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Reddit.. AMC, GME
Hopefully more that than GameOver.
Is a clock-stop similar to a GameStop?
Who knows maybe one day $AVXL will again be a $5 stock.
Thoughts on WTF?
4.4100
+0.4200
(+10.5263%)
As of 9:43 AM EDT. Market Open.
We need to get AVXL in front of them
The collusive HF shorts best be covering.
Might want to real time Nasdaq. Yahoo...lol
10% up at $4.4. They are here.
Will watch the show.
Now 7.7% up at $4.30 per Yahoo finance.
Premarket 6.5% up at $4.25 with volume 3000 shares?
What’s going on? Meme crowd?
Joe, I personally prefer your narrative about the Q1 conference call being a stimulant for the stock that takes time to gain traction. However, I still believe that a significant portion of the move in AVXL yesterday was attributable to the meme phenomenon. It will have the same effect today, or so it appears. Watch and learn.
Thx for this hnbadger1: It is gratifying to see that even the FDA will learn and adapt over time. CNS science will (must) prevail . IMO AVXL presents the best path for this process.
I hope so, but so far they haven’t been able to handle their own expected catalysts.
Need to see an actual MAA filed, validated and successfully passing clock-stop 1 before I might change my mind about Anavex abilities.
Steady, agree with much of what you said. The EMA is the best fit for the attributes of 2-73 in the EMA community. The EMA also features a higher population of AD and Anavex will likely capture a high percentage of the marketplace.
The question I have is there is a considerable amount of work associated with a regulatory filing for drug approval. Does Anavex have the internal resources to handle both an EMA and an FDA filing at the same time? Missling stated that his crew is already working overtime on preparing the EMA data. To me that means they may not be able to handle both at the same time. Can elements be outsourced? Can Anavex handle both at the same time? Comments?
Both gme and amc are doubling pre market this morning.
LOL...the shorts.
No one pulled Anavex. It is am exaggeration at best...Anavex most likely solicited the "pull".
Wow...money well spent!
How many times have you heard just 1 more year? This is our year? Etc...too many to count. Miracle whip is better than Mayo.
Wow. The pumper cabal promoted with reckless disregard for truth by you is really cranking it up to fleece dumb retail out of its money. Maybe someday a legitimate news organization with real healthcare reporters and editors who do fact checking, as opposed to pumper blogs with no constraints on content, will do a story. The more crap I see like this story, the more I’m convinced Anavex is little more than a scheme to enrich management at dumb retail’s expense. By the way, the guy misspelled Blarcamesine. “Blarcasemine - a small pharma innovation by Anavax Life Sciences (NASDAQ: AVXL.”
I wonder how much Anavex and other similar companies pay to get garbage like this posted to blogs.
New Guidance is in DRAFT mode until June 15th. They will gather comments suggestions and hopefully move forward.
And yes, Missling kept ADCs-ADL hidden due to failure and waiting on this new guidance to soften the blow.
IMO . Dr. Jin and his team has been having discussions with the FDA about the new AD guidance and the path forward for Anavex.
Maybe it’s just a coincidence that after almost two years after the ph2’3 AD trial completion, Anavex finally revealed the ADCS-ADL endpoint miss at the same time the FDA dropped it from the new guidance.
I wouldn't mind the entire guidance link.
Interesting details on the new FDA AD guidance-
IV. OUTCOME MEASURES
Both clinical outcome assessments and biomarkers* should be included in clinical trials enrolling subjects with AD Stages 1-3; however, the approval pathway may differ based on the selection of the primary endpoint and its ability to measure a clinically meaningful change. Direct measures of clinical benefit or validated surrogate endpoints may support a traditional approval.' Surrogate endpoints or intermediate clinical endpoints that do not directly measure clinical benefit but that are considered reasonably likely to predict clinical benefit may support an accelerated approval® (see section IV. C.). Under the accelerated approval pathway, postapproval trials have been required to verify and describe clinical benefit.
A.
Clinical Endpoints
Historically, studies to support approval for drugs in the overt dementia stages of AD (Stages 4 through 6) have used an approach which required the assessment of both cognitive and functional (or global) measures as co-primary endpoints. The co-primary endpoint approach was used, in part, because the cognitive assessments used in the studies were not considered inherently clinically meaningful. Conventional approaches to assessing the cognitive deficits of AD use highly sensitive formalized measures of neuropsychological performance directed at particular domains that are capable of discriminating small changes in cognitive measures that may be of uncertain clinical meaningfulness when assessed alone. This approach was typically used in the setting of a therapy intended to treat disease symptoms in later stages of AD (i.e., Stages 4 through 6) and was intended to ensure that a change on a cognitive assessment was accompanied by an observed functional benefit, and alternately, that any observed functional
4 For definitions of clinical outcome assessments and biomarkers, refer to the BEST (Biomarker, EndpointS, and Other Tools) Resource, available at https://www.ncbi.nlm.nih.gov/books/NBK338448.
for serine distin sues and halogies May all, please see the guidance for industry Expedited Programs
"Section 506(c)(I)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356(c)(1)(A)).
