Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
crescentmotor
The scenario you described is indeed possible.
crescentmotor:
Are you surprised a run up in the stock price has not already started?
https://finance.yahoo.com/news/anavex-life-sciences-announces-issuance-110000761.html
I encourage any who need assurance to read this past pr (carefully) from start to finish. Take a deep breath and consider the depth-scope of the work done to conduct required studies and ask yourself,,, again...should I doubt these people or stay w/them? Is this MOA real or not? Has any company ever accomplished ANYTHING CLOSE TO THIS??
Who, when, etc. ?? Do not let the W/S sp be the ONLY method-metric for establishing value. Step back and value the science and the accomplishments. It is real and we own it. If AVXL were vapor (like so many others are) could they/accomplish this. With finite resources they must determine what comes first, that is what we are seeing, IMO.
These are tough calls to make when resources are finite but that is the process we are in. If the PAPENT APP process were fake, that would be different story. IMO, it is all real.
tredenwater2 -excellent observation
All along the way Dr. Missling has humbled himself to not over react on many levels from financing, to MC attacks, to little to no press regarding our significant RWE, RWD, and placebo controlled trial data.
tradeherpete
The little printing company is going to start printing money.
T-38
SAVA looks to be controlled by the MM/Shorts to make a quick buck. In any case the investigation of the stock appears to be continuing.
tredenwater2
It seems our wall to market us growing taller!
30fold
“BTW, IMO, if we do(did) not got this, we would know by now.”
30fold
His remark that “you will know why we did things the way we did them” is a WGT statement.
jonjones325, thanks for a dose of refreshing honesty.
2014
Why would anyone contemplate or even have such a despicable thought.
SAVA info...drug does not pass smell test...
https://ajtrev.substack.com/p/memory-games-part-i-the-data-is-available
https://www.biotechtoinvest.com/research/2020/9/15/all-roads-lead-to-rome-compounds-from-avxl-and-sava-likely-target-the-same-sets-of-molecules
Claims that AVXL and SAVA are same mol...HUH?
tredewater2
Yes 1/2 - 1 or even 2 pts on a cognition test are important but what trumps all is patients experiencing positive RWE and RWD pouring out of the trials in droves.
We shall soon see the proof in the pudding once and for all.
In the aftermath of a market debacle for Biogen’s Aduhelm (aducanumab), three major therapies targeting the same amyloid beta pathway have upcoming Phase III results. Roche’s gantenerumab and Eisai’s lecanemab have readouts expected by the end of 2022, and Eli Lilly’s donanemab has results expected in 2Q 2023.
Meanwhile, Anavex’s blarcamesine hydrochloride, also known as ANAVEX2-73, will look to jolt the AD field with a new therapeutic approach. Phase III results for Anavex’s small molecule targeting the Sigma-1 receptor are also expected by the end of 2022.
jonj325
A lot on deck. Let’s get it done!!
Playing this long game is not fun or easy. It’s all coming to a head now and i believe the wait will be well worth it.
McM..
Anavex has to release certain news when they get it.. however they can perhaps.. get a preview and make plans for news when they release..
repost:
https://finance.yahoo.com/news/anavex-life-sciences-announces-issuance-110000761.html
Blarcasamine
Can someone please explain what this patent really means and how it differs from some of the other patents we have seen come out of Anavex for 273. Is this a patent to go after a basket trial? Does this patent do something different that some of the other patents that we seen protecting the IP for blarcamisine? I like 2037 but just not sure what this one is doing. Thanks/[ quote]
Think of it as the AVXL MOA patent. This is a broad departure from the meds of the past-site-disease specific. IMO, this gets at the CNS (system) , which is the path we are on, unlike competitors and which has frequently been pointed to by Dr. M. and team . IMO, this is a pointer to the new (next 20+ yrs)...medical serial thinking process. (others here more qualified to carry the concepts ref; Falconer for example) . I do recognize a systems message when I see one and this is a massive headlines to BP serial thinking ...say BAAH...BYE Boys.
My guess is Dr..M. has presented and will prove by AI-Vis-other strong evidence w/trial data to close the lid on past Bio-Med-Pharma old school thinking. He just threw a blanket over BioMed futures. The good news is, they still do not get it, All they can hope for is some kind of multiple partnerships w/AVXL going fwd...IMO.
This kind of PAT approval. is as much about BP-product-structure and portfolio obsolescence as it is about the controls going forward. Listen for the GIANT .."OHHH SHAT"...themes going fwd.
hnbadger1
Conclusion
Anavex is about to report on potentially the most game-changing trial of its lifetime so far. I believe the readout of patients diagnosed with Alzheimer’s disease who have been on trial for 48 weeks will be positive, as it will fall within the period of previously reported cognition improvements. I expected Anavex to report improved cognition over that period. That readout is due for the fall of 2022, so it is imminent.
