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SSSSSSCCCCCCCOOOOOOOOOOOOOREE!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
A good question would be..."Will caregivers and family of patients wait for regulatory controllers while RWE indicates an effective treatment is available?"
Times UP...the answer is...DON"T THINK SO. "dramatic" improvement is in the eye of the beholder. Parents, close family, friends will be all over this. New hand held media will need to be closely managed, IMO.
BR
www.anavex.com/wp-content/uploads/2018/05/Anavex-Presentation-May-2018-1.pdf
See slide on page 13 for reference on Precision Medicine process. New tools and new processes will simplify and speed trial conclusions. RWE will provide patient and process findings as WIP, deal with it. The process will emphasize science and prediction of certain results based on biomarkers/DNA and new information from patients already treated. The past trials process is gone, it's over, done. New trials will not be done that way ever again. Prognosticators will need to rethink how they judge process results. IT"S OVER. BYE. Thank god.
OOOOPS, thanks missed that.
IMO, Amsterdam is an excellent choice. Easy access w/strong culture strong record in compliance to Medical device-Pharma requirements. Some of the best military pilots. Great choice.
P-Bear...thanks for an excellent, fact filled post. BR
Well, we'll see I guess. Looking/hoping for good news after much wait.
I am keeping the faith so far.
[quoteWould be most welcome if he is right this time][/quote]
If his presentation includes a focus on Precision Medicine as suggested by the title,including strong Biomarker data, then the old BOOM-BUST reaction might be off the table.
We can all recognize the difference between smoke and live rounds. I am thinking he has not come all this way to just blow smoke. That would REALLY piss everyone off and he knows it.
Any thoughts on the significance of + trades over last couple of days?
Understood.
Talon.
A retrospective validation of A2-73 efficacy using RWE protocol for the Aus. safety trials would be an interesting and useful activity. AVXL would likely be able to convert what has been called, "anecdotes", into useful regulatory process information/records.
Great news...may also be read as "How to do RWE"
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM610442.pdf
Thx georgesk...great DD.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610509.htm?utm_campaign=06122018_Statement_FDA%20Commissioner%20statement%20on%20incorporating%20the%20patient%20voice&utm_medium=email&utm_source=Eloqua
Doc, would you please do an analysis of this AAIC poster title and tell us what your findings are?
Very much appreciate your insights. BR.
AAIC 2018, July 25th - 2 Developing Topic Posters:
"Full Genomic Analysis of ANAVEX®2-73 Phase 2a Alzheimer’s Disease Study Identifies Biomarkers Enabling Targeted Therapy and a Precision Medicine Approach"
https://www.wsj.com/articles/eli-lilly-astrazeneca-drop-two-late-stage-alzheimers-drug-trials-1528797681
Let's see, is it GAME OVER ...or GAME ON ? Will BP start to look longingly at AVXL and the portfolio of CNS treatment options? The dynamics of the situation are changing under our feet.
Anyone who has ever flown in an aircraft at 40,000 feet over SE Asia and looked UPPPP to see the tops of thermals rising to 60+ thousand and knows there is no way to get around the turbulence knows what is going to happen. We are in for a very dynamic period, no going back now folks. Hang on.
These guys will not just leave the field w/their tails between their legs. Stand by.
One second thought, I guess that is why we now have Dr.G and his new team.
Another amyloid trial blown up.
Will there ever be any kind of self assessment process look at where over the last 20+ years they could have seen this coming, like maybe after the first 5 trials did nothing.
Looking like this will be a good week, IMO.
Even though the usual suspects have not shown up yet this week there is some evidence the Fudsters are out of ammo. Keep calm, return fire.
I am working on a new APP.. I call it FUDAWAY. It is better than just "IGNORE". Some features include; automatic screening for 5 year old level thinking by poster, recurring theme sensor b/c I don't get paid to be smart, automatic "C'MON MORON " reply w/o typing and using precision Ihub posts. More to follow.
Suggestions for new features??
TAU , HUH....hope there is some science that shows causal relation.
Jon...very well done. You have linked facts w/the point made earlier by Investor 2014. He emphasized the importance as your article states.
Nicely done and an important link to keep in mind. Dr.M. is a bright guy, he chose the Poster title wording very carefully. It fits exactly w/the science as pointed out so well here and it ties word for word with what Anavex has been saying for a long time. Word for word. Nice indeed.
This is not a fantasy, it is really going to happen. Precision Medicine will require scientific facts, hopefully well understood. We all understand that it is the god given right of every scientist to start from scratch and to argue w/divergent theories. BUT, the AD Amyloid BP/WS crowd deliberately ignored powerful contradictory facts about Amyloid Tau for years while patients suffered and died. That, IMO cannot be considered good science, well practiced.
It will be interesting to see how many Posters @AAIC 2018 will include Amyloid in the title.
Exactly, CNS diseases have left deep scars in many families and our great scientific studies have only nibbled around the edges. Do not want to go down the rat hole on why at this point.
Getting older is no fun, IMO. That moment when you realize hey, what just happened is bad enough. Then, to have to face years of diminishing body functional capability on even the most basic stuff really sucks.
I am not qualified to fully understand what "restoration and regeneration" translates to in terms of projecting adult capabilities but ..."Bring it on ", it has to be better than the alternative. And, how about these dear little kids w/RS and all the rest of CNS indications. The stakes could not be higher. If not now then certainly soon.
BTW, it will be interesting to watch how WS parasites react when they see the scenario that is shaping up. All the corrupt games will have to be adapted to the new rules of Precision Medicine for Bio products development. They are a clever bunch so they will do something but now they better understand sp are based on science. The trials will not be on IF it Works BUT only on HOW WELL and what is that worth?
https://ep70.eventpilot.us/web/planner.php?id=AAIC18LITE#view1
If anyone is able to get and deliver here all the related information it would be great addition.
The second topic is also important as it the regeneration/restoration message is almost miraculous by inference.