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Let’s suppose that Anavex does need to run a new trial and it’ll take another 2 years. It wouldn’t be the first time the collective on this forum got it wrong. Remember 2018 New Years when everyone thought that we’d have submitted to the FDA by then?
But my point is who cares if there’s another trial for AD? All that means is they submit for Rett approval first, which I think was the plan all along to preserve the priority review voucher(s).
That's one way to look at it. But I see something different.
I see a CEO who has navigated a difficult path. Over the past 7 years there have been countless hit pieces and short attacks, numerous baseless allegations and frivolous lawsuits, a pandemic, a recession and several competitors' drugs biting the dust to get the company to where it is today: front and center at CTAD 2022 presenting data about a novel MOA for treating Alzheimer's disease.
And the company has something like $149 million in cash and minimal debt. This is an enviable financial position any biotech startup CFO would love to inherit.
Dr. Missling isn't perfect but he's done a good job of putting Anavex in a position to succeed. He took some bold risks not attempting to partner with anyone too early on, and in three days we find out if he made the right decision.
I don't know what the data will be, but I am almost certain at worst it'll be neutral and that's a win for me. I'm not in any hurry and if the stock price drops while they run another trial, so be it. I've owned the stock for 100 months, what's another 18-24?
I agree. I just don't like baseless pumping, followed by disappearing acts. We went through this in 2015 and a bunch of novices lost big. Wash and repeat by the same clowns...
I laugh when I read people counting their money before the trial data is in. The stock gods have a fun way of hammering these people back into reality.
Smart move. Not worth risking accidentally saying anything that could get him in trouble for premature disclosure.
In the legal field they tell clients to keep their mouths shut. I’m sure the company’s attorneys told Dr. Missling the same thing and he stuck to the script
Sell it all now, Mortimer! Sell sell sell!
If that's all that were going to be said, that would probably not have an adverse impact on the share price.
So, I guess the question now becomes what happens if there isn't a PR like that? Can we infer mixed data results? We already know the hit pieces will claim the trial failed no matter what they report (see: NWBO) but I still don't think we will see any similar press releases from the company until CTAD. We'll see...
Interesting points that I hadn't considered. Thanks for clarifying your position.
I hope that Dr. Missling doesn't give everything away in a partnership. I am particularly excited about the mystery indication. I believe that it's going to be ALS.
But why would Dr. Missling release the data now if he's not required to? Doing so would deflate the CTAD presentation's impact and give hack pseudo-journalists the opportunity to pre-write their data rebuttals. What's wrong with waiting for CTAD if the data is truly a game changer? I don't see the logic there.
I put the odds of a partnership announcement this week at 3%. It'll happen one day, but most likely not anytime soon. Dr. Missling gains full leverage after the FDA approves the drug. Until then, any negotiations will be predicated on the remote possibility of an FDA rejection and will bake that risk into the amount offered for the partnership.
Shorting is necessary to create liquidity in some markets. It's the unregulated, unenforced naked shorting that is the problem.
I may be mistaken but isn't there an investor on this board who will be attending CTAD? If so, maybe we'll get access to some real-time information. Although I suspect that Anavex will have published the data in a PR prior to its late-breaking presentation, otherwise it creates an unfair advantage to those in attendance to receive access to material information before the general public. But I thought I saw a post about someone who is going to be at CTAD.
Data will probably not be available to anyone until 12/1. It's a week from today. We've all waited 7 years, what's another 7 days?
The irrational exuberance is a point of caution for me, just as the millionaire talk was a huge red flag back in 2021. There will probably be a lot of disappointed people when Monday comes and goes and there's no data readout. And I'll bet at least a handful of weak hands sell because they don't have the patience to wait another 72 hours.
Maybe the panic selling will prove to be a smart move if the data is bad. Or maybe they'll be kicking themselves and will have learned a costly lesson that Buffet summed up by saying, "the market is an efficient mechanism to transfer wealth from the impatient to the patient."
