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Talon, your observation on sp is as excellent one. We know from recent AAIC conference papers that BIIB are capable of misleading practices. this week a Boston publication describes BIIB recent firing of one employee for whistle blowing. They claimed she was dropped b/c of org changes.
Organizations establish their own cultures regardless of the field they are in. I would dearly like to see our SP perform better ASAP but not at the expense of solid credible science.
Good idea...what are the odds. Let's do Lottery style.
Locate and interview/video all the AD trial survivors world wide. The people can be located from trial records used by Anavex,Lilly,PZ,BIIB,J&J, etc from every country WW. Compile all the records of those who have been (insert defined rules here) successfully treated. Verify that all pts were properly determined to be legitimate AD (some stage) diagnosed prior to their trial starts.
Now when you conduct the post trial interviews conduct patient interviews and series of standard cognitive tests under strictly controlled conditions.
Summarize the results and report using video evidence along with other best methods to demonstrate the efficacy of the treatment and trail results.
Results show what??? Oh, there are no known post AD trial survivors WW with the ability to participate in and interview?? You say they have either passed or cannot respond due to their AD condition (can't show any cognitive skills needed for testing). The only test patients ever to survive any such AD diagnosis are Anavex A2-73 patients and they are all doing well, some even returned to normal live-(see testimonial videos ).
Well, there it is then, the entire AVXL trial population are liars, including hospital staffs and clinical staff. You cannot prove they are really AD survivors and since no one has ever survived AD diagnosis we must conclude the whole thing is a farce,it never happened. The statistics say the claim of effective treatment is not a valid conclusion. These things never happened or can be statistically rationalized away as not significant findings. Done.
Talon-Falcon-totally agree
Any theories on why the SP keeps falling, even when we didn't screw anything up or missed a date? going up is OK ya know.
plexrec...great effort.
Someone w/skills and knowledge to set up a site where we can all send and retrieve relevant notes/facts/stories/pr's etc. Maybe we can inspire AVXL to take us seriously about wanting them to be much more vocal w/stories and news. Maybe we can avoid the legal bitching and all the AH's who always show up with expert opinions on why things cannot be done...Like someone said..."First, kill all the lawyers".
drv17...
cninc...I have seen these but there is no posted link that I am aware of. Having continuous access for ref would be helpful.
Cool...will be off line until about 9:00 AM EST
sokol [quoteThe AVXL 2-73 stories about responders needs to be spread as the Anavex clinical trials progress. ][/quote]
Exactly correct. Patients stories Must be credible, technically accurate and truthfully done. That is all we need.
Biostockclub...Tripletts????WHOA NICE-God Bless them all
I can not do the victim thing well at all. The system is clearly broken. If we have to wait for BP/FDA/layered politicians on the payroll we are screwed.
I like the leapfrog idea. Getting real people who have recovered from AD is a showstopper. Having the results demonstrated is key and would overwhelm the foot draggers instantly. I feel no obligation to defer at this point to the incompetence now driving the bus. They have just again demonstrated their capability and we need to remove them. patients/caregivers/RWD-RWE/infrastructure/medical staff and RTT initiative is available.
Redefine the process for conducting trails based on RWE-and quality of life. Ban all BP interests from any involvement until we are done. Australia, Spain and NA are ready. IMO, we should assume that no one in the existing establishment would help.
MycoftHolmes...many thanks for your excellent follow up. BR
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.