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abew4me
Ya Know, a guy could totally lose any remaining sense of humor on a day like this.
Cannot spike fast enough or far enough for some of us...BTW, we earned many consecutive days just like this...get used to it...TIA.
AB-E-NORMAL ...well, It's a START
D-Mike...
test ...8:39 am ...pilots and crews report to your ready rooms. Prepare the flight deck for air operations.
Bioinvestor5
WolfofMia
Dr.M., I need your help w/this. Have been here for years and support your team and the process all the way, but I have limits. Would appreciate any help you can offer right now. The sooner and bigger the better. TIA.
bas2020...
TOLD YA...Sigmar1...Anavex 3-71 ... treatments await..."Go AVXL"...https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10501138/
WGTHAT, (HF) also
boi
Anyone have a rational explanation for this (looks like) massive collapse? Is it REALLY good news in some kind of trick disguise? or An indication the real bottom fell out of AVXL? Confusing me. Who gains by this selling??? Is this just some kind of WS trickery????...seriously
IMO, being LONG AND LOYAL means you have put up with the liars posts and the thieves dishonesty knowing all along you have studied the available facts from AVXL and the , "Buy In". If those inputs change then you may feel free to reconsider. Keep an open mind-thought process for new information/facts. You never go to sleep and your never leave AVXL staff behind in your thinking, even when it is a bad day. Semper fi...hold the line. Dr.M. will not let us down.
McM
NOW WHAT IS GOING TO HAPPEN ON MONDAY to SP ???TIA
One question has to be answered. Will FDA top decision makers want to get the 50+ years of Amyloid Thesis plaque AD-CNS cause behind them in one sweep , or not???? By signing up w/AVXL science and BIO markers they are able to snatch victory from the jaws of certain (very public) science failure . Yes, we all understand there will be deals cut while politics re-position their public message.
If Dr.M. is able to keep AVXL in sight while we work in the background to cement the language, then FDA can be helpful (by at least being quiet) while the real science gets published and understood.
A complex stew of science, image, results and lots of BIG $$$$ is in this POT. IMO, AVXL has presented a low profile so far which has not helped AVXL SP much but such posture may help get the FDA moving-motivated to work w/us. We do not need to rub their faces in a checkered history, IMO.
Bottom line is. It looks like AVXL has got the goods and can prove the results are the REAL THING. Now lets make it stick and cut some GREAT BIG deals .
Wolfofmia
https://finance.yahoo.com/news/anavex-phase-2b-3-trial-113000676.html
Some news we have been waiting to see..."Go with throttle UP..."
sab63090
Dr.M.
Excellent summary of the status and our future potential...it's all about the Bio-med process being followed. IMO, at some point all competition will be forced to fold camp and leave the field, Only a matter of time now.
Great work Plex...thx.
Xena...read this ...it sounds consistent w/what you have said here. (If you die with cause of Cancer or Cardio...then they got a place for you $$$)...otherwise you may not fit the Gov. model for known cause....the system does not know how to handle your cause of death...hence no $$$$ support in the Gov. reporting system...technically..."it /your medical/clinical data is.????.... never happened".
https://www.hopkinsmedicine.org/news/media/releases/study_suggests_medical_errors_now_third_leading_cause_of_death_in_the_us
Thx... it is time to move on.
We appreciate the kind messages and thoughts. Dr.M and the entire AVXL team have worked to mitigate-prevent AD-CNS disease losses going forward. It's a tough situation but the future looks brighter and, it is time to move on.
Tredenwater2 and all,
Thanks, life is truly too short .
plexrec...Thanks...nothing like RWE to make the point...
Dr.Stephen MacFarlane--7 years ago talking up 2-73--and the drug not yet approved--what a pity !!https://www.dailytelegraph.com.au/news/national/steve-macfarlane-explains-the-alzheimers-worldfirst-drug-trial-at-caulfield-hospital/video/03fe27ae89bdce4912cabf865a99ed80
Thanks Bill, Congrats and great story of how your process work made a big difference. Deming was an impressive guy to work with. His life work and how he influenced-changed so many practices for such a long time and his legacy of change management practices remains a life changer for many.
Well everyone.....WELCOME TO THE SWAMP of SYSTEMS...not sure if this knowledge is a blessing or a curse. We will probably never be done , but the good news is. We are in front . Our task, job, whatever is , "finding and connecting all the dots in the CNS SWAMP". Anyways, that is the path that AVXL has been on while the rest look for " THE DOT AND DONE". Ain't gonna happen. Many here get it or can sniff-sense this path is real and correct. The good news is, AVXL and team (including this board) have no choice now. Let's not be discouraged when the R.O.W. doesn't quite GET IT.
I have had the good luck to have known and briefly worked w/ Dr. Peter Senge (having completed his course of studies @ MIT years ago) . I also met and work briefly w/ Dr. W.E. Deming . He was also an amazing-brilliant guy whose ideas just dripped off of. IMO, he truly led USA out of the wilderness not understanding "HOW TO, IDENTIFY AND SOLVE PROBLEMS. " ...He would often point out that .."The first step in solving a problem is...recognizing that one exists." . He would then lead the team in how to define the problem in actionable terms, which then lead itself to developing solutions. We have all seen this in our daily lives today but it was not long ago (30-40 years ago) before SPC and other basic tools were used /applied in daily life).
IMO, if these guys were asked to comment on or consult w/FDA on CNS (systems work) FDA leadership would revolt and not accept any guidance, just like the American Automobile industry rejected his (Deming's) training while Japanese New Car Quality practices taught them the meaning of HUMILITY. They eventually developed methods like SPC to produce controls and then eventually to , "Do it right the First time".
