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"Didn't take time to figure the FX affect."
Yeah, neither did I LOL
Was hoping for longtermbeliever's Korean Soda King connection to finally start throwing millions at AVXL. I guess he is still busy doing his DD...
Would really like for us to get a successful top line Rett EXCELLENCE readout before we get any further AD news. That alone could possibly get us back over the 52-week high ($13.23), which would be a nice level from which to spring up on any further AD news (or Rett NDA submission news)...
That type of environment should certainly be good for the biotech sector as a whole and result in a rebound from this nasty 2 1/2 year decline...
Agree 100%. However, if AVXL is fortunate enough to partner up with a BP, gain AD approval in Europe and begin recognizing revenue (which should certainly be enough to get AVXL's share price above $50 at a minimum), then I believe at that time we will see the first buyout offer come in with an 80% - 100%+ premium above the then current AVXL share price...
I assume this is our iHub mrplmer now posting on Stocktwits...
I wonder if today's news will be enough to convince Tom Bishop to make AVXL his "Top Pick For 2024" (if I recall correctly, he made AVXL his top pick for both 2022 and 2023)...
OH NO! Hate seeing price predictions from attilathehunt...hehe
Yes it was, hopefully to be followed by some more nice positive surprises in the near future...
If not adjusting your 25% chance for AA, what % chance would you now give to just any AD approval anywhere in the world?
At the very least, one would think today's announcement will result in a much more interesting upcoming CC with all or nearly all of the analysts currently covering AVXL attending...
Nope...but definitely a much chance now to get them for Christmas 2024!
Hopefully, much more...hehe
FWIW - Comment on this morning's news from dadofmarcmax on Stocktwits:
Anavex Initiates Regulatory Submission of Oral Blarcamesine for Alzheimer’s Disease to European Medicines Agency (EMA)
GLOBENEWSWIRE 8:00 AM ET 11/20/2023
NEW YORK, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp.(AVXL) (“Anavex” or the “Company”) , a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders announced today that representatives of Anavex met with team members of the European Medicines Agency (EMA).
These meetings discussed the debilitating pathology of Alzheimer’s disease and Anavex’s blarcamesine (ANAVEX®2-73) Alzheimer’s disease clinical program results, including data obtained in the ANAVEX®2-73-AD-004 study.
Pursuant to discussion at the meetings, Anavex initiated the process for submitting a Marketing Authorisation application to the EMA with the submission of the Centralised Procedure request with the goal of the Authorisation allowing direct access to the market of the European Union for oral blarcamesine for the treatment of Alzheimer’s disease.
Anavex’s goal is to take care of patients in a patient-centric way with the preference for convenient oral treatment options for Alzheimer’s disease not requiring complex logistics resources and added personnel for drug administration and monitoring for brain edema and brain bleeds.
Severe symptoms in relation to Amyloid-Related Imaging Abnormalities (ARIA) is a known risk factor for Alzheimer’s patients taking the class of drugs called monoclonal antibodies, and requires constant and repeated MRI examination, for which not all regions in Europe are currently sufficiently prepared and equipped for in addition to the requirement to address affordability and inequalities in patient access within European Union countries.1,2
“We look forward to working together with the team from EMA,” said David Goldberger, RPh, MLS, Senior Vice President Regulatory Affairs at Anavex. “We continue to work towards fulfilling our purpose of improving patients' lives with oral blarcamesine not requiring any complex additional procedures for the treatment of people with Alzheimer’s disease.”
There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 2030, according to the European Brain Council.3
The World Health Organization (WHO) estimated the cost in Europe of caring for people with dementia, including Alzheimer's disease, at $439 billion, or $31,144 per person in 2019. That includes hospital care, medicines, diagnostics, informal caregiver time, community services and long-term care facility costs.4,5
“There remains an urgent need for convenient once-daily oral treatment options for Alzheimer’s disease, and Anavex is moving forward to potentially addressing the preference for simple patient-centered administrations and shared decision-making,” said Christopher U Missling, PhD, President and Chief Executive Officer at Anavex.
In addition to significant improvement in dementia symptoms, blarcamesine demonstrated reduction of pathological aggregation of amyloid in early Alzheimer’s disease as well reduction of brain volume loss, a well-known marker of neurodegeneration.
