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How should this be read?
I had a different read of the rule/embargo requirement. The actual data/late breaking content will follow the embargo rule for publication on Saturday. If the PR interpretation is correct then others might follow the BIIB PR plan, but have not seen any other example yet.
This process-results write up makes me wonder what the executive management at BIIB was thinking. One poorly done set of trials w/obviously flawed sponsorship control will impact their credibility for a long time. Money talks I guess. They badly need AVXL science, IMO.
Yes, God works in mysterious ways sometimes. We all expected the typical BIIB media blitz and sure enough, we got it. The next few days are going to be very telling. We need a couple of good days.
GOT IT, thanks. So we might expect a similar practice from other CTAD presentations, including late breaking PR summary from AVXL.
more BIIB PR w/specifics ref to CTAD???
https://finance.yahoo.com/news/eisai-biogen-announce-presentation-additional-123123463.html
Did BIIB get the compulsory hold the news memo from CTAD?
https://finance.yahoo.com/news/eisai-biogen-announce-presentation-additional-123123463.html
It may be notable that he was speaking to a room full on finance/investor types...I read him as emphasis on financial catalyst...
camk:
Any thoughts on the use of this test as pass/fail criteria during AD trials? If, Y, then this is big.
https://www.bizjournals.com/prnewswire/press_releases/2018/10/15/NY39817
basparks79:
We should be looking for a few (maybe pfizer) BP to refine their new product introduction/development internal models. These BP all have established templates documented around the OLD SCHOOL which direct/dictate all internal development/science activities. When Precision medicine was defined by FDA as the new model it must have caught them all by surprise. All of BP must be turning themselves inside out trying to (define-document and do=establish) new compliant models. Old ways , literally 50+ years, will not die easily. This cuts both ways as the good news is AVXL may be there first w/goods that comply with new P.M. requirements. The bad news is, these new models do not fit w/old BP models for doing business. So, although BP may want to play they are literally not able to use a lot of what has been done by AVXL.
This is all IMO but I do know how these things have worked during previous changes. It is just not a simple buy out of processes b/c the BP people will not be capable of judging how well AVXL did it's homework. Any buy out will be a leap of faith. More likely some kind of partnership until BP figures out what Anavex have done and how it works in their own system. Assimilation might take a while. SO....This puts all the pressure on TOP MANAGENT to take a leap. IMO, not a simple thing for BP top management to do. They will be slow to react, IMO. Pending some inspiration for results this week.
powerwalker link:Thx
Thanks Biostockclub...If you're happy, then I'm happy.
BIIB-unusual earnings caution by analysts ref: Tuesday BIIB earnings see AD comments. Curious considering their typical pre conference blitz/style.
https://finance.yahoo.com/m/bcefc859-c897-33b6-a62e-fed035459dd4/ss_analysts-wary-of.html
Considering what they have done in the past near big AD conferences (which ultimately blew up on them) maybe this is a kind of blink. Or, maybe it is evidence of a little humility? NAAHH. As W.E. Deming would say..."Understand the meaning of variation."
jimmy67:
See Xena-Dado link:
Xena: WOW-Nice:
Flash:
Doc328...question.
First, thanks for your contributions here over time.
What impact do you think any positive results from initial testing/screening will have on timing?
Is the system capable of adapting to positive (read effective) responses from first testing? At present these kids do not have a chance. Do we expect everyone to calming standby if first kids start to recover some key function?
I sure don't.
Just a thought on news vs NEWS, heads up.
Regrets if this point is sooooo obvious , why bother.
As we get trials started and results from all sources begin to contribute to the core we must stay alert. A micro-mini-biotec such as AVXL has insufficient resources to even bless the correct spelling of most that will be published if AVXL hits possible/probable targets, much less content verification. I say, that is a nice problem to have and fully expect there will be good and bad days.
The really good news is that (SOMETHING) is going to roll the CNS holy stone away from the tomb of doom and some people who are other wise healthy can join us. The old rules of good/bad-pass/fail-true/false, etc. need to be applied w/caution. Keep our heads up, required separate the flyshat from the pepper 101.
Penny.D:
79', the cards have been dealt IMO. BIIB was silent this week and we had a surprise on Friday. That is not a normal pattern based on 3 years of watching action. Both Monday and Friday are typically quiet around here. Things have changed as of today. Your prediction for next week is right on.
Xena:
[quoteYankees - 27 World Series wins
Red Sox - 5 World Series wins
Just saying.....][/quote]
No debate on facts. They are the best that money can buy, sadly not all of their fans should be out walking around though. IMO. Stay tuned for WS.
