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Stop me if you have heard this before, see Homeostasis...
Getting older is as much a state of mind as a physical reality, overcoming the pains is easier than keeping a sharp mid and positive attitude. A friend of mine used to say, "the good thing about getting older is, it doesn't last that long". That thought is motivation enough for most of us, refuse to "get" older. A2-73 should/will change many lives we hope.
I made the mistake of asking how Homeostasis was measured in CNS context the other day, only to be told that.....YOO that is REAAALLY STUUPID question (my emphasis).
Eventually, if AVXL-Dr. M. is right about this, every clinic on the planet will be conducting these tests and all our current MRI/X-ray equipment will be used as sea anchors.
Bater...yup. In my opinion he must have been thinking along these lines when he set expectations about these trials starting in quick order. Can not help but wonder about the scope of things we do not yet know we don't know. This really is a process of validation (not verification) disguised as a trial, you are right there
It is fun to talk through. If it all works out there will be one hell of a massive celebration that will go on for years.
IMO, Dr. M. chose Rett trial to go first b/c of the dramatic positive impact which might be generated. I also believe that end points for A2-73 trials are likely to include patients condition as much as they will test scores (MMSE example). Quality of life will be huge as a key metric for the new FDA trials acceptance criteria, IMO.
It will be refreshing if we have patients being interviewed about how they are feeling vs a caregiver discussion on their deepening state misery.
Is it too far down the road? Maybe, but Rett results may present results that put the critics to rest. IMO, that is why he picked it to go first.
JJ...we also need to consider the FDA backlog around trials right now. It looks like all the new rules are being worked out while many important new ideas/products are waiting to be formerly evaluated.
So far, AAIC agenda may be thin. Dr. M is a forward leaning/leading kind of guy. His leadership style comes across well in all he does. Restating results can be done by others. My guess that until the trials backlog is broken we are in for more waiting, which presents severe challenges all around but we cannot do anything about it. A kind of quiet period, hope it does not delay us for long.
https://finance.yahoo.com/news/biogen-present-data-alzheimers-association-113000412.html
This just in...BIIB says..earth is still flat, feeling obligated to say something....
ANAVEX 2-73, a Sigma-1 Receptor Agonist, Targeting Neurodegenerative and Neurodevelopmental Diseases
Possible example of future precision medicine vs toxic chemistry and radiation...FDA approves new Leukemia treatment...comments from FDA session in today's news. Similar treatment history to AD pts, these kids did not do well with old methods either. Strong message here about changes needed. Dr. M. is leading the way.
Agree. I re-listened and was delighted to see his points of emphasis, particularly those CNS Homeostasis and the human body resetting with A2-73. He starts with on emphasis on the CNS self healing process being similar to recent BT oncology trials. Massive turn around about to happen all for the good of patients, families, economies world wide. An exciting thing to be part of. BIIB and BP have a chance to help/lead or be roadkill.
What does your Magic 8 ball say about the pathetic volume today?
http://raps.org/Regulatory-Focus/News/2017/07/07/28050/FDA-Officials-Master-Protocols-Needed-for-Precision-Medicine/?utm_source=Email&utm_medium=Informz&utm_campaign=Informz%2DEmails
FDA on new Master trials protocol..(sound familiar?)
Thanks, I assumed the answer would be something like what you wrote. No known reliable/easily done test. If eventually this type of evaluation-status can be converted to measurements (in vitro tests/other for example) then we will not have to conduct MMSE evaluations which by inference determine pt. AD status.
Appreciate your response.
Falconer, if you were to measure CNS Homeostasis how would you do it. Maybe a dumb question but there it is. What sort of clinical tests, samples could be used? Thx.
Yup, agree.
Penny, it was unusual for a micro mini Bio to get invited to DC forum, agreed. You seem certain he was singled out b/c of Anavex line up. What is your reasoning supporting the assertion. I do not disagree it was not just a random event but how can you be certain?
Gottlieb says...
Good point, maybe this IS the fast lane or at least E-Z pass. I do prefer silence to low content fluffy PR's.
