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Biostockclub, as you point out, the AAIC 2018 process was a kind of humbling learning experience. Those of us who were certain the AAIC staff would intervene and take a bullet on the BIIB show were wrong. I hope we now see that no one is going to call the establishment system out. It is broken, unable to fulfill even the most basic legitimate science forum goals. Many wait and expect to experience the best, state of the art credible science on a disease that takes no prisoners. AAIC's judgement was questioned and they folded like a wet noodle.
I have learned I think that the Dr.Fleming antibiotic cycle will repeat itself unless there is a science process AD+ intervention. AVXL has much stronger AD science than any other PII/III biotec. What we heard was a muffled attaway-so what. We need some way of getting our story out and some way of becoming credible quickly at the highest level. That will take money, connections, political strength and a machine to make it move when we need it to. Non of this is consistent with the current AVXL culture.
Multiple simultaneous trials will help a lot but that involves basically following the same ole established path. We do not own that process path and we are not configured to pull it off quickly. I am as big an AVXL fan/supporter as any and will not change but I also see a flaw. We owe it to ourselves to call it like it is. We cannot rely on the rest of the world to value the AVXL science until they see it work which is going to take a long time. We do not have a long time. We need an intervention like a partnership, FDA open technical recognition, political boost, maybe even recognition by another country as an expedited trial. If only Fleming were here we could ask him about a do-over process.
Genee, you misunderstood. I was not happy with the content of AAIC response. I was happy they sent a nicely written professional answer. Sad to say it was content free" That was my concern and still is.
My response:
falconer
Steady T..
Bear..
If BIIB researched and found A2-73 to be a far more effective treatment than their current (majority of BIIB WW revenue/profit) ...then what? Do they offer an alternative MS treatment? Phase in the new treatment-keep the old one?
Liars get themselves in trouble under such conditions. BIIB have shown they are liars (why not assume this is part of their culture). They cannot suddenly start telling the truth.
sokol-an honest person-thx-
OK, that Discala. I get the need money thing but looking for movement. The science looks valid. Staying in but would sure like to see signs of life.
Talon, I sure hope you are right. IMO, if two firms w/conflicting interests want work something out then, they will. If they are fundamentally at odds (culturally and scientifically) then it is a standoff. In this case there does not look to be a lot of middle ground, if A2-73 restores cognition then that is all she wrote. No one wants or needs the BAN story/brain swelling/dubious math.
The science seems exclusive, but that's just me. not sure how much real investment/commitment they have in BAN.
Xena, you and Biostock are onto something. There has to be a lot going on to force Dr.M. to take the trials offshore. Sure, price and support matter a lot to small company but I still believe there must be more. The days of the FDA insisting that everyone must meet their requirements in order to do business in the US are about to change.
Obviously we may never know all the details but I feel good owning stock in a company that is self assured to the point where they break the mold and make things happen. As you suggested, the FDA will have some splainen to do if the Aussie trial gets feet while NA is stuck or if Spain gets PDD done while we cannot even get simple RS started. I do wish the whole thing would move at some faster pace that made sense, if that means doing it all in other countries OK w/me.
This recent AAIC cycle w/PR buzz storm around a technology that a child could see was flawed really got my attention. I asked AAIC what kind of controls they have and they said basically, not much. Guess what? AAIC needs to review it's process controls. The BIIB money obviously greased a lot of gears. Now, every CNS micro biotech is going to take a hit. Do not want to lay in the gutter for another cycle.
True Dat...
I am beyond wishful thinking. I am basically a process guy trying to figure out what step is next and what sequence makes to most sense. There at least 2 big issues for me in working the problem solving process. 1. No one in charge. 2. The problem statement is not defined (there are many different ones). I will then assume the FDA is in charge and the problem statement is :There is no effective treatment for numerous CNS diseases including but NLT(AD,PD,MS,PD,RS and others).
The FDA has demonstrated no skills in identifying and initiating scientific investigations of CNS diseases (lots of evidence of this).The FDA would explain that is not their job.
Since the FDA has not been leading the CNS disease treatment process has defaulted to the private sector which is motivated by cost/benefit and sp appreciation.(sooner the better) This results in mixed episodes like the one (AAIC 2018)we just went through where SP is driven sky high and then crashes. No CNS patient benefits by sp drives directly, in fact they are hurt b/c new possible treatments do not get attempted due to perceived market environment risks. The FDA does have lots of rules/processes and controls but they do not ensure solutions, only costs.
The CNS solution process runs on money, which may/may not be tied to good science or effective treatments. The motivation loop between patient need and science effective treatment cannot be closed w/o money in this model. If AVXL solutions are going to be understood and effectively applied it will only be because we add money. Some kind of partnership is the best/quickest money path. This path also leads to better visibility which then reinforces the money link. This process tends to be self reinforcing where money/begets more money when the science is proven to be effective. More money-to-more initiatives-more trials-more knowledge-more trials-and so forth.
