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Nice catch. Looks like this got released 4/12, yesterday. During my discussion w/Anavex PR guy yesterday he was quite vocal about how supportive/helpful the FDA was being w/trials protocol-planning. IMO, if Precision Med. raises the bar for IND/PII requirements(as it should) then maybe we will see more of this kind of intervention. We are sure due.
tred...great message...thx
thanks...any link/price/other comments?
plex...BR...will provide more details later on today...no earth shattering stuff but to me....all very good to hear....NOW, I feel no gaps in trust and do expect Dr.M. will provide details as soon he is able.
trials will start also
Agree, it would be nice to get positive results.
As an intellectual proposition...OK we get it, But REALLY?
https://www.bloomberg.com/news/articles/2018-02-14/biogen-drops-after-alzheimer-s-drug-trial-change-raises-concerns
Cannot keep a straight face when you read this pr piece...
comments like...,"Not a good sign" and "considered a very risky pipeline candidate"
I can just imagine the yelling that went on before this release...for example..."I don't know...tell them it is statistical noise abatement".
IMO, they bought some time to splain a very expensive trial that no one expects to produce positive or usable results. We'll see, hey, "what could go wrong"?
Normally I would not debate the FDA-free enterprise bit and the whole point you make for the processes we rely on. However, I have been really struggling with the pace or this CNS (including AD) work(clinical results /IND/PII trails and the overall effectiveness of the previous/current FDA scientific problem solving processes. Particularly the past 20 years of AD trails and what has come from them...nothing of any value. How many times do you need to prove what is NOT the cause? I do not accept that outcome, having myself sat in many technical problem solving, goals driven complex technical process discussions. This process is broken, they produce solutions w/serious side effects and then will accept adding caution comments/labeling. But, keep products on market saying more good than harm is being done? That is just sloppy processing and sloppy engineering. Such outcomes must not be tolerated. These kinds of failures start at the top including top FDA management. We have been paying for a process that is broken and which would have failed in free enterprise if used by a commercial firm.
This from a previous post. The video is shocking and will help put some pieces in place. I do not believe all of this, however some arguments are powerful. I think we are at least obligated to keep an open mind on such points.
I understand the FDA is working on warning labels for Kentucky Fried Chicken, Pork Rinds, Deep Fried Catfish and few other such culture-comfort foods. Just like they did for Cigarettes, problem solved. Does it bother anyone that BP are the same people who will be hurt financially if A2-73 actually is effective? Any chance the slow walk process we are seeing would be different if somehow AD-CNS was really a priority for the FDA.
YUP...agree
I am not an advocate for any kind of Government National Healthcare system but..... If we had a national healthcare system in U.S., what would FDA do differently? Would Dr. G. then be responsible for developing an effective AD treatment process, for example. There is an absolute vacuum on healthcare responsibility and leadership. Some even suggest the link between BP and FDA is corrupted.
We know that the first step in solving a problem is admitting that one exists. Thanks Xena for pointing to these facts.
This link originally provided by Investor 2014 helps provide additional context. As Schewart said, "Information w/o context is worthless" .The video is > 1hr. Advise you watch in segments NTE 15 mins. It is powerful stuff.
Note: Trails may also = Trials,.... it's complicated.
Doc328..? Comments on new AVXL slide package? Thanks.
http://anavex.com/wp-content/uploads/Anavex-Presentation-March-2018.pdf
A layman's read sees fewer trails for a while. NEW precision trails set the bar much higher. Numerous focused paths/markers. Strong PII results will be seen differently?
I am trying to get a sense of any REAL progress being made. I have observed that sometimes science-research gets tracked into their own time-space continuum. Wondering if that partially explains AVXL silence. Their clocks literally stop in awe of new learning.
Never looked...ride low in the saddle and stay off the horizon...this is going to take time....but, we will prevail...BR
Anyone who owns the AVXL stock and is not happy w/sp has a right to bitch. Anyone else, not an owner< doing public service by complaining should get a friggen life.
sp declines over past months w/o any credible PR from AVXL is just not acceptable as shareholder it pressures me to agonize stay or leave. If I did sell and leave I would not come back and post here. Stress is not good for anyone, and this is stressful. If the unverified comments here add to the holders stress then we have to wonder why they do it. It is destructive and uncivilized, unless you are an axxhole. Doing the same 1x1 or in public would result in you axx getting kicked daily, so that process works as such the stressors are removed.
IMO, we have deliberate forced selling being done, this is not gravity or normal market atmosphere pressure this is the intentional driving price down for a reason by a large foundation/holder. Since we expect news of some positive nature soon (trials/MTA/BO//other) AVXL will relieve pressure like a 3 beer bladder. The sooner the better. Those applying pressure will then see big gains along with everyone else. That is what is going on here. In my world everyone intentionally driving sp down like this would have a big A tattooed on their forehead and every little girl who has been treated/recovered from RETT would have lifelong license to take whatever action she chose on the offender. IMO, that is an example of justice.
Any theories on why AVXL is being attacked? Mine is this is not just retailers bailing out.
Cannot help but be disappointed for these patients.
Totally agree.
Bingo..
We may be overdue for our long established practice of management by example. I remember the story of the quality manager in an Asian refrigerator manufacturing site. The site was shipping an unacceptable number of defective devices. The story goes that the quality manager was taken out to the parking lot and executed. All defects stopped. Here, we just lock them up.
[quote I could only watch it 10-15 minutes at a time][/quote]
I had identical reaction, overwhelming. The stats are mind blowing but credible. I accept about 70% on the face presentation w/ credibility of presenters, particularly the academics. The big P stats/links w/Medical DR's are intuitively correct based on my own experience and real life. The scope and $$$value of the corruption all fits w/recent learnings from DC. I often wondered how poor boys/girls could go to DC and within years become multi-millionaires, now I get it. The synched up Amyloid moves by BP make sense when this context is provided. Tip of the iceberg...we hope.
2014...thanks...this is powerful stuff.
Good to know, thanks.
I am very familiar w/S&A. WOW again. Well Done.
You may be right. It appears systemic.
Thanks Xena...another success story.
In summary: We should not be surprised there is no effective treatment for many CNS diseases even after decades of spending/efforts. Seriously, the issue here is that Dr. M. and others like him are somehow left to their survival skills training to succeed, in spite of the millions of patients in need. Many patients are relying on the equivalent of bake sales (3rd party orgs) while BP has continued to produce stuff covered w/warning labels while they pocket zillions $$$. All while we wait for (who knows) to agree on simple IND trial plans. The process is broken.
We may never know with any level of integrity what REALLY happened in BP over the past decades of AD trial and error or other CNS failures. Somehow, we should make sure that never happens again. Science should, if nothing else, insist on integrity.
Thanks Xena...I have a question...mostly rhetorical. When I read statements like the one quoted here I ask. Just exactly WHO IS RESPONSIBLE to FIND and effective AD treatment? The FDA always says...(it ain't me) w/o actually saying that. They will say things like below, and we let them get away with it.
Aero,