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Agreed. Thanks.
And don't worry about other investors buying more shares to driver up the price. It will happen eventually. In the meantime, the institutions continue to fill their coffers.
Quote: "From this conversation came my theory that maybe Missling & Company hasn't issued a proper update to the TLR "because they don't have to" (in combination with fear of setting themselves up for pot shots from the world's AFs and not really accomplishing anything useful -- except for nervous shareholders, like me; that from the long view, it makes sense to wait and put out a comprehensive paper that may actually persuade skeptics)."
Thanks Joseph. I basically have the same conclusion that Anavex will publicize all of the data via a peer-reviewed paper.
On another subject, what is your theory as to why TGD has been preparing for commercialization? (The have mentioned it several times over the past few weeks)
This question is open to anyone...
Quote: "...but I believe my theory for a possible non-PM trial is plausible, and we can't guess well between the possibilities without knowing more. If the theory is correct, and the surrogate biomarker evidence is good, we'd be on our way to getting 2-73 to the Alzheimer's market "relatively soon" (well before another trial is completed) while not limiting the population it can treat."
Joseph...Did your clinician friend contribute to this theory or is this your own?
Same quote: "If the theory is correct, and the surrogate biomarker evidence is good, we'd be on our way to getting 2-73 to the Alzheimer's market "relatively soon" (well before another trial is completed) while not limiting the population it can treat."
Perhaps this is why Anavex has been preparing for commercialization?
I skimmed through it briefly and it looks to encapsulate and categorize all of the new drugs (and their target methods) that are testing for AD.
IMO, there is really nothing new or exciting to report.
Actually, if you look at a 6-month chart of the XBI you'll see that AVXL should be above $10...so I think it's way undervalued (oversold) right now. (See 1/12 thru 1/31)
If the XBI continues to break down, I agree that AVXL could fall further. But if the XBI hangs tough--like it did today!--I fully expect AVXL to continue its climb above $10.
We should know which direction the XBI is heading by the end of this week.
AVXL just hit $9.73. Hasn't been that high for almost 3 months. Nice
Maybe we'll hit $10?
Yes. I believe they said the TLD will be out in the 2H. But my question is if they plan to give us an updated TLR?
TLR = Top Line Results...which is the bare minimum.
TLD = Top Line Data...which is much more in depth.
PowerWalker and Hoskuld...Please add these two questions to your list:
1) When will Anavex give us an updated TLR with supporting data?
2) Has Anavex submitted their data to be peer-reviewed yet? (If not, when do they expect to submit it?)
And, if Dr. Kun Jin is present please ask him if the FDA is still using Ariana's KEM software to analyze data?
Thanks much!
Joseph...I don't know if Anavex is prepared to release partial data to answer your questions. Again, I would refer you to the post below from February 17th...especially the part that I underlined within the text below:
hnbadger
Friday, February 17, 2023
This is from AVXL IR:
The company is working on another
video and an upcoming press release
that will address many of the
questions that you asked. Moreover,
some of the answers will elaborate
on specifics, all of which we believe
will provide a thorough
understanding of our initiatives. At
this time some of your questions can
not be answered today, because new,
updated data will be available to us
in the near future, all of which we
would need to disseminate such
information in accordance with
Regulation FD - via press releases
and/or 8k filing, not through an
individual email or one-on-one
conversation.
Thanks 100fold from ST
Now, fast-forward to this month and we finally see that, yes, Anavex was indeed receiving new data that nullified the previous CTAD data. (See below)
"With newly available preliminary efficacy results of surrogate biomarkers, we consider initiating discussions with regulatory agencies for Accelerated Approval Pathway for ANAVEX2-73. In parallel, we plan to proceed with the initiation of our confirmatory Alzheimer’s disease study."
https://www.insidermonkey.com/blog/anavex-life-sciences-corp-nasdaqavxl-q2-2023-earnings-call-transcript-1149124/
Whenever someone asks for specific (new) data to compare against the old CTAD data that was removed, I always referred to the post by one of the MB members back on February 17th; because it explains why Anavex took down all of the old slide decks for the P2b/3 trial. (See the post below)
hnbadger
Friday, February 17, 2023
This is from AVXL IR:
The company is working on another
video and an upcoming press release
that will address many of the
questions that you asked. Moreover,
some of the answers will elaborate
on specifics, all of which we believe
will provide a thorough
understanding of our initiatives. At
this time some of your questions can
not be answered today, because new,
updated data will be available to us
in the near future, all of which we
would need to disseminate such
information in accordance with
Regulation FD - via press releases
and/or 8k filing, not through an
individual email or one-on-one
conversation.
Thanks 100fold from ST
Now, fast-forward to this month and we finally see that, yes, Anavex was indeed receiving new data that nullified the previous CTAD data. (See below)
"With newly available preliminary efficacy results of surrogate biomarkers, we consider initiating discussions with regulatory agencies for Accelerated Approval Pathway for ANAVEX2-73. In parallel, we plan to proceed with the initiation of our confirmatory Alzheimer’s disease study."
https://www.insidermonkey.com/blog/anavex-life-sciences-corp-nasdaqavxl-q2-2023-earnings-call-transcript-1149124/
So, until we receive all of the updated data from the P2b/3 trial it would be senseless to try and answer your question. (And btw, I think Doc already knows that too.)