I also believe that Anavex will report good data in the open label extension study in Parkinson’s Disease Dementia, scheduled for the end of 2022.
Anavex 2-73 is facing competition in Rett syndrome, but seems to have a better safety profile than its competing drug.
Finally, the stock has sold off formidably well at this point, knowing its biggest catalyst is right around the corner.
These four elements are strong reasons to be bullish on the stock.
For lack of sufficient understanding of the mechanism of action of Anavex 2-73 and its place in the state of the science, given the disparity between patients reported and given the seemingly down-trending data after the 57-week timepoint, I will personally wait to take a position. I am curious to see which biomarkers Anavex will report on in its upcoming readout in Alzheimer’s disease. Depending on that readout, I may take a position.
Therefore, though I am bullish on its upcoming readouts on cognition measures, I rate the stock currently as a hold.
plexrec[quote]"The next 14 weeks-"[/quote]...so, what's going to happen next?. It is clearly time to move on, now that the FDA has run out of AMMO and FEET (shot away) . The Amyloid thesis is dead, even the FDA would be happy to move past their embarrassment in failed leadership. Put away the Amyloid Dart Board.
Ensure the way forward is constrained to "things that can be measured"...as Drucker has famously said , " If it cannot be measured , it cannot be improved"'. AVXL is clearly leading the field w/AI and meaningful methods to measure causal relationships to the portfolio of CNS disease. That is the case we have proven and invested in. No Doubt, the FDA and most will happily support something that shows efficacy and can be measured . It is time to work the science of measurement and proof while the dark days of silence are put behind us.
The Amyloid thesis is dead. The FDA and BP MUST Bury it and move on. We have plenty of science and proof to mark and guide the way forward . JUST DO IT as Dr.M. has been already proven the way forward.
Plex is exactly correct. The next few months will be explosive for those willing to listen and learn. AVXL will lead the way, FDA will watch and learn while BP must suffer in silence.
Today is a triple witching day, so don’t expect an “up” day.
Great post: Excellent examples of how the next learning cycle might progress. Also, these observations present a possible list of :Things we know we do not (yet) know.
Per this post: it would seem that not all patients can tolerate their assigned target dose, which presumably applies to the 50mg cohort more so than the 30mg one. Anyone reviewing that post are welcome to propose a calculation that tells us the actual proportion of patients assigned a 50mg target dose actually reached what dose and concentration.
We could however, based on knowing that High mean concentration was achieved in n=8., say that in the P2b/3 AD study 80% of the 50mg dose cohort might achieve above 4ng/mL concentration .
Now, we also know, as a peer reviewed fact from below, that only n=2 patients had all the factors required to achieve improved cognition through PartB of the P2a AD study. The rest declined at various rates better or worse than SOC.
In the P2b/3 AD study approximately 170 patients are assigned to 50mg. 80% of those may reach High mean concertation n=136.
Using again what we know from the P2a study, overall about 16% of patients will likely dropout, maybe on balance more in the high dose cohort. So now we have 101 patients with High mean concentration.
20% of 101 High mean concentration patients also have all the other factors for strong response to A2-73, which is then n=20.
So that would be my take on Strong Responders, meaning those who exit the P2b/3 study with less dementia than when they came in. That in itself would be astounding!
The other about n=80 High mean concentration patients may decline at various rates slower or faster than SOC.
In the 30mg cohort a few would likely reach High mean concentration and also possess the other factors needed for strong response to A2-73. Hard to say how many, but clearly less than 20%. To be generous say about 2% given dropouts too, say about 3 patients. The rest declining more or less as SOC.
Hence, overall responders meaning better than SOC, including the really strong responder, I assess to be somewhere between 20-25% across dose arm patients. So about 85 in total, some 23 of them doing really well.
Altogether my assessment would then be an excellent result that just may get us Accelerated Approval and a P4 trial or at least a very likely succesful P3 Precision Medicine trial to follow
georgejji
Trial ddatata is collected on paper and transferred to computers and/or transferred from one computer and program type to another. All of these create opportunity for errors. Sometimes people forget to transfer the data from one system to another.
You have no knowledge of the real world.
Anavex Life Sciences CRO must audit the data to make certain that the data is complete and correct BEFORE the database is locked.
THAT IS WHAT IS DONE AT THE END OF ALL CLINICAL TRIALS.
GD
How is EISAI doing the data base clean and analysis so fast!? This is the way
real companies run their business,
MayoMobile...very helpful..thx..