Seriously, if you were in the massive FDA queue awaiting trials approval as discussed in recent new director hearings would you be running your mouth or would you be patient?
Agree with this possibility. Deference to the FDA would explain a lot. Also, if A2-73 does what we think it does then it is a massive medical/political event to big to manage by AVXL. BP will be sucking wind if FDA is driving. Or not.
On a clinical research clock, this just happened a few seconds ago...
79' , Been thinking along those lines.
"T", of course it is a small number, you are correct. A key discussion background point has been the Dr. M thesis on CNS Homeostasis attributed to A2-73. If true the dots connect more easily and to date there has been no contradiction that we know of. The other good news is medical experts have admitted they do not know, what they do not know about AD. An A2-73 cup half full path works for me. If small, well controlled/precision trials consistently show positive results and they do not contradict the hypothesis then maybe BP years of massively expensive trials were just the wrong thinking. A2-73 proves itself to be BTD. Is it that simple?
Nobrainer, thx for the link. Just when you think you are having a very bad day you realize what some of these patients and their families must go through...it is just sooo good to see a positive 3rd party write up saying nice things about A273...this is ALL gonna be worth it when these pts and our SP recovers.
treden...Now THAT'S a positive ATTITUDE. Nice
"Strong message to follow."
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm565148.htm
This new initiative may help speed things up a little.
We sure are due.
frrol, just curious. What would you say if there was no accurate, clinical metric/criteria that one could point to and say, this AD patient has stopped regressing or is clearly recovering? Is the ultimate measure that patients feel/look better, they are able to carry on with their lives? Like recovering from a bad cold.
We do not know what we do not know...YET.
mickyboy...I have been in a lot of other countries both in the U.S. military and as civilian doing work. My message to you is, stay right where the f you are and we will all get along fine. You can have your infection filled homes, clogged streets, filthy lifestyles, crime, violence and attitudes. Do not judge what you clearly don't get. There is an old expression that comes to mind.."no better friend, no worse enemy". We like our country and we work every day to make it better, those who do not will be w/you soon.
" Each market will close early at 1:00 p.m. (1:15 p.m. for eligible options) on Monday, July 3, 2017, Tuesday, July 3, 2018, and Wednesday, July 3, 2019. Crossing Session orders will be accepted beginning at 1:00 p.m. for continuous executions until 1:30 p.m. on this date. All times are Eastern Time."
come one...come all
Goose...a nicely done message. Dr. M is not overplaying his hand and that drives some people nuts. Some of us wonder why he is(as it appears) deliberately understating the potential value of his holdings ?
We can only speculate on the tactic he is using. There is no stream of fluff PR's or high profile,low value appearances/appointments as one might see with many comparative firms. Silence may not be golden but it beats betting against historical fail rates of 99.4%. Anyone investing in a pharma-device-plan that has an historical failure rate approaching certainty but who thinks they "Got It this Time" is a lot worse off than our retail holder, IMO. Is there really any such thing as "Minor" brain swelling? Adverse event...well yah. The old expression of , "you can't shine Shxt" comes to mind
The only explanation that I can come up with for the silence is there are other influential parties involved who are basically controlling the timing of events, maybe politics. Second possibility is they are still awaiting analysis/results , which of course could go on forever. Possibly some combination of these. I think if A2-73 flamed out on short final we would know by now.
Yep...he would have known a lot of what we do not know.
FWIW my theory on this delay is there are several 2nd-3rd parties involved (FDA, BP, AVXL, politics). We are herding cats with massive consequences and risks being concurrently managed by all in a program context. The science and the patient stories will all eventually be very public, if we have the goods.
As investors we do not know any of this of course but it is easy to assess what must be going on. In this context then, not releasing any potential status is understandable to some degree. The challenges are financial, political and scientific and of course peoples lives are at stake.
All IMO only. Still a believer but nervous about what I do not know.
If AVXL is right about the A2-73(Homeostasis)story then these guys are still heading the wrong way. Wouldn't they at least delay