett because there are no approved alternatives, the Rett community supports Anavex and there’s anecdotal evidence that it works.
If Blarcamesine works for anything else, I’ll consider it a wonderful bonus.
It isn't fake nor was it debunked. I've reached out to the Alzheimer's Association and received similar feedback. The reality is that the Alzheimer's Association doesn't care which drug(s) get to market but it's not going to go out of its way to endorse a little-known molecule developed by an even more obscure small-cap company. Not when there are billions of dollars being spent by the larger players in the field.
At some point if Blarcamesine is effective as we all believe/hope it is, it'll get published in a peer-reviewed journal and at that point there will be a lot of mea culpas from a lot of organizations. Think of it from the Alzheimer's Associations perspective -- what benefit does it gain from endorsing Blarcemsine right now? To the rest of the world, Anavex is still a long-shot and is being treated as such. Only time will fix this, so we've just got to be patient (and vocal).
What we do know is that Lecanemab is going to be expensive, a pain in the ass to administer, and as rare as they are the side effects are significant when they do occur. The bar is not set too high for Anavex to surpass it, but Dr. Missling is going to have to do this on his own without the Alzheimer's Association's help. I'd be willing to bet that we'd be in the same spot with the Rett Society if any of the big Pharma companies were developing a Rett drug. It's just the way the world works...
No, but global warming may lead to an increase in Alzheimer's, creating more demand for treatments.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4298706/
If I were Dr. Missling I wouldn't want to release any more information to the public either. It has to be so excruciatingly frustrating for him to have to watch the internet erupt with claims that he's a liar and scammer while message board posters twist his words into something completely different like a bad game of middle school "telephone."
If the stock price is going to be hammered every time he speaks no matter what he says, why speak much at all? Eventually he'll get to speak to the FDA and that's the only audience he cares about.
The good news is that if Blarcaamesine is approved, the free market will have several options for physicians to prescribe and let the best drug win. Cash flows will determine the stock price, and Dr. Missling can move into the role he is much better equipped to play: the CEO of a profitable company in growth mode. This is where his Kellogg MBA is going to be put to good use and it's during this time the stock will show its greatest gains. Most of us will have moved on by then.
Buy the rumor, sell the news. I'm not surprised your stock went down. It sounds like it's just a temporary price move, if it can gain FDA approval.
Let the traders and the impatient and the risk averse have their scraps. If Blarcamesine works better than Aricept and is easier to administer than Lecanemab and is safer and less expensive than Aduhelm, it should be approved.
The value of Blarcamesine approval isn't going to be realized for 12-18 months because it'll take that long to get the manufacturing and distribution operations running in sync at full efficiency if Dr. Missling decides to go at it alone.
Those who want to short the stock or wait for more information should have time because Anavex is in a holding pattern for the time being. The risk, of course, is that partnership news could be announced at any moment. We know of one meeting Anavex allegedly already had last month with an investment bank. My guess is there have been other meetings with other firms that we haven't heard about. Where there's smoke there's usually fire.
I was ridiculed when I said that CTAD would be a non-event for the stock price despite the significant milestone.
The stock price will not go up until there’s approval for Rett or a partnership/buyout, and both of those are several momths away.
What’s happening now is a controlled accumulation from funds that see Anavex as a less risky bet than it was a month ago, and they’re trying to buy as many shares for as little as possible. They’ll get the traders and investors looking to protect profits, but it appears most of the shares aren’t for sale just quite yet.
We all have our sell price. With more good news the market cap should go up, just not right away. I’ll wait.
Here's a question that you fail to answer: if Dr. Missling is a liar or worse, why is the share price hovering in the $7-$8 range? Why hasn't the stock price collapsed to the intrinsic cash value? It's unlikely that current longs are buying more at enough quantity to keep the price afloat. So who is creating the support at current levels?
PS: There are plenty of possibilities. You just choose to ignore the others that don't fit your narrative.
I can name hundreds more companies that crashed before they succeeded. Share price does not always reflect intrinsic value. Just as you see the company as being overvalued, someone else on the opposite side of the trade sees a long opportunity. My point is that it's too early to tell who is correct based solely on a single metric like share price.
