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No, it shouldn't. As much as I would love for it to trade that high because I own a few of the $45 Jan 20 2023 calls that will probably expire worthless, the reality is that Anavex is still a non-revenue producing biotech with significant hurdles to clear before it's able to begin generating income. Just look at the Alzheimer's Association's refusal to even acknowledge Blarcamesine as one of many obstacles that Anavex's management will have to navigate. Unfortunately for us, Lecanemab is in the driver's seat and will be the next blockbuster drug to be approved. Fortunately for us, Anavex appears to have a better drug and I am hopeful the better drug will prevail -- but it'll take time, and it doesn't always happen (see: VHS vs Betamax, Windows OS vs Mac OS in the business world, etc).
Anavex shouldn't be trading for $200 by the end of the year. It shouldn't be trading for $50. But to your point, SAVA shouldn't be at $30+. Countless other biotechs are overhyped and overpriced. So if you want to compare Anavex vis-a-vis to the rest of the market, sure, it's undervalued. But that doesn't mean the market is correct.
Let's wait until there's some revenue and cash flow before we begin to make projections about valuation. The first step is getting approval. Then it's convincing doctors to prescribe Blarcamesine. Neither of those will be easy accomplishments, even though logic says they should be.
"So the only thing left is meet with FDA and plan for a large P3 trial which can start only in H2-2023 and give any results after H2-2025 at the earliest."
That's funny, a fortune telling machine on the Atlantic Beach boardwalk told me the same thing. Fortunately, neither of you knows the future. It's possible that another P3 Alzheimer's trial will be required. And if one is required I would be willing to bet the farm that not nearly as many people will bet against success the next time based on this trial's data.
Of course, it's also possible that the FDA looks at its available treatment options and decides to grant conditional approval with the requirement for additional study based on Anavex's safety. profile. That's an option you conveniently left out when you used the singular "only."
But playing devil's advocate for a moment, let's suppose that you're correct -- that the FDA will require another trial and the focus shifts to a Rett readout in 180 days. That really isn't all that long of a time to wait. June/July doesn't feel so long ago because it wasn't. And I think most investors are confident that a successful Rett trial will lead to approval which will lead to revenue which should tide everyone over until the Alzheimer's trial finishes up.
So while I agree that there is plenty of time to buy shares at today's price or below, I question why that is a bad thing? It's like someone saying you can buy a winning lottery ticket but the drawing won't be until 2025. Who isn't going to buy and hold?
I was going to ask if the weekend is enough time to get the 30 vs 50mg data?
If so, I’d expect a PR Monday morning, trapping many new shorts who bet against AVXL today.
I don’t believe that Dr Missling spends his time thinking about how to burn short sellers, but I can’t imagine he enjoys seeing his credibility attacked and part of me hopes that maybe this was the plan all along to withhold the best data for Monday morning…
The CEO equivalent of a 1-2 combo in boxing…
"Btw just absolutely massive trading volume today."
Volume often precedes price. Watch the transfer of shares from retail to institutions over the next 180 days. Once this stock is 85% owned by insiders and funds, it'll start its path toward its intrinsic valuation.
We have good data but we're still a zero-revenue producing startup without an approved drug. A lot has to happen before this stock trades at triple digits. Summer '2021 and the days of GameStop led to crazy valuations across the market but those days are long gone.
Anavex will have to increase it's share price the old fashioned way...through patience and a well-executed business plan.
That's like, your opinion, man. -- The Dude
Disaster? No. A disaster would have been a failed endpoint and the stock trading between $3 and $5 right now. In what world is being up 20%+ a disaster? Maybe some people had false expectations for what the share price should trade at today, but that's on them. I'm perfectly content with a 20% gain and a significantly de-risked investment from 24 hours ago. Even if we have to go at another P3 trial, I am confident that Rett will provide a nice revenue-producing appetizer while we wait. This is a classic buy the rumor sell the news scenario.
Shorts are exiting as they should. Some made money and some undoubtedly aren't happy with losing 20%. The stock price isn't going up because there are a lack of buyers. Some aren't buying because they already have enough stock (this is the category I fall into). Some aren't buying because they're spooked by people like you who say the sky is falling, what a disaster, look out below! And mostly what we're going to see is the slow transfer of shares from retail to institutional investors. These funds aren't interested in paying a premium for their shares, so they'll do what they can to keep the price contained as long as possible while they accumulate.
At some point one of two things will happen: Anavex will partner or get bought out, causing a one-time parabolic increase. Or it'll grow naturally on its own and its cash flows will preclude a low valuation.