Contains Nonbinding Recommendations
Draft — Not for Implementation
benefit could be attributed to a benefit on cognition and was not attributable to changes in other conditions. This remains a generally acceptable approach for stages of AD with detectable cognitive and functional impairments (Stages 3 and higher). Using this approach, the typical duration of a clinical trial in the symptomatic stages of AD has been 2 years or less; however, FDA recognizes that it may take longer to establish a clinically meaningful treatment effect in early AD due to the minimal or absent cognitive and functional deficits seen in those stages of the disease.
Additionally, many of the assessment tools typically used to measure functional
impairment in patients with later dementia stages of AD (Stages 4 through 6) would not be sensitive to detect subtle functional changes in early AD. Therefore, FDA may consider other approaches, including endpoints based on cognitive assessments or surrogate endpoints, which may allow for shorter trial durations as a basis for approval in the earliest stages of AD (i.e., Stages 1, 2, and early 3).
Cognition, in its entirety, encompassing all its constituent processes and domains, is essential for daily functioning. As previously noted, it can be challenging to interpret the clinical meaningfulness of small changes detected on sensitive neuropsychological tests; however, more marked cognitive changes may represent a change that is clearly clinically meaningful. It follows, in concept, that cognitive changes of a particular magnitude, or breadth of effects across multiple domains, or change in trajectory over time, may represent clinically meaningful change, independent of measures of functional change.
In the setting of therapy that targets underlying disease pathophysiology, changes in the long-term course of core cognitive measures of AD relative to placebo may potentially provide evidence of clinically meaningful effect with respect to the clinical progression of the disease. It would generally be expected that such effects on cognitive measures would be supported by similarly persuasive effects on the characteristic pathophysiological changes of AD.
In patients in the earliest clinical stages of AD (refer to section IV. D., Considerations for Specific Stages of Early AD), FDA will consider strong justifications that a persuasive effect, considering both magnitude of effect and statistical robustness of the findings, on cognition alone as assessed by sensitive neuropsychological tests may provide adequate support for a marketing approval. Given the array of available neuropsychological tests, a pattern of putatively beneficial effects demonstrated across multiple individual tests would increase the persuasiveness of the finding; conversely, a finding on a single test unsupported by consistent findings on other tests would be less persuasive. Whether effects on cognitive outcome measures would be capable of providing evidence of effectiveness in the absence of a meaningful change in function to support either traditional or accelerated approval would require detailed discussion with the Agency. However, in a trial with relatively short-term assessments, such as a trial for a therapy intended to treat symptoms of AD, an effect on sensitive measures of neuropsychological performance of uncertain independent clinical meaning (e.g., a word-list recall test) would generally not allow for an overall finding of efficacy in the absence of meaningful functional benefit.
Contains Nonbinding Recommendations
Draft — Not for Implementation
B.
Time-to-Event Analysis
The use of a time-to-event analysis approach (e.g., time to the occurrence of a clinically
development.
C.
Surrogate Endpoints
Clinical trials showing an effect on a surrogate endpoint that is determined to be "reasonably likely to predict clinical benefit" can be the basis for accelerated approval,' including for drugs intended for the treatment of AD. For example, in certain circumstances, FDA has considered a reduction of the brain amyloid beta burden, as assessed by positron emission tomography, to be a surrogate endpoint that is "reasonably likely to predict clinical benefit." That endpoint, in clinical trials that enrolled participants with Stage 3 and 4 AD, has thus been used as a basis for accelerated approval for monoclonal antibodies directed against aggregated forms of amyloid beta, with postapproval trials required to verify and describe clinical benefit.
The acceptability of a surrogate endpoint for use in a particular therapeutic development program for early AD may depend on the stage of disease, population enrolled in trials, therapeutic mechanism of action, and availability of current treatments. A surrogate endpoint that is determined to be appropriate for use in a particular therapeutic clinical development program should not be assumed to be appropriate for use with a different product or trial population.
Sponsors considering the use of a biomarker as the primary measure of effect should discuss their plans with FDA early in development. In general, even if accelerated approval is considered as the initial approval pathway, clinical outcome assessments should be included in clinical trials for early AD to assess early clinical changes that may potentially provide support for any changes observed on biomarkers. Evolution of the scientific understanding of AD may also influence these considerations.