Place your bets...
Doing so would take all the wind out of the sails at CTAD. No thanks. What you're proposing is akin to opening Christmas presents a month early.
Got it. That I do agree with...
I respect your contributions to this forum, you're one of the only posters here who I actually take the time to read everything you write, but I disagree with you on this issue. I don't think scientists at Biogen or any other big Pharma are spending their time on iHub message boards reading what a bunch of small-time retail holders are writing.
My point was more that no matter what Dr. Missling presents, it's not going to overshadow the other presentations. It'll attract some attention, give something for the attendees to think about on their flights home, but I expect most people there will curb their enthusiasm and the share price movement will reflect this (i.e., if there's good news maybe we see a 15-20% pop, but we could just as easily see a hit piece come out that day followed by a short attack). As I am not planning on selling on 12/1 regardless of the data, the stock price is of little concern to me on that day.
I don't expect there will be much fanfare at CTAD. Certainly not to the level many here are predicting. I get it. As investors, this is an exciting make-or-break moment that we've waited years to happen. But for most attendees, Anavex is just one of many interesting presentations that they'll attend. And while Sigma-1 may get some more credibility on 12/1, I don't think it's going to be an "earth is round" moment that causes everyone to rush to hear what Dr. Missling is presenting to the point where other presenters are left with an empty audience.
As for the stock price, a positive PR may cause a 10-20% pop and more importantly should create a new price floor even if it fills the gap. The long-term share price many want to see is still a few years away, after Blarcamesine has been approved and is generating substantial revenue and is a household name to those who suffer from CNS disease.
This is a good point. The flip side is that the hurdle has been the same size for years and there's still a 99% failure rate. What makes me intrigued about our chances is that we've stumbled on a new way to jump that will hopefully make clearing the hurdle a little more likely. We'll see.
No, it shouldn't. Not yet. Not until it starts producing revenue. Right now there's no guarantee Blarcamesine gets approved. We all hope and expect that it will but nothing is for certain and until it is, Anavex's market cap is trading where it should. In time it may be a big enough of a blockbuster hit drug to warrant a $20B or greater MC.
1. Don't believe any "get rich quick" schemes or stocks. Every so often its possible to hit a home run but in your situation, slow growth is the fastest path toward accumulating wealth through investing. Here are some basic tips that apply to all ages and situations:
Buy quality stocks that have a history of paying dividends, and reinvest those dividends.
You don't need to own 20 or 30 stocks, just one or two of the best companies in 5 different sectors that aren't highly correlated that pay dividends.
50% US stocks
10% Metals
10% Bonds
15% Cash
15% High risk / high reward companies like Anavex.
This is a fairly conservative portfolio but if your high risk stocks are winners, can still generate wealth fairly quickly. If you're not comfortable investing in bonds, you can always diversify with international stocks instead.
Good luck!
Correct. The data is embargoed until it is shared live. This doesn't mean that someone like Adam Feuerstein who has media credentials can't request the abstract and receive it early -- he's just not allowed to share anything until the embargo is lifted.
What he can do is request the abstract, have something pre-written, and publish it seconds after the data becomes live. Legally he's in the clear even if it does violate the spirit of the embargo process.
Free advice is worth what you pay for it, but here goes: you should consider selling that half now because there's going to be more hit pieces, and based on his past history Dr. Missling will continue to ignore them as he should.
There may have been a time in 2015 or 2016 when Anavex's financial position was so tenuous that a blogger like Adam Feuerstein or Jean Fonteneau or Tim Sykes could harm the company, but those days are over. Anavex has a sufficient cash runway so even if the share price drops short-term, there's no immediate need for additional dilution.
If I could bet on the odds of there being a hit piece and a muted response, I'd wager the odds of positive data are over 50%, but the odds of a hit piece is closer to 95%.
Everyone has a risk tolerance level they're comfortable with. I expect many more long-time investors will share your sentiment this week because we're approaching the now-or-never moment.
