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I suppose that is possible to find someone who would do that. After these results, I’m not selling one share until I’m forced to. Don’t need the money and will enjoy watching this baby biotech claim it’s rightful place among the big boys. I may be tempted to sell if I see that I could buy myself a plane. Happy to be here pre split with all my original shares (and then some). No regret not selling at $30. I thank God for this little drug that eventually will be used to combat ALZ! I find the idea of selling OTC so intriguing BTW. GO AVXL! Thank you Jesus. I’ve decided to retire from monitoring this ticker after doing so for 8 years. It has been a true pleasure being part of this MB. Thank you to all of you for all your insights and discussions. What a ride! The best is yet to come and there’s no question in my mind that we found the diamond in the rough. Maybe we will met in New York one day with our cocktail telling tales of the wild rides we experienced! God bless you all. Cheers LONGS!!!!
What you’re saying will be written in news articles in the near future… this is the beginning of the end of the amyloid junk. It’s a no brainer, a no bleeding brainer!
I will forever remember the moment I read it. I thought of all those who have ALZ, all those who died from it and cried and thanked the almighty. What a beautiful gift to us. YES!
Since 2014. Thank you Jesus for this miracle molecule. Let’s get this to the people! Congrats longs and cheers!
Yes, words matter. But we don’t need to quibble over it. We all know that Anavex isn’t known for being cautious with their wording in PRs, especially over the wording about who will publish results - lawyers or not.
You are free to guess what everything we know to this point means. I’m a fact finder and seeker of truth. Based on everything we know, I can discern with reasonable certainty that our results will be somewhere between meeting all endpoints to not meeting one or both primary and secondary endpoints.
But I hope and pray for the former.
https://www.biospace.com/article/releases/cortexyme-s-atuzaginstat-slowed-cognitive-decline-in-participants-with-alzheimer-s-disease-and-p-gingivalis-infection-in-phase-2-3-gain-trial-additional-top-line-data-presented-at-ctad-2021/
https://ir.quincetx.com/news-releases/news-release-details/cortexyme-present-results-gain-trial-phase-23-study-atuzaginstat
https://ir.quincetx.com/news-releases/news-release-details/cortexyme-reports-gain-trial-data-demonstrated-relationship
While I’m hopeful results will be good and happy that I’ve been invested in AVXL since 2014, I don’t agree that a press release announcing a company will present its results in the oral late breaking portion of CTAD means results will be good. This company’s results failed to meet endpoints. Also, their results were also published in a journal.
This certainly isn’t a get-rich quick stock like others. I’ve been surprised by AVXL’s trial successes (PDD) before because I had lower expectations. While I’m hoping for complete trial success, Im not expecting it. That would just be miraculous and, while I’m a big believer, CNS diseases have proven to be the most difficult to mitigate, not to mention reverse.
If we do get mixed results, I will feel good but sad for those who suffer from Alzheimer’s as they will have to wait. One thing that I’m hopeful about is that the sub-group data might be so compelling that FDA will move much more quickly to help us with P3 given all of the other positive outcomes from the sister trials.
But let us pray. The power of prayer is great! Miracles happen and perhaps we’re due for divine intervention right now given all the negativity in the world right now.
It’s easier for those of us who invested early pre reverse split or even 2 years ago to sit here right now in disbelief that people aren’t grabbing AVXL shares when we’re sitting on half a mil - millions dollars in paper profits.
New S/H are starting from different place - it’s costing them $15 / share to initiate an investment in a very small biopharma whose MOA is radically different from historical MOA and with no treatment yet approved by FDA in a space that has been impossible to solve! Plus, MOA is not intuitive/ easy to understand. I’m not surprised we’re where we are.
You either believe in the science enough to leave it all on the table or take a percentage off the table just in case, or sell for a very nice sum. The aha moment won’t come until we see results.
As he was describing the effects of Blarcamesine on the trial participants in both PDD and Rett, he prefaced each effect by saying, “but not only that”- so said the phrase about ten times. It was a bit odd but I would say effective. It seems like strategy of approach was to emphasize that all of these results were positive yet unexpected. AND the fact that he said the same thing for the 2 indications - seemed to emphasize that Blarcamesine effects are definitely more than coincidental. (just in case there are AF-like naysayers). I’m not sure if I believe he KNOWS results from Phase 2b/3 ALZ trial. I heard him more hopeful than confident. Could be wrong though.