Hope this satisfies your inquiry.
abe
Good post.
Anyone going to the ASM this week should ask TGD if they considered the AA pathway from Australia's TGA first...as opposed to going through the FDA here in the U.S.?
Which brings up another question...
If Anavex fails to get AA status through the FDA, does it disqualify them from applying through Australia's TGA as a backup plan B?
Yes, you did disclose the number of shares you owned back in February. (See your post below)
At that time, I posted that I was trying to buy a block of 30,000 shares and you responded with this post:
Anshu2
Re: abew4me post# 403658
Thursday, February 16, 2023
You got my attention.
What’s your thesis (or basis) in short?
I have a comparable amount, but planning to slowly unload. My main thesis is that AVXL is a very attractive acquisition target ($20-30 now), but of course not banking on it — but that provides a basis for stock appreciation.
[You made that statement BEFORE you knew that AVXL announced plans for commercialization. I'm sure your opinion has changed now]
Anshu...I have two questions:
1) Are you still invested in AVXL? (As I recall, you had approx 30,000 shares)
2) Regarding the 8-6 Adcom decision for SRPT from the FDA; Does each group (the 8 that voted FOR...and the 6 that voted AGAINST) submit a report as to why they made their decisions?
Something like the Supreme Court...where the Majority and the Minority each gives a summary for their positions.
TIA
Very inspirational. Thanks for sharing!
Hey Raja...good to see that you're still around.
AVXL seems to be inching up on a regular basis. You better jump back in before it gets away from you!
He also said that they were getting ready for commercialization of A2-73. So how does THAT fit into the AA scenario unless it's a P4?
That's good information. Thanks Doc.
LOL...witty!
Raja...are you still around?
I think all of Denali's drugs will eventually fail in a P3 trial.
[BTW, they said they would address the FDA letter below, but I have yet to hear anything one year later.]
Denali Therapeutics Announces The Co. Received A Formal Clinical Hold Letter And Is Moving Forward To Address The FDA's Observations Related To The Preclinical Toxicology Assessment And To Provide The Information Requested To Initiate Clinical Studies
6:45 am ET February 14, 2022 (Benzinga) Print
As previously announced, Denali Therapeutics Inc. (“Denali”) was informed on January 12, 2022, via e-mail communication from the U.S. Food and Drug Administration (FDA) that the DNL919 Investigational New Drug (IND) application to begin clinical testing was placed on clinical hold. Denali has now received a formal clinical hold letter and is moving forward to address the FDA’s observations related to the preclinical toxicology assessment and to provide the information requested to initiate clinical studies, including proposed changes to the clinical trial protocol, the informed consent form, and the investigator brochure. Denali intends to provide an update once a clear path forward has been established.
Alphabet City is in New York. Are you going to the ASM next week?
$9.26...off to a good start.
LOL...pretty cool. I'm sure that he had to give some background information of St. Dymphna to prove his knowledge of her.
Great post. Thanks!
Another patent protecting our molecule. Good to know.
I recall an earlier patent for the crystalline composition some time last year...so we now have two crystalline patents...plus the patent protecting the enantiomers of A2-73 back on April 4th make a total of three patents protecting our molecule.
Wow...you have a great memory there, Talon!
That's good DD.
Thanks.
Joseph...you're blowing my mind here, buddy!
"The presenter of the explanation of AA was an acquaintance of mine in high school – my HS girlfriend's best friend -- whom I haven't seen nor followed since my senior year as a college undergraduate. So that was a kick. Her brother is generally considered the world's foremost string-theory physicist."
Wow...nice find.
About ROCHE...
Throughout our 125-year history, Roche has grown into one of the world’s largest biotech companies, as well as a leading provider of in-vitro diagnostics and a global supplier of transformative innovative solutions across major disease areas.
One particularly important area where we are placing our Partnering efforts is in Neuroscience. We believe the field of Neuroscience is on the cusp of important breakthroughs in both early diagnosis and treatment. Our relentless pursuit of scientific innovation is taking us into areas of enormous unmet medical need and progress in treating diseases of the brain and nervous system.
Our collaborative efforts have resulted in one of the strongest and most diverse pipelines in the industry, spanning the spectrum of nervous system disorders from the rarest to the most common.
Partnering opportunities we are looking for:
Neurodegenerative diseases (e.g. Alzheimer's disease, Parkinson's disease, Huntington disease)
Neuroimmunology and neuroinflammation (e.g. Multiple sclerosis)
Neurodevelopment and psychiatry (e.g. Angelman Syndrome, Schizophrenia, and Autism spectrum disorders)
Neuromuscular diseases (e.g. SMA and Duchenne Muscular Dystrophy)
Yes. Good post.
