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Hey well yes she did, even if she had to kiss one hell of a lot of toads.
sokol,
My note has less detail but is essentially on the same point. Claims made and presented at AAIC should at least be credible. How does any kind of V&V of these treatment claims get checked before they are allowed to go public w/some assigned AAIC credibility?
We witnessed as a lot money changed hands following the BIIB PR the other day. Now, a lot of that PR has gone off as a gas, why? If we are serious about delivering treatments that actually help then we must have standards and we must apply them.
There is no way the FDA can accept the material presented by BIIB as evidence for PIII. IMO.
Thx again and I very much appreciate your comprehensive message. I hope they do. We are basically on the same page.
Sokol...thanks. My note to her included some information about myself and background which I do not want posted here.
http://www.pmlive.com/pharma_news/biogen_and_eisai_claim_mid-stage_win_for_alzheimers_drug_1243440?SQ_DESIGN_NAME=2
Suffice to say I asked her to advise me if AAIC reviews the claims for efficacy based on trial information or if they just accept presentations as is.
This link in particular got my attention because it has such obvious, basic errors I wanted to know if AAIC was going to let BIIB slide with their trial claims on patient stabilization, other. BIIB says they have results but have not had a chance to review them yet??
Also, we know BIIB earlier changed the S/W tool and methods being used b/c the earlier trial failed. They then expanded the sample size but have not looked at all the data yet. HUH? A new system w/new S/W w/undetermined config being used to deliver world class AAIC presentation, etc. Not on my watch.
The PR they put out contained fundamental Quality Systems 101 errors. IF AAIC allows them to go with this trial w/o clarification it would a big embarrassing mistake.
Sokol,
I have sent a mail to Nicole. Will let you know here if/when I get a reply.
sokol...great. Thank you.
Mycroft...thanks for the link. I looked at an attached link to the BIIB recently reported results and have a question you may be able to help with. See below from the BIIB story:
BIIB positive PR this A.M., this is an example of what MUST BE CHALLENGED ASAP. Is the claim at all credible in the context of FDA requirements? IMO, if the AAIC face off is going to be managed we better get out in front or at least challenge these claims.
https://finance.yahoo.com/news/biotech-stock-roundup-biib-apos-134101873.html
Bio, thanks for a truly extraordinary assessment of the field in front of us. You bring out some of the same concerns I have and I am certain many others do as well. The playing field is not even close to being level. AVXL looks to many like they should not even be there, much less a contender. I agree w/this assessment also.
If BIIB wants to deal on MS we should engage them and begin a planned process for mutual success. MS patients win, AVXL wins and BIIB win. This strikes me as an optimal near term best case.
I also agree that AAIC has turned out to be the right place and the right time to make a decisive science move. The agenda is set up to minimize the AVXL science point of advantage, chosen by back room influence. The point you make about BIIB science and the Amyloid hypothesis is critical. The BIIB trial process looks very dubious/weak but is well financed(read paid to get headlines). Will the audience care about the flawed science? Does FDA have the stones to deny them? Good points.
It is down to the science and to some degree the credibility of the process. AVXL has no choice but to go for the throat, both offense and defense. Find a way between now and 25th to leak key facts, light the fuse, somehow impact the trial extension/timing/sequencing of events by before the 25th. Get our name out w/more news.
There can be little doubt by observers now that the FDA has lost any claim to it's leadership role, unless they step forward w/meaningful intervention. Does the BIIb trial include ANY of the Precision Medicine protocol? Let/insist the FDA do it's job, be open about this. Look closely at the BIIB trial, the stats, the controls, the participants and how results were compiled. The whole thing stinks. Take these last few days to interrupt the opponents strategy. Just how are the results credible? Is it the BIIB money talking or the science?
Above all though, AVXL asked to be in the room, asked to be at the table, wants to be heard and respected....now they have to act like it and not defer to any higher power. The science is superior and the process for precision medicine/science is absolutely consistent w/what the FDA said it wanted. That has to be an ace. Put your big boy pants on M., GAME ON.
