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“ I would think one has to assume that the latest stats presented were primarily the work of Kun Jin. Therefore, is it too outlandish to believe that (of all people currently walking around on Planet Earth) Kun Jin himself knows better than probably anyone else what the FDA will want to see in order for AVXL to have the best chance of getting AA granted for AD?”
Yes LBSR!!!!!! This is my exact thoughts on all the BS FUD being spread today!!
Ignore the noise. Rett approval and AD AA coming.
Andrew Barwicki
5:49 PM
Xxxx xxxxxxx
The data (information) regarding end points is not exclusive.
Moreover, this information allows us to pursue FDA approval.
There will be additional information, press releases and/or SEC 8K
filings, that we intend to disseminate and/or file by Dec 31, 2023.
Agreed Hoskuld. I think people are not understanding what this PR was.
This was not the full data report with all the detailed data
Sure there was “missing data” and vague statements in the PR.
Full data will be detailed in the peer review
What time will the AF hit piece be out?
Pietrzkiewicz37m fromST mb
SAVXL “they did not broke the results
into 30 and 50 mg dosed. What is
interesting is the p value for brain
volume loss. If it is .0005 which
means .05% chances to be a fake
results then it is very strong signal
that even those on 30 mg are getting
the benefits of Blarcamesine. The
other mark of Alzheimer's is
shrinking of brain tissue. This is the
hard data point versus soft data like
cognition.”
100fold on ST-
You miss what's going
on here. The big picture. This
company is not simply seeking fda
approval for a compound. No more
than MSFT was just about developing
a software program. This is a
platform company making early
strategic decisions on personnel,
strategy and direction because they
have discovered the next evolution of
CNS treatment. A new paradigm for
treating everything from pain to
cancer. In the same way MSFT
created an environment that aligned
with a human intuitive graphical
interface and went on to completely
monopolize computing, Anavex is
aligning the body own defense
mechanism with CNS health and will
completely monopolize the space.
Buying shares at this price is a gift for
long term shareholders.
Dr Sabbagh, an Alzheimer’s KOL ,has been over the data-
“given the robust clinical data of blarcamesine (ANAVEX®2-73) in Alzheimer’s disease I look forward to joining the scientific team at Anavex to move forward a path for patients and their loved ones to be able to provide an effective therapeutic which can be taken orally and is generally safe.“
The good news is, this should all come to a head in the next 3 months or so. Like many here, been here since 2015.
It’s been a long, bumpy ride.
Also fudsters- F1ash, Squealing squid,and Amateur 17 seemed to have moved on!
UPCOMING MEETING
Rotary
Rotary Club of Metro NYC
DATE
WEDNESDAY 13, SEPT
TIME
6:45PM - 9:00PM
LOCATION
2148 A BROADWAY, SECOND FLOOR
NEW YORK, NY 10023 (WEST 76TH ST)
DR. CHRISTOPHER MISSLING
CEO OF ANAVEX LIFE SCIENCES CORP
4 RSVP:
1 HTTPS://TINYURL.COM/RCMNYC913
Join us for our Dinner Meeting.
Our featured speaker is the CEO of publicly-listed Anavex Life Sciences Corp. He will speak on
the latest developments in the field of novel small molecule treatments for some of the most
challenging central nervous system (CNS) diseases facing society today, including Alzheimer's,
Parkinson's, Rett syndrome, and other rare diseases. Following the completion of several
promising clinical trials, Anavex is progressing from its research focus to a commercial stage
company working towards bringing their treatments to market to benefit patients across the
globe and ensure access to the company's new CNS treatment paradigm.
“ the health
insurance representative stated that
from his perspective, he was only
inclined to pay for an accelerated
approval drug if two indications
presented during clinical trials such
as removed amyloid plaque and
improved cognitive ability.”
Looks like
Anavex has their bases covered.
And Biogen and Lilly’s MABs??
Improved cognitive ability??
If Dr. M want’s to “surprise” the market, there won’t be a 7:30 PR on a Tuesday or Wednesday.
4:00pm maybe?
Trainguy on ST-
SAVXL
I had this panel discussion on in the
background today. Just before the
10 minute mark the opening FDA
speaker mentioned that amyloid
plaque is an accepted surrogate
biomarker for accelerated approval
of Alzheimer's drugs. During a later
panel discussion, the health
insurance representative stated that
from his perspective, he was only
inclined to pay for an accelerated
approval drug if two indications
presented during clinical trials such
as removed amyloid plaque and
improved cognitive ability. Looks like
Anavex has their bases covered.
ForestFoxes
11:48 AM
A very informative 3 hour video can
be found on this link regarding the
accelerated approval program:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172756324
Pazzo , don’t you know by now ffrol would never make a mistake like that! He is superior to everyone on this mb. Just ask him.
"The scientific community has essentially finished with
amyloid - we've identified it, developed drugs, and can
clear it," Dr. Carmichael says. "The fact that clearing
amyloid doesn't substantially change the progression of
the disease means that other things are also going on in
the brains of Alzheimer's disease patients."
At UCLA, researchers are investigating, for example,
how inflammation may impact Alzheimer's disease
progression, as well as the role of the protein tau.
"There are a lot of interesting questions," Dr. Carmichael
says, "that now are even more important to answer."
"What's been surprising, and a bit disappointing, is that
these drugs didn't have as dramatic an effect on
cognitive recovery or cognitive decline,
Dr. Carmichael
says. "They had a very, very
- that's two 'verys'
modest effect on cognition."
