SIGMAR1 As Cell Stress Indicator In Alzheimer’s Points To Great Results In Phase 2b/3 For Blarcamesine. $AVXL
AUGUST 24, 2022 ~ PIOTR PIETRZKIEWICZ


Another Paper Supports Anavex’s SIGMAR1 Platform

Just a day before Anavex published release with reference to a paper looking into Alzheimer’s patients brain geograghy of mitochodrial dysfunction, synaptic density, oxidative stress and their impact on brain volume. All this was done in vivo that is on living AD patients as novel radiograghic markers to measure these in PET scans became available. Imagine, you have a AD patient, you inject him with this marker, then put him into PET scan machine and get image of his brain with location and density of that marker in his brain as the marker binds to specific enzymes or proteins connect to given physiological function.

The Papers Approach To Alzheimer’s Does Not Focus On The Plaque

I would even add that the approach actually dismisses the plaque and focuses on measuring the occurance of mitochondrial dysfunction, oxidative stresss, synaptic loss and the degree of cell stress. It is surprising to find that among the authors were scientists from Biogen, AbbVie, Pfizer, Takeda and Bristol Myers Squibb. This would mark a determined departure from the plaque theory. Nevertheless, the most important aspect of the paper is that for the proxy of cellular stress SIGMAR1 receptor expression has been selected, and it was present in all the AD patients. They are using SIGMAR1 receptor as indicator, and not to purpose it as therapeutic target. The discussion of inquiry into SIGMAR1 expression among Alzheimer’s patients and the placebo group is the most interesting to investors in Anavex. Namely, the paper beyond using SIGMAR1 presence on the brain cells makes suggestions of great importance to the expected therapeutic effect of Blarcamesine.

Alzheimer’s is associated with cell stress which in turn leads to greater expression of SIGMAR1 receptor on the stressed cells.
Brain has redundency in its capacity for plasticity. Onset of cell stress preceeds any symptoms of dementia or cognitive decline. Yet, with cell stress SIGMAR1 is strongly expressed even long before symptons of cognitive decline.
The paper suggests that previous studies which measured SIGMAR1 expression in more advanced Alzheimer’s patients were flawed by not accounting for Donezepil strong binding to SIGMAR1 receptor so that the marker could not bind to it and mark the SIGMAR1 occurance. In other words SIGMAR1 expression is strong even in more advanced patients but their brains are already devastated by the disease.
If SIGMAR1 Is A Valid Therapeutic Target Then Expect Great Things From Blarcamesine In Phase 2b/3

From evolutionary point of view the expression of SIGMAR1 in Alzheimer’s has to serve some function, or at least it did. In the results from phase 2a AD and PDD Phase 2 it is obvious that there is strong therapeutic effect. The paper does not make this connection, it just uses SIGMAR1 to validate the point that cell stress is present in AD brains, and that identity can be made between Alzheimer’s and SIGMAR1 elevated expression. This strengthens the ANAVEX’s claim to expect oversized therapeutic effect in Phase 2b/3 AD. If the first sign of cell stress is SIGMAR1 expression preceeding any symptoms and agoinists like Blarcamesine can set in motion processes leading to restoring homeostasis then Blarcamsine can become the Pill Before Dementia.

That appears to be the case. Who is surprised?

https://ih.advfn.com/p.php?pid=nmona&article=88896540

Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, and other central nervous system (CNS) diseases, today reported a relevant new peer-reviewed publication in the journal Science Translational Medicine, titled "Widespread cell stress and mitochondrial dysfunction occur in patients with early Alzheimer's disease."1
ANAVEX®2-73 activates the sigma-1 receptor (SIGMAR1). Data suggest that activation of SIGMAR1 results in the restoration of homeostatic function within the body and is pivotal to restoring neural cell balance and promoting neuroplasticity.2
In this publication, position emission tomography (PET) and magnetic resonance imaging (MRI) markers were utilized to show that impaired mitochondrial oxidative phosphorylation and synaptic loss are central to neurodegeneration in the cellular pathology of Alzheimer's disease (AD).
One of the featured observations was an increase in SIGMAR1 expression in the early stages of AD. Increased SIGMAR1 expression may be an endogenous, compensatory mechanism for the loss of other receptors and proteostasis.3 However, PET scans of patients with more advanced AD diagnoses show a reduction of SIGMAR1 expression.4
The publication is consistent with previous scientific findings that AD is a multifactorial disease, where several pathways interlink and cause cognitive impairments.5 Currently available drugs tend to target only a single pathway and mitigate the symptoms of AD without slowing the disease progression. Combinatorial therapy has been suggested as a treatment strategy; however, the existence of drug-drug interaction is a concern. Hence, there is a need to develop drug molecules that can target multiple pathways to halt disease progression and improve memory function.
SIGMAR1 has emerged as one of the prominent targets in treating neurodegeneration. It is involved in modulating glutamate levels, maintaining endoplasmic reticulum (ER) function, and regulating calcium. SIGMAR1 activation promotes neurogenesis, reduces reactive oxygen species (ROS) formation, suppresses neuroinflammation, and ameliorates Aß toxicity.6 SIGMAR1 also promotes autophagy and results in the degradation of amyloid-beta precursor protein (APP), thereby normalizing Aß production.7
Recent studies with ANAVEX®2-73 and ANAVEX®3-71 show that SIGMAR1 activation also involves mitochondrial performance, an intricate phenomenon that provides energy for cellular functions.8 SIGMAR1 agonists, including ANAVEX®2-73 and ANAVEX®3-71, have been reported to reduce toxic Aß, tau, and neuroinflammation.9

