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Nah, it's all good. Everything is on track for Alzheimer's. The problem is lofty expectations + impatience. Everyone thinks a P3 trial is doom-and-gloom and spells the end of the company.
I see Rett approval bringing in sufficient revenue to make everyone investing at current share prices some money. Maybe not millions, but it'll be a solid single or double for most investors. I don't think it's beyond the realm of possibility that Dr. Missling leaves some money on the table by partnering for a P3 Alzheimer's trial with a company equal to that of Eisai or Biogen.
The author is also short the stock so he has his own biased lens through which he's viewing th situation. Time will tell who is correct but a P3 trial only means that everything is progressing smoothly. If the data were complete dogs*t the Alzheimer's trial would have been shut down and the company would have pivoted and that's what the PR would have said.
All is well for now.
"No, FDA is not that simple. FDA review will look at numerous things and raise many questions. Ones I can imagine are related to: dropouts, titration, no dose response (if 30mg shows no benefit) and this a small trial (160 in treatment), etc. FDA will have many more questions that we can’t even think of. "
1. Dropouts are common in trials, especially when dealing with older patient populations
2. Re: dose dependence, the other night I was at an office party and had a single beer. I didn't even feel the slightest buzz. If I had 4 or 5 of them, I'll bet my co-workers wouldn't have let me drive home. Maybe 50mg is the magic number to see results?
3. Anavex is copying the oncology path with a precision trial. This allows for fewer participants. Also, Anavex designed this trial after having conversations with the FDA. It's highly unlikely the FDA would have allowed the trial to move to P2B/P3 if there were concerns about trial design, and it's even more unlikely that Anavex would have ignored the FDA's guidance.
There's also a reason why you're posting to this message board all day, every day. If you truly believe that $15 is the best case outcome and that more likely the stock is heading down in the near future, and for the sake of argument let's suppose you're being truthful about sitting on a profit from many years of holding the stock, most intelligent people (and you seem to be intelligent based on your understanding of more complicated research methodology) would sell immediately and move on to any of the other 4000 publicly traded companies that may offer a better risk/return.
And yet you're holding your shares, posting on this message board all the time even though you know nothing you write has any impact on how Anavex proceeds or what the FDA decides. So, what is the purpose of trying to convince others that they're wrong and Anavex is hiding something?
This was never a stock for the faint of heart. Ultimately it’s a two-part bet. The first part is betting on the drug working, which is out of everyone’s control. The second part is betting on Dr Missling knowing how to maximize value once it’s approved. I think this will be the area where he shines based on his experience and education
Disappointment typically comes from poorly managed expectations.
It’s easy to get caught up in the hype, but the days of wild valuations are over. The stock was never going to sail based on this one gust of wind. For that it’ll take FDA approval and we’re probably 6-9 months away from that at a minimum.
I can wait.
Anavex knows what it's doing and how to conduct a proper trial, and if you're able to dissect potential problems with the data, so too can one of the paid researchers Anavex hired.
The simple fact is that there's a sense of entitlement from some shareholders who believe that Dr. Missling must present all the data the moment it's available. In reality, he just needs to report the bare minimum to satisfy SEC disclosure laws, which he did at CTAD. If the data offered isn't good enough for you, either bet against it or move on to any of the other 4500 or so publicly listed companies.
If Dr. Missling is telling the truth, he doesn't have the complete data yet. If he's not providing the data intentionally, it's good business strategy not to reveal the entire hand if he believes that the company may be an M&A target.
Let's wait and see what the FDA says before you start talking about lawsuits. It's a nice way to try to scare some nervous shareholders but it's way too premature at this stage to claim as fact that Dr. Missling's actions are nefarious and illegal.
Yes, that is a nice dream but unrealistic in both timeline and expectations.
Most likely, there's going to be radio silence for a while. The message board will continue to kill time guessing the next move. Some longs will become frustrated and leave, shorts will claim victory, etc. Business as usual until one day we'll wake up to hear that the Rett P3 data is in. Or that Anavex has secured a partnership. Or the full data from the Alzheimer's trial has been published in a peer-reviewed journal.
I believe all three catalysts are going to happen soon, but soon is relative. For me, that means by Christmas 2023.
Mayo, following up here. What about the data in particular excites you the most and what changed your opinion after the video? Based on your interactions at CTAD, how do you envision the next six to twelve months unfolding?