Data from the blarcamesine in Alzheimer’s disease Phase 2b/3 randomized clinical trial will be published in an upcoming peer-reviewed journal.
About Anavex Life Sciences Corp.(AVXL)
Anavex Life Sciences Corp. (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 and a Phase 2b/3 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.(AVXL) 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. (AVXL)
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 Frölich L, Jessen F. Editorial: Lecanemab: Appropriate Use Recommendations - A Commentary from a European Perspective. J Prev Alzheimers Dis. 2023;10(3):357-358. doi: 10.14283/jpad.2023.44. PMID: 37357274.
2 Jönsson L, Wimo A, Handels R, Johansson G, Boada M, Engelborghs S, Frölich L, Jessen F, Kehoe PG, Kramberger M, de Mendon?a A, Ousset PJ, Scarmeas N, Visser PJ, Waldemar G, Winblad B. The affordability of lecanemab, an amyloid-targeting therapy for Alzheimer's disease: an EADC-EC viewpoint. Lancet Reg Health Eur. 2023 May 22;29:100657. doi: 10.1016/j.lanepe.2023.100657. PMID: 37251789; PMCID: PMC10220264.
3 https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/
4 Jönsson L. The personal economic burden of dementia in Europe. Lancet Reg Health Eur. 2022 Jul 25;20:100472. doi: 10.1016/j.lanepe.2022.100472. PMID: 35910037; PMCID: PMC9326307.
5World Health Organization (WHO); 2021. Global status report on the public health response to dementia.
Image: https://www.globenewswire.com/newsroom/ti?nf=ODk4MjA2MiM1OTM2MTc1IzIwMTk1Mzk=
Image: https://ml.globenewswire.com/media/ZGZiMDczNTEtMDhiOC00YjA3LWFjOWItYzg5NjYxYmQyMGYyLTEwMzExNzY=/tiny/Anavex-Life-Sciences-Corp-.png
Image: Primary Logo
Source: Anavex Life Sciences Corp.(AVXL)
"stellar results"...let's hope so
"WGT"...assuming we actually get "stellar results" then we just might be on our way to "WGT"
Hopefully, the FDA will indeed grant AVXL AA for AD sometime in 2024 (Feb'ish a bit too early for that...hehe) and your concern will be forever alleviated by a resulting share price exceeding $60, along with the long-awaited delivery of your sparkly brand new bicycle for Christmas 2024!
That is one heck of a dream! But hey, dreams do come true sometimes, right?
Sure would be nice to see your dream become a reality...
If I was forced to make a bet, I would take the "under $12M" burn on the last Quarter
(especially if you add in the interest earned on the +/- $140M cash on hand)
The amount of dilution during the just under five (5) month time period from February 7, 2023 (78,032,135) through June 30, 2023 (81,390,916) was 3,358,781 shares (707,112 per month avg.). It will be interesting to see how much dilution actually took place during the latest near five (5) month time period since June 30, 2023 when we get the new O/S during the FYE conference call next week...
"On-time" technically still possible so long as submission to the publisher occurs on or before this Friday, November 17th...
Note To FeMike: My statement above should in no way be interpreted as providing an excuse for NWBO. It is simply a statement using elementary school level mathematics based upon the date ranges provided by NWBO in their last PR.
Disclaimer: Obviously, I do not for one second actually believe that Friday, November 3rd was the day the consultants returned to work. I highly doubt anyone would believe that to be the day during "the week of October 30th" they actually returned to work LOL
Hopefully, the when is at some calculated point in time after the submission of the Rett NDA to the FDA rather than after the FDA's approval (fingers crossed) of the Rett NDA...
FWIW - Since the prior PR stated that the consultants were due to return sometime "during the week of October 30th," it is possible that they did not return until as late as Friday, November 3rd. If that was the case, then delivery to the publisher might not happen until this Friday, November 17th...
Maybe HC Wainwright will raise AVXL's price target by the $10 it just took off of ANVS's price target...