FDA strongly supports and encourages continued research in understanding the role of biomarkers in AD and stresses the potential importance of biomarkers in the successful development of effective treatments appropriate for use in the earliest stages of AD.
Precompetitive structured sharing across the AD scientific community of rigorously collected standardized data is a crucial component of this research.
An investment in Anavex Life Sciences Corp (AVXL) is predicated on the promising potential of its lead drug candidate, blarcamesine, for treating Alzheimer's disease. Here are the key points supporting this thesis:
Unmet Need in Alzheimer's Treatment:
Alzheimer's disease currently lacks effective and patient-friendly treatment options. Existing drugs may have FDA approval but are not widely endorsed by the medical community due to limited efficacy and complex administration methods.
Blarcamesine's Advantages:
Blarcamesine is a once-daily oral pill, offering a convenient and patient-friendly alternative. Unlike current treatments that primarily address symptoms, blarcamesine shows potential disease-modifying properties, targeting the underlying disease mechanisms rather than just alleviating symptoms.
Scientific Validation:
Data from several studies indicate that blarcamesine not only stabilizes brain mass but also interacts with the SIG-1 receptor, which is linked to neuroprotection. These findings suggest substantial efficacy, reducing the scientific risk associated with the drug's success.
Broad Therapeutic Potential:
Beyond Alzheimer's, blarcamesine shows promise for treating other neurological conditions such as Parkinson's disease, schizophrenia, and Rett syndrome, expanding its market potential and therapeutic impact.
Regulatory Climate:
The regulatory environment is increasingly favorable for AVXL. The European Medicines Agency (EMA) has invited AVXL to file for regulatory approval without requiring additional studies, significantly reducing the regulatory risk. This indicates a high level of confidence in the drug's existing data.
Impending Regulatory Milestones:
AVXL is poised to file for regulatory approval with the EMA by the end of this year or early next year, a major milestone that could greatly enhance the company's valuation. This potential approval represents a significant value inflection point that could result in substantial returns for investors.
Investment Horizon:
For investors with a short to medium-term outlook, AVXL presents a compelling opportunity. The advanced stage of blarcamesine's development and the imminent regulatory filings suggest a near-term catalyst that could drive significant appreciation in the company's stock price.
In summary, AVXL's investment appeal lies in the promising therapeutic potential of blarcamesine, its favorable regulatory trajectory, and the broader market opportunities within neurodegenerative and neurological diseases. The upcoming regulatory filings with the EMA are critical milestones that could unlock significant value for the company and its investors.
Thanks, george. I like that the article highlighted the 25.97% short position of AVXL in the opening paragraph.
If the shorts use this to attack the stock again, I'm adding to my position.
Missling has said he wants the OLE data before filing with the FDA.
Somehow I doubt that the FDA is that concerned with the EMA. Given what Missling said about starting with the EMA first because their process is the longest, he may be planning for the FDA and the EMA to have decisions in about the same time frame.
The EMA has a greater sensitivity to the costs of a drug and the costs to the economy than does the FDA. I suggest that is why the EMA was "pulling" on Anavex. The FDA doesn't weigh those considerations as we have seen with the mab approvals.
I may be naive in my thinking on this. Certainly the FDA and all other agencies would like to see a successful AD drug that is easy to administer and comparatively cheap make it to the marketplace. That would be a political win, a bureaucratic win, and a medical win.
FWIW I listened to the CC again and what stood out to me was the EMA “pulling” Anavex into submitting for approval. Why now, why Anavex? Why the EMA only and why hasnt the FDA, who has seen the same amount of data, felt compelled to “pull” them into submitting an NDA? Or…have they?
At first thought I felt like going down the corrupt Fda rabbit hole with my thoughts but then it donned on me and I realized that actually the Fda may have pulled us in but is on thin ice here. We all know the crow they are about to eat based on their desperation approval for a drug that barely made it on the market for a year+ before being “pulled”, talk about being “pulled”! Lol.
Anyway they have to navigate the corporate tapdance with those that have invested/wasted billions of dollars and hundreds/thousands of lives in the process. This being said I see Lequembi being approved as the final “ok, now we are even” last ditch “backscratch” so to speak. The last ditch effort to save face for a greedy, blind, wasteful dead dynasty of mabs. This is where we are being pulled by the Fda comes in.
With the final mab that ever gets to soon to be approved (combo therapys aside) the recent relaxing of the endpoint criteria is, imo, in essence a direct “welcoming” or “pulling” of our drug into submitting an NDA asap. They have to approve Lequembi and then its all hands on deck for Blarcasamine. These things take many months to contemplate and draft so this has been in the works for some time, again imo, maybe 2+ years? Now rethink about who just joined our company that came from the Fda, any coincidence he joined our tiny company over 100 others?