TIA
That is one of the only criticisms I have of management -- I would have liked to have seen Dr. Missling and others put up some of their salary so they have a financial stake just as we do. Doing so would project confidence at a time when doubt is easily spread. And to be honest I don't have a good explanation that isn't bearish as to why there haven't been insider purchases, so the objective part of me weighs that into consideration.
But ultimately I think Dr. Missling is more the "why pay for something you can get for free" type of person so the lack of insider purchases isn't nearly enough to make me believe that AVXL is inferior to SAVA. Dr. Missling isn't a carnival barker and I appreciate that. Let's let the data do the talking and see how good of a negotiator Dr. Missling is if there are partnership opportunities in the near future.
You'd think so, right? The problem is that a lot of influential people stand to loose a lot of money and power if Lecamenab isn't profitable. Anavex needs a partner who can go punch-for-punch against an industry giant like Biogen or Eisai. Dr. Missling knows this and partnership is now my odds-on favorite for the next big catalyst. A partner like Pfizer would have zero problem funding and running an additional P3 trial if the FDA requires one, nor would it balk at having to wait 24 months if the reward is having the next blockbuster CNS drug.
The scary thing for shorts is that it's possible discussions are already underway. This would explain why Dr. Missling is taking meetings with hedge funds, and why Alzheimer's was removed as an A371 indication -- if I were a BP looking at partnering for Blarcamesine, I would absolutely require a no-competition clause to prevent Anavex from taking my money and using it to develop another drug for the same disease.
Mayo, thanks for this. When you said that your opinion changed slightly after the video, to what were you referring.
Are you still as optimistic now as you were on 12/2 at 8 pm?
Jesse Livermore also went bankrupt several times and ended up committing suicide. He lived fast and hard and it ended in tragedy. He was also a trader, not an investor. Warren Buffett says not to own a stock for a day that you wouldn't own for 10 years and the best holding period is forever.
I think they knew they had a winner. Personally I don't buy the "blame the CRO again" excuse and it wouldn't surprise me if they had most if not all of what they needed to feel confident submitting to CTAD prior to Anavex's rumored meeting with an investment bank in mid-November, shortly after it announced it would be presenting at CTAD.
As I mentioned before, why would Anavex present all the data if it didn't have to? There's benefit to keeping some things close to the vest. Or it could be that Dr. Missling is telling the truth and honestly needs more time. Nothing nefarious and he presented what he could at the time.
Attending CTAD was worthwhile if only because it makes a statement that the scientific community takes Anavex seriously enough to give it a coveted oral presentation slot. But everyone knew going into CTAD that Lecamenab was going to be the star of the show and outshine everything else all week. My friend once changed his birthday party to another day because a more popular kid was having a birthday party that same weekend. Unfortunately for us, right now there's a more popular drug right now that everyone wants to talk about. Anavex was always going to be a sideshow at CTAD. But this doesn't mean it was an inappropriate venue to present good results.
Let's get this data peer-reviewed and published in a journal. Announce the final data set then and put the final nail in the coffin before submitting for approval.
Be careful of believing everything you read.
Even if it is true, that's hardly going to move the needle. $2.5mm is big for a retail purchase but it's peanuts compared to the $30mm in volume the other day.
When funds start buying the stock is going to whiplash. I believe that is what we are seeing now.
Great question! I think Pfizer. But it's anyone's guess...
In 2022, the Houston Astros collective team ERA was 2.90. For comparison, the MLB team average ERA was 3.96 last season. By all accounts, the Houston Astros as a team had a dominant pitching rotation.
Justin Verlander's ERA was 1.75. Separating him from the rest of his team, it's easy to see that he pitched one of the best seasons in MLB history.
30 mg + 50 mg combined = Houston Astros team ERA, which was good enough to win the World Series.,
The 50 mg alone = Justin Verlander's ERA, which was good enough to convince the Mets to pay him $43 million next season when he'll be 40 years old.
That's how good Verlander was last season. Let's hope the 50mg subgroup is just as dominant, and unlike the Astros, there was no cheating taking place!
I'm in the market for a new car. I know it's a terrible time to buy and I don't have as much leverage as in past years, but I'm going to negotiate the best price possible. What I am not going to do is go into the dealership with all my cards exposed. I'll mention my trade-in after I've negotiated the dealer's lowest price and the used car trade-in will become a separate negotiation.
