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https://www.nytimes.com/2018/11/09/health/alzheimers-dementia-celebrities.html?action=click&module=Discovery&pgtype=Homepage
It's about highly educated, accomplished people who have dementia-early AD and the coming out processes they have engaged. A few moments of reflection on what an effective AD treatment would do is warranted by world leadership. We should not be treating AD as an abstraction only spoken of in hushed terms or discussed as an intellectual proposition. If an enemy in some country were doing this to our people we would eliminate them. Set national medical condition equivalent to DEFCON 1, war is imminent, act like it.
Just Excellent:
You got to love this.
[quoteChance
A p value is a measure of the likelihood that, if the hypothesis being tested is due to chance, the results generated would in fact be seen. A 0.05 value is equal to a 5% likelihood, and raising this bar to 0.005 would clearly cut this probability to 0.5%.
So far so good. But it is also key to appreciate that for this to apply a hypothesis must have been specified prospectively. To test a dataset retrospectively to find the analysis that yields a particular p value is absurd, yet this is what biotechs routinely do with failed studies, knowing that some investors will assume that the measure with p<0.05 next to it shows clinical efficacy.
Another phenomenon, known as p value hacking, involves making post hoc changes to a study in an attempt to push the p value generated across the magical threshold. This is common, with biostatisticians apparently routinely asked to remove certain patients to falsify statistical significance, for instance.
A slightly more advanced hack is to eyeball open-label data to guess what type of analysis would show an effect, before formally applying a statistical test. True, design and endpoints can be changed before testing for significance without risking a trial’s integrity, but in reality this is plain cheating.][/quote]
http://www.evaluate.com/vantage/articles/analysis/vantage-views/whats-p-value
This paper should be required reading for BIIB staff. Thx investor.
Me to, it is perfect.
A disconnect that I see is in SP for AVXL not reflecting the real value of the knowledge gathered and controlled from A2-73 CNS trials to date. There has been only very limited sharing of what is known from trials. Some here have carefully analyzed what has been made public and pointed to voids.(intentional ??) IMO, the connection to what is known and precisely therefore what is not known will be kept for future application. To borrow/para from Dr. Senge on, " knowing what we do not know". Precision Medicine will/has clearly defined the interface on what we know in great detail for some in AVXL-land, not us, (we would not attract people like Dr.New guy from Oslo unless you have such knowledge) ... someone knows. Learning (CNS-AD, PDD, other) happens at this interface where we get great details on what we know, it now becomes very clear what we do not know. (Amyloid Thesis people never knew what they did not know (IMO) as results were basically pass/fail). So, I claim that is how learning happens at this interface of knowing/not knowing. An analogy to semiconductor physics is useful here. At the junction of N/P charged materials in semiconductors there is something called the depletion region. Plus and minus charges must be equal or the junction is unstable and leakage current occurs until the charges are equal and opposite. (standby for analogy). If Knowledge is a big positive charge then it presents an equal and opposite negative (absence of knowledge), the more we know the more we discover what we do not know. IMO, AVXL staff cannot say what they know w/o giving away pieces of the farm. Additional proof by PDD, other trails will add to the body of knowledge. I hate to say it, but for now, the cloak of silence is necessary. IMO.
Sokol: thanks very much for this:
BIOhecker4"
Excellent note:
You cannot make this stuff up. I admit I want badly for AVXL to launch after years of preparation but I see the verifiable facts as such that the AVXL advantages cannot exist in nature as they are. Some change must happen, either the facts must change or the SP must launch. Bah-Bye shorties.
I once heard a Marine Gunny Sgt. describe/demonstrate how a TOW missal worked. At the end of his talk he said...But, there is one defensive maneuver the enemy can take...he can spread his legs and put his head far back between his legs and kiss his ass goodbye.
LEAD, FOLLOW OR GET OUT OF THE WAY. IT"S SOUP.
Congratulations, so you wrote the book they are probably still following, w/editing over time. Similar experiences as credentialed WW 2nd/3rd party focus in Medical devices, H/W-S/W, Pharma, industrial sterilization and a few others.
IMO, depending on how much RWE/RWD profiles/cases and trial records, objective evidence and case expertise the regulatory people have a form of conditional use could be done quickly for A2-73 for specified indications.
We know that this basic management approach has been in practice for years but only recently has become a formal QMS requirement. Australia would be one of the leadership countries involved with these developments. USA and EU are widely involved as well through 2nd party (informed bodies) and 3rd party (FDA-in country regulatory body). So, the format is very commonly done WW. Risk based management is in fact a requirement for registered firms. It is not a leap at all for such QMS professionals to comfortably develop a risk based model for A2-73 use and apply it.
tredenwater2:
Talon, thanks for the effort and follow up. Not what I was hoping for but caution with these kids is of utmost importance.
Thanks again...I guess we'll see soon enough. Do not recall this pattern here, w/such low volume does not make sense.
OK...thanks. So, it may/may not hold. The very light volume and hold level strikes me as artificial or staged? Just a thought.
jon...
TC65:
Jon: