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Welcome to the board leaping frog. Have you been lurking or did you just recently hear about Anavex?
I agree that it would be a nice shareholder perk if there is a problem in meeting the demand for A2-73.
Biostockclub I like your's and Nidan's analogy of all coming together to form an unstoppable force.
Thank you and all the other experts on the board for educating us non-biology knowledgeable members with all of your postings.
That is a 'cool' video. It makes me want to assemble a squadron of drones so if/when I crash one or more I will immediately have replacements. When results of Anavex's trials begin to merge to form the unstoppable force I'll be able to do that.
Xenia you are amazing and very much appreciated for all of the work you do. I have one question - Do you ever sleep?
When I introduce people to Anavex I direct them to your "Compilation" and tell them it is the "Cliffsnotes for 5 years of very deep due diligence".
Thank you for all you do.
That is interesting Grassy. That is an interesting concept for obtaining financing.
It does make a person wonder who approached Patrick before doesn't it?
I don't like taking pain meds so I would opt for a couple of good bock beers or a nice red wine
I speculate that AVXL share price is being held down currently to keep Anavex from getting back on the Russell Indexes.
Doc 328 reported that tomorrow is reconstitution ranking day so let's see what happens after that. Big pharma has a lot to lose and has a lot of control to hold our price down unfortunately. I am very thankful that Anavex has taken our trials out of the FDA hands at the present.
Some on the board have expressed concern about the ability of Anavex to have the capability to supply A2-73
(and rightly so) if and when it is approved for multiple CNS diseases. .
I think we should propose that long term shareholders be provided with a "Priority Prescription" so that we would first in line to receive this drug. LOL !!!
Thank you Great Tree for posting this artcile. I do not think it has been posted before.
It is a very well written piece that should be very encouraging to RETT Syndrome families and hopefully bring added pressure to obtain accelerated approval form the FDA. I pray that A2-73 will get approval to provide a great deal of improvement to those afflicted and their families.
You are blessed to have Dr. Kaufmann attending to your daughter Katelin.
I will add Katelin and you, her parents, to my prayer list. May God be with you on this journey.
That is very encouraging. I live in a retirement community and see a number
with the disease and see them continue to worsen. It is sad to say the least.
But let us hope that A2-73 connects those signals back to the brain (if that is the finding they come up with in that study using that therapy).
Irish an BAltimore. I believe Investor discussed a number of ways these preferred shares can be designed to be very effective. I don’t have time to find his posts now but hopefully he or someone will re-post them
What are the duplicate trades such as 15,691 and 15,691 quantity and same price of $3.42 at exact same time that show up on Level 2 ? I see these duplicate type trades quite often.
Mar. 12, 2018 8:50 AM ET
It would have been helpful to prevent someone from thinking this is Lane's current analysis as Basparks pointed out.
Axovant Launches Arvelle Therapeutics to Commercialize Epilepsy Drug
Published: Feb 14, 2019 By Mark Terry
I might have missed this but I don't recall seeing anything on the board about this.
Arvelle is launching by licensing European rights to cenobamate from SK Bio-Pharmaceuticals. This is a novel investigational anti-epileptic drug for the treatment of partial-onset seizures. Axovant takes a 5 percent preferred equity stake in Arvelle after the initial planned capital raise of more than $100 million from a global syndicate of investors.
In November 2018, SK Biopharmaceuticals filed a new drug application (NDA) with the U.S. Food and Drug Administration (FDA), which was accepted in February 2019. It has a target action date of November 21, 2019. Arvelle expects to file a Marketing Authorization Application (MAA) based on data that came out of SK Biopharmaceutical’s development program.
Two of Axovant’s programs are nelotanserin, a highly selective inverse agonist of the 5HT2A receptor, and RVT-104, an early-stage asset. Nelotanserin is being evaluated in patients with Dementia with Lewy bodies (DLB) or Parkinson’s Disease Dementia (PDD) who are experiencing REM sleep behavior disorder (RBD). RVT-104 is a proposed combination of a higher than presently approved dose of cholinesterase inhibitor rivastigmine and a peripherally active muscarinic receptor antagonist. It is being studied as a possible treatment for Alzheimer’s disease and dementia with Lewy bodies.
Confirms A3-71 to be tested for Frontal Lobe Dementia (FTD)
Pipeline graphic:
https://www.sec.gov/Archives/edgar/data/1314052/000161577418014328/img001_v1.jpg
Note the small print at the bottom stating fading arrow represents ongoing or planned studies.
Another reason to vote YES on Preferred Measure.
