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BIIB biggest weakness is MS. M. is smart he will figure out how to plan and execute an effective mission.
Biostockclub...thanks. I believe you got it right. this is not a drill.
https://www.cnbc.com/2018/07/06/biogen-alzheimer-drug-success-and-the-long-tail-of-dementia-drug-fails.html.
If AVXL had a PR like this I would not be pleased or optimistic. I guess this could be taken as evidence of where the bar is set. If the FDA approves w/this kind of proof for anything other then RTT then I am glad we are using Aussie Govt.
I expect our report to say we have assessed the markers for patients who responded well and have a lock on their Biome. We have assessed the remainder of our trial population and established that XX% of them have the same markers as the early responders. We then undertook a continued A2-73 naïve treatment to the remainder of the trial population and measured positive responses in all. At the request of participants and caregivers.
All treated patients show stable to improving cognitive testing results. Please watch this video of our trial participants choir as they sing, "Oh Happy Days". Our next trials begin soon in Aus and NA.
The End.
My own assessment of BIIB continuing w/this trial after similar failures/withdrawals by other BP is they have a higher threshold of pain for law suites and patients condition. Clearly the FDA was telling BP, hey, you are on your own, we do not have your back any more on the AD Amyloid/Plaque pursuit. Maybe more but that was my read/assessment.
Recall everyone was amazed when BIIB said they would keep going after they completed a statistical rationalization and refined success. BIIB seems to have a different set of corporate values than most. IMO, FDA has positioned itself between the BP trials and lawsuits for years, if it is an FDA sanctioned trial...do not try legal action. When they yanked that the majority hit the silk.
Biostockclub...AKA, 'Easy Rambler'.
When we see people at your level posting here, we know we are in the right place. thanks for your thoughts.
As Falconer has pointed out when Fleming made his famous petri dish observation and then acted on it no one knew he just started what would come to be known as anti biotics, a new field of medicine was born. Huh, it took many years for SCIENCE to value/understand what this meant. Millions have benefited from that work since. No one knew what to call it at the start. That is where we are now w/CNS medical practice.
As an analogy, Dr.M. has noted and stated that Anavex is a mini-micro effort for development of a CNS Homeostasis-restore-regen capability.(Clinical people do not know what to call it yet) Most BP look at eachother and say (Yah sure Kid, take a hike). But M. insists, NO REALLY and I am going to use AD, PD and RS trials to validate the process/concept. He emphasizes that he is not in the AD business he is in the CNS restore/regen business. IMO, it is going to take a while for BP-science to get it, just like it took time to get antibiotics.
He says..."This, is a football"...like in the movie.
falconer...kinda scary ain't it.
As an evolving culture we seem to be emerging from the FDA trial and error methods (and if that doesn't work, try a bigger sample). My guess is that Fleming started out w/one petri dish. He was bright enough to note that what he saw should not be happening, but it did. As I understand it that is about what Dr.M. said/thought when he noted the Homeostasis hypothesis w/restore and regen as an explanation for the 32 patient safety trial. "That" is not supposed to happen.
As you have continuously pointed out here, shat happens.
Best regards...yours in science...Nidan
Reyeton...thanks for this link. Wow, the FDA has suffered from more than just bad luck and incompetence. Who Knew? Very scary-eye opening stuff.
Tradeher and Flconer:
Good effort...we'll see won't we.
Jimbo, thanks for the comment...
Biostock, thanks for your generous comments, coming from you makes them particularly valuable.
You suggest they did this as a reaction to our recent trials announcement. Hope so, but did not know they could move so fast. If you are right on the point it means they were sitting on this announcement when they got triggered by AVXL plans. Huh, if true they are even bigger weasels than I thought before. I defer to your judgement on this as I know not much about them, except their record stealing from little guys stands out.
No risk of fogging over here. I have been shot at myself and believe in the motto..."No better friend, no worse enemy". Something needs to be set straight here.
Mutual respect, all the best.
Curiouser and curiouser as we review todays events and Biotech SP actions. HUH?? Anyone who has spent even a few days seriously reviewing the status/results of the FDA AD trials over the past 10+ years would have to wonder. Let's just assume a close relative of yours was just diagnosed w/AD and you REALLY CARED about helping.
If you have studied and concluded that there is no evidence of a causal relation between Amyloid and AD and the Billions spent in trials and many patients deaths clearly show this. And, you witnessed, studied how FDA and virtually ALL BP have recently walked away from the plaque thing, dropping it like a hot potato, almost like they read the book that says..."FIRST DO NO HARM". What would think about the BIIB sp action and AVXL sp?
