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.
Mayo, I have had a question that has not been answered or opinion given that you may be able to answer since it involves a misfolded protein.
"Simufilam is Cassava Sciences’ proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA) protein in the brain."
Since filamin A is down stream from the S1 receptor; once Anavex 2-73 restores the S1 receptor to homeostasis, would that restore filamin A to proper folding, thus making SAVA's drug redundant and not needed?
Many thanks Mayo for the in depth analysis, this time on protein folding and misfolding:
Key Findings & Facts:
Protein misfolding is a relatively common cellular event caused by genetic mutations, translation error, abnormal protein modifications, thermal or oxidative stress, and incomplete formation.
Unfolded protein response is activated in response to accumulation of unfolded or misfolded proteins. It aims to restore normal function of the cell by halting protein translation, destroying/clearing misfolded proteins, and increasing expression of genes involved in protein folding. If these objectives fail, the unfolded protein response turns toxic to homeostasis by prompting apoptosis (cell death) at elevated levels.
After cross-referencing Anavex's AAIC AD/PD Gene Clustering Poster (2022) it appears likely that Blarcamesine has implications in all three unfolded protein response pathways - not just IRE1 as was previously thought.
https://www.sotcanalytics.com/update-compendium#h.piozvv6tu1kq
All the markets closed red, XBI red, SAVA down big at 11.13%; and yet AVXL closed up on the green side. I'll take that any day considering the market condition today.
AVXL bucking the red market with a gain, no surprise as it was obviously oversold Friday.
Even the XBI and SAVA with an earlier green sp is in the red now.
KB the fact that Elon Musk has Asperger's syndrome which is a CNS disease, and which at some point in the future Anavex will likely have a trial on the disease is not a " grasp at straws ".
"Elon Musk Explained How His Brain Works in a Viral TED Talk
The 50-year-old Tesla and SpaceX CEO shared more about his experience with autism."
https://www.menshealth.com/health/a39899459/elon-musk-ted-talk-brain-aspergers-autism/
"Elon Musk revealed this month that he has Asperger's syndrome. He may have known that his whole life, or he may have learned it relatively recently, as recognition and diagnosis of this mild form of autism have grown in recent years."
I'm pretty sure at some point in the future Anavex will have a trial with Autism/Asperger's which is a CNS disease.
https://www.inc.com/minda-zetlin/elon-musk-aspergers-self-test-entrepreneurs-temple-grandin.html
Anavex's own Nell Rebowe hangs out with Elon Musk's mom. Pictures furnished by Mayo on ST.
https://stocktwits.com/symbol/AVXL
AVXL Due Diligence for new eyes and reference material for old eyes; DD for the weekend warrior - 8 Sources:
Update Compendium, a 3rd party independent review and projections with data and sources.
Projected Blarcamesine Revenues & Market Cap; plus a wealth of other data and important details. Compiled by Mayo:
https://www.sotcanalytics.com/update-compendium
Jun 2022 Commentary on Anavex's First Educational Video.
A report from various members of the company management team on current operations and future projections:
https://www.anavex.com/vnrjune2022
NEWS: Anavex Announces First Entire Clinical Alzheimer’s Gene Pathway Data of ANAVEX®2-73 at AAIC 2022
https://www.anavex.com/post/anavex-announces-first-entire-clinical-alzheimer-s-gene-pathway-data-of-anavex-2-73-at-aaic-2022
June Corporate Slides.
Very useful for a visual look at all the Anavex programs, trials, graphs, and useful data:
https://www.anavex.com/_files/ugd/850d88_6d847f744209465f82a4ad655bb25941.pdf
Piotrpeterblog.com is an independent analysis blog on Alzheimer and CNS Drugs.
https://piotrpeterblog.com/
An extensive list of a wide range of various topics with links, compiled DD, and recent posts. Compiled by XenaLives
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=166917727
A report given by Dr. Randi Hagerman, a recognized leader WW for CNS conditions and treatments. Compiled by tradeherpete.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168422630
Anavex Company, an Overview; compiled by Mayo Mobile:
https://drive.google.com/file/d/15i9suShnAjC_Vq5gEl-ocp3ebsWKr0fd/view
Good luck with the DD, feel free to ask the knowledgeable board any questions.
RedShoulder
TTT, once again a nice find.
I cannot imagine the total number of rare CNS disease that will eventually be treated with A2-73 and A3-71 as the company matures.