"This independent paper provides further evidence of the relevance of sigma-1 receptor activation as a compensatory mechanism to chronic CNS diseases, which is currently being tested in a late-stage placebo-controlled ANAVEX®2-73 Phase 2b/3 clinical Alzheimer's disease study with expected read-out this fall 2022," said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.
Anavex Life Sciences' precision medicine platform includes small molecule drug lead candidate ANAVEX®2-73 for the treatment of Alzheimer's disease, Parkinson's disease, and Rett syndrome and ANAVEX®3-71 for schizophrenia, frontotemporal dementia, and Alzheimer's disease.
Economic Burden of Alzheimer's Disease10
Alzheimer's disease is the most common cause of dementia and the fifth leading cause of death in adults older than 65 years. The estimated total healthcare costs for the treatment of Alzheimer's disease in 2020 were estimated at $305 billion, with the cost expected to increase to more than $1 trillion as the population ages. Most of the direct costs of care for Alzheimer's disease are attributed to skilled nursing care, home healthcare, and hospice care. Indirect costs of care, including quality of life and informal caregiving, are likely underestimated and are associated with significant negative societal and personal burdens.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients with Rett syndrome. 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. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. ANAVEX®3-71, which targets sigma-1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the company on Twitter, Facebook, Instagram, and LinkedIn.

Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company's most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: andrew@barwicki.com
1 Venkataraman, A. V., Mansur, A., Rizzo, G., Bishop, C., Lewis, Y., Kocagoncu, E., Lingford-Hughes, A., Huiban, M., Passchier, J., Rowe, J. B., Tsukada, H., Brooks, D. J., Martarello, L., Comley, R. A., Chen, L., Schwarz, A. J., Hargreaves, R., Gunn, R. N., Rabiner, E. A., & Matthews, P. M. (2022). Widespread cell stress and mitochondrial dysfunction occur in patients with early Alzheimer's disease. Science translational medicine, 14(658), eabk1051. https://doi.org/10.1126/scitranslmed.abk1051.
2 Advances in Experimental Medicine and Biology Volume 964 (2017) Sigma Receptors: Their Role in Disease and as Therapeutic Targets.
3 Brimson JM, Brimson S, Chomchoei C, et al. Using Sigma-ligands as part of a multireceptor approach to target diseases of the brain. Expert opinion on therapeutic targets. 2020; Wallace DR, Mactutus CF, Booze RM. Sigma binding sites identified by [3H] DTG are elevated in aged Fischer_344Å~ Brown Norway (F1) rats. Synapse. 2000;35(4):311-313.
4 Mishina M, Ohyama M, Ishii K, et al. Low density of sigma 1 receptors in early Alzheimer’s disease. Annals of nuclear medicine. 2008;22(3):151-151.
5 Prasanth MI, Malar DS, Tencomnao T, Brimson JM. The emerging role of the sigma-1 receptor in autophagy: Hand-in-hand targets for the treatment of Alzheimer's. Expert Opin Ther Targets. 2021 Jun 10. doi: 10.1080/14728222.2021.1939681.
6 Nguyen L, Lucke-Wold BP, Mookerjee SA, et al. Role of sigma-1 receptors in neurodegenerative diseases. Journal of pharmacological sciences. 2015;127(1):17-29; Moriguchi S, Shinoda Y, Yamamoto Y, et al. Stimulation of the sigma-1 receptor by DHEA enhances synaptic efficacy and neurogenesis in the hippocampal dentate gyrus of olfactory bulbectomized mice. PloS one. 2013;8(4):e60863-e60863; Rosen DA, Seki SM, Fernández-Castañeda A, et al. Modulation of the sigma-1 receptor–IRE1 pathway is beneficial in preclinical models of inflammation and sepsis. Science Translational Medicine. 2019;11(478):eaau5266; Maurice T, Volle J-N, Strehaiano M, et al. Neuroprotection in non-transgenic and transgenic mouse models of Alzheimer's disease by positive modulation of s1 receptors. Pharmacological research. 2019;144:315-330.
7 Jaeger PA, Pickford F, Sun C-H, et al. Regulation of amyloid precursor protein processing by the Beclin 1 complex. PloS one. 2010;5(6):e11102.
8 Goguadze, N., Zhuravliova, E., Morin, D., Mikeladze, D., & Maurice, T. (2019). Sigma-1 Receptor Agonists Induce Oxidative Stress in Mitochondria and Enhance Complex I Activity in Physiological Condition but Protect Against Pathological Oxidative Stress. Neurotoxicity research, 35(1), 1–18.
9 Lahmy V, Meunier J, Malmström S, et al. Blockade of Tau hyperphosphorylation and Aß 1–42 generation by the aminotetrahydrofuran derivative ANAVEX2-73, a mixed muscarinic and s 1 receptor agonist, in a nontransgenic mouse model of Alzheimer’s disease. Neuropsychopharmacology. 2013;38(9):1706-1706; Fisher A, Bezprozvanny I, Wu L, Ryskamp DA, Bar-Ner N, Natan N, Brandeis R, Elkon H, Nahum V, Gershonov E, LaFerla FM, Medeiros R. AF710B, a Novel M1/s1 Agonist with Therapeutic Efficacy in Animal Models of Alzheimer’s Disease. Neurodegener Dis. 2016;16(1-2):95-110.
10 W Wong Economic Burden of Alzheimer Disease and Managed Care Considerations Am J Manag Care. 2020;26:S177-S183.


