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As expected we are in a ..."cat and Mouse game" , with the WS-MM criminals (IMO). But the longer that goes on the higher the risk of fatalities for the criminals. They have survived this long in the past by ..."Hit and Run" tactics. They are already isolated, self identyifying, being notified their cover is blown and they will be/are targets.
McM, we must recognize by now that the true life saving value of the AVXL science (like a few others) gets dismissed when the WS dark side metric of SP is used to define true worth. Others in WS must stiffle and control true clinical value via SP games behind the curtain. IMO.We expected this, IMO.
IMO, the good news is Dr.M. anticipated this and has planned a cautious findings release strategy accordingly. IMO.
jtsmgoblue
Study of the Mechanism of Action of Blarcamesine(ANAVEX®2-73): Whole Blood Transcriptomics Analysis (RNAseq) Identifies Treatment Impact on Compensatory Pathways by Restoring Key Neurodegenerative Pathways Functionality, including Alzheimer’s and Parkinson’s Disease Pathways C. Williams1, M. Kindermans1,F. Parmentier1, F. Goodsaid1, E. Hammond2, C. Missling2, M. Afshar1 1Ariana Pharma, Paris, France, 2Anavex Life Sciences, New York, NY, USA
Poster text:
IMO, we have done the work needed to prove/demostrate efficacy. Sadly AVXL had to work it's own system/plan to get to this point. Does anyone really wnat to leave key go/no go decisions of this consequence in the hands of the FDA and BP/WS??
Let the data talk, who knows, maybe a little integrity will shower on this parade.
My sense is Dr.M. and the AVXL team have not come all this way to leave any critical decisions in the hands of any untrustworthy entity (who ever that maight be). This about people's lives. The international medical system will be watching closely. We intuit what the answer should be.
Like it or not, facts are on the table, strong results do not lie. IMO, ..public, this process had to be run this way..."Out in the wide OPEN domain where there is NO PLACE TO HIDE". Well done.
Bless these people who did this work and those who will directly benefit from AVXL treatement...well, I guess WGT...
Int J Mol Sci. 2020 May; 21(10): 3517.
Published online 2020 May 15. doi: 10.3390/ijms21103517
PMCID: PMC7278930
PMID: 32429229
Transcriptomics in Alzheimer’s Disease: Aspects and Challenges
Eva Bagyinszky,1,2 Vo Van Giau,1,2,* and SeongSoo A. An2,*
It will be interesting to note the reactions to the AVXL work. Since just about every research work for decades has consistently beat the Amyloid thesis drum while AVXL has consistently gone a different path.
Some may trash AVXL just b/c of the differing paths and the trheat such path may present. We shall soon see if that really matters or if the case made by AVXL is very strong and compelling. My limited experience has been that after decades (3+) of beating the same drum w/very little -no causal proof (by many, many very smart people) that drum is broken.
Maybe a new tool app will reveal a new path somehow previously not seen, missed. We'll see. IMO, insticnts tell me the UPSTREAM path presents as/is a new causal source. In any case this is going to be very interesting to watch. If AVXL have compelling stuff w/strong findings on root cause for AD and other CNS diseases I do not expect the room to light up w/congrats (even though maybe it should). .
I do expect pharma press ,BP and academics to be caught standing in the silent zone or perhaps puzzled, other. After spending a lifetime of beating a certain drum many may be inclined to simply pound their drum harder. We'll see I guess. .
Best wishes and support to the AVXL team as CNS-BP enter into a critical next phase of , "Show and Tell", for all the marbles.
Study of the mechanism of action of Blarcamesine (ANAVEX®2-73):
Whole blood transcriptomics analysis identifies treatment impact on compensatory pathways by restoring key neurodegenerative pathways functionality, including Alzheimer’s disease pathway
Virtual Platform
Sun, Jul 31
7:00am - 11:55pm (Pacific)
Author Block: Coralie Williams, MSc1; Martin Kindermans, MSC1; Frédéric Parmentier, PhD1; Federico Goodsaid, PhD1; Edward Hammond, MD, PhD, MPH2; Christopher U Missling, PhD2 and Mohammad Afshar, MD, PhD1, (1)Ariana Pharma, Paris, France, (2)Anavex Life Sciences Corp., New York, NY, USA
THX ...
Xena
XenaLives
IMO, (an analogy) AVXL have been conducting search mission(s) surveillance operations in a directed area for suspected CNS disease causes. We have been identifying possible/suspected targets (multiple possible upstream causes), many are beyond visual range. These unconfirmed targets are often called SPOOKS. (see BIIB) The process for conversion of a SPOOK to (the real thing) BOGEY can be complicated and has risks.
