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Talon wrote....wow just think...
Bisotockclub...brilliant summary of our current situation ...thanks.
On the field of battle, our opponent has blinked and that has been recognized by this post and others. A Japanese expression hanging in my office.."The war of the future will be won on the battlefield of quality".
[quoteBottom line: Total desperation in the industry. They are creating a huge media smoke screen to hide our drug and relegate its significance to obscurity.
Many years ago, John F. Kennedy ran for US Senate seat in MA. He was not widely known at that time and his Democrat opponent did something very clever, politically speaking. They ran a candidate who had changed his name legally to John E. Kennedy. As you might guess, his name was listed alphabetically before JFK’s and many voters were unaware of the middle initial and simply pulled the lever for the first candidate on the ballot with the name which they associated with the brilliant campaign Kennedy had run.
It was a very slick (not illegal) move: try to confuse people with similar sounding names and overwhelm them with choices. The article mentions genetic predisposition which sounds much like our genetic biomarkers. Most are too lazy or uninformed to know what’s what and it could mean the difference in the outcome of an election or media buzz surrounding hopeful drug candidates.
This is clearly what’s being done in the interest of trying to protect the BP grasp (and possibly with FDA blessing) on an industry which has failed miserably and is now on the verge of being outdone by an unknown biotech company having early success with genetically enriched precision trials and the backing of the Australian regulatory body.
Sorry for the lengthy post. I wanted to underscore the desperation and high stakes and propaganda tactics I see being employed.
As for each and every drug mentioned in the article, they are all “losers” as Trump would say. They had their chance; they are dead and they aren’t coming back. If they had any promise something would have turned up in the past 30 years, not on the eve of a Conference which contains an actual breakthrough...now they have all seemed to rise from the dead. That just doesn’t happen in real life.
Thanks. Best of luck to us all. They are quaking...for real.
Stay sharp.
Bio][/quote]
Biostockclub...as always the best. from BIIB/Alpha PR.
sokol...excellent observation, IMO.
tredenwater says:
By my count this is BIIB PR#3, just today...as was predicted here (credit someone), the binary event PR cloud is on schedule.
https://finance.yahoo.com/news/biogen-host-investor-webcast-discuss-123932456.html
https://finance.yahoo.com/news/wired-news-biogen-present-data-110000323.html
Thanks Biochecker4...this is what I am looking for and also, when will "late breaking" speakers-abstracts be available? Cannot seem to find that.
Biostockclub. Thanks for posting this. BIIB previous PR has been followed by numerous second guessing articles which expressed legitimate concerns. The original PR also stated in the body of the text that they had not yet fully evaluated the data. HUH?
I was reminded of the old S/W cartoon where the boss is telling staff as he runs out of the room to, "Get started writing the code while I go figure out what they want."
This would actually be humorous if it were not so serious. Here we are a week before the next big conference, possibly a very important technical conference, and no one has a clue what the results will be. We run the complete range from "Binary event", but b/c it's a massive-huge secret we cannot even give a clue or we would have to kill every one of you, to NADA.
FDA and others (IMO) have managed the scientific/process of discovery process so poorly that most of us who care have no confidence what is about to happen. I personally feel that (unless we have been mislead) AVXL will show evidence that an effective pharma treatment is at hand and we can say that with very high confidence level, in fact approaching certainty.
Over time I have myself done and also witnessed where technical people get so close/tangled in their activity/science they literally cannot see/hear any alternative thoughts. It is tough one b/c good people honestly think they have the secret sauce but they really do not. That, IMO, the biggest risk that AVXL investors have right now. Did the team overlook/miss/dismiss anything? I would note that this is not the same as being intentionally mislead. We will soon know I guess. That is what trials are for. All M. has to do is verify that the science is real and it works, this is not the same as the old trial shotgun days which included more discovery or TBD.
Sokol, thanks. We are seeing things the same. I do expect AVXL will have a lot to show but cannot say what SP that will/might result in. We are in the vapor along w/many others at this point. After so many years/trials/ false promises and PRs like BIIB just did investors are snake bitten. They will believe it when they see it.
We shall see this cycle soon enough. Having studied carefully and considered all the informed people/posts here I am not sure what I could have done to reduce risks. Except for the recent PR from BIIB (which I consider to be a false positive) things have been quiet.
There are not a lot of believers out there.
Anyone w/knowledge of?
What is deadline for PR on AAIC "late Breaking". I am thinking it is .."Day of"..True...Y/N
Show logistics at a parade like this one is promising to be can be tricky. Presenters are on the road w/limited resources and time. Schedules can be compressed by unplanned events/things that happen. Therefore, having things planned/synched up to go time is roughly now. Cannot tell if this is a bells and whistles major turnout or not. Hope to see that w/lots of PR's.
In any case, time is up for preshow events-news...today and Friday are it b/c once things start it is late to be in control. Cannot tell if this is normal build up to AAIC or slower than normal. According to my theory ether today or Tomorrow is time to lite them off.
