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In AA, the biomarker data is not bolstering the endpoint data — but biomarker data becomes the KEY data (Ie basis of approval. What is additionally needed is to show/know that biomarker is a “valid” biomarker —- through past studies or current — not sure what biomarker they gave in mind.
They got the biomarker data — recently? 10 months after trial completion? Which forth-world country are they operating in??
Confirmation. Of:
The primary endpoints were NOT met — else they wouldn’t be resorting to surrogate markers for AA.
They are still CONSIDERING to INITIATE discussing with FDA, after one year of trial completion and 5 months of having had all the data. That means — FDA meeting in 6 months, at best.
The confirmatory trial initiation will take 2-3 years at least!!
So, what do YOU think is wrong with the picture?
CM’s words may be true — but still can/are much less than what’s required for approval (a trial that proves what he is claiming, if he is being truthful). That’s — 5 years away, if at all.
It’s like saying .. I’m “looking for” $100+. Sure.
What’s the primary endpoint measure for EXCELLENCE?
RSBQ delta?
RSBQ OR?
RSBQ-AUC Delta?
RSBQ-AUC OR?
If OR, what’s the threshold?
Whole arm, or if there is “pre-specified” subgroup (that we/world aren’t aware of)?
Haha. Man — the level of gullibility among the die-hard AVXL fans!! Astonishing.
We’ll find out more soon on ER?
Data engineering, or hiding the truth (Ie the wait will be permanent—just like PDD’s full data). Yes, 5 years wait == permanent, for all practical purposes.
How does what Missling says (about what outcome measure they met) has anything to do with what FDA needs for approval?
You gotta think straight.
Really? Which company do you know which took 6 months (after data access) to release primary endpoints’ data?
And buy a third failure?
There is no additional approval-worthy data for AD. Absolutely.
Biggest evidence to that is the 5 month silence (!!) after they have had all the data (it takes only a few hours/couple of days to crunch the desired data without any “data engineering”).
Stock manipulation going on. The cabal (MMs, hedge funds, company agents, longs, etc) propping the stock price using the nothing-conference event as an excuse the fool the fools.
If there is anything noteworthy in the data — why wouldn’t it be PR-ed by now? 9 months after trial completion and at least 4-5 months after having full data at hand.
Only blindfolded fools will believe that AVXL has approval-worthy data that it has decided to hide (from investors and FDA discussions) till after publication.
IMO, AVXL has nothing more than some contrived non-dose sub-group analysis — which is of no value as far as approval is concerned. It is just SEARCHING for something PR-worthy, where the bar is generally low ….. but AVXL is struggling to meet even that bar after 4 months of data analysis!!
Any reason to believe it would be any different?
IMO — if the trial “fails”, then we’ll see the same story repeated. If it succeeds, then perhaps we may get a clearer PR.
The fundamental problem doesn’t seem to be about slow/delay —- but about clear success vs failure-spun-into-success via data engineering which takes a lot of time.
So, if EXCELLENCE fails then delayed reporting can’t be avoided.
CM lacks the courage to be honest about failures.
I know it doesn’t. But it’s shocking/surprising that the answers would be sooooo different. Regarding avxl, I have tried similar questions and I have gotten similar answers all times.
For the exact same Q/prompt as yours, I get a very different answer (below). I’m just surprised at the answer you got — it seems magically impressive to me. Can you try again and confirm? Thanks.
=====
As an AI language model, I cannot predict the future or provide the probability of specific outcomes for any company or product. The likelihood of Anavex Life Sciences (AVXL) achieving approval for A2-73 (also known as Anavex 2-73 or blarcamesine) in Rett Syndrome or Alzheimer's disease depends on several factors, such as the results of clinical trials, regulatory review processes, and the competitive landscape.
As of my last knowledge update in September 2021, Anavex Life Sciences had reported promising results in Phase 2 clinical trials for the treatment of Rett Syndrome. However, for Alzheimer's disease, the results and progress of clinical trials were less clear.
To get an accurate and up-to-date assessment of the likelihood of approval for A2-73, it is essential to monitor the latest clinical trial results, regulatory news, and statements from the company. Consulting with experts in the biopharmaceutical industry and financial analysts specializing in the sector can also provide valuable insights.
Positive clue. It’s unfortunate that these are the best clues we have to go with — rather than concrete data analysis/readouts.
None. I was just refuting the previous post about a bogus summary from GPT (I can’t find a link to it).
Don't be naive.