I call BS that Anavex only received the data 24 hours prior to CTAD and that Dr. Macfarlane flew in all the way from Australia without having any idea what he's going to present. Dr. Missling wouldn't allegedly be meeting with investment banks if he had nothing good to discuss.
The truth is Dr. Missling doesn't have to present the full data right now so why would he? Sure, impatient longs and day traders are frustrated but that's not Anavex's concern. Dr. Missling's job is to increase shareholder value and he can't do that without a product to sell. His focus should be and most likely is on the FDA -- and if the FDA wants the full data, it'll get the full data.
In the meantime, there's no need for Dr. Missling to provide full data just so he can appease Biochecker and Anshu and Kund on this message board. Doing so wouldn't be smart strategically, just as it's not a good idea for me to tell the car dealer that I have a car to trade in too early in the negotiations.
Like my old business school professor used to say, "strippers don't enter the stage fully nude because they're smart enough to not leave profit on the table."
Dr. Missling is smart to wait to release the full data at a more opportunistic time. Everyone knew this CTAD would be about Lecanemab anyway, so even the best data release would be overshadowed by the larger giant. If Anavex is truly an M&A candidate, keep the ace card close to the vest for as long as possible.
I'll bet we get full data around the same time we learn of a peer review article, and we get a partnership in place shortly thereafter.
And if he really did submit to CTAD blind, he's a riverboat gambler on a winning streak. Either way, all appears to be well with Anavex and Dr. Macfarlane did not sound disappointed per Mayo's CTAD writeup.
What video? And what are your perceptions of the data now?
"timing is everything in this world"
I agree. Timing is everything. And Anavex is able to afford a larger P3 trial without any shareholder dilution because Dr. Missling sold some shares when the market was just silly with valuations across the board. That's some good timing.
We're also entering a recession. Companies are responding to higher interest rates with less spending, and many are starting to hoard cash like a squirrel stores nuts for the cold winter. Anavex should be finishing this presupposed larger P3 trial around the same time the economy finishes its contraction cycle and we'll be in a position of great leverage if the data is positive.
Having the next blockbuster drug emerge at the same time larger BPs are flush with cash and ready to spend money again isn't a bad fall-back plan.
I still think there's going to be a P4 conditional approval as Mayo suggested. That seems to be the path Dr. Missling is pursuing and given Blarcamesine's safety profile, the benefit probably outweighs any risk of inefficacy.
I hope you’re right! I think for those who can afford it, off-label will happen. But the real fireworks begin when it’s accessible to the majority of the patient population.
Thanks for sharing the 20% statistic. That’s higher than I’d have guessed for off-label use.
Perhaps. Until I'm proven wrong, I believe Lecanemab will be approved and will serve as a placeholder until something better comes along. Unfortunately for Biogen and Eisai, there won't be much of a window to monetize their drug unless they're able to play the lobbying game and sabotage the competition -- which as much as I'd like to think the FDA is corrupt, if Blarcamesine is as good as advertised it will be approved whether in 9 months or 39 months from now.
I say let Lecanemab go on the market for a while. Let caretakers deal with recurring infusions and the high cost and for some, serious side effects. If anything, it'll just create more demand when something better comes along.
Viagra was great when it was the only game in town, but then Cialis entered the scene and could be taken once every 36 hours instead of once every 3 hours, and took away a substantial amount of the market share. I think the same thing happens with Anavex.
What's wrong with waiting a few more months? Seriously. If someone is frustrated there's nothing stopping him or her from selling and buying back later. I don't understand your logic or frustration. You speak of the mistake of urgency in your post, yet you sound like immediate stock price appreciation is of the utmost importance.
It isn't. The stock price is anchored until Anavex gets revenue, either through product sales or a partnership or a buyout.
I'm betting there will be a PR within six months that Anavex has found a partner to take Alzheimer's across the finish line. What do you think will happen to the share price then?
Conclusion? I feel like we're only just getting started. Everything up to this point was basically the pre-season. Now we know that Anavex is going to present its data and make its case for approval -- worst case the FDA says not yet, and Anavex can run the next trial without any shareholder dilution.
Besides, three years goes by fast in the grand scheme of things. Covid doesn't feel like that long ago. Time will pass. I'd rather wait three more years with a winning lotto ticket than wait 24 hours with a losing one. There's a 96% failure rate in Alzheimer's research. I don't think people appreciate what Anavex just accomplished with a successful trial.