I think it is safe to say the Fda has been keeping an eye on their “pet project” from its first inception of the ph 2a adaptive new trial protocol THEY designed and that WE ran way back from 2015. Yes, it is not only the EMA that is hungry, it is also the Fda that wants us to submit and I wouldnt be surprised if this gets into a “bidding war” of who gets to actually approve the next big blockbuster Alzheimer SOC first. AA anouncement would be fine with me.
Stay tuned my friends, popcorn in hand with a front row seat!
Tred
Ah.............very refreshing. Thanks!
Insider Financial. Great find, georgejjl..👏
GREAT NEWS for AVXL stock
https://www.insiderfinancial.com/post/anavex-life-sciences-nasdaq-avxl-alzheimers-missing-link-next-target-of-meme-stock-mania
Good luck and GOD bless,
Take care, Redshoulder
Anavex Life sciences is a bronze level sponsor for the ASCEND 2024 Rett Syndrome National Summit!
https://www.instagram.com/rettsyndromeorg/p/C66UcoLspBT/
Good luck and GOD bless,
Article that supports mrp's assertion that Anavex needs to put "the pedal to the metal" before the AI invasion.
https://finance.yahoo.com/news/big-tech-sees-neurotechnology-as-its-next-ai-frontier-100022978.html?.tsrc=fin-notif
Glad your getting back to Normal Red. As to our stock price With Approval we will be more like X20 X30
John k9uwa
Thank you and big thanks to MayoMobile!
I can wait one more year; however, I will need a thing or two that I can be distracted with while I'm waiting, like a big jump in pps x2, x3 I hope. : )
Weird. Had the same kind of dream. Community dreaming. Left me in a helluva good space when I woke up, that's for sure.
This is a GREAT online article!!!
https://medium.com/@irwinbooks/breaking-anavexs-blarcamesine-reduces-plaque-in-alzheimer-s-brains-without-dangerous-side-effects-df893e362a37
Good luck and GOD bless,
A Million+ Today
George,
I notice that at the close a bit over one million AVEXs changed hands today; with a closing price of $3.99. Up over 4% for the day.
Hope this trend can continue. Is the updated Anavex story being comprehended more widely? We'll all watch.
759K at 3:10PM EDT. 50 minutes to go in normal trading hours. time for the shorties to buy their way out before they lose all their gains. Or set on them. Sooner of Later love the smell of burning shorts in the morning. OK we hit 1M right at 4PM.
John k9uwa
george, let him know Anavex short are equal to ~26% of the tradeable stock vs. 25% for GME.
Sure would be nice to hold 4. I doubt we will.
Thanks Falcon for posting the link I overlooked.
The New Sotcanalytics Posting
The new posting RedShoulder referred to is here:
https://www.sotcanalytics.com/update-compendium-2024
When the page opens, simply scroll down to the May 13 posting. Scrutinize the 15 points. All very positive --- information the broader investment public needs to be aware of.
Mayo just posted his analysis of the CC on ST:
-----------------------------------------------------------------------------------------
Brief Summary of the 9 May 2024 CC:
sotcanalytics.com/update-co...
Apologies for lateness. Thanks for reading, exciting times ahead.
Bullish
-------------------------------------------------------------------------------------------
I have not posted for a while due to recent surgery and rehab, and I'm recovering well.
A-273 like the Carpathia will be needed to rescue survivors.
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Anavex®Life Sciences Corp. (the “Company”) is a clinical stage biopharmaceutical company engaged in the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including drug candidates to treat Alzheimer’s disease, other central nervous system (“CNS”) diseases, pain and various types of cancer. The Company’s lead compound ANAVEX®2-73 is being developed to treat Alzheimer’s disease, Parkinson’s disease and potentially other central nervous system diseases, including rare diseases, such as Rett syndrome.
Anavex®Life Sciences’ lead drug candidate, ANAVEX®2-73, recently completed successfully a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation for Parkinson’s Research has awarded Anavex® a research grant to develop ANAVEX®2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX®2-73 into a Parkinson’s disease clinical trial. ANAVEX®3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions.
The Company is in preparation for ANAVEX®2-73 for a Phase 2/3, placebo-controlled trial in Alzheimer’s disease as well as a Phase 2, placebo-controlled trial in Rett syndrome, for which the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for ANAVEX®2-73 and a Phase 2, placebo-controlled trial in Parkinson’s disease.
Headquartered in New York, Anavex® Life Sciences is an American publicly traded corporation on Nasdaq quoted as AVXL
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