Just because a team wins the Super Bowl doesn't mean they get their rings right away...
It's like the legend that Fred Smith took his last $25,000 to Vegas and won big, letting his company FedEx survive another day...
Traders may be disappointed with the lack of a 100% pop in today's stock price but history has proven that it's not difficult to suppress a small-cap company like Anavex -- temporarily. That's the key word. The only opinion that matters belongs to the FDA, and Adam Feuerstein and his ilk have zero influence over what it decides. Maybe another P3 trial will be required and maybe it won't. Time will tell.
While yesterday is certainly worth celebrating, we're still not out of the woods. In some ways the difficult part is just beginning. The FDA can be influenced more easily than a blinded data trial. Logic should reign supreme but if that were the case, Biogen's Aducanumab would never have been approved. The FDA doesn't always get it right and with billions of dollars at stake, it wouldn't surprise me to see increased efforts to delay or derail Anavex's efforts to become the first to cross the finish line. Even if approval happens immediately, companies like Eisai spend millions of dollars hiring attractive and personable sales reps to develop lasting relationships with physicians and offer them golf trips, expensive dinners and other perks. If you think Adam Feuerstein has power and influence, just wait until the seven-figure lobbyists make an appearance.
If Anavex wants to become a major player in the field, it'll take some time -- even with a blockbuster drug. It's like a talented 1st round draft pick who has tons of raw talent but needs time to develop. The stock price will ultimately be determined by the quality of Anavex's marketing team, something we can't assess yet because it doesn't exist. My guess is that we'll never find out because someone will make a partnership or buyout offer that most shareholders won't refuse.
This can't be correct. I mean, I guess it is but it goes against all reason to submit blindly to CTAD and for CTAD to offer a late breaking time slot without having seen the data first...
Wait, Dr. Missling didn't have the data until yesterday? So he took the gamble of going to CTAD with the possibility of reporting bad data? Weird. Not what I expected. Still, not a good look if there are errors in the data. Trivial or not, no need to give the likes of AF even more attack ammo than necessary to try and keep the price down...
Congrats to all the longs here. It's been a wild 7+ years for me and many others. Not sure how this will play out in the coming weeks but it feels nice to know that we live to see another day. Now it's a matter of hoping Dr. Missling can fend off attacks from larger companies with a profit motive and FDA connections that run deep. I think there will be a partnership, and Dr. Missling has the leverage. Good luck!
Correct. I don't think many people realize that we, the shareholders, are not the audience. Nor are hedge fund managers or short sellers or hack journalists. We're all free to form our opinion and the share price will bounce around up and down as we all duke it out over whether the data is good or cherry picked, but ultimately the medical community will decide Blarcamesine's value and the rest of us will act accordingly.
You get it. I’m looking at the data and that will determine my excitement. Obviously I want a nice pop in the share price but if it drops to $5 or $6 on positive data, so be it. The hit pieces are probably ready to go anyway…so I’m hoping for the best but not holding my breath. I just hope the millionaire’s club keeps its collective mouth shut so as to not piss off the stock gods again…
It’s a big milestone for the company but in terms of the share price, I’m not expecting even with great news that the stock goes parabolic to $40+ like many are predicting. If anything even with positive data, based on history the price may even initially drop if there are attack articles and hit pieces falsely claiming a failed trial.
The big event for me is FDA approval. The quality of the data will help me decide the odds of approval. The share price is irrelevant until then because approval is when the big pop happens.
We can have great data and still face headwinds from larger biotechs with political influence that don’t want Sigma1 to become the next big thing. I think good data will lead to approval but the path may still require more hurdles to clear such as AdComm.
Today is a big day for the company. It may not be a great day for the share price. Expect the shorts’ reaction to be negative and be pleased if something better happens. That’s how I maintain my sanity and rational thinking whenever Anavex releases data.
It’s possible. Seems most of the time people get excited to the point of irrational exuberance only to be let down when the price action veers the other way (remember the conference in July ‘16?)
But I’m not looking at today as some sort of major event. It’s good to have data but the event I’m looking forward to is the fda decision. All I need to get out of today is data that’s good enough to get in front of the FDA for review.
No matter what happens today, the stock price will take care of itself. Eventually.
A bird in hand is the right choice for the risk-averse...
I picked up a handful of $45 Jan 23 call options for a .25 each today. Pure lotto speculation but if this thing does get some momentum, it'll have been worth the small risk of losing everything.
We'll see...
Correct. Everyone seems to be misinterpreting what I posted.