The fully-developed future of Anavex Life Sciences Corp may not be with Anavex 2-73. Anavex insiders have seen all of the murine test data and know better than anyone that Anavex 3-71 yields better treatment results. Should (well, when) Anavex 2-73 gain(s) regulatory approval for sales and therapeutic use, I can see the company then quickly moving Anavex 3-71 into new, expanded clinical trials for a number of CNS conditions.
Alzheimer Society International Congress 2019
ASIC 2019
February 18 - 21, 2019
San Francisco Airport Crowne Plaza
Anavex is spreading the word again tomorrow at another venue at
10:30 AM PST
Federico Goodsaid,3Harald Hampel,1
Mohammad Afshar2, Frédéric Parmentier2,
Coralie Williams2, Adrien Etcheto2,
Christopher U Missling4
1Department of Neurology, Sorbonne
University, Paris, France, 2Ariana Pharma,
Paris, France, 3Regulatory Pathfnders LLC,
San Francisco, CA, 4Anavex Life Sciences
Corp., New York, NY
“Longitudinal 148-Week Extension Study for
ANAVEX®2-73 Phase 2a Alzheimer’s Disease
Demonstrates Maintained Activities of Daily
Living Score (ADCS-ADL) and Reduced
Cognitive Decline (MMSE) for Patient Cohort
on Higher Drug Concentration and Confrms
Role of Patient Selection Biomarkers
For those that are thinking of voting "NO" on the Preferred Measure based on previous experience or whatever reasons, I would like to suggest that you analyse the following with an open mind.
Missling is not proposing this on his own. He serves at the discretion of the Board of Directors.
Major Duties of Board of Directors
Brenda Hanlon, in In Boards We Trust, suggests the following duties (as slightly modified by Carter McNamara to be "nonprofit/for-profit neutral").
1. Provide continuity for the organization by setting up a corporation or legal existence, and to represent the organization's point of view through interpretation of its products and services, and advocacy for them
2. Select and appoint a chief executive to whom responsibility for the administration of the organization is delegated, including:......
Please take the time to review the qualifications of our board members and ask yourselves the following questions:
1. Would they jeopardize their world renown reputations by participating in a "scam"?
2. Do I know the reasons for having the Preferred Shares available for whatever uses than they do?
3. Am "I" smarter and have more experience than them?
The excellent and outstanding qualifications of the members is a very large reason I invested in Anavex early on and I will continue to have full faith in them to guide Anavex and our CEO in a judicious manner.
If the measure passes and if Anavex Life Sciences fail as a result of it then you will be able to participate in a class action lawsuit against the BOD afterwards.
I will most certainly be voting "FOR" again since I have utmost faith in our BOD.
Are you going to be a "PIG" and add many shares of AVXL to your large holdings this year ?
"Chuc Mung Nam Moi" longtermbeliever !
RWE -"..regained drivers licence" Maybe you can incorporate this that Investor2014 dug up in your compiled sticky.
Professor Macfarlane said some participants also regained functions previously lost, such as the ability to paint and play the piano while a ..person who re-sat the driving exam successfully regained their licence
I knew we could count on you.
Professor Macfarlane said some participants also regained functions previously lost, such as the ability to paint and play the piano while a person who re-sat the driving exam successfully regained their licence.
And thanks to you cninc for bringing these to the board and refreshing our memories.
Thank you Xena. Your efforts and time spent compiling all of these in your sticky is above and beyond and very much appreciated.
Thank you very much Investor.
I knew one of you much younger and much, much smarter persons would come through. Exactly what I remembered.
Investor2014 Sunday, 01/13/19 10:47:19 AM
Re: drv17 post# 178337 0
Post #
178339
of 178353
Your word is my command: Pauline Stevens[/b]
(My bold emphasis)
I would like to see all of these anecdotal examples that are constantly referred to in Anavex articles in one sticky post. I believe it would assist newer investors to be more informed of early (anecdotal) results i.e. RWE. Also the mention of the man getting his drivers licence back, the golfer that began playing again, the person being able to shop again etc. would be good to include.
Maybe cninc could include these in his current sticky post.
Thanks but I was looking for the one from the AD trial that began playing again. Here is what Xena stated in her Post #178342:
I just did a search of youtube for "Alzheimer's pianist". I came across several videos of other Alzheimer's pianists. One even stated that her mom had started playing again after a period of time.
I noticed one key difference... Pauline was playing from sheet music and all of the youtubes of Alzheimer's patients that I saw were playing from memory. Playing from sheet music involves a complex set of short and long term memory that is not used when playing without music, check out the link on muscle memory below.
I forgot about the sticky Thanks. Again I would really like information on where to find the video of the piano player that was the first one posted about the results of the medicine as I recall.
