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JonJon-Biostocker…anyone.do you see what I see here with BIIB or am I imagining this? This looks like a PM thought vs old school. Is this a form of blinking? In any case the PM process is doing it's influence thing, IMO.
https://finance.yahoo.com/news/spinraza-nusinersen-data-presented-annual-113000069.html
Looks like BIIB has played a Precision Medicine hand and got results that make a difference. The kids win. Good move, see n=x as possible example proof by science and knowledge vs proof by trial.
jonjones:
https://www.fda.gov/Training/GuidanceWebinars/ucm367786.htm
see numerous posts from Xena on this topic, DZ for example
Biostockclub, how can we thank you for your continued value added work. This post should be titled …"READ ME FIRST"
I get that..."Not my job" routine. BUT,
When repeated trials using the same (PROVE THE THESIS) routine show failure x failure for 20+ years that is incompetent management of a process. So then, why did the FDA allow tax payers resources and SO MUCH TIME be wasted? It is basic stuff. If rockets kept blowing up on the pad, someone would be held responsible to find the cause. PM is sure good news but it is really basic process stuff under the hood.
Kevli33, thanks for posting this.
On today's sp action? Does anyone see the trade action so far as a bit unusual? Number of consecutive trades above std dev, mean anything? Any news around? Hide and watch I guess.
xena, the 2nd slide, "Classic one size fits all"(right between the eyes) will w/o doubt be a big part of his talk in Barcelona. "Game Over"...eliminate brain bleeders, eliminate those who will not respond (about %20) and effectively treat responders. "NOW THATS A TRIAL". Competitors can only sit, watch and soil themselves.
Not to get too far ahead of the process here. What will play out between now and HH PM Happy Dance?
https://ciiien2018.org/
We can now see what the PM initiative brings. He speaks w/authority about those aspects of AD treatment/cause which we have heard nothing until now. Could it be that this level of understanding is what caused BP to drop the Amyloid Thesis late 2017, like they were part of a drill team. The contest of proof by trial vs proof by knowledge and PM is just about over, except for BAN-BIIB still underway b/c they did not get the memo. Will that AHAHA moment occur at CTAD?
As the learning process grinds on through the next level a lot of people and institutions have some splainen to do. As Dr.Peter Senge says there are 3 levels of knowledge.
#1. The things we know.
#2. The things we do not know(but), we KNOW we don't know them. (see HH).
#3 The things we do not know, we do not know. (this is the stuff that kills you.).
Learning occurs at the interface defined by (#2) above, which is what the PM initiative is all about, it is the PM process which enables learning. HH is pushing at the( #2. interface) . There is an old semiconductor depletion region analogy(sorry investor) for this interface which might work here. It says that the charge at the (#2) +/- interface must be balanced,(watch out for analogy) it is called the depletion region in physics. so where +=knowledge then +++ will have a large learning interface GAP (strong charge or attraction for new knowledge)so, more knowledge will be generated quickly, conversely when the depletion region is small (Weak-constrained by lack of knowledge) then the learning process will stop or move only slowly by surface leakage until more powerful knowledge is brought to the interface. (w/o a PM process some small leakage will occur at this interface but PM must be applied to move the boundary of #2 into #1). HH makes the point that many things must be learned/evaluated before any balloons go up, BUT IMO, patients will benefit at each learning stage along the way until the science is settled. ALL IMO.
Kevli33...Excellent...thanks for this link
Anyone?? What is next for SP? AND... When? TIA.
jimmy667:
jimmy:
Jimmy Mc:
Rubyred...thx, this is important stuff...let's hope they move on these changes right away. If I had a new drug I would wait until these changes were effective. One wonders how long these obvious process flaws were known to exist and how such thinking lead to the flawed Amyloid Thesis thinking...some of this is actually embarrassing to the FDA. IMO.
Kevli...thanks for this information. Let's hope that the same people who owned the, "Amyloid Thesis", and who dominated how $$$ got spent are not controlling the next moves. As we all know, when changes happen the people at the table have interests which include not looking stupid about their history.
Getting new thoughts and support for them can be tough. At some point throwing away all the old thinking must be done, the sooner the better. Like changing a tire while the car is moving.
BIIB do not impress as open minded leadership.
Jj:
GOT IT. My price is way out there>$200.
IMO, an important background drama dynamic including all the possible combinations and variations on the BIIB story remains a BP mystery to me. They must see that there BAN effort is not going to end well. The old expression of, "You Can't shine SHAT", comes to mind.