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Never miss an opportunity to introduce more uncertainty: FUD:101
Flash-Jon...I have same kind of basic instinct question. The pieces do not fit together for me either. I am expecting some kind of information release from some source soon. This is path not sustainable w/o some news, IMO.
Biostockclub...my tech skills on a scale of 1-10 are about @2. I just copied text from seeking A and pasted.
Biostockclub:
Bodies at rest.
they are riddles written in code, very clever.
T...you and I are on the same page. If no convincing test criteria are available to definitively say pass/fail then OK, say that, and consider it but do not not start a trial b/c you do not know what success looks like yet. Use RWE as a backstop but start.
IMO, the best position is the Biomarker claims made by AVXL. If a patient blah, blah, exhibits certain Biomarker and they are treated w/A2-73 then carry on. There is no cookie cutter method/criteria for acceptance. Do the cognitive evals/testing even as subjective and carry on. Monitor until stability is clinically verified. Eventually, better test methods will evolve but trying to test for some metric when the unknowns are not known is not a good reason to delay any longer.
A2-73 is safe.
Aero-man...
I do not know if any collusion between FDA-BP or others. I do sense that the current status of no signs of cooperation with a small company with legitimate claims to safety and efficacy cannot get a simple trial started following FDA rules and precision science guidelines. Any rational review of the evidence we seem to have suggests that a direct and concerted effort by all parties is warranted.
In my own experience, the regulatory bodies can/do tie up small companies with procedural crap. This kind of delay des not reconcile with the importance and payback of going ahead with controlled AD trials. Risk management ain't that tough a concept to work with. Something here stinks.
tredenwater2, as you may be suggesting the dots just are not connecting right now and the clock keeps ticking away. We have been through a few of these quiet periods. They sure get old fast.
I do expect news about Australian pts from a2-73 safety trials in the next month or so. It has been a while since those people started w/no AE's that we are aware of. If stability has been achieved for 80% (assumption) then that should be at least RWE. Not happy having to grab at straws around here, but alternative is to give up after years of anxt.
all the best.
If we keep this about ...The Process...then we will make some progress. Plenty of blame to go around.
The trials process has not produced conclusive results nor has it lead to verifiable evidence of direction, excepting maybe what NOT to do. The process is broken. The FDA itself is very keen to identify (use form 483) when QMS processes which should have been effective were not. The evidence we have includes decades of industry trial records and lab/preclinical animal study records, countless meetings, academic conferences, patient data and of course autopsy results. Decades of work by smart people have been compiled and witnessed. Thousands of rules/requirements and guidance documents have been carefully created and reviewed by some of the best minds on the planet. All of this and yet there still is no agreement on how to measure AD trial results success? When does someone in charge finally declare an emergency, like any good pilot would. The FDA's own requirements require a self assessment of their system for efficacy and effectiveness. In fact, we as citizens are not doing our duty by letting this continue w/o explanation. Why can't a precision medicine trial for AD be started in the U.S., yet it can be done in other countries? WHY?, Just a simple question.
Millions of innocent patients around the world are stuck in warehouses and these geniuses still have nothing. In fact, we see today that BIIB is still saying they have progress being made. seriously?
If it is not the FDA's process, then whose process is it? They own it or they must step aside and let people like Dr.M. at least move forward and not be forced to go to another country so that he may start. Are the people in charge so wrapped up in their own (fill in the blank) that they feel compelled to block/slow/disable any alternative action?
What is wrong with saying the process is broken. We paid for it and we have every right to see it gets fixed.
Remember the old Jerry Sinefeld quote..."It's not a lie if you believed it when you said it".
These are the guys who will do ANYTHING for money, more of the same. IMO
In case you forgot to take your AD test, it's OK here is a link.
https://www.alzheimerstruth.com/quiz-sf?utm_campaign=ppc_google_alztruth_quiz_20180722&gclid=EAIaIQobChMIoLDo26ax3QIVRVYNCh2ngwzpEAAYASAAEgI16PD_BwE
BTW, in case your results say you need to get help call the FDA and ask for someone who gives a shat. All the best.
it's the little things that matter in the end.
SEE, now that wasn't so hard.(thanks but I knew) So, what's the reason we had to go to Australia to get started? Why did it take decades to figure out they were getting nowhere with the Amyloid thesis? Evidence indicates they would have continued if some new people (Dr.G.?) had not intervened. What else has to happen before we call this problem out. W/in 20+ years CNS-AD will cost us more than the entire US DOD budget. Problems do not get any bigger.
Who is going to call them out (the entire trial process control establishment) and tell them to get this done NOW? As of now we should all be wondering WTF is wrong with getting trails started/done. Why do we have to go to other countries? I am not blaming the FDA only but I think they own it. That was my point earlier. How much longer are we supposed to wait for UNKNOWNS to control future CNS disease treatment? AVXL cannot do this alone, IMO.
Old...says:
New AD test:
Since we now are told that FDA nor clinics do not yet have an agreed test (chemical/biological/electrical/other) to determine if one has AD and what stage they are at. Further, it seems that w/o these test results and exams every 8 weeks or so they will not be able to determine if the treatment you are taking is effective. We find the need to make tests more complicated as we are worried we are missing something. Just living a routine life ain't good enough. Do not start until we say so, or your insurance company will not pay us. I am therefore creating my own certified REAL test questions and list of activities, which, when done correctly will be used to verify you are/are not an AD case.
I feel it is necessary to take these steps so that my investment in AVXL may be rewarded right away. I am tired of waiting for trial people to get on with it.
Key Question:
What day is this? Where are you? Can you brush your own teeth? How did you get here? What is your name? What is you spouses name? Do you own a dog? What is the dog's name (if y)? What did you eat for dinner yesterday? What is your spouses name? What is the date of your spouses B-day, including what year they were born in*, for extra credit*?. Name the 5 Great lakes in U.S.. more to follow:
So, now we can get started. Other CNS diseases, such as MS, RS, PD will be tested according to clinical trial requirements which we can measure.
These trials are free to start as available except for RS b/c we have not yet figured out/or agreed how to measure the results.
BTW, in the future most CNS disease trials will be started with results partially or completely determined by patient physical exams and whether the patient/or care giver says they feel better(placebo controlled). We are now certain the treatment for AD w/A2-73 really is harmless and resolves most/all basic symptoms and the insurance companies will pay.
https://www.dementia.org.au/helpline/free-dementia-kit/
OK, seriously, the AVXL biomarkers indicated about 80% of their trial population had (some) markers. They might be screened for near death experiences to validate your theory.
Sokol...you da man....BINGO...critical thoughts, IMO.
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.