All good. I too like contrarian opinion as long as it's supported with facts or points I hadn't considered.
While I wish that perhaps Dr. Missling had been a bit more aggressive countering some of the initial hit pieces, and I'd like to see him more actively involved with insider purchases to better align his interests with ours, these are minor and forgivable issues if he's able to successfully bring the drug to market. Ultimately that's going to be how he's judged.
My fear with off-labeling is that insurers won't cover it for this use, so my projections are a bit more conservative until Medicare and the Big 3 insurance companies agree to pick up the tab. When that happens, all bets are off as to its earning potential.
It's funny...I bought into this thinking it was just an Alzheimer's drug and now there's potential for a ton of other diseases. I found an article from 2014 about Sigma 1 and ALS. I wonder if this is the rare mystery disease they're referring to?
https://pubmed.ncbi.nlm.nih.gov/24334165/
I think so, but I still believe it has enough backing and enough merit and the risk of death is still so unlikely that it will be pushed forward and eventually approved. Especially if its developers feel there is a time crunch with other competing drugs entering the fray.
Lecamenab is going to be approved. It has too much efficacy and too much support from big players like the Alzheimer's Association and others to be rejected on the basis of a very slight chance of a serious adverse effect.
And for a while I suspect it will make some profit for Eisai and Biogen. The problem is that if/when Blarcamesine is approved, assuming it's as effective it will replace Lecamenab as the standard of care because of its oral vs. infusion delivery system and better safety profile.
Blarcamesine is, as far as we all can tell, a superior drug. Whether the FDA requires more proof is irrelevant in the long run. The odds of a failed P3 trial are very much de-risked now. Even those who clearly have a short agenda (and that's fine, short selling provides liquidity) have moved on from "this drug doesn't work" to "we need more data" to "it'll be another 3+ years.
Fine. I can wait...
Fireman:
1. It seems that you have me confused with someone who is short AVXL. I suggest you re-read my post history. I'm not part of the $1000+ tomorrow crowd but I've owned shares since 2015, own out of the money call options and have supported Dr. Missling since day 1 of my investment.
2. Speaking of Dr. Missling, there aren't many of investors in this forum who think he's doing a good job. I don't think he's a bad CEO just because of some communication missteps. All I care about is whether he can successfully bring the drug to market and then successfully market it. I see a company with positive P3 data and $150 million in the bank. If it takes another 2+ years for P3 trial, so be it. Rett should be a sufficient appetizer. I was critical of the blank check preferred shares, but I've come around to understanding the importance of having a poison pill strategy.
3. Most of my bearish sentiment is to counter the incessant enthusiasm that creates talk of caviar dreams. That time will probably exist but in my opinion we're not going to go from an $800mm market cap to a $20B+ market cap overnight. The company needs revenue to support it. Realistically, right now it doesn't even have FDA approval. Just because I see trends of irrational exuberance doesn't make me a short seller or anti-AVXL any more than you selling your shares when you heard about the millionaires club.
Anyway, think of me what you want. Everyone's wrong about something, and if you're going to make a judgement mistake I'd rather it be about my AVXL motives than a mistake in your line of work. Stay safe and happy holidays. Whatever your opinion of me, I do enjoy reading your posts because I mostly agree with how you think toward the long game.
Anyone have thoughts on the Jan 17 2025 calls?
$3 strike price is trading for $6.90, so essentially the bet is the stock price will be greater than $9.90 within the next 24 months.
I like those odds.
AP Chemistry senior-level homework takes a couple of hours. Analyzing the data from a large-scale trial will take significantly longer.
Patience is a virtue and the world lacks a lot of virtuous people, Fireman.
I've always enjoyed your posts. You and I are among the few who trust Dr. Missling and believe he is on the right path, and we both disliked the paper millionaires club talk.
I don't know much if anything about NWBO but it looks like an interesting investment. I think I prefer AVXL but I can see the appeal of NWBO too -- I also saw that Adam Feuerstein is a critic of NWBO so that is probably a bullish signal.
Best of luck. I think for AVXL the investment is a lot safer today than this time last week.
Dr. Missling could sell this OTC at Walgreens next to the Herbalife capsules and it would still be worth more than the current market cap. Hire a celebrity spokesperson and call it a day. But he won't, because the FDA is going to most likely approve Blarcamesine for Rett syndrome by Easter '24.
If the market were up 450 points Anavex would still probably be down on a sell the news event (conference call), just not as much.