Also we should remember that Anavex is also planning future trials for non-CNS diseases such as the heart.
Restoring mitochondria homeostasis throughout the body and various organs is going to be recognized as a major medical breakthrough, especially for the multitude of various CNS diseases.
I'm requesting comments without reservations on this statement which may or may not be true:
A2-73 and A3-71 both work 'upstream' to bring homeostasis to the Sigma 1 Receptor, which will fold proteins properly including the 'downstream' protein filamin A that SAVA 's drug sumifilam targets; thereby making it not needed and redundant. Anavex's A2-73 will become the strong SOC while SAVA is still in trials.
Thanks in advance for anyone's input.
AVXL Due Diligence for new eyes, weekend warriors, and reference material for old eyes - 8 Sources:
Update Compendium, a 3rd party independent review and projections with data and sources.
Projected Blarcamesine Revenues & Market Cap; plus a wealth of other data and important details. Compiled by Mayo:
https://www.sotcanalytics.com/update-compendium
Jun 2022 Commentary on Anavex's First Educational Video.
A report from various members of the company management team on current operations and future projections:
https://www.anavex.com/vnrjune2022
NEWS: Anavex Announces First Entire Clinical Alzheimer’s Gene Pathway Data of ANAVEX®2-73 at AAIC 2022
https://www.anavex.com/post/anavex-announces-first-entire-clinical-alzheimer-s-gene-pathway-data-of-anavex-2-73-at-aaic-2022
June Corporate Slides.
Very useful for a visual look at all the Anavex programs, trials, graphs, and useful data:
https://www.anavex.com/_files/ugd/850d88_6d847f744209465f82a4ad655bb25941.pdf
Piotrpeterblog.com is an independent analysis blog on Alzheimer and CNS Drugs.
https://piotrpeterblog.com/
An extensive list of a wide range of various topics with links, compiled DD, and recent posts. Compiled by XenaLives
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=166917727
A report given by Dr. Randi Hagerman, a recognized leader WW for CNS conditions and treatments. Compiled by tradeherpete.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168422630
Anavex Company, an Overview; compiled by Mayo Mobile:
https://drive.google.com/file/d/15i9suShnAjC_Vq5gEl-ocp3ebsWKr0fd/view
Good luck with the DD, feel free to ask the knowledgeable board any questions.
RedShoulder
attilla, I do not think they changed the CRO during a trial or before a read out., that just doesn't happen.
I had posted on ST that I thought they had changed CROs based on what I heard, since that post I am not able to verify the source and withdrew that claim with an apology. I did not say anything about being fired mid trial; that just doesn't happen.
I called Anavex IR and he said that he cannot comment on that, but he did say they use multiple CROs.
8,726,226 shares shorted is a factor in keeping the SP down.
An important message and opinion from Reverse Rett regarding Anavex's competition Acadia and their drug Trofinetide. This message indicates that they are not pleased with the adverse side effects.
Anavex's A2-73 Blarcamesine is safe and without any adverse side effects. Most importantly is A2-73 Blarcamesine has shown to be more efficacious in trials than Trofinetide.
Reverse Rett is well aware of both trials and it appears they are waiting on FDA approval of the safer and more effective Anavex's A2-73 Blarcamesine.
----------- From Reverse Rett -----------------------------------------------------
The following points add to our reservations about this application:
There have been some anecdotal reports from families in America sharing positive experiences of the Trofinetide Lavender study. ?However, the data which have been shared by Acadia to date, only show very small differences between patients treated with Trofinetide over patients who received placebo. Also, a relatively high number of people (20%) left the trial; the most commonly cited side effect was diarrhoea. More evidence is needed before the community can arrive at a conclusion regarding Trofinetide and its potential for improving symptoms in people with Rett Syndrome.?
https://www.reverserett.org.uk/this-weeks-trofinetide-announcement/
AVXL Due Diligence for new eyes and reference material for old eyes - 8 Sources:
Update Compendium, a 3rd party independent review and projections with data and sources.
Projected Blarcamesine Revenues & Market Cap; plus a wealth of other data and important details. Compiled by Mayo:
https://www.sotcanalytics.com/update-compendium
Jun 2022 Commentary on Anavex's First Educational Video.