Is anyone on this MB going to attend the ASM on May 23rd?
Excellent summarization, Falconer.
"In reading the article's 42 pages of dense text this contention was validated."
Reading all of that material must've taken you at least several hours!
Thanks for all of your DD...and sharing it back with the board.
I believe Anshu2 has about 80% of his portfolio in that stock too.
Congrats to both of you.
Oh c'mon. This was a learning process for everyone. Even you gave Anavex a 20% chance of getting a P4 trial based on the current data.
So please stop calling people ignorant just because they believe the data will qualify for AA and P4. There's still a possibility that it will happen.
I already told you that I appreciate your DD, but the constant gloating (and now name calling) is really annoying...and uncalled for.
Please be humble however this plays out.
abe
Holy smoke! That video was fantastic in explaining Accelerated Approval.
Start at the 24:50 mark and listen for 6 minutes. That's all you really need.
There's a pretty good Q & A at the 31:00 minute mark...especially the first and third questions. They actually have FDA employees talking on camera about the process.
Highly recommended to everyone wanting to know about AA.
I was cleaning out some of my files and came across Bennyboy's last post before he passed. (RIP)
Pay attention because he has something to say about the P3/P4 discussion! (LOL)
bennyboy1
Wednesday, April 21, 2021 11:31:51 PM
Post# of 415129
I just can feel Early or Provisional Approval with a Phase-4 finish with final approval. We probably have convincing data like never before has been seen in AZ, Rett, PDD and PD! We deserve strong attention with Precision Medicine approach!!!!
How's that for speaking from the grave?
Do you have a link?
Perhaps one day you'll wait until AFTER the market closes before you make a comment?
Since the FDA is familiar with Ariana's KEM platform--which is the same platform Anavex uses--I think there's a very good chance that the P2b/3 data will be overwhelmingly impressive...especially with the genomic data.
FDA Selects Ariana's KEM Platform for Biomarker Signature Validation
FDA has chosen to implement Ariana Pharma's KEM® (Knowledge Extraction Management) decision-support platform to facilitate data analysis for the validation of biomarker signatures. The technology will be used by FDA's reviewers to analyze pharmacogenomic and other data submitted through the agency's Voluntary Exploratory Data Submission (VXDS) program.
Ariana claims the collaboration will help FDA more systematically identify potential genomic fingerprints and develop recommendations relating to the analysis of genomic data prior to the submission of biomarker signatures. "We are looking forward to this collaboration to help the agency systematically analyze all equivalent signatures combining both genomic and phenotypic data, thus increasing chances of selecting the best biomarker signature," comments Federico Goodsaid, Ph.D., FDA's associate director for operations in genomics at the Center for Drug Evaluation and Research's Office of Clinical Pharmacology.
Ariana provides data-mining solutions and decision-support services for clinical and safety studies, drug discovery, diagnostics, and biomarker development. The firm's KEM platform is a rules-based method developed to mine data and systematically extract and manage all consistent hypotheses. Ariana claims the technology can be applied to biomarker discovery to identify the best subset of markers in order to maximize patient coverage, through the ability to evaluate heterogeneous information, including genomic, proteomic, polypharmacology, and clinical data. The firm also suggests that unlike existing numerical methods, KEM can generate and prioritize hypotheses, carry out more exhaustive analysis, and handle missing data.
Ariana offers access to the KEM platform through nonexclusive licensing and service partnerships. In February the firm signed a fee-for-service collaboration agreement with Fovea Pharmaceuticals, through which Ariana will use the KEM technology to carry out systematic analysis of Fovea's PrednisporinTM Phase II clinical data.
FDA's VXDS program (formerly Voluntary Genomic Data Submissions) is designed to encourage the submission of pharmacogenomic data that is currently not mandatory in terms of IND, NDA, or BLA submissions. The agency says it is particularly interested in gaining a greater insight into the types of genetic loci or gene-expression profiles being explored by the pharmaceutical industry for pharmacogenomic testing.
Most particularly, it says submitted data will help it understand factors such as: the test systems and techniques being employed; the problems encountered in applying pharmacogenomic tests to drug development; the ability to reproducibly transmit, store, and process large amounts of complex pharmacogenomic data streams; the scientific rationale for standardization of the naming and characterization of genes used on different genomic analysis platforms; and for developing bioinformatics software programs used to evaluate pharmacogenomic data.
[This article was dated September 8th, 2010]
https://www.fiercebiotech.com/biotech/fda-selects-ariana-s-kem-platform-for-biomarker-signature-validation
It's not just the Sigma-1R that is efficacious. It's the way the Sigma-1R binds and synergizes with the M1 - M4 ligands that makes Anavex's drugs so unique and powerful.
Anavex has numerous patents to protect their drugs.
If the FDA is going to require a P3 confirmatory trial, why is Anavex preparing for commercialization?
So, are you saying that a company can commercialize their product with a P3 confirmatory trial running simultaneously?
That's not my understanding.
The only way to do that is with a P4 confirmatory trial.