Don’t sell longs. The value of this company is worth much, much more than current sp reflects. Even without ALZ, assuming we pack it up and go home with trial failure (not probable, IMO), it is highly probable that A-273 will b approved for Rett worldwide soon. With all other indications in the works, Rett approval probability, and A-371 and the other compound, this company will be bought out within two years or less, likely 2023. And they will pay S/H a lot more than $13 per share. And I believe this is worst case scenario. So stand with Anavex and do as William Wallace did with the Scots and “hoooooooooooold ….”
Basis?
Dec. 1 event is like Jim Carey’s “The Mask”. Our personalities are amplified.
Someone please post the new seeking alpha article here. Thanks
It won’t be an outright failure. Since 2015 we’ve seen a signal in human trials. I remember AF issuing a negative article about how that first time in phase 1, I think, the observed signal was merely the placebo effect. He’s been proven wrong. Every time since 2015, we’ve observed a signal: ALZ phase 1, ALZ phase 2a, USA RTT, AUS RTT, and PDD. 700 people in all I think- is that right? We saw that gene transcription with Ariana confirming the subjects’ genes reactivation with Blarcamesine. This phase 2b/3 was designed specifically and carefully based on all the information learned from all those trials. All of this success can’t be coincidence. Impossible.
If true, I believe buyout offers will follow as big boys will try to dictate P3 design to ensure approval, especially with Rhett readout coming up shortly. Agree with vast majority here that likelihood of downright failure is low.
Having said that, it’s also possible blarc met all endpoints and trying to negotiate with FDA re P3 or P4 - in large part due to good and unexpected outcome of PDD results from decent-sized trial with 70% overlapping measuring factors. Thoughts?
In 2020, AVXL announced *positive* data 3 weeks before CTAD late breaking oral presentation. November 11, 2022 would be the equivalent timing. Isn’t this a better indication of how we should interpret lack of PR announcing Phase 2b/3 ALZ results ? What is your basis for saying lack of PR at this time is a signal that endpoints were not met?
Right. As long as Anavex has strict protections in place to ensure no leaks occur. The fewer people in the org who know results the better. I think it’s likely few people at Anavex know anything. Those who know are high profile types who would go to prison if they were to act on it. The law is in place, in part, to ensure that no insider trading occurs from those who have insider information. Results will be disclosed to shareholders and the public at the same time.
Maybe this has already been posted but I came across this interesting article. I believe this has now passed and is law.
https://www.bassberry.com/news/medicare-drug-negotiation-program-in
I doubt we won’t see at least some positive news. If we have a miss, I expect we’ll have some wins because so far this little drug has shown cause and effect signals. You take this pill - stop the decline or even improve. I know we all invested here BUT think about what any demonstration of cause and effect signal means for ALZ? Even if we don’t see our accounts explode with value right now. Stop and think please what this means for humanity.
Those that are deemed to be quality companies now moved the way we’re moving in their pre revenue stages too. If you take the emotion out of it, you likely wouldn’t doubt it.
Hopefully the science is right and won’t lead us astray. But we’re talking about new hypothesis here, a new paradigm so it takes a lot of intentional and methodical study. This isn’t a quick, let’s make a buck company or management team. GLTAL!!
Re 8-K filing, material information must be reported to everyone in the public at the same time to ensure illegal insider trading (based on non-public information) doesn’t occur. While insider trading would be impossible to hide if top company officers did it, it’s not as impossible or transparent if family of employees did it. Therefore, I think it’s very possible no one at AVXL knows whether the trial was an outright success or an outright failure. And Missling and his top medical people may be the only ones who know general information. The longer we go without a PR, the riskier it becomes that non-public information will be inadvertently leaked. Thus they have every incentive to wrap up TLR. It’s just not yet ready, IMO.
While I’m hopeful you’re correct, why do you think that the closer we get to readout at CTAD without a PR signals the unlikelihood that trial failed to meet endpoints? Or is your comment more influenced by the date the trial wrapped up (~ 4 months ago)? Look at CRTX - their PR was issued about 2 weeks before oral presentation at CTAD as a reference and example that they didn’t PR trial failure until 2 weeks before CTAD presentation?