A report from various members of the company management team on current operations and future projections:
https://www.anavex.com/vnrjune2022
NEWS: Anavex Announces First Entire Clinical Alzheimer’s Gene Pathway Data of ANAVEX®2-73 at AAIC 2022
https://www.anavex.com/post/anavex-announces-first-entire-clinical-alzheimer-s-gene-pathway-data-of-anavex-2-73-at-aaic-2022
June Corporate Slides.
Very useful for a visual look at all the Anavex programs, trials, graphs, and useful data:
https://www.anavex.com/_files/ugd/850d88_6d847f744209465f82a4ad655bb25941.pdf
Piotrpeterblog.com is an independent analysis blog on Alzheimer and CNS Drugs.
https://piotrpeterblog.com/
An extensive list of a wide range of various topics with links, compiled DD, and recent posts. Compiled by XenaLives
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=166917727
A report given by Dr. Randi Hagerman, a recognized leader WW for CNS conditions and treatments. Compiled by tradeherpete.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168422630
Anavex Company, an Overview; compiled by Mayo Mobile:
https://drive.google.com/file/d/15i9suShnAjC_Vq5gEl-ocp3ebsWKr0fd/view
Good luck with the DD, feel free to ask the knowledgeable board any questions.
RedShoulder
Quote:
There was a lot of volume in the last 8 minutes of trading and the price went up 3 cents?? About 260,000 shares…strange
I was watching the trades going off on L-2 and not only did the vol increase with 15 minutes to closing, but the speed of the trades really picked up. This kind of action 15 minutes before the close is starting to be a common occurrence.
The 6% day gain was a great way to end the week.
Thanks Doc for the detailed information..
"On page 1 in the easy to read chart - the FDA averages 243 days and the TGA averages 346 days to approve a drug after application."
"On page 19 for the FDA. 85% of new drugs approved first or concurrently by the FDA compared to the rest of the world!"
"on page 23 for the TGA --- they approved first of concurrently only 1/6 times!!"
Mayo, thanks for the chart. It applies to Anavex with it's trials in foreign countries with each having different lengths of time lines from submission to approval, as you would expect.
Of the 6 countries shown, it is the Australian's TGA that moves the process along with the least amount of time to approval, while the FDA is the longest and is continuing to lengthen the process.
That is pretty interesting considering the multiple Anavex trials located there.
One might conclude that a TGA approvals of A2-73 Blarecamesine uses may be the first country to award an approval.
I think TGA knows as much, if not more, than any other country regarding A2-73 Blarecamesine and it's successes, they may want to be the first to approve.
Why is this? :If Anavex's Alzheimer Ph-2b/3 TLR results are good, to better than good, in a 509 randomized and double blind trial, what purpose would a second Ph-3 trial have, logic would dictate the results would be close.
A second ph-3 seems redundant and delays FDA approval for patients with AD the best medical care by possibly by years, and that could be a no return slow death for some as a result of the delay of a safe medication that works with no failed trails and no serious adverse effects.
Also consider the Alzheimer Ph-2 to back up the Ph-2b/3 trial which was very successful with some stabilizing and some recovering. We have seen the vids.
Why a second Ph-3, if the first Ph-3 was successful and can help AD patients sooner
??
Thanks Bourbon for your detailed notes, I especially like the last word:
FDA Perspective on International Clinical Trials
OIG Report: • Over half of all clinical trial sites are outside the U.S.
OIG Report: • 80 % of applications for drugs & biologics contain data from ex-U.S.
studies:
• 78 % of all subjects were enrolled outside the U.S.
• 87 % of all subjects recent biologics trial were enrolled outside the US.
------------------------------------------------------------------------------------------
Pushing & Pulling Forces:
U.S.
• Difficulty recruiting patients – Fewer feel need to participate
• Higher standard of care
• Mistrust (historical infamy Tuskegee trial)
• Requirement for larger # of Pts
• Insurance precluding participation/HIPAA
• Higher costs: clinical care/Operational/ documentation & training)
Non U.S.
• Reduced cost or economic drivers (clinical care/Operational/training)
• Motivated subjects & investigators
• Rx naïve subjects willing & eager to participate
• Faster recruitment rates/ short timeline
• Availability of large # of patients
• Countries and institutions trying to attract research and clinical trials
• Availability of CROs focused on global trials
• Less regulatory red tap
------------------------------------------------------------------------------------------
Final Thought
“Wherever you stand, the majority of clinical trials are being conducted elsewhere, and yet we all as regulators use these data to allow or disallow marketing of a product, and physicians and patients use these data to decide to use or not use a
medicine.”