Isn't this an identical post to one you made many months ago? What exactly is your tie/interest in RGIN? Do you own shares? Are you trying to talk us off the stock? Why?
Whippinsaw-I am thinking along the same lines:
EBZ...[quoteI happen to think Missling is learning things he wasn't expecting to when he started...such as the gut and absorbtion. I think these types of things delayed and possibly changed trial plans as they were being developed.][/quote]
Totally agree w/this observation. Dr.M. and team were breaking new trial ground when events warranted they had both the insight and ability to change their trail/discovery process as they went. This points to a benefit of a much smaller team and the ability to call your own shots on the run. (longer story) AVXL will always be able to out think/maneuver their opponents as long as they stay small and focused. This is a good thing but must be skillfully done to avoid unintended consequences.
It is looking like AAIC 2018 will be at least playoff level ball, if not wildcard. Bio* has called it all along. IMO, if anyone thinks this will be a fair fight they are not paying attention. Now, this is about timing.
"There is timing in everything." "There is timing in the whole life of the warrior": Musashi.
RWE....better/quicker trials information...new budget pursuit....nice...also note includes more field* data...(my term).
from Dr.G. Note: [quoteImproving Clinical Trials
The development of such a tool can also make the entire clinical trial process much more efficient. And it can enable us to enroll more patients from more diverse backgrounds into trials.
For example, real world data can be used to more efficiently identify and recruit patients for a clinical trial. Key design considerations, such as randomization, can be integrated across clinical care settings, introducing a much more diverse population into the clinical trial system. Innovative statistical approaches — such as Bayesian and propensity scores methods — can combine information from different sources and potentially reduce the size and duration of a clinical trial while expanding the scope of healthcare questions that we’re able to evaluate. This will enable a modern clinical trial system that improves upon trials being conducted in large medical care centers. It could enable more clinical trials at smaller community-based health care providers. Such a system can expand the number of patients we’re able to evaluate, and broaden the information that we’re able to collect, while at the same time reducing the cost of developing this information. We can have more and better information, and a less costly process.
All of this is contingent upon our ability to have confidence in the quality of data we’re accessing to make decisions, be that regulatory or derived from individual patient care. We’re working with public and private partners to ensure optimal data quality, validity, and utilization. Our goal is to develop better data standards, to promote interoperability, and improve data quality.][/quote]
https://blogs.fda.gov/fdavoice/index.php/2018/07/fda-budget-matters-a-cross-cutting-data-enterprise-for-real-world-evidence/
Anavex can't be silenced at AAIC July 25, 2018. 3 presentations so far.
1. Sigma-1 Receptor Target Occupancy Study with Dynamic PET Scan Analysis of ANAVEX®2-73, a Clinical Candidate for Neurodegenerative and Neurodevelopmental Diseases
9:30AM-4:15PM Jul 25
Jessa Castillo, Frederick Chin, Scarlett Guo, Christopher Missling, Aimara Morales, Jun Park, Samantha Reyes, Nell Robowe, Jeffrey Sprouse, Berend van de Wildt
2. Full Genomic Analysis of ANAVEX®2-73 Phase 2a Alzheimer’s Disease Study Identifies Biomarkers Enabling Targeted Therapy and a Precision Medicine Approach
9:30AM-4:15PM Jul 25
Mohammad Afshar, Adrien Etcheto, Emmanuel Fadiran, Federico Goodsaid, Harald Hampel, Christopher Missling, Frédéric Parmentier, Coralie Williams
3. Systematic Processing of Full Genomic Analysis of ANAVEX®2-73 Phase 2a Alzheimer’s Disease Study Identifies Biomarkers Enabling a Precision Medicine Approach
5:15PM-5:30PM Jul 25
Mohammad Afshar, Adrien Etcheto, Emmanuel Fadiran, Federico Goodsaid, Harald Hampel, Christopher Missling, Frédéric Parmentier, Coralie Williams
In my view, the main (and maybe only) catalyst besides BO is some real good bio-marker related announcement in AAIC that will give market the confidence that AVXL has special capability to move with these.
Without that the price will keep going down easily.