If I have time later I might try to locate it myself but I'm buried right now and am hoping someone else has it at their finger tips.
Really appreciate yours and most everyone's input on this board. Thank you
Erv Heaven video. Thank you Penny for cleaning up the video for Erv.
I had gone back to a very old post of mine and did't try it before posting it yesterday. I was rushing to leave.
Now I hope some one can find the video of the piano player and post the information.
Here is a video of an interview with Erv Heaven that was in the trial.
drv17 Member Level Monday, 01/22/18 09:25:42 AM
Re: k9uwa post# 138325 0
Post #
138336
of 178318
Here is a link to the Erv Heaven video.
Investor, that was mean of you to refer me to that document this morning. It was too much for my poor old addled brain to comprehend with all of the "whereases and here-to-fores" of lawyer speak.
It appears to me that since this is an "Interventional Study" that any financial interest would be irrelevant. Furthermore, I did not see where the FDA prohibits any financial interest of a PI but rather just wants them fully disclosed.
From https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm341008.pdf
A.2. Q: What is the purpose of FDA’s review of clinical investigator financial disclosure information and how can sponsors minimize bias? A: FDA’s review of clinical investigator financial disclosure information alerts FDA staff to financial interests and arrangements that could lead to bias in covered clinical studies. The financial disclosure process also provides FDA with information regarding whether and to what extent the sponsors have taken steps to minimize the risk of bias. An important means of minimizing the potential for bias resulting from such financial interests and arrangements is through proper study design (see 21 CFR § 54.5(b)). For example, using randomization and blinding helps to minimize the potential for bias in assigning subjects to receive the test article or placebo and in assessing study outcomes and analyzing results. Similarly, having someone with no financial interests or arrangements evaluate study endpoints, especially in an unblinded study, can help minimize potential bias in assessing therapy outcomes. FDA staff consider the financial disclosure information and the methods the sponsor used to minimize bias during the review of marketing applications to assess the reliability of the clinical data (see 21 CFR § 54.1). Additionally, because sponsors of studies conducted under INDs and IDEs are required to collect financial information from clinical investigators prior to study initiation,7 sponsors can work with FDA to minimize any potential bias. FDA strongly encourages sponsors of studies not conducted under an IND/IDE to collect financial information prior to study initiation for the same reasons.
Descriptive Information
Brief Title ICMJE Study of ANAVEX2-73 in Patients With Rett Syndrome
Official Title ICMJE A Double-Blind, Randomized, Placebo-Controlled, Dose Titration Study of ANAVEX2-73 in Patients With Rett Syndrome
Brief Summary
Phase 2 safety, tolerability and efficacy study is designed as a double-blind, randomized, placebo-controlled study.
7-week placebo-controlled study of ANAVEX2-73 oral solution for the treatment of patients with RTT 18 years or older. A voluntary option will be offered for all patients who meet the exposure criteria for ANAVEX2-73 to continue a 12-week open label extension.
Detailed Description
This Phase 2 safety, tolerability and efficacy study is designed as a double-blind, randomized, placebo-controlled study.
This is a 7-week placebo-controlled study of ANAVEX2-73 oral solution for the treatment of patients with RTT 18 years or older. A voluntary option will be offered for all patients who meet the exposure criteria for ANAVEX2-73 to continue a 12-week open label extension.
Study Type ICMJE Interventional
Study Phase Phase 2
Study Design ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Double-Blind, Randomized, Placebo-Controlled
Primary Purpose: Treatment
Condition ICMJE Rett Syndrome
Thank you George. I wouldn't think there would be a conflict.
It had been questioned a couple of times on the message board and I was trying to point out that it looks like there is a difference between trial site PIs and sponsor PIs as I interpreted it.
Conflict of interest ?
mrplmer Member Level Friday, 01/04/19 06:54:45 AM
Re: None 0
Post #
177370
of 177545 Go
FYI https://clinicaltrials.gov/ct2/show/NCT03758924
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03758924
Contacts
Contact: Walter Kaufmann, MD 844-689-3939 rett@anavex.com
Locations
United States, Alabama
UAB | The University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35294
Principal Investigator: Alan Percy, MD
Sponsors and Collaborators
Anavex Life Sciences Corp.
International Rett Syndrome Foundation Rettsyndrome.org
Investigators
Principal Investigator: Walter Kaufmann, MD Emory University SOM
Falconer - Dr. Kaufman is more than just on the SAB (Startegic Advisory Board.
NEW YORK – January 2, 2019 – 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 diseases including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced the appointment of Walter E Kaufmann, MD to Chief Medical Officer (CMO)
It appears to me that he will be deeply involved in the trenches with his great expertise.