My point isn't that AVXL should forego the Alzheimer's trial NDA if the data is positive. But if they have to run another Alzheimer's trial, I'd prefer for the company to spend its time and focus on bringing the drug to market sooner for another disease, such as Rett, and taking the low hanging fruit of a free $100mm rather than continue to spend money pursuing Alzheimer's.
Obviously if both can be done simultaneously that is the best option of all.
There are lots of things in life that are generally accepted as safe, but still "may be fatal." Driving, flying, skydiving, swimming, the list goes on and on and on.
So yeah, I get what you're saying but you're looking at it too granularly. My point was that once a drug gets to the FDA review committee, safety usually takes a back seat to efficacy until or unless there are serious questions raised from previous trials (i.e., brain bleeding).
I agree. But the "we got this" crowd has been wrong many times so I don't put much stock in their opinions. Hope for the best, prepare for the worst. What we're seeing is the latter right now. Anyone who has sat out on the sidelines isn't going to buy-in last minute. Many who are sitting on profits are going to lighten the load, and right now margin requirements are greater so we're seeing more and more margin calls which lead to more sells which leads to...
It doesn't matter if the stock is at .01 or $100 on Thursday at close before the news is released. Whatever the price, it will meet its intrinsic value sooner or later. Until then...
1. If Alzheimer's doesn't work out, we still have several other trials
2. If Blarcamesine is a dud, we still have another drug in advanced development.
3. And we have $150 million in the bank with minimal debt.
You know what? Now I get it. WGT!
So let me get this straight. You're sitting on a boat load of shares from 2015, which means that you're probably up at least 400%, safely playing a lotto ticket with a decent chance of paying out, and you're upset at the guy who got you to this point?
It's hard to please everyone all the time.
Dr. Missling isn't perfect, but I think you're going to see him excel at the business side. Not PR or communications, but with deal making and business strategy. I'd rather have an MBA from Northwestern managing the P&L than a PhD from MIT.
If it's going to be delayed anyway because the FDA requires another P3 trial, I'd rather see the company shift its immediate attention to Rett.
Even if we have stellar data, where's your evidence that the FDA is going to drop everything to work with Anavex for accelerated approval? There's finite manpower at the FDA. We could be waiting in line with our Alzheimer's NDA for months or longer, no matter how excellent the data may be.
Does anyone remember the parent who posted on Facebook the video of her daughter's progress with Blarcamesine for treating Rett? I vaguely recall her walking to school for the first time but I cannot find the post. Does anyone have a copy of the link or the post? Thanks.
Okay.
I'd still think the fastest path, even with a few month delay, is to get Rett approved and use the voucher to accelerate approval for Blarcamesine. Even though we may think it's the most important drug in the FDA's docket, the FDA may not feel it's as big of a priority as say, a new cancer drug that requires the same amount of manpower to review.
I'd rather have the voucher and know that Anavex will be escorted to the front of the review process line.
Perhaps. That's beyond my level of comprehension about neurological disorders. But if FTD is a specific type of Alzheimer's, what you wrote seems plausible.
Bingo. It's terrible from a humanity perspective if there is a better alternative out there being withheld because of profit motives, but that's the way the world works. The free market will decide if another drug works better enough to spend the time and money required to bring it to production.
That thing on your neck is not a hat rack. I don't profess to know what Thursday will bring. I do know no matter the outcome, some here will gloat and some will cry. 5+ years, countless hours and thousands of dollars worth of emotional attachment are about to come to a head and all we can do is sit back and watch. Tick tock...
But since we're all just killing time anyway, here are some things to consider:
1. It's unlikely that the data is so bad Anavex is going to shift its attention away from Alzheimer's. They wouldn't be presenting this info at CTAD. We've come a long way since the days of Anavex+ (remember the high hopes for that?) and Dr. Missling isn't going on investor road shows, submitting for late-breaking oral presentations, and allegedly meeting with investment banks because he plans on telling the world his company crapped the bed.
2. I see removing Alzheimer's from the A-371 list of indications as a simple oversight. Occam's razor applies here. Or perhaps the data they're about to release is so good that there's really no more need to focus on Alzheimer's for a while. Blarcamesine may be all that's needed. Perhaps Dr. Missling believes that Blarcamesine did so well that it's likely A-371 will only have a marginal improvement, and money is better spent testing other diseases?
3. As shareholders, do we even want Alzheimer's to be the first NDA submitted? I don't if it means precluding the Rett priority review voucher that's worth up to $100 million. $100 million is a lot of money to forego, even if you do have a blockbuster drug on the horizon.