View source version on GlobeNewswire.com
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AVXL
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Latest AVXL News
08/09/22 7:00 AM
Anavex Life Sciences Provides Business Update and Reports Fiscal 2022 Third Quarter Financial Results
08/03/22 7:00 AM
Anavex Life Sciences to Announce Fiscal 2022 Third Quarter Financial Results on Tuesday August 9, 2022
08/02/22 7:00 AM
Anavex Announces Long-lasting Effect of ANAVEX®3-71 Preventing Cognitive Decline in a Transgenic Rat Model of Alzheimer’s Disease at AAIC 2022
07/31/22 10:00 AM
Anavex Announces First Entire Clinical Alzheimer’s Gene Pathway Data of ANAVEX®2-73 at AAIC 2022
06/21/22 8:00 AM
Anavex Life Sciences Announces Its Very First Scientific Educational Video News Release
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INDUSTRY
Pharmaceutical Preparation Manufacturing
WEBSITE
anavex.com
CEO
Christopher Missling
SECURITY NAME
Anavex Life Sciences Corporation
ISSUE TYPE
cs
SECTOR
Manufacturing
SIC CODE
8731
EMPLOYEES
20
TAGS
Health Technology
Biotechnology
Manufacturing
Pharmaceutical Preparation Manufacturing
ADDRESS
51 W 52nd St Fl 7th
STATE
New York
CITY
New York
ZIP
10019-6163
COUNTRY
US
PHONE
18446893939
About Anavex Life Sciences Corporation
Anavex Life Sciences Corp. is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer's disease, Parkinson's disease, Rett syndrome and other central nervous system (CNS) diseases, pain and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), recently completed a successful Phase 2a clinical trial for Alzheimer's disease. ANAVEX®2-73 (blarcamesine) 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. ANAVEX®2-73 (blarcamesine) also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 (blarcamesine) for the treatment of Parkinson's disease. ANAVEX®3-71, which targets sigma-1 and muscarinic receptors, is a promising preclinical drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation.
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Dr Missling has been criticized for being overly methodical and conservative with the way he does things.
He has received guidance from the FDA on the trial design before implementing the AD trial.
He hired TWO former FDA employees that both oversaw hundreds for NDA’s and drug approvals

Knowing that the FDA would likely request a second P3 and delay approval 3-4 YEARS, I find it very hard to believe that
Missling would take a huge gamble like that.

ANAVEX IS CO-SPONSORING THIS EVENT


The 2022 Reverse Rett Winter Gala will take place on Friday 2nd December at the stunning venue of Church House, Westminster!