Or is your comment that this, in combination with your other factors, signals that unlikelihood?
We have the representative authorized to speak for the professional biotech investors amongst us. Mind sharing what their professional strategy is with regard to AVXL??
The implication from your post is that (at least as far as you’re concerned) results will be mixed and therefore will require an explanation. So you’re saying that the way he presents this type of data will dictate how market will react. Is that correct?
No need to explain if data is either entirely successful (blarcamesine meets primary and secondary endpoints) OR not (it misses primary and secondary endpoints).
If the former scenario occurs, who in their right mind would sell?? Even if P3 is still needed for whatever reason. There’s no explanation needed. If the latter occurs, no explanation will save the sp from nosediving - even if subsets of data show promise.
CRTX filed an 8-K announcing end points were missed on the same day they issued a PR - October 26, 2021.
They announced participation at ‘21 CTAD for late breaking oral session September 27. CTAD occurred November 9-12, 2021. Draw your own conclusions from this information.
Agreed. In 2016, AVXL issued 2 PRs - first around November 22 giving positive update of trial results, and the second one 2 days before start of CTAD announcing primary and secondary endpoints met.
Where does this test come from: 30% of patients getting a response of at least a 30% disease progression alteration?
Bingo! and wouldn’t it b too late to get any information for anyone who’s deciding to de-risk, or sell altogether? Can folks in NYC gather intelligence to discern what the general mood of AVXL personnel is?
Wow- this thing will be north of $50 by Dec 1 if this gain keeps up …
So exciting - better (more sustainable) than last years run. Congrats to all my fellow pre forward split longs. Don’t know if I’ll b able to resist not selling some but I’ll definitely keep a good number to see what happens. Best.
That is unfortunately not true.
https://www.yahoo.com/entertainment/cortexyme-present-additional
How does someone who invested millions stay calm at this time, BTW? I invested six figures and am a little nervous. 300-400% return looks pretty good right now. BUT, something holds me back. Haven’t yet sold.
I think this delay is still “normal” for this company. If we don’t hear by December/January, then it will turn into an abnormal delay for me.
So disruptive that one can’t help but think of the possibility of nefarious behavior. My Dad used to say “you shouldn’t even trust your own shadow.” This advice has served me well. I’m not a conspiracist, but there’s so much money at stake here that I hope they thoroughly vetted everyone involved in this trial in particular. I’m skeptical by nature and training so apologies if I’m sounding a bit crazy…
1. George is a shareholder - while an owner, he doesn’t speak for the company.
2. We may not hear until Dec./Jan. or even Feb./March.
3. Tranquilo - data will b released when it’s ready good or not so good.
4. Pray that data from much larger group reflects and proves out what earlier data showed from much smaller group; and
5. Derisk and forget about it for 3-5 months.
I’m looking to derisk by selling 1/4 of my holdings within a week - especially if we don’t get CTAD news.
So let’s assume AD results don’t show statistically significant and clinically meaningful changes. I believe blarcamesine will nonetheless be approved for Rett. I don’t need the money right now and the tax bill if I sold at current price would be tens of thousands closer to six figures…
Why sell even with run up to $20?
In three to five, this will be at least $20 with Rett approval and concomitant revenues. Anyone else in my boat and using similar strategy?
I didn’t know you represented the broader biotech investment community. And that you are authorized to make these representations on their behalf. I’ll pay more attention to your posts going forward.
It’s worth getting one just to see her - unless it’s fake. I suppose that’s possible.
just “wow”
Really? Because of Rett? PD? I want to hold AVXL like my Apple stock that I bought about the same time (2013 or ‘14) which is the backstop to fund my kids’ college and that I’ll transfer to them when they get their degree and get married so they can buy their first house. But I’m not as certain. I’d love to just hold AVXL and “throw away the key”. I haven’t sold any for that reason. Will it be approved for something ? AD would be the grand prize but I suppose if they gain approval for smaller illnesses it would be worth to just hold like Apple. Thoughts from other longs? What will you do now that AD readouts are likely the first catalyst?
This is not SAVA mb.
I’m encouraged by the information. It’s a slow process but likely necessary to give us best chance for approval. AD data obviously not ready. If precision medicine means “cherry picked” but fixes/mitigates AD and PDD, I’m 100 percent grateful to God and the docs. Perhaps this stock is not for you.