FWIW - BlackRock has increased their position in AVXL by approx. 483,000 shares over the last ten (10) months:
2023-01-31 13G/A BlackRock Inc. 5,262,666 5,578,159 5.99 7.20 4.35
https://fintel.io/so/us/avxl2023-11-13 13F BlackRock Inc. 6,061,191 2.06 39,701 -17.78
I'll be a happy camper if/when (hopefully when, for obvious reasons) the decimal point moves one position to the right in each one! hehe
You forgot to add the picture of your "dog"...hehe
"...when the Rett NDA is filed and then approved."
From your lips to you know whose ears Steady_T!
FWIW - I am NOT lending (nor have I ever lent) any of my NWBO shares to Fidelity.
Was simply reporting the interest rate that Fidelity is currently paying...
FYI - Fidelity currently at 19.5%
IMHO all of your projected dates appear to be the most accurate!
So they probably meant to say the following:
“With this timeline, the submission of the MAA to the publisher would take place between mid and late November.”
No possible way for the submission of the MAA to the MHRA take place sometime in mid to late November unless we get a PR tomorrow saying that it has been submitted to the publisher AND the publisher can get it submitted to the MHRA in 2 weeks (Nov 21) or 3 weeks (Nov 28) at the latest...
Hoping 100fold ends up being spot on with his thoughts below from Stocktwits.
If so, I'd be plenty happy with just a 10fold increase in the AVXL share price by Christmas 2024! hehe
Let's hope the hiring of this Goldberger dude translates into 2024 being the year of the NDA(s) filing(s)!
Anavex Life Sciences Appoints Senior VP of Regulatory Affairs
GLOBENEWSWIRE 8:00 AM ET 11/6/2023
NEW YORK, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp.(AVXL) (“Anavex” or the “Company”) , 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 announced the appointment of David Goldberger, RPh, MLS as Senior Vice President Regulatory Affairs. Mr. Goldberger brings over 40 years of pharmacy practice and pharmaceutical industry experience and has most recently been with Otsuka Pharmaceuticals Research and Development (Otsuka) as Vice President Global Regulatory Affairs, U.S. and Europe. Mr. Goldberger will succeed retiring Senior Vice President Regulatory Affairs, Emmanuel O Fadiran, RPh, MS, PhD.
“We are delighted to welcome Mr. Goldberger to the Anavex team,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “Mr. Goldberger has an impressive background in leading the regulatory strategies for numerous product developments including subsequent NDA submissions and helping to deliver drug candidates to patients worldwide in addition to expertise in overseeing global regulatory interactions for CNS development projects. We also want to express our gratitude to Dr. Fadiran for his years of outstanding leadership and contributions to Anavex.”
Before joining Anavex Mr. Goldberger has most recently been with Otsuka where he led the Regulatory Affairs efforts to gain approval for multiple CNS products, including ABILIFY MAINTENA®, REXULTI®, new indications for ABILIFY® as well other product and therapeutic area approvals. Prior to Otsuka he held senior level positions in Global Regulatory Affairs for Johnson and Johnson (J&J) Pharmaceutical Research and Development in Global Regulatory Affairs. Throughout his career he has covered the full range of investigational products development and marketed products across multiple therapeutic areas including psychiatry and neurology. Mr. Goldberger has extensive experience in working with the U.S. FDA, EMA, Health Canada, and other global health authorities. In addition, he led CMC Regulatory Affairs, Labeling, Regulatory Operations/Technology and Medical Writing areas. Mr. Goldberger holds bachelor’s and master’s degrees from Rutgers University.
“I am very excited to be working with the Anavex portfolio, which has great potential to significantly impact the treatment of patients with neurodevelopmental, neurodegenerative and psychiatry disorders,” said Mr. Goldberger. “I believe that I can help build upon the work done to date and move the products toward regulatory approval for the patients who need them.”
About Anavex Life Sciences Corp.(AVXL)
Anavex Life Sciences Corp. (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 and a Phase 2b/3 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.(AVXL) 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. (AVXL)
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
Image: https://www.globenewswire.com/newsroom/ti?nf=ODk3Mjk1MyM1OTEwOTI2IzIwMTk1Mzk=
Image: https://ml.globenewswire.com/media/N2MxMDM1Y2YtYzE0OS00YzcxLTgyNTQtNTE1NDIyMDZjMTgzLTEwMzExNzY=/tiny/Anavex-Life-Sciences-Corp-.png
Image: Primary Logo
Source: Anavex Life Sciences Corp.(AVXL)
"now that I have only 0.4% shares of AVXL compared to a year ago"
So for every 1,000 shares of AVXL you currently own you actually owned 250,000 shares of AVXL just one year ago...WOW!
