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georgejji
It will take a few for the crowd that follows BP to fully understand the clinical SYSTEMIC IMPACT of this presentation. IMO, this insight into S1R AS A SYSTEMS CATALYST will be tough for the old serial action Amyloid action herd to internalize. YES, boys and Girls your clinical world just got vaporized...
Massive-great news-great work ...NOW...lets get commercialized WW ASAP
Gambit53
sab63090
AS planned: Any Questions??
oldand...
georgejji
Agree, this is positive for AVXL and shr holders.
I read this as our upstream MOA-S1R spin-offs are about to begin. IMO, many-many CNS disease patients WW will directly benefit.
Change and positive growth to support what we now (or are soon about to) know is our best-only responsible path to complete the next phase of our WW mission.
YUP, agree. People just get nervous around change.
IMO, there will be more - fill in the blanks.
Regarding MFJJ developments, while we've been waiting for our MJFF study to start the technology and science around us has moved forward in a way that will strengthen 2 upcoming Anavex trials.
First is the small PET imaging study and second the trial design of Anavex's PD study slated for Australia.
https://www.michaeljfox.org/grant/evaluation-anavex2-73-blarcamesine-participants-parkinsons-disease
https://shakeitup.org.au/new-treatment-shows-clinical-benefit-in-patients-parkinsons-disease-dementia/
Blarcasamine...
your last email has what looks like something that you copied and pasted from somewhere.
J_K
[Major Breakthrough in Parkinson’s Research from MJFF
Join us for a special Third Thursdays Webinar to discuss a groundbreaking MJFF-funded discovery. More details to come.
https://www.michaeljfox.org/webinar/major-breakthrough-parkinsons-research-mjff/
The MJFF has strong leadership skills and a positive following WW. They impress as an organization that is focused , using multiple mechanisms to be a visible and effective focal point for solution, not just "LOOK AT ME", but serious management program continuity.
Other such rare disease effort can be seen and heard including RETT- RSD, Autism and a long list serious CNS RARE diseases WW. With continued support from AVXL Australia team and other selected WW RARE CNS DISEASE then not only can a lot of visibility and focus be raised By Dr.M. and the Australian team CNS Rare disease organizations WW might be able to help focus the CNS RARE Diseases in an AVXL-Australian coordinated and effective manner.
If all CNS RARE diseases efforts WW had a collective -effective- focused science effort to collaborate the science work around the universal CNS AVXL S1R collaborative effort (including required ancillary research-trials ) effort then a massive WIN_WIN CAN BE a CNS diseases WW vision based on AVXL core science can be seen. IMO, Australia is dispositioned with AVXL and A WW network to make it happen.
We recognize that the TERM..."RARE CNS DISEASE"' can often be read as ...get in line and good luck.
BUT, if The PD research program is seen as a model ...(how to do...CNS RARE DISEASE pathway ) , then anything is possible. BTW, this may have been Dr.'M's plan all along which can now be seen to take shape using PDD as the core example.
So, an expanded AVXL CNS RARE Diseases program may now have hope and resources to move forward WW. WOW.
Jj325
If MJFF is about us, he will hint at it in the new slide deck
georgejji
NEWS!!!
NEW STUDY SHOWS IMPROVED SYMPTOMS IN PATIENTS WITH PARKINSON’S DISEASE DEMENTIA
https://shakeitup.org.au/new-treatment-shows-clinical-benefit-in-patients-parkinsons-disease-dementia/
Shake It Up Australia Foundation is a not-for-profit organisation established in 2011 and in partnership with The Michael J. Fox Foundation (MJFF) promotes and funds Parkinson’s disease research in Australia aimed at better treatments and ultimately a cure.
https://finance.yahoo.com/news/anavex-life-sciences-present-22nd-110000388.html
Anyone else see today's small info. PR as a very strong message during a time of uncertainty ?
I read this as a , "check this out", kind of note during a period of ..."lay in the weeds by others".
IMO, this is what leaders do while competitors keep off the horizon.
J_K,
Thanks for your insights on this.