So, this is some of what Dr. M. and team face when trying to work with the FDA top management and the current WS corruption. The existing system either cannot or refuses to look at (See ) that THEY ARE THE PROBLEM. ....just as Xena has pointed to or identified some of the symptoms of what is broken.
The evidence of (what is broken as an example) lies in claims FDA has driven on Amyloid Plaque as the CAUSE OF AD and who knows what else. So, WE AVXL stockholders are swimming upstream and will continue to do so until someone like W.E. Deming scares the shat out of WS&FDA. An anecdotal story..."I was in the Detroit -Mi. audience long ago to attend a HOW TO symposium w/hundreds of TOP GM/FORD/Chrysler leadership who were there to find out how to fix their quality/sales problems (B/c the Japanese car manufacturers were kicking their asses ) .
Dr. Deming started talking and w/in 15 mins half the arrogant AX holes got up and left their seats...stormed out. Dr. Deming told them...( "YOU ARE THE PROBLEM>>>YOUR LOUSY MANAGMENT PRODUCES CRAP AND PEOPLE ARE BUYING JAPANESE CARS BECAUSE OF YOUR INCOMPETENCE...."). It was funny to see but very dramatic.
So, when is the FDA going to set up a session w/ people like Dr.M and the AVXL team so that they can lead the FDA out of the wilderness??? It should be clear that until a similar event happens for CNS diseases no US progress is likely.
Hey, wait a min. Is THAT WHY DR.M and the AVXL team just published the CNS WW TRIAL (s) results so AVXL can do the massive HOW TO REVEAL. ??? now all we need is for someone w/knowledge and courage (Like Dr. Deming) executes the (so far) impossible -dramatic WW CNS trial results.
https://www.systemicleadershipinstitute.org/the-historical-link-between-systems-thinking-and-leadership/#:~:text=Senge%20describes%20systems%20thinking%20as,The%20first%20is%20efficiency.
Xena
What about this table from NIH which IMO blows the lid off all other news...https://www.clinicaltrials.gov/search?term=anavex&limit=25&page=1
Search Results
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Viewing 1-12 out of 12 studies
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Study Title NCT Number Status Conditions Interventions Sponsor Study Type
1
An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease
NCT02756858
Completed
Alzheimer's Disease
Drug: ANAVEX2-73
Anavex Life Sciences Corp.
Interventional
2
Phase 2a Dose Finding, PK/PD and 12 Month Exploratory Efficacy Study of ANAVEX2-73 in Patients With Alzheimer's Disease
NCT02244541
Completed
Alzheimer's Disease
Drug: ANAVEX2-73 Oral
Drug: ANAVEX2-73 Intravenous
Drug: ANAVEX2-73 Oral
1 more
Anavex Life Sciences Corp.
Interventional
3
OLE Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001
NCT04575259
Completed
Parkinson Disease Dementia
Drug: ANAVEX2-73
Anavex Life Sciences Corp.
Interventional
4
OLE of Phase 2b/3 Study ANAVEX2-73-AD-004
NCT04314934
Active, not recruiting
Alzheimer Disease
Drug: ANAVEX2-73
Anavex Life Sciences Corp.
Interventional
5
ANAVEX2-73 Study in Pediatric Patients With Rett Syndrome
NCT04304482
Completed
Rett Syndrome
Drug: ANAVEX2-73 oral liquid
Drug: Placebo oral liquid
Anavex Life Sciences Corp.
Interventional
6
ANAVEX2-73 for Treatment of Early Alzheimer's Disease
NCT03790709
Completed
Alzheimer Disease
Drug: High dose ANAVEX2-73
Drug: Mid dose ANAVEX2-73
Drug: Placebo oral capsule
Anavex Life Sciences Corp.
Interventional
7
Phase 1 Study of ANAVEX3-71
NCT04442945
Completed
Healthy
Drug: ANAVEX3-71
Drug: Placebo
Anavex Life Sciences Corp.
Interventional
8
ANAVEX2-73 Study in Parkinson's Disease Dementia
NCT03774459
Completed
Parkinsons Disease With Dementia
Drug: High dose ANAVEX2-73
Drug: Mid dose ANAVEX2-73
Drug: Placebo oral capsule
Anavex Life Sciences Corp.
Interventional
9
ANAVEX2-73 Study in Patients With Rett Syndrome
NCT03941444
Completed
Rett Syndrome
Drug: ANAVEX2-73
Drug: Placebo
Anavex Life Sciences Corp.
Interventional
10
Study of ANAVEX2-73 in Patients With Rett Syndrome
NCT03758924
Completed
Rett Syndrome
Drug: ANAVEX2-73
Drug: Placebo
Anavex Life Sciences Corp.
Interventional
11
Effects of Ketamine on ERP/EEG Measures in Healthy Volunteers
NCT04928703
Completed
Healthy
Drug: Ketamine
ERP Biomarker Qualification Consortium
Interventional
12
Event-Related Potential (ERP) Biomarkers in Subjects With Schizophrenia and Healthy Volunteer Subjects
NCT04025502
Completed
Schizophrenia
Device: Event-Related Potentials (ERP) and Electroencephalogram (EEG) testing with the COGNISION® System
ERP Biomarker Qualification Consortium
Observational
25
studies per page
Make no mistake about it. This is where (Commercial) AVXL solutions are headed..."ensure access to the company's new CNS treatment paradigm.
From Dr.M..
Make no mistake about it. AVXL Commercial Solutions has BIG P surrounded, and they do not know it.