You say that nobody liked the data but I'd say nobody hated the data, either. Nobody's saying that the trial failed and that's it for Blarcamesine, turn the focus to A371. Worst case for Anavex, they have to run another trial. In the meantime, the Rett data should be sufficient for approval and that will bring in more than enough revenue to tide investors over until the PDD and Alzheimer's data is complete.
The dangerous game you are playing is assuming that other biotechs aren't interested in the data. Because if they are, word can spring any moment of a partnership. And I'd be willing to bet that the market will have a much more favorable reaction to that news and the share price will reflect such sentiment.
It takes approximately 10 years to drive a drug through the FDA process. Missling also had to deal with the pandemic. He deserves more time.
If a P3 trial is ordered by the FDA, the skeleton is already built. They have relationships with test sites and it's going to be much easier recruiting patients this time with the current positive data reported two weeks ago. "
There reality is that even with another 24-36 months, Blarcamesine is still on a timely track. Grade Dr. Missling however you want with how quickly he was able to rush Blarcamesine to market --- he also made the decision to divert attention and funds to run other trials to provide AVXL more than one shot on goal -- but now it's time to assess whether he has the business acumen to succeed and maximize shareholder value if Blarcamesine gets to market.
I believe he does. Northwestern is a top-tier business school and Dr. Missling has lots of experience in this area.
Sort of like how REGN went from $40 to $5 from 2000 - 2005. It's $720 now.
ISRG went from $34 to $11 during the 2009 recession. It's $262.53 today including two 3:1 splits.
So while you choose to look at AVXL as a story whose stock history has already been written, I look at it as one whose story is just beginning.
It takes on average 10 years to see a drug through to approval and distribution. So far Blarcamesine is around 7-8 years old in its current form. Add to that a pandemic that shut everything down for a year or longer.
Dr. Missling hasn't had all that much time all things considered, and the fact that the stock has doubled in 5 years shows that investor confidence is on the rise. Also, it reached $30 at one point so at its highest point it returned over a 30x gain from when many investors bought in sub-$1.
Fungi trial?
Correct. The idea that Anavex is winging it and just coming up with its own trial design and endpoints unilaterally is absurd, yet it's basically all the short sellers have to cling to in face of positive data.
If the data weren't good enough to submit to the FDA, Dr. Missling would have made it clear that more research is needed. This was the first time I can remember that he didn't use the term "cautiously optimistic" when describing the results.
I believe Anavex hit a home run. We'll see.
I once missed a flight out of LaGuardia because I was on the toilet. I had every intention of boarding the flight but life had other plans.
It turns out that flight had a mechanical issue and had to be emergency diverted to a small regional airport in rural Pennsylvania. The passengers were forced to board a bus to drive them to the nearest large airport where they had to wait for several hours to be re-booked on different flights.
Sometimes missing a planned deadline isn't the worst thing to happen. If we get some good data, great. If nothing else happens between now and the end of Q4, I'd still say that 2022 was a pretty good year for Anavex in terms of advancing toward the end zone.
Besides, this is the dead period for the stock market. I'd much rather wait a few weeks with a positive announcement after everyone's back from the holidays and ready to start investing their Christmas bonuses.
It amuses me that message board statisticians think they know more about trial design than the researchers Anavex has vetted and hired.
There are serious implications for knowingly manipulating data. It happens every so often but I find it hard to believe that Dr. Missling would so blatantly lie about meeting the endpoints when that isn't the case.
My bet is that the data is acceptable to the FDA because the FDA has been advising Anavex every step of the way. More likely, those who do not believe in the data have a vested financial interest in seeing the share price drop. They know they cannot control institutional holdings but it's easy to spook a few retail holders into selling, especially those unaccustomed to pre-revenue biotech volatility.
I'll hold my shares and wait until the FDA decides if the trial data and design is valid. No other opinion matters.
If that's the case then I'd have liked to have seen more positive recent posts from her family/caretakers. Only one post mentioned Anavex, but it would be nice to see her fully cured. Perhaps one day. Until then, all Anavex has to do is show an improvement and I think that by that standard based on what I saw on the website page, Anavex is going to be a success.
I remembered the name of the young woman whose family has created a Rett awareness page on her behalf.