I think Winston Churchill had a similar problem and coined the phrase "That damned dot".
You know, I really don’t get why he didn’t announce dosing. Surely it is a bigger milestone and catylst than 1st enrolled. Doesn’t make sense. You know as a ceo of a biotech that you shout out very loudly that your trial has officially started.
"When people look back to see what we did and why, they will understand." (Missling paraphrase from the ASM
Overall Missling exuded confidence. He spoke passionately about our prospects and it was genuine. Despite having presented the same thing countless times, his excitement for our data rubbed off on me.
It was encouraging to hear him want to buy more shares. He spoke like it was a gift at these levels.
It was comforting to hear him speak of failures and how we are not like them. He even referenced Axovant pumping their drug and how he didn’t want to be like them.
I walked away feeling there is a bright future ahead of us. I also understand that this will take more time than many of us expected. However, they are marching forward with their eyes on the prize.
A late Happy Veterans Day greeting to all who served our country and swore allegiance to and honored it’s flag.
The USA is deeply indebted to the approximately 10% of the population that dedicate their time in service to
‘Keep America Free’ .
Thank you for your service.
“Phoney” That’s what Yankee Doodle went to town on riding on his ‘phoney’ . He was looking for the AVXL P2b/3 trial .
Sage4-the Alzheimers Association states " Every 65 SECONDS SOMEONE IN THE UNITED STATES DEVELOPS THE DISEASE." (Note this does not include all forms of dementia) I have just copied portions from their site.
There is 604,800 seconds per week divided by 65 seconds equals 9,034 developing alzheimers each week according to Alzheimers Association.
Alzheimer's Association - Logo
Search
Walk To End Alzheimer's
Together, We Can End Alzheimer's
Find Your Walk
The End of Alzheimer's Starts With YOU
ALZHEIMER'S AND DEMENTIAEn Español
Facts and Figures
m.
Share the facts and join the fight.
5.7 MILLION AMERICANS ARE LIVING WITH ALZHEIMER'S. BY 2050, THIS NUMBER IS PROJECTED TO RISE TO NEARLY 14 MILLION.
Every 65 SECONDS SOMEONE IN THE UNITED STATES DEVELOPS THE DISEASE
Xena, This is a great compilation of many/most significant posts. Thank you for all of the work you do and your contribution to this board along with many others here. It will be very valuable to people that are new to this site.
As an older engineer type it has been extremely valuable to aid me in the basic understanding of Anavex Life Sciences and their extensive pipeline.
The discribed scenario works only if the PR firm is dedicated: Anavex’s PR firm surely recieves 100+ questions per day about Anavex and it would surprise me if they didn’t serve more clients...
I contacted CTAD regarding poster presented by Dr.Macfarlane and was informed that they do not have poster information available. They only publish the abstracts from the oral presentations.
I emailed Anavex IR three times and did not get a response. I finally called them today and Clint finally brought my messages up.
Here is the response I received from him.
Clint Tomlinson <ctomlinson@anavexcorp.com>
10:48 AM (5 hours ago)
to me
Ed,
The poster that was presented has nothing included that isn't already publicly available through our most recent presentation from CTAD.
Thanks
Clint
On Wed, Oct 31, 2018 at 11:50 AM Ed Gossack <etgossack@gmail.com> wrote:
Third request for poster P91 (CTAD 2018) presented by Dr. Macfarlane on Oct 24-27, 2018
Was it pulled from presentation ?
Was it presented but not to be made available to investors or public?
Or ????.
I had four communications with CTAD and they said they only provide abstracts and not entire posters.
T/Y
"We think differently and have NO FEAR." Maybe Dr. Liar didn't lie after all.
Thank you Bio for all of the work you do in the analysis of AVXL. Also thanks to all of the excellent scientifically knowledgeable posters on this board (I'm afraid to list for fear of overlooking someone) to help those of us that do not have that background.
This was a very successful conference for Anavex (IMO) and will look forward to Lane Simonian's article and/or an article by Michelle Sullivan (Alz_Gal) in Seeking Alpha to shout to a large audience.
It is possible that Anavex could PR HH's presentation at 3:45 PM Barcelona time which is 9:45 AM EDT.
From CTAD 2018 information
When are abstracts available?
All embargoed abstracts will be made available on October 27th at 5pm Paris Time at www.ctad-alzheimer.com. Our embargo policies are strictly enforced. All research is embargoed until the date/time that it is shared at a CTAD presentation, symposia or poster session. After the abstract presentation, you may publish/write on the abstract content.