AAIC presents itself as a serious/well organized conference. We have all attended such conferences, sometimes to wander around and kick tires. Other times get focused and actually engage the learning process b/c it matters.
We have not spent the last few years studying/peeling at/pushing growing our knowledge base to only walk away intellectually. If AVXL were not in the middle of AAIC some of us would walk from them NOW. That would suggest lack of focus and meaning. Yes, they are a little tiny company, but they are MY little tiny company and I expect them to kick some ass.
If not now, when? If not AVXL, who? The existing system has shown that it is not capable of producing an effective AD treatment. WHY NOT? If this is not hard ball then what is?
All the best.
TTT--thank you , I will continue to review the agendas.
GOT it...now just imagine (it's called AAIC for a reason) the one set of information being presented here is consistent with WHY EXACTLY some people get AD and others do NOT GET AD and WHAT TO DO ABOUT THAT.
If I were there (understanding the brilliant research history of those who have gone before and also understanding they have got not much to show for it) I would certainly want to see what was being said and the proof being offered. But, that's just me.
Anavex is not going to get much if any attention, and certainly not from healthcare reporters.
AAIC Titles for Posters by AVXL Team...
If you were BIIB you would be asking....What could go wrong and, if it did, what would happen?
Anavex can't be silenced at AAIC July 25, 2018. 3 presentations so far.
1. Sigma-1 Receptor Target Occupancy Study with Dynamic PET Scan Analysis of ANAVEX®2-73, a Clinical Candidate for Neurodegenerative and Neurodevelopmental Diseases
9:30AM-4:15PM Jul 25
Jessa Castillo, Frederick Chin, Scarlett Guo, Christopher Missling, Aimara Morales, Jun Park, Samantha Reyes, Nell Robowe, Jeffrey Sprouse, Berend van de Wildt
2. Full Genomic Analysis of ANAVEX®2-73 Phase 2a Alzheimer’s Disease Study Identifies Biomarkers Enabling Targeted Therapy and a Precision Medicine Approach
9:30AM-4:15PM Jul 25
Mohammad Afshar, Adrien Etcheto, Emmanuel Fadiran, Federico Goodsaid, Harald Hampel, Christopher Missling, Frédéric Parmentier, Coralie Williams
3. Systematic Processing of Full Genomic Analysis of ANAVEX®2-73 Phase 2a Alzheimer’s Disease Study Identifies Biomarkers Enabling a Precision Medicine Approach
5:15PM-5:30PM Jul 25
Mohammad Afshar, Adrien Etcheto, Emmanuel Fadiran, Federico Goodsaid, Harald Hampel, Christopher Missling, Frédéric Parmentier, Coralie Williams
I believe. As we near the AAIC with powerful, game changing revelations expected , our stock has not run up; it has been driven down.
Whatever comes next will be big and will be a total surprise
What are the chances that a lot of us suffer from Cognitive Dissonance?
IMO, it is something to be aware of, as I believe we are doing collectively. IMO, performance pressure is huge for AAIC and M.-TEAM. We all know it and all we can do is watch and listen.
AAIC-2018 is truly a Binary event, IMO. The greater context is the obvious and embarrassing poor judgement by BIIB. How can BIIB even joke about doing an AAIC poster on their recent announcement. Now THAT is conative dissonance, IMO..
We called it here when we saw it a couple of days ago. If AVXL had done anything like that many would have taken the money and ran, as it appears others have. But on your point of cognitive dissonance, I think we pretty much call them as we see them here...sure we want good news but w/Dr.M. at the switch we do not get to see that very often do we?
stand at ease.
Biostockclub...thank you for posting the link.
Wow...this from the article...the absolute LAST THING THEY WANT TO SEE AT BIIB EXECUTIVE MANAGAMNT ….this is the kind of comment that sticks to the wall...IMO. ZERO CREDIBILITY FOR BIIB...THE END.
"Biogen is playing a type of numbers game. In its aducanumab trial it added more participants leading to speculation that it was not seeing positive results (or not positive enough) in the original group. For BAN2401 it increased the number of participants in the high dose group and changed the statistical analysis midstream (the latter of which is at least questionable)".