TTT-https://act-ad.org/app/uploads/2018/06/ACT-AD-Comments-on-FDA-2013-D-0077-05172018.pdf
[quoteFor Stage 1, ACT-AD supports the use of biomarkers to measure pathophysiological changes as a primary efficacy measure and its use as a basis for accelerated approval. The draft guidance finds “at present no sufficiently reliable evidence that any observed treatment effect on such biomarker measures would be reasonably likely to predict clinical benefit (the standard for accelerated approval).” We support FDA’s fervent plea for continued research on biomarkers as a basis for successful clinical development. The lack of data to fully evaluate the predictive ability of biomarkers is discouraging for the entire Alzheimer’s disease research field. We hope the National Institutes of Health and other public health organizations continue to prioritize the development of biomarkers for Alzheimer’s disease after reading this draft guidance. Additionally, the call for a persistent treatment effect on disease course is valid, and we understand the candid appraisal of existing biomarkers as currently insufficient for predicting clinical benefit.
][/quote]
This looks a lot like the AVXL AAIC 2018 poster topic.
tradeher...[quoteso the FDA would have to explain to The Donald why everyone else had the most needed drug in the World and the USA did not. ][/quote]
I thought the same thing. Then, within a matter of weeks, BP dropped their respective AD-Amyloid hypothesis trials like hot potatoes. And, we noted, they never got any press/ink/news..NADA. Except for BIB they all got the memo and walked, IMO b/C they knew it was a loser and that the FDA was backing off. No one ever said a peep, no seeking A-B-C, no apologies for putting you through this hell, etc. Just POOF , gone. They all walked and now BIIB is still in denial. We'll see what happens next. They just brilliantly ripped off the market to an awful lot of $$$. Whoever pulled that one off should be asked what's next?
If A2-73 scores well next week the people who bailed out on Plaque trials will all be hero's but they will not be able to talk about it.
Hi Talon...thx again for your read of the BIIB latest.
As I see this in a showdown kind of AAIC line up, tactically BIIB just blinked. A little bit of change the subject, smoke, deflection and frankly axx covering. The most recent BIG PR when they talked about great news trail stuff they ended up w/a massive amount of money buying in. How would you feel if you bought that story and shares then this pile of stuff shows up?
Yes, they have lots of $$ and a big PR budget as we can see but they are thin on science. IMO, they know they are thin on science and are doing the old spinning plates, trained seals, dancing bears multi ring approach. The media needs to print/copy something so they will follow BIIB instead of the German guy w/the funny hair. Works every time.
I am staying w/the science guy but dancing bears are always neat to see.
Kevli33...yes.
A famous guy(Dr. Peter Senge) has commented something like this...there are 3 levels of knowledge..
1. Things we know.
2. Things we know we do not know.
3. Things we do not know, we do not know.
Best served w/a slice of humble pie.
from above link.
https://finance.yahoo.com/news/data-presented-biogens-alzheimers-disease-113101527.html
New PR from BIIB
Anyone care to comment on this (kitchen sink) PR. Note the placement of latest BANXXX.
This might be seen as a type of cover effort b/c of credibility loss lately as shown by even SA.
Interesting strategic move but ...REALLY?
walker, Good question, I just want him to be clear and decisive to the extent the science allows. I do expect him to comment on the nature of the precision medicine learning process and each iterative scientific development. After all, we do expect he will be showing AD+ results that have never been shared or proven, any one of which is worthy of note by the room. Hope he shares not only what happened but why it happened.
The BP in the room will be anxious to see what he has. We have all been through a lot even just on this board over the past 3 years+, I can imagine what M's staff feels. After this they will all hit the famous wall of exhaustion. I think we need deals to be done and announced (soon) so that moving on is the responsible and proper thing to do. IMO, if he really does present what we hope then the rest of the world may just step forward and insist large scale action be taken. Even massively good news could get tricky. He is smart enough to expect just about any possible outcome.
Above all he must connect the dots in a convincing way so that we are all able to move on.
Biostockclub...Brilliant work. I said then and repeat, the executive management at BIIB that allowed that last PR is about money,only. Stuffing the dead Amyloid hypothesis down someone's throat would be appropriate at this point and we are likely to see it happen.
There is a big baseball rivalry in the NE U.S.. Fans of these two teams not only want to see their team win but they also want to see the other guys lose. That is the kind of victory we want.
IMO, if it were not for the precision medicine initiative, we would never witness what we are about to see. We are saying that the amyloid hypothesis will be disproven. Most of the BP has already resigned themselves to that. But, either their signature(MF) will be on the paper or...
it's complicated, but you get the idea.
XENA
The SP response was noted here at length by some of us. We saw immediately that the PR had low technical merit and that the SP bounce was not based on sustainable results. Nothing has happened to change any of that. Points to the scale of challenges faced by AVXL. There's an old expression that does come to mind on the original BIIB PR, "You can't shine SHAT".
biostockclub...Thanks for once again adding significant value here.
https://seekingalpha.com/article/4187666
The article linked by you and here points out how vulnerable stockholders/buyers are/were. Some of use here had an immediate GAG reflex when we read the original PR piece seeing that the hype was not technically justified then or now.
All the best. BTW, I am w/David on this match.
FROM PR 070318
http://www.neurotropebioscience.com/
Noted similarities homepage design for NTRP and AVXL. Looks like a good potential BIIB score also? Just saying, RETT, Fragile X?. Some of this stuff you can cut w/a knife, IMO.
Stay alert out there.
Read on, they are not exactly the same although I understand your point.
https://seekingalpha.com/instablog/6460311-unemon1/4985776-behind-neurotrope-clear-overwhelming-links-fraudsters
Would BIIB and NTRP have an understanding?
OK...thx...need/want to see some positive outcome here ASAP.