4. I trust Dr. Missling. He's not perfect, but I think he's intelligent and understands the business world arguably better than he understands the science/FDA process. I judge biotech CEOs on two levels: pre-approval and post-approval. I think whatever deficiencies he may have shown will not be so prevalent when making business decisions. Currently Anavex is running multiple late-stage trials and still has $150 million cash, no debt, a significant line of credit to tap into, a relatively low float, and poison pill protection to discourage a hostile takeover. That's the business savvy I want to see when a company begins generating revenue. I believe he knows how to scale a company. We'll see.
If we know that Thursday isn't going to be awful news, that means it'll either be mediocre, good, or stellar. Fortunately for us, the bar is set so low with Alzheimer's that even if the data is just mediocre, the FDA, and more importantly the medical community, could decide that "mediocre + safe" is better than "good + brain bleeds".
But I think the data will be good, not mediocre, and that will certainly be good enough to at least begin the the NDA process and see how the FDA responds. I'm betting on it moving forward but it'll have to get past an AdComm first.
I agree with most of what you wrote. I don't see the Alzheimer’s trial failing in your definition. If the data were so bad that Anavex is no longer interested in pursuing Alzheimer's, they wouldn't be presenting this to the world at CTAD and CTAD certainly wouldn't have provided a coveted late-breaking oral presentation to make such an announcement.
Why is it interesting that nothing was mentioned about Anavex? It's a big deal in the echo chamber because we all have a personal interest in the outcome, but I'd venture that most people attending CTAD are only familiar with Anavex at the most cursory levels.
There are so many other presenters, each believing his or her research is the most important on the entire slate. Anavex right now is still a small fish in a big pond. Maybe our fish becomes a little more visible on Thursday afternoon.
As I suspected...short covering ended and the stock faded back into the red.
It'll continue to see-saw between those who think Missling is a scam artist and those who think he's a legend. 48 more hours to place the bets, take profits or mitigate existing losses.
Tick Tock.
See again, I don't think you understood what I was saying.
I know that safety alone is insufficient for approval. But we also already know that Blarcamesine is safe. So the question now becomes whether it's effective enough to justify the time and expense of submitting to the FDA for approval.
And when it comes to a rare pediatric disease, the FDA seems to have more of a soft spot for approving drugs that otherwise may not have been approved based on questions surrounding imperfect data.
As for the FDA and insurance companies, approval is not mutually exclusive to reimbursement. It can sometimes take years for an insurance company to finally approve covering the cost of a an expensive treatment, especially for rare diseases. Insurance companies are in the business of trying to do everything possible to deny a claim. They'll label a drug or device as experimental and take a wait-and-see approach toward paying a claim.
Getting a drug to market is hard. Getting insurance companies to cover a new drug can be even harder to accomplish. Do a quick Google search and you'll find a list of drugs the FDA approved because they were safe and at least marginally effective, but insurance companies still won't cover except for the most expensive policies with the highest premiums most people can't afford.
But don't take my word for it. Here's a link to Blue Cross. Second sentence for why a drug may not be covered:
"It might be because it's a new drug that doesn't yet have a proven safety record."
So yes, the FDA does approve drugs and then let insurance companies decide whether they want to pay for it. Safety is irrelevant because all drugs that make it to P2 or P3 have been proven safe.
Nah, this is just short covering from yesterday and a few traders playing the dead-cat bounce. SAVA is up, the XBI is up. Let's see how this finishes the day. My hope is that it stays green but it only takes about a quarter to drop the price back into the red.
Half of this country is suspicious about COVID vaccines and refuse to take them or were forced to in order to keep their jobs. You may be underestimating just how far people will be unwilling to go when it comes to putting unknown substances into their bodies -- especially if they see no actual benefit to doing so.
Yes, there may be some who figure "what do I have to lose." But there are probably an equal number who say, "What do I have to gain?" and would decide not to continue if there weren't noticeable benefits.
I am more interested in seeing how long it takes for MayoMobile's summaries to leak to the rest of iHub. My guess is that it won't and we'll have to wait until December 7th to hear his perspective, which at that point will be just for fun and games since the market will have fully digested the data and formed its own opinion of the company's future.
Buckle up.
I'm not sure I follow what you're saying. I never stated that Anavex can just submit anything to the FDA willy nilly. I said that data that isn't spectacular should still be sufficient to submit if it shows a semblance of potential for an affected sub-group.