If funds were going to sell they’d have sold on a Friday. This is temporary.
I think the FDA wants to see a safe and effective treatment that is superior to Aricept. Lecamenab is superior and it’s probably safe enough for most patients. I think it’s a lock to be approved.
But it’s also a pain in the ass to administer and it’s expensive and has some nasty potential side effects that, while improbably, will almost certainly make some physicians give pause…particularly if there’s an equally effective drug that is safer and easier to take and cheaper.
The question is whether the FDA will accept this data as proof of efficacy. I think that it might, if only because there’s a lack of better alternatives.
We find out in a few months. If it’s funds buying in, they have the means and ability to fade the price while there’s still a shroud of mystery hanging over the data. If they want in I’d imagine they’d try to pay as little as possible.
If it’s funds dumping their shares then you’re probably correct. But my guess is we’ll see elevated institutional ownership in the next quarterly
The drop today is more reflective of the overall market decline than anything specific to Anavex. Now is a good time to sell for those who speculated on the outcome of the trial but we're about to enter the dead period for a few months. I expect periodic PRs that will pop the price but the stock should tread water between the $8-$14 range for a while before climbing as we near Rett readout and an update re: FDA advancing Blarcamesine for Alzheimer's.
Anavex was rumored to be meeting with Piper Sandler. If its meeting with one investment bank it's probably planning to meet with others. Piper does have a bankruptcy division but with $150mm cash and no debt, I doubt Dr. Missling stopped by to say hello to that team. It also has a mergers and acquisitions team. Hmm...
Do you think waiting 1-2 years for a potential blockbuster is a long time for a company like Pfizer or Merck? Now is the ideal time for a company to make a partnership offer because it's a win-win. Anavex gets much better terms than it would have a month ago, and the partner company can invest more knowing that the risk is significantly diminished and possibly a P3 trial won't be needed (again, a big company like Pfizer has influence that Anavex doesn't).
If I were holding any sort of short position I would be worried that while Rett and P3 Alzheimer's may be months or years away, respectively, last week's trial introduced a potential new catalyst: a partnership or buyout that could be announced at any moment. Tick tock...
Doubtful, because off-label would require patients to pay out of pocket. Insurance won't cover Blarcamesine for anything other than a Rett diagnoses. So, I think it's possible that some who can afford it may do the research and request Blarcamesine but most patients will take whatever their MD prescribes and that will most likely be Aricept or Lecanemab depending on the doctor's tolerance for potential adverse effects.
Doc 328,
I respect your opinions here. And I think you are probably correct that an additional P3 trial will be necessary, but I don't think you can say "no doubt" that another trial will be required because nobody knows what the FDA is going to do. There's a case to be made that if Blarcamesine is safe, and there aren't better alternatives, why not approve it and see how it performs in the real world.
The risk of selling shares isn't the waiting game for 2+ years. Rett syndrome approval should happen within 12-15 months if the trial is a success, and I can see a partnership announcement or buyout well before then. I don't think many will bet against the next P3 Alzheimer's trial and Dr. Missling may decide if he has to run another trial, to go ahead and partner up now. He still has significantly more leverage than he did a week ago.
Fortunately the only opinion that matters is the FDA’s and their staff couldn’t care less what you think.
My guess is that every other biotech that wants in on the Alzheimer's therapy profit potential will be analyzing Anavex's data carefully and is assessing its own valuations independent of the current market cap.
At some point Dr. Missling will partner with a powerhouse rival to Biogen / Eisai and the Alzheimer's race will begin. Physicians will finally have more than one option and time will tell which drug is superior. When/if caregivers hear about a drug that can be taken orally at night and the worst side effect is dizziness, the cream will eventually rise to the top. I don't believe there are many caregivers that want to deal with bi-monthly infusions and the low but verifiable possibility of brain swelling.
I was critical of Dr. Missling for not partnering earlier. I still think it was an aggressive gamble to take for a company that has zero revenue, but Dr. Missling played the hand and the river card turned up in his favor. For that, I congratulate him with the CEO brass balls award. Partnership should soon be on the horizon and if I were short Anavex this would be my greatest fear...
Agreed. I've told myself "serenity now" several times over the past 7 years, particularly when Anavex releases positive data and some A$$H&*# writes a hit piece full of blatant lies. I'm all for criticism if it's warranted but at the end of the day, everyone knows that soup is not a meal.