My Expectation for CTAD 2022
1. Late breaking abstract submitted and reflected on CTAD webpage in the first few weeks of October.
2. Stellar data to be presented at CTAD with ~80% (with 10% variance) of the high dose group showing stabilization or improvement. [based on statistical probability]
3. Large Cohen’s D effect sizes (~0.8 or greater in high dose group and ~0.5 or greater in moderate dose group). Statistical significance achieved across the board except for possibly sleep (RSCAQ measure) which will likely show improvement trends but may not show statistical significance.
Hopeful Items but Not Expected
1. PR announcing CTAD abstract submittal
2. PR announcing CTAD abstract approval w/oral venue
3. AD and PDD OLE data correlated and released simultaneously at CTAD.
ANVS
Annovis Bio, Inc. 19.60 +4.30 +28.10%
Any theories on why ANVS is up today?
poonch1ine
The Rett community will sort the better drug promptly, if they haven't already.
That means use the dosage that is appropriate for the individual.
IMO, some time soon the AVXL SP will begin to more properly reflect the real value of the science and expected results from of AVXL trials. Until then the SAVA and others SP is more an indicator of smoke and mirrors efficacy than reality. As some say, "w/one foot on the dock and the other in the canoe". ...They must all either get out or get on or ..get wet. A silly game w/limited choices.
Example: from Yahoo msg bd...
Ivan8 minutes ago
this from Seeking Alpha on 7 Sept.
Blarcamesine is likely to release results from its 48 weeks phase 2b/3 trial in late Fall. The majority of participants in the high dose group should either improve or stabilize over that period of time.
The main take away for investors is that based on its likely efficacy and safety the FDA will probably grant Anavex's blarcamesine accelerated approval.
Less
tredenwater2
They are “boldly” moving forward behind the scenes. I expect more regular company releases from new position hires as we get closer to TLD release whether it be 40 second tweets or company presentations. Seems like Dr. Missling is allowing the Eaglets to test their wings while still in the nest. Soon they will be soaring out collecting on their own so to speak.
tredenwater2Excellent suggestion:
With all do respect imo you are setting yourself up for disappointment. After 6 years you should know by now that the pps is going to do what the pps does with every HF “absorbing” cycle. All that matters is right now is when TLD results for AD come out and/or a partnership announcement hopefully soon there after.
Lets all patiently wait together.
Doc328
As the study proceeds sites enter data into the study electronic data capture where it is quickly checked
abew4me:
Good question.
Quote: "I just don't see how you partner the same drug for different indications. What examples are there of this?"
While just listening to an RSD video talk (which was given by Dr.K. and staff lead by Dr.K. and staff I was thrilled to hear him say that..."We already know, we will have more than one company here ". He clarified this by adding a comment on the MOA-S1R massive CNS product application potential. This must not be taken out of context, he was speaking globally about the potential of what AVXL has and is doing.
As share holders we need to be realistic about what is going on and what the portfolio of planned trials now underway . Dr.K. was very cautious and clear headed in his comment. He was describing the current RSD trials and status . Even though he was only focused on RSD trials he was clear about the future. AVXL is not a one trick pony. AND, we all better (adjust) get used to that reality.
[quote) I'm a bit near sighted right now so I'll be happy to see $12.49][/quote]
His comment meant to me that some level of uncertainty is baked into what AVXL is going to be able to manage due to the dynamics of the environment \time , the needs of pts., and the complexities of the regulatory/business/science variables. we are certain to run into.
We must try to be realistic about what will be happening next.. Dr. K. did not say that...I am reading the workload as realistically as I am able. THIS (AVXL) IS GOING TO BE YUUUGE...VERY SOON. IMO, we are on a roller coaster for a while here. I also project that as AVXL trials show the efficacy of A2-73 and as others recognize the power WW of our MOA it is going to get very stressful around here. IT's ALL GOOD.
Dr. K. has impressive credentials also.
Biography:
Dr Daniel Klamer, Vice President of Business Development and Scientific Strategy of Anavex, has more than 15 years of experience in neuroscience and the orphan disease space, with acquisition, partnering and R&D experience in Europe and the USA. Prior to Anavex he worked at Retrophin and Neurosearch Sweden. At Neurosearch Sweden, Dr Klamer led and evaluated multiple discovery-phase neuropharmacological research products with an emphasis on strategic evaluation of preclinical and clinical development. Dr. Klamer earned his PhD in Pharmacology at The Sahlgrenska Academy at University of Gothenburg, Sweden, his MBA at Fordham Gabelli School of Business, and his Post-Doctoral training at the Department of Psychiatry, Yale University School of Medicine. In addition, Dr. Klamer holds a position as an Associate Professor at the Department of Pharmacology at The Sahlgrenska Academy at the University of Gothenburg.
https://asgct.org/advocacy/policy-summit/2022-agenda
.whoever they are:?
IMO, all of this talk about new things needs to be in some context which, IMO, is at best clouded at the moment by serious questions of political competencies at all levels.