Wow, that's a pretty hefty increase (nearly 25%) in those User Fee Rates...
FWIW regarding potential value of Priority Review Vouchers:
Why "absolutely certain" about Roche, but only simply "believe" regarding JNJ, Merck, Eli Lilly, Biogen and Pfizer?
OT: Posting this only because many here use X (f/k/a Twitter) because it's kind of funny and strange...and Georgejjl did in the past comment that he believed Elon Musk and/or Tesla might be interested in buying AVXL one day.
"Leak: Elon Musk Said He Wants X To Be A Dating App, Too, In An All-Hands Meeting On The Anniversary Of His Twitter Takeover" - Business Insider
BENZINGA 3:32 PM ET 10/27/2023
https://www.businessinsider.com/elon-musk-wants-x-to-be-dating-app-leaked-meeting-2023-10
In a video meeting on the anniversary of Musk's Twitter takeover, there were some new ideas for X.
One was for the platform to offer dating app features, people present for the call said.
Such features tie into Musk's ambition for people to "pay for everything" they do on the platform.
A year into owning X, Elon Musk is still coming up with unexpected ideas for what he wants the platform to be.
A company-wide meeting on Thursday, the year anniversary of when Musk took over Twitter, hosted by Musk and his CEO of a few months Linda Yaccarino, was mostly an ad nauseam going over the various product changes to the platform, according to two people present for the video call. These individuals requested anonymity as they were not authorized to speak to the press. Their identities are known to Insider. Both described the call overall as "scripted," but it wasn't without off-kilter comments.
During the call, Musk attempted to take a tone of excitement for what X will look like over the next year, the people present said. X will in 2024 be a "fully fledged" dating site, he insisted, as well as a digital bank. These details have not been previously reported, although other elements of the call were reported by The Verge as was the email that went out to staff right before the call by Fortune.
Musk did not get into details of how exactly X would become a dating app, if there was any user demand for such features, or what further product changes would be made to turn it into one, one of the people present said. However, the idea is in line with Musk's push for features that require payment, as most dating apps today are some form of subscription service.
An X spokesman did not respond to a request for comment. X's email line for the press sent the automated response "Busy now, please check back later."
Getting more users to give X payment and banking information ties in with Musk's long-held desire for X to offer full payment and banking services to users, part of his ambitions to create an "everything app" like WeChat, one of the people present said. "He wants people to pay for everything," the person noted. Musk said during the meeting he expects X to be capable of functioning as a bank by next year, the person added, whether or not users want it to be.
"It doesn't seem to be what users really want," the person said.
Musk can be persistent. For new users in New Zealand and the Philippines, a fee of $1 per year is now in place for the platform's most basic feature or posting is part of the initiative toward payments and banking, the person added. Such a small payment will make little impact on X's struggles with revenue, but it may give X more financial information from users that could be later plugged into payments features.
X is still in the process of getting the appropriate licenses in each US state to offer any kind of banking or money transfer services. The platform so far has received licenses in nine states, most recently Iowa and Mississippi, according to an online log.
In keeping with a "hype" tone, Musk also insisted during the meeting that X's nascent video features were as good as YouTube and floated another new idea of X video becoming part of smart TVs, one of the people added. That comment was reported by The Verge. Insider previously reported on Musk's push for live video at X and his aspirations to turn the platform into a video-centric "media channel."
Despite Musk's attempt during the meeting to boost the future of X, its remaining employees are not convinced. Several employees submitted questions before the meeting regarding the company's financial state as advertisers and users continue to flee the platform. People also asked about its current valuation, of which one of the people said there has still been "zero transparency." Others asked whether long-promised equity or stock grants would ever materialize. None of those questions were addressed during the meeting, both of the people present said.
"The story was that committing to Twitter 2.0 will be rewarding," an employee previously told Insider, "but he's failed to deliver."
NWBO
$0.758
+11.84%
Volume - 1,198,539
Price movement is great to see, but lack of volume not giving any reason to become too excited. At least not yet...