IMO, AVXL is about to make that BOGEY call. ...Hope they make that call during the next day or so. BTW, once AVXL makes the call of BOGEY, BOGEY, BOGEY -heading and distance the SHAT hits the fan. It will be HARDBALL TIME.
Recognize that a lot of very smart-capable people want to make a lot of FUD $$$ by/w/games, etc. This one will not work that way, GAME TIME IMO. EOM.
attilathehunt
What do folks think about/expect for next Monday's sp action? If Sunday presents new -positive information then Monday could move BIGLY. And who says..."Nothing exciting ever happens around here???"
HUH..splaination please...Gambit53 TIA...
tredenwater2.
Georgejji,
I do not expect that team to stand by doing virtual-LIVE stuff on July 31, from 7:00 AM till 11:55 PM...c'mon man. My guess is they will have a 3+ hr. +/- show and tell which is then recycled multiple times. This does have "VERY Big News" headline presentation of critical science.
Anyone else got the insights about NASDAQ AD Bio sector resetting about to happen? Call it a shakeout (SAVA sp vs reality for example) . Not wishing any bad things on anyone just seeing a need to GET REAL about the science while the stock trading games hopefully get played out somewhere else.
FDA have process rules/regulations and compliance requirements which are all very well written. The international rule set for compliance and maintenance of the processes are well established by FDA (cGMP/FDA Regs, etc.) Each country will have compliance monitors for international ISO conformance and verified compliance) and anyone doing sales in USA/EU/other must similarly ensure by some regulatory plan/schedule to keep fully compliant w/international rules/regs.. This process is managed by ISO/other compliance bodies (Exemplar , etc) WW. If we refer to recent posting of AVXL WW Quality managers position we see these AVXL expectations/requirements clearly spelled out in appropriate detail.
I have noted here the absence (of AVXL trials in USA in recent pubs). Maybe I missed it but this would perhaps suggest to me an awareness of the (Big Pharma/MM ) issues that might exist, as suggested here.
Bottom line, I am confident a massive AVXL effort will always be in place to ensure full compliance w/FDA regulations WW by proactive and reactive means and methods.
IMO, Biogen and Sava are recent examples of what happens when top management wants and scientific facts are on different paths. When science-results do not resolve w/what top management wants financially then tough choices must be taken. (lies happen) Scientific truth (should/must) always prevail in the end. As far as we know AVXL have been consistent in playing by these rules while staying alert to any contradictions.
We will recognize any contradiction when we see it and must insist our top management act accordingly, unlike SAVA/ BIIB. Or, we each must follow our own Plan B.
Market is a mess right now george...you may want to reconsider until the WH-etc gets it's shat in one pile.
Expect a LARGE INCREASE in BUYING of AVXL stock just before the close of trading TODAY, 25 JULY 2022
Excellent work MatoMobile. Thak you:
Blarcamesine & Fragile-X with Comparisons to the ATR-X S1R Study: In 2016 Anavex presented impressive Fragile-X preclinical work which nearly mimics the ATR-X results. Fragile-X mice dosed with Blarcamesine completely returned hyperactivity to normal, rescued associative learning, and reduced impairments in daily activities (similar to partial ATR-X recognition improvement). Additionally, Blarcamesine treated Fragile-X mice completely restored BDNF gene expression levels, slightly surpassing WT mice - which was similar to the ATR-X results. These improvements were associated with decreased depressive and anxiety-like features. [Pictures of these improvements can be found on page 23 and 25 of my PDF]
Assessment: What is really exciting about all of this conjecture is the applicability of S1R agonistic properties to XLID-wide indications. The vast majority of X-chromosome mutations result in similar behavioral, intellectual, and neuronal deficiencies. Considering Blarcamesine's effect on chromatin remodeling, it is highly likely that its ability to reduce gene expression error and return these functions to normalcy would be beneficial to nearly all (if not all) XLIDs; including Fragile-X, ATR-X, Angelman Syndrome, Rett Syndrome, Downs Syndrome, and other autisms. Additionally, the improvements shown in the ATR-X and Fragile-X preclinical trials would also be immeasurably beneficial to neurodegenerative diseases like Alzheimer's disease, Parkinson's disease dementia, FTD, and more.