This annual event marks a highlight in the Rett community’s calendar – an evening of glamour, entertainment, inspiration and determination.

A chance to come together to celebrate all that has been achieved, to look forward to the next chapters, and to enjoy kicking off the festive season in style!

Punctuating the elegant drinks reception and sumptuous three-course dinner will be first-class comedy, mesmerising magic, captivating live music and the chance to let your hair down and dance the night away, not to mention a fabulous array of prizes in our auctions.

We’re delighted to have the generous support of Anavex Life Sciences and Blackbridge Communications as sponsors for this year’s event.

“ Auvelity’s oral NMDA receptor antagonist and sigma-1 receptor agonist activity, which targets glutamatergic neurotransmission, provides clinicians a long sought after new mechanistic approach which may benefit the millions of patients living with this serious condition. In clinical trials,”

Axsome Therapeutics Announces FDA Approval of AUVELITY™, the First and Only Oral NMDA Receptor Antagonist for the Treatment of Major Depressive Disorder in Adults

Should benefit AVXL with their sigma-1 MOA approval.
Maybe it will bring some attention to sigma-1 drugs.

RedSholder, I apologize for reposting your post from Stock twtz
this morning. It seems that I stirred up a lot of controversy over the CRO that you are having to answer.
Hnbadger

Will the new CRO have to start from scratch or redo the work of the old CRO?
Maybe the current CRO will complete the trials already in work and the new CRO will begin with the upcoming trials?
Lots of questions…

I don’t know the answer to either question.
RedSholder, are you out there?

Yes, you are right, changing CRO’s in the middle of AVXL trials is just a big yawn..

WOW BIG NEWS FOR ANAVEX!!!Question is , will it delay any of the ongoing trials??
————————————————————————
Red Shoulder just posted this on Stock Twt-
Anavex has a new CRO and
let the previous one go. I'm sure
he was dissatisfied with the time
taken up by the last CRO. I think a
change in the CRO will make a big
difference.
I think the new CRO will get the
job done fasted than the last one
or he would not have hired them.
He initially said late Sept or early
Oct. Then later said Fall which
covers late Sept or Oct.
I read somewhere where the new
CRO is #2 largest CRO.
CRO stands for Contract Research
Organizations.
———————————————

Red Shoulder just posted this on Stock Twt-
Anavex has a new CRO and
let the previous one go. I'm sure
he was dissatisfied with the time
taken up by the last CRO. I think a
change in the CRO will make a big
difference.
I think the new CRO will get the
job done fasted than the last one
or he would not have hired them.
He initially said late Sept or early
Oct. Then later said Fall which
covers late Sept or Oct.
I read somewhere where the new
CRO is #2 largest CRO.
CRO stands for Contract Research
Organizations.

Looks like it’s finally happening. The Amyloid thesis is being debunked and getting attention.
Every AVXL investor needs to watch is video.

I would love to hear Dr Schag’s option on Anavex.

Hmmm… mention of A2-73 or A3-71 or any drugs for that matter. Only natural supplements.

MayoMobile-I’m curious about your thoughts on the article as it pertains to Anavex.
https://www.nature.com/articles/s41419-022-05153-5

Despite what the few experts on this MB say, I am convinced that Dr. Missling and company already know the outcome of the AD, PPD EXT and Excellence trials.
In the real world, people talk. Caregivers and Family members are held to a NDA, but if the patients are making a noticeable improvement, it’s hard not to notice.
The company doesn’t have the specifics, such as P values, but they already know if it’s a bust or success…..IMO of course

Great article..bodes well for AVXL’s drugs MOA

Nidan everyone knows that AVXL is dead money for the next year as we were told yesterday!

https://ih.advfn.com/p.php?pid=nmona&article=88814655

NICE!

Is it common for the EMA or the Australian TGA to approve a drug from a US company before the FDA does?

“DEAD MONEY “ AVXL up 6%…that’s odd

Also, what is going on with EXCELLENCE?? Still TLD readout by end of the year? Why so long to recruit a small number of girls?

Hopefully Tuesday will shed some light on the future of Anavex.

RETT was supposed to be the first NDA/approval. That probably will still happen.
Looks like the AD TLD readout will be the make or break unfortunately.
With a great or even good readout, all missteps and delays will be forgiven.

If another P3 is required, there will be a lot of P/O’d share holders because Anavex took a big gamble and set approval back 3-4 years.
Maybe the thinking was that PDD has a 70% correlation with AD so that would qualify. However, for what ever reason, they sat on the PDD data for two years.