In this process, the only path to effective CNS disease problem solving involves money. The more money, the more processes, etc. Sadly, control of the solutions and control of the money appear to currently have contradictory leadership visions. Partnering ASAP is the best solution.
What are likely AVXL-BIIB prenuptial agreement conditions? AD-PD-MS-RETT-insomnia-anxiety-Depression-Pain...other?
Will this be long/short a ceremony, maybe shotgun? Massive for many people.
https://seekingalpha.com/news/3374298-biogen-slump-pressures-biotechs
According to this we are not being sucked into BIIB turbulence as badly as some other so far today.
Thanks to both you and Xena...my thought was someone in a position of authority knew and they acted b/c of money. It might have been to keep their jobs or b/c they felt protected.
I defer to your respective understanding of how the system works. The consequence to the rest of us is of course it just puts a lot more pressure on the FDA to knuckle down as an unintended consequence, which is the LAST THING WE WANT.
allthat, agree w/you it is baffling. Unless, you plan to rip off as much $$$ as you can and that is your only motivation. The biotec smoke will provide some cover for many. The people at BIIB top are the ones who need to be investigated to set examples. Patients/families hopes got raised, investors got hooked in and now they are paying. Very troubling.
https://finance.yahoo.com/news/biogen-sinks-alzheimers-data-leaves-124148203.html
BIIB doubts will linger for a long time. Credibility is a terrible thing to lose.
If BAN2401-BIIB are approved by FDA that will be evidence to me that the U.S. healthcare system is completely compromised and corrupt.
https://www.wsj.com/articles/alzheimers-drug-shows-benefit-but-some-experts-say-more-testing-needed-1532550600?ru=yahoo?mod=yahoo_itp&yptr=yahoo.
The BIIB executive who approved the PR for BAN2401, which then triggered the PR blitz, which then fueled speculation by investors, which then reinforced the PR flurry resulting in more SP explosion, which then sparked more buying (IT MUST BE GOOD OR THE PRICE WOULD NOT BE GOING UP) should be locked up. This was/is all based on weak science and a disposition to keep your mouth shut if you like your job when the truth is gone missing.
Solid science and honest use of an executive position is not too much to expect from our Pharma-regulatory system. When this process is abused and liars (only motivated by money) are in charge, then we all lose. If the FDA gives these guys any approvals then we all lose. IMO.
Looking for a webcast link for todays presentation...looked everywhere...no joy...thx
Mycroft...thanks for sharing you assessment. Your insights are highly valued.
Yes, that is how I read it.
Contest on counting the weasel words in this BIIB PR:
https://finance.yahoo.com/news/eisai-biogen-present-detailed-results-143601587.html
If this was not serious, it would be laughable science, a variation of fake science.
Bear says-
All hands. Stand-by to commence flight operations. Clear the flight deck of all unnecessary personnel. Pilots and crews report to your ready rooms. This is not a drill.
You will feel the ship heel over as it turns into the wind and speeds up to get 30+knots over the deck. Game on. All the best, this is what we worked for.
Promising results of RCTs bring hope for #breakthrough treatment and prevention of #Alzheimer #AAIC18 https://t.co/hyxzTKYzPs
— A/Prof Tuan Anh Nguyen (@DrTuan_Nguyen) July 25, 2018
[quote"Sorry but BIIB data is doctored and unimpressive. They will fail in the end just like every other amyloid clearing treatment. Meanwhile Anavex (AVXL) is quietly chugging along and, I feel, will have very impressive data to present; shocking all of AAIC and beyond. BIIB is scared."
][/quote]
Friggen excellent news and post...this is exactly the kind of grass roots information we need. I do not expect the corrupted media to actually do a proper assessment of the BIIB data. In fact I expect the media to repeat and to amplify what they think will get them positive feedback and more $$.
They not do an honest/competent review until someone rubs their face in it, sad to say that is the way things are today.
Biostockclub: Thanks...consider this totally private opinion: you say...
Biostock, I would comment on your write up of Biogens work to date for this AAIC following your thoughts.
We have at times here wondered out loud about the FDA-BP-Corruption and the dismal performance of the Established system to come even close to an effective AD treatment over the past decades. IMO, this AAIC 2018 cycle could serve as a case study example for what is broken in the process. Between the massive PR Buzz and poorly done BIIB hyper text it should not surprise anyone that we have no AD treatments after 20+ years. I make no claims at being a scientist but even I can see what is wrong. Xena has posted many examples, but common sense shows the root clearly. IT"S ALL ABOUT MONEY!
With any luck today will be different with Dr.H and the AVXL team doing a presentation on (REAL) Precision science. We shall see if the world is ready or not.
All the best.
new seeking Alpha pub...07/24/18 5PM+/-
https://seekingalpha.com/article/4189655-anavexs-endgame#alt1?source=email_rt_article_readmore&dr=1
Question on AAIC procedures-filters:
Is it unusual for a small company like AVXL to have this level of (#3) presentations at a AAIC? Seems like quite a load for a tiny company. They will man the floors for posters and do a standup/podium.