I put the odds somewhere in the ballpark of 50% positive data, 30% neutral data, and 10% bad data. I just can't imagine Dr. Missling and/or Dr. Macfarlane flying cross-country to stand on stage and tell their colleagues that all the investor roadshows, all the previous CTAD appearances, were all a waste of time because thetrial crapped the bed. If the data were terrible, why go to CTAD for public humiliation when an after-hours PR is sufficient.
And if the focus were on precision targeting, I'd expect Ariana would have a greater role in presenting the data.
It won't be that hard. It's easy to create a template with fill in the data blanks, all geared toward a negative slant. Insert one or two quotes from the PR, write a sentence refuting it for xyz reason(s) and hit publish.
A good writer could have a hit piece or a pump piece 80% pre-written. Filling in the data would take a few minutes and so would refuting it. It might not hit the wire minutes after the data becomes public but I'd guess within an hour or two we'll see news, including from Adam Feuerstein. If nothing else, there will be a few tweets to serve as a placeholder until he has time to slop something together.
Journalists are allowed to request the abstract prior to public release. This is probably how AF can post lengthy analysis minutes after data readout -- pretty impressive for a guy with no formal science training to read, comprehend and write a full article so quickly.
I am 99% sure we'll see another hit piece or three before all is said and done, including immediately after 12/1. And it will have a dampening effect unless MayoMobile or that Lane guy decides to write something for Seeking Alpha, which could mitigate any hit pieces (assuming the data is good)
the tampering has been put to rest from the FDA. Whether investors choose to believe there was no funny business is up to them, but I don't think it's as big of a factor now as it was several months ago when there was a legitimate chance SAVA would collapse entirely.
The fact the stock price is selling for a 10% premium to the offering price indicates the market has confidence in SAVA.
I don't know that Anavex will have the same sort of confidence factor for a while, even if it does report positive top-line data on 12/1. Partly because SAVA is more well known and partly because SAVA hasn't attracted the ire of pseudo-journalists like Adam Feuerstein, who is allowed to request an advance copy of the abstract (makes it easy to pre-write articles and have them published minutes after the data embargo is lifted).
Is it possible that Dr. Missling is selling shares? We'll know in a few months. More likely though is that it's a combination of tax loss selling and the final chance to lock in profits or mitigate risk before CTAD.
The share price is up more than 10%. It was .85 a few days ago.
The problem with free speech is that everyone gets to voice their thoughts.
Buy, sell or hold. Those are the only three options. Complaining is a waste of everyone's time, and most certainly yours.
PS: The stock chart is still very much intact, if you're into that sort of thing.
NWBO will probably need to announce an offering soon to raise much-needed cash. Anavex is in an enviable financial position, due in large part to Dr. Missling's business acumen and conservative approach to spending.
It's nice to see Adam Feuerstein being made to look like the clown he is. To his credit, he built his reputation on his accuracy to sniff out BS, but somewhere along the line he became more like his mentor/former boss, Jim Cramer -- pretending to look out for the little guy but in reality catering to select group of clients who pay monthly fees and making them money via the path of least resistance, giving them short ideas in a historically profitable sector to bet against.
If Anavex has the goods we all hope it does, it should be the knockout blow to AF's credibility. But it won't be, because he'll never admit he was wrong. He'll move on to some other phase one biotech and his Anavex tweets will eventually disappear into Twitter's virtual ether.
We'll see. I just hope that Anavex makes biotech journalists like Adam Feuerstein work hard to find an angle to attack the data this time. We all know it's coming but in the past the data has had too many potential openings for criticism. Hoping this will be the nail in the coffin.
I would love to see Anavex trading in the single digits again, as long as it's before 12/1 and the stock price isn't down more than 40% from the current level, which could indicate an unlikely data breach. Until CTAD, nobody outside the company has any idea how the outcome plays out, but reading between the lines all indications point to neutral to positive news.