As Anavex prepares for the Fragile-X conference this week, their presentation appears to be focused on behavioral phenotypes & receptor occupancy in Fragile-X patients. In a recent study, two male Fragile-X patients had an expression microarray analysis conducted. The results of this gene expression deep dive revealed that as a result of their primary FMR1 gene mutation, over 90x other genes saw a 1.5-fold deviation from standard. The complexities of gene-to-gene interoperability and dependency on each other no doubt makes finding similar phenotype patients for clinical trials quite difficult as it would be hard to assess holistic benefit for such different patient types - not to mention male vs. female considerations. I am extremely interested to see just how Anavex intends to find the best patient cohort and how they plan to assess change via receptor occupancy in these differentiated patients. More regarding Fragile-X and XLIDs can be found here.
Yes, in light of recent news on Amyloid plaque fraud as an AD causal path. Symptom , but not cause.
How a serious AD investor could support that offering is past my understanding. See recent news.
https://www.pharmaceutical-technology.com/comment/cassava-closes-door-controversy/
On 10 February, Cassava Sciences, a small biotech company based in the US, announced that the US Food and Drug Administration (FDA) had denied a Citizen Petition and associated supplements filed by investors questioning the credibility of positive data from the company’s Phase IIb trial (NCT04079803) of its late-stage Alzheimer’s disease (AD) asset, simufilam. This news was a relief for Cassava and has immediately boosted the company’s shares, a much-needed upturn after extreme fluctuations over the past year. Despite this win for the company, GlobalData believes that simufilam still has further hurdles to face in securing a solid position in the AD market.
Simufilam is an orally administered filamin A inhibitor with a novel mechanism of action that restores the shape and function of altered filamin A, thereby blocking the formation of amyloid deposits and tau phosphorylation and potentially slowing AD progression. Previously reported Phase IIb data suggested that simufilam improved validated cerebrospinal fluid biomarkers of neuroinflammation and blood-brain barrier integrity, as well as cognitive scores in patients who were dosed twice daily for 28 days. In addition, Cassava is moving forward with two pivotal Phase III trials, RETHINK-ALZ (NCT04994483) and REFOCUS-ALZ (NCT05026177), which will further assess the safety and efficacy of simufilam in the treatment of mild and moderate AD. GlobalData estimates that simufilam will launch in the US in the second quarter of 2026 if positive results are achieved in Phase III trials.
Quote:
THIS, Could result in a busy week of dubious-fudster stuff if not cautious...a little bit of /only a few lies will do a lot of harm in this environment. Hope apprpriate precautions have been taken. Go to DEFCON II .
Tredenwater2(quote) Nidan I agree! Anavex’s credibility will be attacked again. Imo Dr. Missling has kept a low profile because he knows whats coming both in terms of great trial data and attacks.
Walk quietly, speak softly, and carry a big stick!
Bourbon _on_
One thing can be done...accelerated approval for 273 for alz PD and Rett. Take all the trials and OLE, file the NDAs simultaneously, and get "back into" a triple approval. FDA, say yes!
Xena
I believe that Friday's manipulation to support means that it will be a buyer's week
georgejji
NEXT SUNDAY
Study of the mechanism of action of Blarcamesine (ANAVEX®2-73): Whole blood transcriptomics analysis identifies treatment impact on compensatory pathways by restoring key neurodegenerative pathways functionality, including Alzheimer’s disease pathway
Virtual Platform
Sun, Jul 31
7:00am - 11:55pm (Pacific)
Author Block: Coralie Williams, MSc1; Martin Kindermans, MSC1; Frédéric Parmentier, PhD1; Federico Goodsaid, PhD1; Edward Hammond, MD, PhD, MPH2; Christopher U Missling, PhD2 and Mohammad Afshar, MD, PhD1, (1)Ariana Pharma, Paris, France, (2)Anavex Life Sciences Corp., New York, NY, USA
Well Done...hopefull and worth the time.
Bourbon_on_
Manipulated Alzheimer's data created amyloid thesis
Just when you thought it couldn't get worse, BP has been chasing a cure based on corrupted science data
https://www.yahoo.com/news/manipulated-alzheimer-data-may-misled-180201391.html
Bourbon on...
OLE is a form of p4 before a p4 is even asked for.
Hard for me to believe this is a genuine AHHAA MOMENT for the FDA-BP-MM-crowd.
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Manipulated Alzheimer's data created amyloid thesis
Just when you thought it couldn't get worse, BP has been chasing a cure based on corrupted science data
https://www.yahoo.com/news/manipulated-alzheimer-data-may-misled-180201391.html [/quote]
IMO, Dr.M. will be posting a new job on Monday for his personal "Food Taster".