The poster titles give a good idea of what will be presented topically. We will see what level of detail and consequently the scope of treatment efficacy. Since no one has ever survived an AD diagnosis and lived to talk about it, no matter how you cut it, it's YYYUUUUUGE.
We hope M. has a presentation which credibly demonstrates the science and a process for diagnosis and treatment which will be demonstrated on a larger scale for AD and which can be easily recognized as good science.
IMO, we want/need some responsible body/agency to step forward to sponsor a process of fuller testing and integration for the greater good while we expand private diagnostics and treatments to include other indications.
It's all good.
The issue for me is we need to have someone w/a position of (at least semi authority, even if self assigned) public acceptance hummm a few bars of the AVXL fight song. PUBLICALLY.
We do need a mouthpiece who is credible and capable of putting our message out and keeping it in front of the public. Just about anyone on this board could tell our story but we do not matter much.
It has been correctly pointed out that we need an "Authority" to carry our story. Normally companies like AVXL would rely on FDA publication of trial results to ring the bell. For a lot of reasons the FDA is not visible nor are they one the point. Hey, if Dr.G. had nice things to say about our pursuit of the Precision science process when referring to progress/results that would be a good example of what we need.
Adam Feuerstein announces Spaxit, Spains overnight exit from the EU. In a shocking news article that will undoubtedly rock the world markets tomorrow, Adam Feuerstein claims to have exclusive inside information that Spain is no longer a member of the EU where data leading to drug approval in one member country can be used to support drug approval for all members.
I’m hoping for no hold back, and that Anavex goes for the gold providing the world and us shareholders with the information we have been waiting for.
traderherpete-says.
We want Anavex to be the authority since we believe they have evidence of slowing and in some cases reversing the symptoms of Alzheimer’s Disease. Since we believe this has happened and no one else has achieved this, we feel Anavex is now the only Authority worth listening to.
IMO, these 3 presentation titles represent the most powerful set of detail that one could wish to see at this point in time. If they execute and present this information accordingly, this will be an historic event.
Guess Missling must be quite sure what he is doing.
Hey CNS DISEASE WORLD , READ THIS:
“We are excited about the approval to initiate the Phase 2 study of ANAVEX®2-73 for the treatment of Parkinson’s disease dementia, which will focus on the effect of ANAVEX®2-73 on both the cognitive and motor impairment of Parkinson’s disease,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We continue leveraging our precision medicine approach to drug development to provide intelligence beyond many traditional neurology trials to disease areas with high unmet needs.”
Whole Biogen game is clear now
We see these issues around here all the time
the problem is more about how FDA procedures are applied and enforced (owned by Big Pharma) than the procedures themselves.
outside of the USA red flag bologna.
Pre-Market does seem kind of weird without any action
[quote the genomic biomarkers learned from the P2a study.][/quote]
Hey guys, does the Dr.M. repeated ref to "precision medicine" approach suggest that this process of scientific methods being applied allowing for WW application of technical skills and knowledge??/I think Yes. He is doing a new process w/new rules and it will work.
Just a thought but, is little ole ANAVEX flipping the bird to FDA trial strangulation, trial by $$$$, and strongly suggested corruption/incompetence that has controlled the WW BP processes for decades.
Massive process changes underway and who would have thunk it is all based on getting back to basics. JUST FRIGGEN EXCELLENT.
Quote from PR...good to see this kind of text about being rational and open...IMO
The Company ‘s trial design for the Phase 2 program in PDD includes genomic, precision medicine-based biomarkers identified from patients previously treated with ANAVEX®2-73. This novel approach has informed clinical trial designs and is expected to yield insight as to potential responders, and to enrich future regulatory submissions.
“We are excited about the approval to initiate the Phase 2 study of ANAVEX®2-73 for the treatment of Parkinson’s disease dementia, which will focus on the effect of ANAVEX®2-73 on both the cognitive and motor impairment of Parkinson’s disease,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We continue leveraging our precision medicine approach to drug development to provide intelligence beyond many traditional neurology trials to disease areas with high unmet needs.”
A willingness to put those phase II patients out there is something significant in my opinion.