You have to conclude....this is ALL ABOUT MONEY. All the talk about "precision Medicine" and proof and WW searches is all crap. IT'S ALL ABOUT MONEY.
I hope Dr. M. just blows the doors off these AXXHOLES and that we all take some time to feel a little better about the AVXL science and then move on to better lives. The best news here is that against a stacked deck, the AD patients will not get better unless and until they get the real thing, and we can put that in the bank. Anyone in BIIB that let them publish what they did and is now celebrating knows what they did. I want to see AVXL kick some ass.
You ask...is BIIB news good or bad for AVXL?
From a financial standpoint it looks like if you have a lot of $$$ to do trials that do not move the bar at all if you pass then you win as BIIB. It is not clear at all if AD patients are any better off than they are now. More than anything (IMO) the SP jump shows that money really matters in Biotech. Now, the trick is to convert money $$$$ (lots of it) into an effective treatment for AD. So far, it looks like money is not a cure for AD and the bar has not been moved.(Injected, brain swelling, only slows progression...etc.)
Not sure about the timing of the release just before AAIC. Is this a timing thing or just a coincidence?
Net/net IMO this BIIB is good news for Dr.M. and anyone holding AVXL as it begins to present a case for just how much an effective treatment is worth.
Sad isn't it....[quoteSo if I read BIogen's release accurately: Their 18 month Phase 2 results aren't as good as AVXL's Phase 2 results, yet Biogen is up $6 billion on the news in the aftermarket, meanwhile AVXL is languishing (for a short while anyway) at $150 million.
][/quote]
You would think some senior, responsible person somewhere in BIIB or FDA would have intervened here prior to this PR.(we almost got to the top of Everest but....).
In a way this story should be used as some kind of ref. for people who want to look back 10 years from now. As an example of what used to pass for science. If anything, this is good news for AVXL and the story we have to tell. This helps to make the point of just how much better the A2-73 story is. BIIB says, "yes, it's true, I would not give this to my mother but if we run a big enough sample we can say with certainty that it does not work."
benny...agree w/waste message ...But is positivity a word?
I predict there will be an endless string of new patents as the science evolves over the next decade. In fact my guess is that some are now in draft as we speak.Get Real... CAN WE PLEASE NOT HAVE THAT DISCUIION AGAIN HERE>>>TAKE IT AWAY.
(a riddle) If the majority exhibit cognitive stability and the responders were naïve then how many of tot population have responders genetics/biom/same?
Note: This question will be in the exam.
"The pen and the sword, in accord". Musashi.
Investor, in the US there is an old street expression that comes to mind after reading some of your posts. "If you think I did not cut you, try to move your head".
Penny...thanks for this great link.
Excuse the expression but this message is something in martial arts that is known as ,"a groin kick". Very effective.
all the best
WOW, powerful and exactly correct. Thanks.
Be ready for changes because they are on the way.
Of course this board has been through many ups and downs over past few years.....BUT. If A2-73 AD is the first to get RWE/data/results from new trials IMO a massive flashover will impact other trials/indications bias to succeed. Everything w/A2-73 written on it will become golden.
At first I was convinced the RETT choice was a good one for 1st b/c of quick read/turnaround. Then we would see a bias to other tougher trials w/a kind of snowballing based on precision science and Biomarker-Homeostasis readout.
Now, he will speak to findings at AAIC AND will have an AD trial ready to start. From a (BUY THE RUMOR) standpoint the AD (AAIC) RETT-PD sequence makes more sense. He will be able to describe why and what the biomarker prescreening is all about and show some cards from Australian 32 pt. trial. He may be able to review a recovered AD patient or two.
He can and probably will make the case that this is still a risk but not a crap shoot like the old days.(see BP Amyloid backlash) AD will by far be perceived as the bigger disease and will draw more attention to the AVXL name and precision medicine processes.
Additionally, my guess is he will be doing a "late breaking" at AAIC and will have every opportunity to show the flag. If he makes the case for biomarker prescreen effectivity all BP will be like a bunch of 4 year old with their little faces pressed up against the window at the local cookie bakery. If I were Dr.M. I would hire someone to start my car for a few months.
Irish...
Biostock...thanks, great post/thoughts are always insightful. Bear, great to see your posts again.