Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
IMO, we will borrow a page from the Oncology Precision Medicine trials book in AD future prospective trial planning. A2-73 combined with information unique to the patient will be used to restore the unique CNS Homeostasis of that patient. In the meantime A2-73 will have been established as the stabilization platform and safety carrier. Not sure how trials were done in Oncology to allow such but it is where we need to go. It will occur in stages of course but the main platform of CNS Homeostasis stability will happen first. The measurement of this effect in cognitive terms will vary by patient of course.
Ultimately (as jimmy has said for years) the combination will be ,"the way of the warrior".
Wow Sokol...We must be physic. Great link.
My own theory is that each and every one of us is either an AD patient (known) or will be. There is a curve somewhere and we are all on it. Some of us die before we develop measurable symptoms. I think AD is a prewired human condition which either presents symptoms that impact our daily lives or it does not.(see cognition) Something either wears out or does not according to our DNA/genetic makeup. When whatever it is that wears out hits you will be standing in the middle of your favorite shopping mall and suddenly look around, momentarily unable to figure out where the hell you are or how you got there. It will pass but that is going to be a scary GOTCHA moment, and we all have em'.. Stop making this trial more complicated than it has t be.
QOL varies as a function of how you treat yourself and your genepool destiny. IMO, some of us can live until we just cannot move anymore but our brains are still running like a clock. Others will eat that "one last twinkee" and it's lights out.
The fact that our science guys have not discovered the hot reset button for AD is not surprising considering my theory be/c, There AIN'T ONE.. A2-73 is our reset button. Of course this gets complicated when we try to fit my theory into the FDA view of the world around trial targets. Too bad boys, b/c there are millions of them, reasons that is.
Has AD been made more complicated than it needs to be? Is Amyloid plaque just fat on the brain like we all get around the gut when we drink too much beer and get no exercise? If you are not getting good blood circulation in your brain (b/c of ???) are you more likely to suffer memory loss leading to symptoms of AD? (see my thesis on snowballs) If you concentrated on getting good sleep (see life habits) are you less likely to experience memory loss? And so on??? Concentrate on blood circulation to the cortex for openers. Will A2-73 do that and is it good enough to use as trial endpoint? Hey it is at least as good as the amyloid hunters theory.
If A2-73 is effective as a treatment by restoring CNS homeostasis simply doing a brain-CNS reset. Does the brain just happen to be the end of the line for the consequences of everything that you ever ate, drank, did foolishly, which some have greater tolerance for than others? Does every human simply have their own threshold for the amount of crap they can do to their body before it says..TIME OUT?
Some of us can stay up all night and bogey while others have 2 beers and crash. My own unscientific diagnostic. A2-73 is a type of reset button. Measuring it's effectiveness should be parsed to whatever level makes sense for each patient. We are getting close folks, lets get this done.
BTW, I just made this up.
Exactly right yet the Amyloid Thesis prevailed and was used to justify huge spending on time consuming trials which proved nothing of value. What are BIIB investors thinking even today?
Steady T:
Biostock wrote and I agree totally:
Thanks again Biostockclub:
We need to keep in mind that the FDA inspectors/gatekeepers are responsible for following the LAW.There is no PM LAW. They do not create the LAW. IMO, someone needs to figure out how to apply PM guidance while some level of scientific reasoning unique to each patient is applied. Till now only rule is …"First, do no harm" and it is NA to FDA rule players. How will the first rule of medicine be applied when these things have never been done and the current acceptance standards are not relevant?
Tough call which should not be given to the AVXL team but my guess is the FDA "Prove it " guys are not going to take the point.
Just curious, anyone ever tell you that your style sucks? Google AXXHOLE.
Biostockglub...predictions??? If my memory is correct you have had very good accuracy and content predictions in the past on what happens next.
Can you look into your crystal ball and comment on what you think will happen next w/AVXL and the world around sp? It feels to like something is going to play out soon.
TIA
Doc328, thanks for the information.
Thanks Biostockclub...will need to keep a watch for LLY amyloid developments.
Jimmy667:
Biostockclub:
Peter is a great guy and brilliant thinker. I did a 2 year intern task/workout w/him.
Dr. Peter Senge has done great work in systems dynamics @MIT. (his book, "The Fifth discipline" is helpful). He describes a number of archetypes, many of which might be applied here. One of his archetypes is called, " fixes that fail". One characteristic is a process that keeps getting repeated in spite of unintended consequences, (previous failures) usually w/ follow up delays. (nothing new) People who have found themselves in one of these management death spirals will tell you how hard it is to detect your own process failures. Talon would tell you that the term "Death spiral" has a very specific meaning for pilots and it is easily analogous to what has happened in the CNS disease space. Hint, pulling back on the stick while in a death spiral only accelerates the out of control dive condition, the opposite of what seems intuitive. IMO, the Scientific method of reasoning begat the FDA trials process, the rest is history. Somehow they never understood they were in a death spiral, which BTW is what killed John Kennedy Jr. off Cape Cod.
So, let's all move on then. Precision Medicine-Science looks to me to be the next version of the Scientific Method...but...it now includes breaking through the walls of, "Not knowing what we don't know". Well, we are going to find out w/the help of some excellent new AI tools and with a process team who have challenged the establishment and (so far) are still alive. The PROCESS is what matters.
Your cup half empty philosophy is well known to members of the MB.
Thanks Biostockclub:
Xena, my suggestion, take a couple of days and do something else. We need you for the big game.
Yes, understand WS closed was curious about ROW (UK, FR, AUS, GER) etc. PR/news could come from anywhere in case of AVXL. It will not take much for a flashover IMO.
Will markets be open Monday, not including WS?
A classic post on what this (AVXL) is all about. When an otherwise healthy human has their life destroyed while they watch, what could be more devastating?
If everything we have been given to read/told about Anavex and A2-73 and if this turns out to be some kind of snake oil farce then so be it, but we will have done our DD.
IMO, we are witnessing a kind of medical development process asteroid strike on an established system which has been almost totally ineffective for years. Now experts predict the healthcare cost of AD w/in 30 years will be greater than U.S.DOD projected budget. So, if destroying lives is not sufficient motivation then maybe projected costs will be.
I have recently begun to consider that FDA/other BP/government leadership has been holding back. They cannot be so incompetent as to not see the importance of CNS diseases-treatment. Is status quo acceptable as long as the erevrgreen bills get paid?
Something is not right, there are/have been snake oil events for sure but AVXL is not one of them. Someone needs their ass kicked.
I would imagine the fact that they are also still breathing should help. Add to that, no brain bleed, sleeping OK and few other basic self care things. People will notice theses things. On the downside they do not get a chance to meet a lot of new people every day.
Not at all shabby. There has to be a pony in here somewhere.
Xena
AVXL from down under rally is likely based on past performance. On the other hand, the best team that money can buy, NYY has been all but statistically eliminated. Maybe the NYG will do well....yeah right.
SOKOL says:
OK, we'll see I guess. Lots of guidance written on this kind of obvious issue by FDA.
Bourbon:
f1ash...all very good points. Yes, we will need to hit a lottery or make moves to achieve the goals. I am hoping he can sequence actions/results to minimize the impact.
powerwalker, thanks. Yes, it reads better. The structural sequences and (shall/may) delivery is till inconsistent w/today's needs and technological capability/style. Overall, if sponsors must wait they are going to be looking elsewhere. IMO, if AVXL gets results by going a different path the FDA will have to adapt instead of insisting that everyone else follow them. IMO.