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers#:~:text=Glioblastoma%20and%20Alzheimer's%20disease%20treatments%20advance%20through%20clinical%20trials.&text=A%20personalized%20vaccine%20developed%20by,aggressive%20form%20of%20brain%20cancer.
Lots of FUD being posted today on this holiday when most people are relaxing and having fun with friends and family!
I guess that is enjoyable for some!
From Michael Tavares on FB-
September 15th, Anavex CSO Dr. Walter E. Kaufmann will be delivering one of six keynote talks at the SSBP (The Society for the Study of Behavioral Phenotypes) 25th International Research Symposium. He will also participate in a live Q/A discussion alongside Dr. Randi Hagerman and others. https://ssbp.org.uk/
His keynote abstract, Development of Targeted Treatments for Rett Syndrome, can be viewed here: https://onlinelibrary.wiley.com/doi/pdf/10.1111/jir.13075 and below:
DEVELOPMENT OF TARGETED TREATMENTS FOR RETT
SYNDROME
W. E. Kaufmann1,2
1 Anavex Life Sciences Corp, New York, NY, USA
2 Emory University School of Medicine, Atlanta, GA, USA
Rett syndrome (RTT) is a severe neurodevelopmental disorder (NDD), characterised by multiple impairments, which affects predominantly females. Until March 2023, no drug treatments were available for RTT’s core symptoms. The recent approval of trofinetide by the FDA and the beginning of gene therapy trials represent major achievements with profound implications. They also represent a culmination of a process that began before the identification of mutations in the MECP2 gene as the main cause of RTT.
Knowledge on the pathology and neurochemistry of RTT and development of mouse models of Mecp2 deficiency has been instrumental in both identifying and validating new treatments. Availability of disorder’s natural history data has also been a major contributor. Efforts in the USA, Europe and Australia at characterising the range and evolution of neurobehavioral and systemic manifestations of RTT have allowed the most adequate selection of trial participants and the development of outcome measures.
The success of trofinetide’s studies, in combination with positive results of the mecasermin (recombinant human IGF-1) and blarcamesine (sigma-1 receptor agonist) drug development programmes, support strategies targeting multiple cell signalling pathways and endogenous homeostasis for ameliorating the numerous and greatly impairing symptoms of RTT, even in adults. These improvements have been observed despite short-duration treatments and suboptimal endpoints. Consequently, drug trials have facilitated the testing of therapies with even greater potential: attempts at correcting the genetic defect underlying RTT. Early information supports the safety of gene therapy in RTT; however, more time will be needed to determine their efficacy. The approval of a drug targeting core features of RTT has changed the stakeholders’ mindset, becoming not the end of a pathway but rather the first step in developing new treatments (even combining approaches). This and other learned lessons should be carefully examined by others in the NDD field.
Keywords: Drug trials, Gene therapy, Mouse models, Natural history, Neurodevelopmental disorders, Outcome measures, Rett syndrome
From Rett FB post
Annelise's Army • Follow
1d • G
Never give up trying, Annelise doesn't.
Annelise only learnt how to use a straw last
year, the past few days she has been learning
to hold her own cup!
Is Annelise still taking the medication
Anavex 2-73 !!! Does it appear to be helpful
if she is ?? Thank you very much!
Annelise's Army
yes Annelise is still
taking Anavex 2-73 we have found it
helpful for Annelise.
ENROLLMENT (ESTIMATED)
450
https://clinicaltrials.gov/study/NCT04314934?term=Anavex&rank=4
ANAVEX2-73-AD-EP-004
STUDY START (ACTUAL)
2019-10-10
PRIMARY COMPLETION (ESTIMATED)
2024-07-31
STUDY COMPLETION (ESTIMATED)
2024-07-31
https://clinicaltrials.gov/study/NCT04314934?term=Anavex&rank=4
https://www.mdpi.com/1422-0067/24/16/12980
Thanks 5RingsPatsRule from ST!
https://medicalxpress.com/news/2023-08-hypothesis-mitochondrial-dysregulation-contributor-schizophrenia.html?deviceType=desktop
Bodes well for upcoming A3-71 trial!
Thx Trainguy on ST
That could be really great news for Anavex!
Thanks sokol
Interesting info attila!
Have you been following the lawsuit against Cidadel from Northwest Bio?
Yes Bas! I agree with all those points.
First week of October
https://pubmed.ncbi.nlm.nih.gov/37429704/
I don’t remember if this was posted.
The response from IR to Trainguy was this often discussed topic-
“Communications with the
FDA are ongoing and it would be
impossible to constantly disclose
each and every correspondence. If
and when something is material, we
will issue a press release and/or file
an 8K.”
Question to IR fromTrainguy1 on ST-
If the FDA agrees to evaluate
Blarcamesine for accelerated
approval for Alzhiemers, has the FDA
indicated what parts of the standard
NDA need to be submitted to obtain
accelerated approval? Also, is
Anavex's response to 21 CFR 312.120
[Foreign Clinical Studies Not
Conducted Under An IND] required to
obtain accelerated approval?
>IR-We communicate with the FDA if
and when needed, as such, final
decisions are made based on
management, board of directors and
scientific advisors input, as well as
potentially lawyers and others that
are well-versed in the dealings with
the FDA. Communications with the
FDA are ongoing and it would be
impossible to constantly disclose
each and every correspondence. If
and when something is material, we
will issue a press release and/or file
an 8K.
Adam F out with a new AVXL hit piece-
https://www.statnews.com/2023/08/10/anavex-blarcamesine-rett-syndrome-clinical-trials/
Wow, really? I think it’s time to take a break from this message board!
Pathetic.