I’m still trying to believe in TGD’s quote “when it’s over, you will see why we did what we did “ but I must admit, it’s getting harder to believe.
Why sit on PD/PDD data for two years?
Why is it taking a year and a half to recruit a handful of Rett girls?

Why has Fragile x been promised for two years?
Why so long on the mystery rare indication?
I read that SAVA recruited 300 trial patients rather quickly.
Is the precision medicine focus really worth the years of additional time?

That’s kind of what I was thinking. Maybe the day after announcing the TLD, they announce the BP partnership (Merck)with the CEO of the BP touting the great ph3 results.

When the AD TLD is released this fall, a fully expect an all out assault from Adam F, Jesse B and many more.
Doesn’t matter how good the data is, they will twist the data
to spread FUD. They are probably working on their responses already.
Count on it!

I sure hope Dr Missling is prepared and has a response. Maybe some kind of one-two punch.

I’m having a hard time understanding why it is taking so long to recruit the additional girls for the Excellence trial.
Yes, I understand the Covid lockdowns and vaccination issue,
But we are not talking about many girls.
With Reverse Rett org involved plus Rett’s leading KOL, Dr Kauffman on board , you would think that there would be a waiting list to join the trial.
What am I missing??
Time is NOT on our side with these trials.
WGT

“ Our early interactions with regulators have shown us that they much more strongly favour treatments which have clear cut positive effects, even if they are expensive.”

I hope that they are referring to Anavex!

What are the chances that our two former FDA employees have informal talks with their former colleagues about the matter? Of course we will never know.

I know many disagree, but I really would like Anavex to form a strong partnership with a dominant BP like Lilly or Merck.

There is too much money involved for Anavex’s disruptive drugs should the trial results come back positive which I believe they will be.

IMO , the FDA will be more inclined to approve Anavex’s drugs if they are partnered with a large BP with an existing infrastructure of research, manufacturing and marketing.
Yes, we will give up a large chunk of our profits , but if the pipeline is what most of us believe it is , there are DOZENS
of indications to apply for.

It’s painfully obvious that the rest of the industry does not want Anavex to exist. Every time good data is released, we get beaten down.

https://www.npr.org/sections/health-shots/2022/08/01/1113825311/alzheimers-researchers-are-looking-beyond-plaques-and-tangles-for-new-treatments

Thanks for your “glass half empty “ thoughts on the poster.
Because as we know, the FDA has dozens of very promising AD candidates lined up. Especially all those Amyloid prospects.

Clinicaltrialguide
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4. Anavex Life Sciences (AVXL) - Anavex is
another big player in Alzheimer's research with
a drug candidate, Blarcamesine, in phase 3
trials in over 500 patients. This drug is a Sigma-
1 receptor agonist which has proven to restore
neurodegenerative processes. This drug is also
indicated for Parkinson's Disease and Rett
Syndrome. As the data continues to pour in
from the studies the stock is likely to go up with
the potential of skyrocketing with a
breakthrough.

Interesting twitter post
——————————————————-
potchi @MD18246876 • 26 jul.
Als antwoord op @zeusPharma
AVXL could be the next penicillin (accidental
discovery).
AVXL 2-73 developed as S1R agonist but could also
be a inhibitor of FKBP12 that blocks necroptosis to
stop or slow down neurodegeneration
—————————————————————

Sorry for your loss McM, should have stuck with AVXL

Looks like Anavex’s competition is narrowing,
Amyloid drugs being called out.
Cassava is facing big problems.

Time for Anavex to shine!

Let’s go Dr Missling. Make it happen!

Ot- SAVA down -46% pre-market

WASHINGTON, July 27 (Reuters) - The U.S.
Justice Department has opened a criminal
investigation into Cassava Sciences Inc involving
whether the biotech company manipulated
research results for its experimental Alzheimer's
drug, two people familiar with the inquiry said.
The Justice Department personnel conducting the
investigation into Austin, Texas-based Cassava
specialize in examining whether companies or
individuals have misled or defrauded investors,
government agencies or consumers, according to
the sources, who spoke on condition of anonymity.
The sources did not provide details of the focus of
the probe and whether the department was looking
into any specific individuals.
As in any Justice Department investigation, this
one could lead to criminal charges or be closed
without any charges being brought.

Great post Tred! Makes sense.
When you have possibly the most disruptive drugs to come along in years, it’s best to fly under the radar .
Although frustrating for shareholders, it’s the smart thing to do

The wolves are circling.