Well done, T-38.
falconer
Seems pretty clear. Missling agrees with the “be careful” crowd on this message board. He’s not going to release any information that might induce overly-optimistic, speculative equity investing in Anavex until the new data to be released are utterly compelling and will induce prompt FDA approval; probably first for blarcamesine for Rett syndrome.
JUST IN CASE...Google source ....The stock market observes Good Friday as a holiday, so the New York Stock Exchange and Nasdaq will both be closed.
plexrec
Dr.Cummings is talking about--he mentions for AD disease--"changing thereputic landscape--AD drug development pipeline--small molecules directed at disease modification--away from amyloid-tau theory--- kind of sounds like the Anavex MOA--platform---just my humble opinion--FWIW----https://adpd.kenes.com/hear-from-our-speakers/?fbclid=IwAR30iJdoYTmJqq7vM4NNrOPdG2lSZJYFs0x0YFG_JdgKNirTwMHPuOXikd0
This Timing suggests Devine intervention to me. Bless them all.
WOW...AD patent re A2-73...hot off the press.
NEW US PATENT DATED 4 APRIL 2023
ENANTIOMERS OF A2-73, ANALOGUES, AND SIGMA AGONIST ACTIVITY
https://image-ppubs.uspto.gov/dirsearch-public/print/downloadPdf/11617734
Good luck and GOD bless,
Here is a report given by Dr. Randi Hagerman.
Dec. 16, 2020
Presentation at the Ladenburg Thalman Health Care Conference.
Hi I’m Dr. Randi Hagerman,
Fantastic report from one of the best informed-experienced clinicians WW. Perhaps from this we can project just how massively -clinically important such a message brings to CNS disease patients and families WW.
IMO, a whole new world for CNS diseases science is being opened. How to do such a REVEAL w//sensitivity and integrity must be a massive challenge.
So Many DOTS, So little time. Bless them all.
Holiday NYSE Nasdaq
Good Friday Closed (April 7) Closed (April 7)
Even though the famous Anti-biotic petri dish AAAHHHAA momentt was only one step in a long learning process. Of course no one really quite understood the long term consequences (what it all meant) for a while and so (IMO) that is about where we are now. Our S1R AhAAA moment is bigger and more complex by many orders. We can either call it now or wait for a next step...then what...will that then reset our watch or catapult us to some new level of (progress ...BUT...what does trial result REALLY mean???).
As share holders we await (THE MOMENT) so we can put it in the BANK and move on. Since we are sensing we are THIS close to the actual learn MOMENT then we get to wait for very event , which then must be studied and understood for consequence in science w/o SCREAMING from the roof tops...yet. AVXL cannot do a PR w/every daily LAB news bit.
Maybe it was easier to own BIOMED stocks before anyone really knew what they were doing (what to do/expect as learning happens).. SOOOOO, stand by...to stand by. We will know when the ship turns into the wind and starts to accelerate. It will happen. This is NOT A DRILL. All of this will/MUST merge at some point.
It seems to me Dr Missling is lining all his trial data ducks up for a takeover.
Hoskuld
The article says bulk plaque remains a plausible but unlikely solution. That is contradictory: that solution is plausible. Regardless, that is not the most salient issue with beta amyloid plaque approach: plaque is downstream and removing it (soluble or insoluble forms) does not result in clinically meaningful impact on AD patients.
Brains Shrink With Anti-Amyloid Alzheimer's Drugs
— Treatments accelerate brain atrophy, but reasons why remain a mystery
https://www.medpagetoday.com/neurology/alzheimersdisease/103817
This was just an ole, why hide for over a year. Make what you can out of the data and move on. Keeping the mystery alive about the ole data then coming out to tell us that there were only 20 people in it and Covid was the reason is just wrong.
Something Biblical
Lilly's early data on next-gen Alzheimer's drug shows 'robust' amyloid reduction but a familiar adverse event
https://www.fiercebiotech.com/biotech/lilly-sneak-peek-next-gen-alzheimers-drug-shows-rapid-and-robust-amyloid-reduction-familiar
Of course Anavex's blarcamesine does not cause any similar severe adverse events.
Good to see this, suggest it be studied carefully.