Fergus Sweeney, EMA
“Today we recognize that to successfully protect U.S. public health, we must think,
act, and engage globally. Our interests must be broader than simply those within our own borders.”
Margaret Hamburg, FDA
Commissioner
FDA link:
https://www.fda.gov/media/91849/download
Many thanks Mayo for the notes, very helpful.
I especially like the parts you bolded:
"Additionally I'd like to make mention that we have adequate manufacturing and supply in place for a rollout assuming approval and commercialization"
Q: Can you speak to the imaging use of Blarcamesine vs. therapeutic use at a commercialization level? Also, how are you thinking of optimizing the value of Blarcamesine in U.S. territories. Can we talk about partnerships? Please also add context regarding IP protection in places such as China?
A: We did notice in all three indications that S1R shows up in two different genetic forms (WT [80-90%] vs. mutation) and WT had better results. With high enough dosing however, there is not much difference between WT and mutation. We are in parallel developing a diagnostic test in order to go into the market with the ability to identify WT-gene patients if necessary. We will see if the AD and EXCELLENCE study will require such a selection. It may be that there is enough benefit in both S1R-gene groups that we don’t need such a diagnostic but will have it just in case. We are planning on marketing Rett syndrome and possibly Fragile-X ourselves. We are in discussions with European, Asian, and Chinese companies to market outside the U.S. We are also looking at global partnerships and regional partnership opportunities. We ARE in discussions for this already for a worldwide roll-out. We have filed patents to become aggressive with protection in China – always including protection in the U.S., Europe, and Asia, with specifically in China.
I think the most important piece of new information that affects Anavex chance of becoming the SOC for Rett was this 'Reverse Rett' article, found by makemydaze in the referenced post.
Quote: At Reverse Rett, we are receiving some questions about this announcement and wanted to share our perspectives.
The following points add to our reservations about this application:
There have been some anecdotal reports from families in America sharing positive experiences of the Trofinetide Lavender study. However, the data which have been shared by Acadia to date, only show very small differences between patients treated with Trofinetide over patients who received placebo.
Also, a relatively high number of people (20%) left the trial; the most commonly cited side effect was diarrhoea.
More evidence is needed before the community can arrive at a conclusion regarding Trofinetide and its potential for improving symptoms in people with Rett Syndrome.
Reverse Rett link:
https://www.reverserett.org.uk/this-weeks-trofinetide-announcement/
AVXL Due Diligence for new eyes and reference material for old eyes - 8 Sources:
Update Compendium, a 3rd party independent review and projections with data and sources.
Projected Blarcamesine Revenues & Market Cap; plus a wealth of other data and important details. Compiled by Mayo:
https://www.sotcanalytics.com/update-compendium
Jun 2022 Commentary on Anavex's First Educational Video.
A report from various members of the company management team on current operations and future projections:
https://www.anavex.com/vnrjune2022
NEWS: Anavex Announces First Entire Clinical Alzheimer’s Gene Pathway Data of ANAVEX®2-73 at AAIC 2022
https://www.anavex.com/post/anavex-announces-first-entire-clinical-alzheimer-s-gene-pathway-data-of-anavex-2-73-at-aaic-2022
June Corporate Slides.
Very useful for a visual look at all the Anavex programs, trials, graphs, and useful data:
https://www.anavex.com/_files/ugd/850d88_6d847f744209465f82a4ad655bb25941.pdf
Piotrpeterblog.com is an independent analysis blog on Alzheimer and CNS Drugs.
https://piotrpeterblog.com/
An extensive list of a wide range of various topics with links, compiled DD, and recent posts. Compiled by XenaLives
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=166917727
A report given by Dr. Randi Hagerman, a recognized leader WW for CNS conditions and treatments. Compiled by tradeherpete.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168422630
Anavex Company, an Overview; compiled by Mayo Mobile:
https://drive.google.com/file/d/15i9suShnAjC_Vq5gEl-ocp3ebsWKr0fd/view
Good luck with the DD, feel free to ask the knowledgeable board any questions.
RedShoulder
tradeherpete and tred, this is all we need to know out of that pile of babble:
"Lecanemab is an investigational humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (Aß) aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD."
We have recently had the amyloid funeral based on premises of false data, when are they going to finally bury it?
https://ih.advfn.com/stock-market/NASDAQ/biogen-BIIB/stock-news/88752596/eisai-presents-new-findings-on-lecanemabs-investig