If the data is neutral, expect another trial and a 20-30% stock price drop. Most of the long-time posters here will still be able to exit with a substantial profit. It'll add another 12-24 months for those who wish to hold through to the end.
Reading between the lines, however, why would Anavex be meeting with Piper Sandler (assuming the rumor is true) -- they're either meeting with the mergers and acquisitions division or the bankruptcy division. And I don't think it's the latter...
I believe Dr. Missling intends to submit the pediatric Rett data first to secure the priority review voucher. Would submitting to the FDA for approval for another indication preclude applying for the voucher if Blarcamesine has already been approved? I don't know. Maybe someone else here does. But that would be one of my several guesses that answers your question.
Another reason is maybe they're still in discussions with the FDA to figure out the best path forward and whether another trial is necessary. Maybe they're waiting for approval in Australia first and will use that to help boost the odds of FDA approval.
It's a good question to ask but I don't think it's appropriate right now to assume that no NDA = bad news or poor management.
This isn't going to be popular on this forum but I'm expected a somewhat blunted response to positive data at CTAD, too. If Dr. Missling presents excellent results we should see the stock price go up on or around 12/1, but my guess is that it'll be a 20-30% move -- not the 100%+ gains that many here are expecting.
The big gains will come in due time when Anavex has a partner, or a manufacturing and marketing platform, and is reporting significant revenue and cash flow each quarter. That's going to take getting insurers on board and insurance companies are going to drag their feet and take their time before approving Blarcamesine reimbursements.
All IMO of course.
Precision medicine may take longer to find the right trial participants. It's possible, even likely, that Anavex isn't for everyone. That doesn't matter. If it's able to help even a small percentage of the Alzheimer's population, it should be approved by the FDA. I'd rather Dr. Missling take an extra 18 months to try and select the best pool of trial applicants than throw mud at a wall and hope something sticks with a trial design that doesn't incorporate precision targeting and genetic analysis.
I don't think it's mystifying there hasn't been a run-up. Run-ups occur when there's a significant transfer of interest from the current owners to new owners. Existing retail holders aren't going to average up significantly enough to move the price. Commercial buyers are going to wait until the investment is completely de-risked before jumping in fully, so there's a stagnant gap that will only be filled with positive top-line data.
Meanwhile, deep in the back of everyone's mind there exists the possibility of another P3 trial. Whether the notion is the product of reality or the product of short sellers stoking fear is irrelevant.
Investors were also burned by similar run-ups in other companies last summer. The economy is in a much different place today, as is the stock market. Conditions that existed then are no more and run-ups across every sector have become fewer and further between.
Wait until the top-line data is revealed. Most of us should be able to infer Anavex's next step based the results and if it appears an FDA submission is imminent, I think you'll see the run-up begin then.
Why could that be? There’s a rare pediatric voucher on the line if they submit in the proper order…
"Credentialed media can request advanced copies of abstracts by emailing CTAD media representative, Melissa McGue at MMcGue@MessagePartnersPR.com with agreement to honor embargo"
This is how hit pieces are able to be published within seconds of data release to the public...
So, I guess knowing there will be hit pieces that will probably be successful in tanking the share price immediately after data is presented, what can we collectively do to try and mitigate the damage? Clearly this is a group of investors willing to work together if they're sending a stranger to CTAD.
Why didn't they? There could be any number of reasons, but not all of them mean the sky is falling and we should all panic sell our shares immediately.
On December 1, top-line data will be announced. At some point after that, the data will be peer-reviewed and we'll get a random PR one morning that it will be published in some scientific journal, possibly Nature since that seems to be the go-to for Anavex.
Interesting idea but I think it introduces too much unnecessary risk. What would the reaction be if an elderly person develops stage fright and all of a sudden word spreads maybe the drug isn't too effective in the real world. Besides, this is a scientific conference and not the appropriate place for human props. The doctors and scientists in attendance will take Dr. Missling's data at face value, and if they don't, they will once the peer-reviewed journal article is published.