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IMO, this guy is a signal to many others to , suit up and "Report to your Ready Room". We'll see others so, it will not be pretty before this is over. We may even begin to see the new-replacements make a little noise, but most likely not. 100 years is a long time, lots of DB's laying around.
Just a thought on dealing w/the unintended consequences of any BIO-MED change (good and not good) in a system. In this case a very complex system (CNS w/many unknown-unknowns). We must at least be aware of any Woops possibilities. What if we solve one problem but accidently create others, then what?...it goes on of course. Might such an unintended consequence (NOT AE) string of event(s) be a planning/news timing factor? S1R gets around. Just a thought I am certain many might be dealing with.
scroman1. Agree there have been differences in WW regulatory bodies and FDA interpretations and requirements since before the ISO standards were agreed and established. Have been directly involved in resolutions/trials/investigations/consent decrees , etc . myself.
If I am understanding your concerns on abilities to address and resolve these product/clinical issues can you provide any current/ real world example where significant differences have not been resolved. It will take time and it is/can be complicated but it is all doable. TIA
too simple
plexrec
plexrec
georgejji
scorman1
Owning AVXL stock reminds me of that famous line from the movie, "Forrest Gump". Owning AVXL stock is like owning, "A BOX Of CHOCOLATES".
McM
Rubeyred77
IMO, any joint exercise/business-science merge between AVXL and BIIB would result in an internal cultural civil war followed by mutually induced self destruction.
https://www.yahoo.com/news/multiple-sclerosis-discovery-could-end-170412612.html
Similar thinking to AVXL (Upstream MOA thesis in CNS ). Look for more AHA-A-A moments going forward as THE MEDICAL -bio-pharm BEGIN TO BETTER understand the TERM (SYSTEMS) and to apply the implications . There are multiple examples of this (CNS) SYSTEMS THINKING CONCEPT. For example, are human nerve fibers actually also conductive elements for bacterial infections as shown by work studies on why HUMIRA pts almost never get AD?
falconer66a
WGT...
Gator328
abew4me
Study shows some FDA approved drugs actually failed their trial goals, including AD -BIIB drug...
https://www.yahoo.com/news/1-10-drugs-dont-achieve-215421263.html
Joseph_K...
Does the fact that AVXL gets new patent Applications and grants a lot more than others our size (seems like more that other (micro-BIO's)) mean AVXL have a different over the S1R horizon management headset or is our MOA -upstream headset seeing a massive target rich environment that others do not want to see??
IMO, it is a GOOD THING.
Hoskuld
georgejji---thx for this
georgejji: IMO, this is a breakthrough path of reasoning for AD-PDD (other CNS diseases). All the pieces fit, IMO. (I make no claims to understand the AD Bio) the SYSTEMS parts are critical as they lead to the right discussion on "Knowing more about what we do not know, we do not know". IT'S ALL ABOUT THE SYSTEM.
https://www.scientificamerican.com/article/for-alzheimers-sufferers-brain-inflammation-ignites-a-neuron-killing-forest-fire/
Bourban
Can anybody explain what is going on w/the SP today ? Why down? What is being said/done to cause what we are seeing? AGAIN...???We should at least be stable-flat...IMO.
sumbuysumsell[quote]Food for thought. There's power in staying quiet.
[/quote]
YUP, (for example) The FDA has been completely wrong on the whole Amyloid Plaque thing for at least 100 years now???HUH...wonder why??? SILENCE WORKS...(along w/BP and who knows about the herd??). IMO, Massive $$$$ is part of the answer.
Anyone see/understand how multiple regulatory body approvals works/benefits/slows/accelerates the open market sales picture for A2-73 (for example?). Since it seems clear that FDA would have to be suicidal (due to multiple time internally established tangles and conflicts) to lead the parade for AVXL CNS treatment approvals. Then, which national-body or reginal interests stands to benefit the most by approval use-scripting-sales for their populations of clinical users?
A. Who will be first? When? Why ?
B. How does FDA unscrew itself from Amyloid thesis CNS disease past w/a straight face and move on? (CAN THEY) (THEN WHAT?)
What other top management regulatory issues are in the way of moving FWD right now???
What will be AVXL-Dr.M. and staff's next move to drive the above issues??
OK, let's not let some rough water screw up all the good-great work done by the AVXL operations/Mgmt. team. Very rough SP day today after a strong effort to get here , We have been through worse than this.
CARRY ON.
We credit Dr.M. that this is not just a conventional card game of wits. AD is about people (family members) getting treatment or not for a disease that will kill them. The sooner a few liars-criminals-get executed to demonstrate seriousness ,, the better.
Thank you powerwalker...thank you...WGT...
So Powerwalker, then looks like that old expression ..."You are NOT CRAZY, they REALLY ARE AFTER YOU...!!!....comes to mind.
Twice Worthy