Thanks for the reply falconer...have a great day
XENA
chrismiss says:
steady T
Maybe we will see evidence of agreement or at least develop an understanding for concepts like CNS Cellular Homeostasis vs Amyloid Thesis at this CTAD. Form a basis for BP-regulatory bodies-academics-equipment producers-clinical organizations- patient advocates that it is OK to agree on how to measure AD.... It is critical that someone declare an AD-CNS disease emergency (like A/C pilots do). Then, take action.
This is a key and critical observation. After many years there is still confusion or lack of agreement on the most basic AD diagnosis stat. If a function of conferences, academia and joined regulatory bodies meetings is to get some standards of basic trial criteria then this sure strikes as a good place to start. Define how AD is measured, no REALLY.
For example by comparison: In the 60's the struggling micro electronic industry players were tearing eachother's faces off over performance metrics/cost. We almost had no electronics industry then. It was the same old story, the big guys with all the money drove the bus. Then a very smart guy (Moore @Fairchild) established a correlation between semiconductor device feature size and possible device component speed/complexity and overall cost/performance. It became known as Moore's law, which allowed complexity escalations, etc. . Most important, it allowed the learning process to work.https://www.britannica.com/technology/Moores-law.
This simple physics relationship has held for decades. Turns out this simple, easy to apply metric united the entire semiconductor and related electronics industry WW around competition that was based on features and performance that mattered. This simple law brought focus to cost/performance/science/product technology/ mfg. equipment technology/manufacturing requirements ultimately determined what worked ..the list goes on. Could this happen in CNS diseases?
Not having such basic AD-CNS understanding is IMO a direct failure of BP industry and agencies like the FDA. Well, we all get the idea I guess. Instead of having decades of secret trial protocols and secret special sauces.(most of which failed) Essentially, we have not really been able to learn from each other (trials) b/c the basics have not been established. Consequently the learning default thinking by massive trials method has been adapted, which obviously has failed as a learning method/process. Eventually, Precision medicine will reveal the truth to all by developing a Moores Law -CNS disease equivalent. IMO.
Maybe someone will take the BIIB paper by this person and do something smart like lead and collaborative. Huh, maybe BIIB is actually leading here. We'll see. Till now AVXL has been alone on this path, IMO.
A softer, gentler BIIB? Blink, Blink??
https://finance.yahoo.com/news/biogen-present-data-alzheimer-disease-113000596.html
Very Interesting subtle shift in intensity. Nice. Even a mention of the CTAD learning opportunity.
Curious. What if rock solid verifiable evidence showed all (n) A2-73 responders now present no (ZERO) evidence of AD symptoms after almost 3 years
Kentucky-Plex-Investor-good feedback. No debate w/any comments. The numbers only MMSE W/DL scores data could be enhanced w/a few examples IMO. Not hyper stuff but w/examples people can relate to for those living w/AD today. Let's face it AD really steals a lot, particularly it steals time.
Yes, AVXL are a small company in a big ocean of whales. One could easily say, "what's the point?". For me, the (conventional-trust me) system has failed. If one has a family member w/CNS disease diagnosis(like me) one quickly recognizes the scope/depth of the failure-medical-clinical-academia-regulatory and so on. The guys w/the biggest PR budget are in control of what people think and they know it. When I study AVXL I at least see a small entity showing results that no one else has even come close to duplicating. I recognize a flash of a possible breakthrough. At the same time I see numerous examples of the elite all raving about Amyloid Thesis wonders or variations of same. Why??
A big conference where AVXL A2-73 news gets lost in the noise is just more of the same path . I want to see something that gives off a very bright light and generates a lot of heat, not same ole stuff-style. Appreciate the valued positions you each take.
Investor2014: Excellent summary and assessment of the recent AVXL actions and plans. HH is certainly an impressive guy who has devoted many years to doing his work in a certain manner. He impresses as a guy who has firm convictions and that not only is Precision Medicine the correct path but the methods of the past were not effective. He would not put his reputation on the line if he disagreed and to his credit Dr.M. is allowing HH to perform as pilot in command.
The Biomarker process which has been applied by AVXL and the relted retrospective evaluations are IMO classic solid engineering & science. The fact that AVXL has CTAD last speaker in late breaking is also notable. Of course this could all be only the beginning of a very long process but I do not think that is the case. The fact that there have been no contradictions that we are aware of is critical to any kind of breakthrough thinking. (one reason I never bought into the Amyloid Thesis is all the exceptions and outright contradictions) AVXL has put the pieces together allowing a plausible and validated story.
Summary: A2-73 early results indicate the AD treatment is/will be safe and effective. The process is reproducible within a range of known controlled variables. Smart, honest people have self corrected and will present their data. Additionally, I am expecting RWE/RWD to be shown which will blow the room away. BTW, it would be nice to see BIIB join up, am not counting on that. But, if they do then this phase of the investigation is done, the next phase will present a massive success.