Anavex's silence for 4 months post- partial/problematic-data is deafening. It supersedes all other arguments in favor of *perceived* efficacy.
Chat-GPT's summary of Anavex.
I know some posted a summary from Chat-GPT 4.0 of Anavex chance of approval -- and I was very impressed. However, that IS BOGUS.
I tried the below and got the below summary. Judge for yourself.
Question/Prompt: what is the summary of Anavex's clinical trial results on Alzheimer.
Chat-GPT's response:
As of my knowledge cutoff date in September 2021, Anavex Life Sciences was developing Anavex 2-73 (blarcamesine) as a potential treatment for Alzheimer's disease. Please note that my information might be outdated, and you should consult recent sources to get the most up-to-date information on their clinical trial results.
Up until September 2021, Anavex had completed a Phase 2a clinical trial for Anavex 2-73, which showed promising results in terms of safety, tolerability, and cognitive improvements in patients with Alzheimer's disease. The trial suggested that Anavex 2-73 might have a positive effect on cognition and function in patients with mild to moderate Alzheimer's disease.
In addition to the Phase 2a trial, Anavex was also conducting a Phase 2b/3 clinical trial called ANAVEX®2-73-AD-004 to evaluate the safety, efficacy, and tolerability of Anavex 2-73 in patients with Alzheimer's disease. The trial aimed to enroll around 450 patients and was expected to be completed in 2022.
Please keep in mind that these details were accurate as of September 2021, and the status of the clinical trials and their results may have changed since then. To get the latest information, consult recent news, company announcements, and updates from Anavex Life Sciences.
Can someone present a clear and unambiguous data summary from the previous two Rett trials? If easy/handy. I’m sure I’ll struggle to find and summarize it from multiple PRs and presentations, even if it exists.
Why should a CEO care about retail investors?
4-month silence certainly means that neither dosage arm met the endpoint(s) by themselves.
In which case, AVXL doesn’t even have a treatment dose (main point of a well-designed P2) for P3! I don’t see how a P3 can be designed with high confidence from here …
I may have, but those were dreamy expectations.
Assuming normal expectations — AVXL is not going to justify/elaborate on how/why the primary endpoints were met.
Of course, there’s a lot more they can/may share about the data beyond that.
Which “how” part is unclear to you?
Assuming, ORs are the endpoints and the numbers in the CTAD presentation are accurate.
What is missing then? You can’t expect AVXL to share the calculations for p-values.
Per my modeling, AVXL would hit $150,000 per share in 1 year. And, I’m being very conservative here.
Unimaginable imagination!
Sheer incompetence and unprofessionalism.
OTOH, how does it matter? I mean -- the communication being screwed up -- doesn't fundamentally change anything. If these results were PR-ed a year ago, what would it have changed fundamentally? Nothing.
However, more important Q is --- when is CM planning to start the P3 for PDD? Maybe, he is being conservative .. and wants to get more confident about a trial's success before pumping $50-100m into a trial/indication.
That’s cluelessness.
Or maybe, stock manipulation IS the reason why the stock is at $8.5 rather than $5. Manipulation by pumpers.
Biggest positive of todays PR:
They seem to have suddenly learned how to present data! First PR with a table!
Good things to come, I hope.
Is AVXL just a disappointment (due to CEO’s incompetence in some aspects) or is it a “scam”? The latter possibility can’t be completely dismissed — because the CEO has certainly lied a few times (eg regarding RSBQ-AUC in AVATAR. Perhaps, similarly about P2b/3!).
12/5 CC was disastrous. Even more disastrous was the last ER CC where he pretty much confessed that RSBQ-AUC in Avatar was a last-minute made-up endpoint to hide the trial’s failure on RSBQ!! He lost all credibility then.
Nope, it’s not common sense to wait for 3 years to release full data — especially to wait for a trial from another indication to complete!
No, it’s not common sense.
It’s hoodwinking.
Of course. It’s all my opinion. But it’s just simple common sense.
You’ll feel at peace once you accept the P2b/P3 trial to be P2 (as is extremely likely the case). Then, all will make sense (companies don’t typically release all data about P2 —- esp not the negative ones).
For now, yes. If RSBQ-delta fails, I’m sure he’ll switch to RSBQ-AUC again …
Cash in some bank.
SVB has less to do with debt but with cash deposits.
Does AVXL have any exposure to SVB, and/or other small banks that could possible get caught in this SVB-initiated mess?