It's up to the FDA to decide whether to approve a drug, but Anavex can submit whatever they'd like whenever they'd like. Dr. Missling has been extremely cautious to time this correctly, to the point where many on this forum wanted him fired for taking too long to submit.
I believe Anavex has data that it believes is good enough to submit to the FDA. On Thursday it will share this data with the world. Whether the FDA decides to accept the submission for review is beyond Dr. Missling's control but the data is ready to go. The only holdup might be if Dr. Missling decides to submit Rett first after the Excellence trial concludes, so as not to interfere with the rare pediatric voucher that is worth up to $100mm.
Nope. Not at all. If the data were staggeringly bad, they'd have PR'd it on a Friday afternoon and followed up a few weeks later with another PR informing the shareholders on the new corporate strategy and how the $150mm in cash will be used.
They clearly saw enough positive data to submit to CTAD, and CTAD saw enough value in the data to award a coveted late-breaking oral presentations slot (something AVXL has not had in years despite a continued presence at CTAD).
Correct. Rett syndrome may not have been on the forefront of anyone's mind when first investing in Anavex, but it could be the life preserver that saves the company (and our investments).
A poor Alzheimer's result will probably result in mass selling to the point where Anavex once again becomes undervalued. People will assume that if A273 doesn't work for Alzheimer's that it won't work for Rett or anything else. But I think the bar will be set much lower for Rett patients because it's a rare disease with no treatments that affects kids. As long as Anavex is safe, I see the FDA approving Blarcamesine for Rett syndrome and letting insurance companies decide whether they want to cover treatment costs. A similar thing happened with Sarepta many years ago.
Let's also not forget the $150 million in cash, zero debt, and A-371 to fall back on. Poor results or another trial will be a painful gut punch on 12/1, but not a fatal strike to the company's long-term prospects.
Excellent post.
I'll add that if there is a data leak, I'd expect the stock to be down a lot more than just 25%. It was a rough day yesterday in general with the market dropping several hundred points. We're seeing tax-loss selling begin and a competing drug is showing evidence that it may not be safe. And of course there were those who were genuinely expecting the data to be released yesterday. All of these factors contributed to the price decline, but I'd imagine that truly poor results would have tanked the stock even more.
From a risk/reward perspective, I don't think many people are expecting truly terrible, back to square one results. Assuming that's valid, the data is going to be decent, it'll be good, or it'll be great. Good is probably sufficient to move forward with an NDA. I think that's where we'll end up. Good, not great, but good enough to kick over to the FDA to see what it thinks. Worst case the FDA punts back to Anavex with a request for more data. Best case it gets approved. I like those odds, especially with another shot on goal coming soon with Rett -- a disease that desperately needs a cure and one the FDA is more likely to be sympathetic toward (see: SRPT and how it failed its AdComm meeting but still got FDA approval)
The planning won’t take nearly as long this time around. That’s the benefit of precision medicine. They know exactly what to look for now. But even if it does take longer, if Blarcamesine gets approved for Rett within the next 12-18 months it’ll take the sting out of a delayed Alzheimer’s NDA.
Yesterday was an obvious day to sell for many reasons:
1. Overall the market was down several hundred points
2. Tax loss selling season has begun now that we are past Thanksgiving
3. Time is running out for the risk adverse to exit AVXL
4. Fund managers are mitigating risk, especially those sitting on profits. Portfolio managers do not get fired for selling a winning stock early, but they will lose their jobs for holding a dog of a stock for too long. If they can sell for 25% profit, they’ll get their bonus this year. Why risk clients’ money on an unknown outcome?
5. It’s possible that Anavex was selling shares to raise money. We won’t know for a while but if that’s the case, it’s more likely they’ll have another trial. But I didn’t get the impression that Dr. Missling needs an immediate cash infusion.
6. Didn’t a competing drug just announce yesterday that it has safety issues?
All of these are reasons for the big drop. If news had leaked my guess is that we’d see a drop much greater than 25%. We’ll see. I expect a few more days of panic selling. It’s human nature.
Good point. Devil’s advocate…wouldn’t it be equally or nearly as strange for the company to run another AD trial immediately after submitting an NDA for the same indication? Could it be that they are confident in the Alzheimer’s data and no longer feel the need to rush through an AD trial with A371, so now they can focus on other diseases such as schizophrenia?
I don’t think Anavex will unilaterally decide to run another trial until after the FDA requires them to do so. I think Anavex takes its shot on goal first with the NDA…unless the plan all along is to submit Rett first in which case another AD trial isn’t as big of a deal if it has approval for another disease
I’d put the certainty at 100%.