Google: Annelise's Army Facebook, then scroll down to the September video of her walking around the school. Very inspiring stuff to see firsthand.
It sounds like she's had some rougher days in the posts following the one at her school. For all we know she could be taking the placebo. Regardless, it looks like between that video and the other testimonial that Blarcamesine is working in the pediatric trial. Fingers crossed for good results there.
I think there will be a buyout for the entire pipeline but not by the end of next year.
There was a video posted to Facebook several months ago by a family of a girl who was able to walk unassisted to school for the first time in several years. It specifically mentioned that she was taking Blarcamesine. I've looked for the video recently and couldn't find it, perhaps someone here has a better memory of it than I do. But that was all I needed to see to know that the data is supporting real world experiences.
I wonder how willing an insurance company would be to cover Lecanemab if there were a cheaper alternative that is equally effective?
The FDA is the first step but if a drug isn't covered by insurance providers, approval is basically a moot point. Biogen and Eisai know this, too.
Nobody boards the Titanic after it’s hit the iceberg. This is a positive sign for Anavex that the researcher believes in the data. Perhaps it’s just a money grab but I don’t think most people would risk a prestigious career to vouch for a company that’s peddling lies to its stakeholders.
More likely, he believes in the data and sees potential for a blockbuster drug.
Occam’s razor.
I used to follow this company when it was TapImmune, about six or seven years ago. It fell off my radar but I always thought it had potential back then. Can someone please point me in the direction of a 30,000 foot overview for what this company has been up to over the last few years and the estimated timeline for completing the P2 trial that's currently underway?
More importantly, has management given up on the breast cancer trial that was in collaboration with the Mayo Clinic? I don't see any reference to that trial on the company website.
Thanks in advance for any updates you can provide. I've been invested in another company that received financing from Lincoln Park and that's what got me noticing this company again.
I agree all looks well for Anavex. But I'm not ready to call the game quite yet because there are still a few innings left to be played and for now, those who have a vested interest in seeing Anavex fail will do their best to convince shareholders to part ways with their stock. The game ends when the FDA makes its decision -- I believe we'll have an AdComm and conditional approval with more data needed before the FDA fully releases Blarcamesine onto the population without restriction.
One thing that stood out to me was Dr. Missling's tone in the conference call and also the quotes in the 12/1 PR announcement. In the past he's used verbiage like "cautiously optimistic" and "additional testing will be required." Not so in the most recent PR. He seemed confident that he has enough to go forward with the NDA process. My guess is that we'll partner with someone well before the FDA makes a decision.
It's a pre-revenue company. If Blarcamesine gets rejected across the board, the stock probably trades around $2.50/share. There's about $2/share worth of cash in the bank and it has a separate pipeline with a promising molecule called A-371. However, I doubt the market would value it at more than $50 million or so given it's still in Phase 1 testing and the Anavex brand would be tarnished from the failed Blarcamesine trial.
Now, being rejected is different than the FDA requiring an additional P3 trial. Being rejected means the FDA does not believe there is any hope of it ever being approved, so the company decides to pivot to Plan B. There is a chance the FDA may not approve Blarcamesine right now, or the approval will be conditioned upon providing follow-up data after it hits the market. Either of these will blunt the share price slightly, but they won't drop the stock to the cash per share valuation.
The near-term floor is probably somewhere between $4-$6, if we didn't hit it already in the mid 7s.
Astrazeneca has a $215 billion market cap and is the 8th largest pharmaceutical company in the world. I think it has plenty of size and reach and financial ability to purchase Anavex outright if it wanted to.
For comparison, Roche has a $267B market cap, Pfizer has a $293B valuation, and Sanofi has a $119B market cap.
Astrazeneca is larger than Novartis, Bristol-Meyers Squibb, Amgen, Gilead, Glaxo, and Bayer (among others). And it desperately needs a CNS blockbuster drug in its pipeline...
My guess is that it'll be Astrazeneca. My hope is that it'll be Pfizer or Roche. But Dr. Hammond has relationships at Astrazeneca that I think will tilt the scale in its favor. In 2018 it pulled its Alzheimer's drug trial so now I think it'll go the costly route of acquiring a company in that space to compete with Biogen and Eisai.