Finished commentary on preliminary PDD OLE data. As always, I may make amendments over the next 24-48 hours. https://www.sotcanalytics.com/update-compendium-2023
My Timeline Projections for 2023
As the company approaches commercialization, there are a number of key milestones I am anticipating this year. These are my personal projections and trading should not be conducted based on these timelines.
Partnership: I expect this to be nearing completion, if not completed by May. Looking forward to a partner that can assist with manufacturing, promoting, and distributing Blarcamesine worldwide once approved for Alzheimer's specifically (which of course I expect based on this 2b/3 with potential for a phase 4).
Full AD Data: I expect this to be released by April and no later than June.
Parkinson's Disease Dementia OLE Data: I expect this to be released very close to or in conjunction with the full AD data, so in April to June. I have low confidence in this particular timeline however as I believe the data is probably available at this time, so release may be quite soon.
Submissions for Alzheimer's Approval to Begin: I expect submissions to the FDA, EMA, and TGA (possibly to include the MHRA [UK] and HPFB [Canada]) by July and no later than August.
Rett EXCELLENCE Data: I expect data to be complete by June and no later than end of July. It is possible the company may wait until a relevant scientific event to release however.
Submissions for Rett Syndrome Approval in Pediatric & Adults to Begin: I expect submissions to the FDA, EMA, and TGA by September and no later than November. I have a feeling Anavex may have interest in attempting to have this indication approved in Japan as well based on previous comments by Dr. Missling.
Fragile X, Schizophrenia, PD (to include imaging trial), PDD, and Undisclosed Indication Trial Commencement: I have no projections for timelines on these trials commencing. I do expect at least 2-3 new trials to begin by the end of 2023.
Assessment: SOTC Analytics assesses 2023 as probably the most important year Anavex will have as a company. We are expecting partnerships, commercialization (or definitive notion towards beginning commercialization), and the completion of Anavex's Rett Syndrome trial suite. Considering recent influxes in investment by funds and institutional investors, as well as key developmental milestones expected, we believe the proverbial launch-pad has been set and this year likely represents the final opportunity to accumulate at discount.
Redshoulder on Anavex? WTfx? Very good question.
My simple assessment is, the current regulatory systems knowledge base do not know/understand what to do w/AVXL next. The knowledge presented by PDD and other trials if off their charts. They simply are baffled on...NOW WHAT????.
The system has produced almost nothing of true value for 50+ years, in-terms of new CNS knowledge . They are puzzled, confused about what should they do next? It's understandable of course. No one has have presented strong evidence of an effective CNS disease treatment, anywhere in the world. They have no idea what to do, IMO.
Dr. M> knows that as soon as he begins to clarify concepts and demonstrate the way forward then every (AF-AXhole on the planet will come alive w/meaningless crap ).
So, it's kind of like he is damned if he does show even more proof . If/when he does the parasites will use the very facts he presents to question and attack. He might just be staying off the horizon in order to keep his adversaries silent, until it is too late for any of them. Eventually they will all go off as a gas.
Over 1 million shares of AVXL bought so far today!!!
https://finance.yahoo.com/news/anavex-2-73-blarcamesine-shows-110000130.html
We shall fight the shorts on the seas and oceans, we shall fight on the beaches, we shall fight on the landing grounds, We shall never surrender'
Let this mark ,"The End of the Beginning", for PDD, PD and many others.
Now, we need a couple of strong positive partnering surprises .
falconer66a
Does any of this relate in any way to Anavex? Sure does. The science of the Anavex molecules, acting in neurons and as ligands of the sigma-1 receptor protein, is entirely new science (in the last decade). Publicly the depths of this new science are not completely known or revealed. To presume that the Anavex molecules might potentially treat only the three diseases presently being tested, Rett syndrome, Alzheimer's disease, and Parkinson's disease dementia is typically short-sighted; constrained by the mere three clinical trials for the three diseases.
Watch, in the next five to ten years a lot more diseases and conditions will be found amenable to successful blarcamesine therapy. Anavex, privately and quietly, is thinking far outside of the box containing the existing randomized controlled trials.
kevinindenver
The fact PDD data has also been presented at AD conferences is often omitted by those who have fun with FUD.
The broad upstream mechanism of action of S1R and muscarinic modulation may help multiple seemingly different indications.