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Curious. What if rock solid verifiable evidence showed all (n) A2-73 responders now present no (ZERO) evidence of AD symptoms after almost 3 years
Kentucky-Plex-Investor-good feedback. No debate w/any comments. The numbers only MMSE W/DL scores data could be enhanced w/a few examples IMO. Not hyper stuff but w/examples people can relate to for those living w/AD today. Let's face it AD really steals a lot, particularly it steals time.
Yes, AVXL are a small company in a big ocean of whales. One could easily say, "what's the point?". For me, the (conventional-trust me) system has failed. If one has a family member w/CNS disease diagnosis(like me) one quickly recognizes the scope/depth of the failure-medical-clinical-academia-regulatory and so on. The guys w/the biggest PR budget are in control of what people think and they know it. When I study AVXL I at least see a small entity showing results that no one else has even come close to duplicating. I recognize a flash of a possible breakthrough. At the same time I see numerous examples of the elite all raving about Amyloid Thesis wonders or variations of same. Why??
A big conference where AVXL A2-73 news gets lost in the noise is just more of the same path . I want to see something that gives off a very bright light and generates a lot of heat, not same ole stuff-style. Appreciate the valued positions you each take.
Investor2014: Excellent summary and assessment of the recent AVXL actions and plans. HH is certainly an impressive guy who has devoted many years to doing his work in a certain manner. He impresses as a guy who has firm convictions and that not only is Precision Medicine the correct path but the methods of the past were not effective. He would not put his reputation on the line if he disagreed and to his credit Dr.M. is allowing HH to perform as pilot in command.
The Biomarker process which has been applied by AVXL and the relted retrospective evaluations are IMO classic solid engineering & science. The fact that AVXL has CTAD last speaker in late breaking is also notable. Of course this could all be only the beginning of a very long process but I do not think that is the case. The fact that there have been no contradictions that we are aware of is critical to any kind of breakthrough thinking. (one reason I never bought into the Amyloid Thesis is all the exceptions and outright contradictions) AVXL has put the pieces together allowing a plausible and validated story.
Summary: A2-73 early results indicate the AD treatment is/will be safe and effective. The process is reproducible within a range of known controlled variables. Smart, honest people have self corrected and will present their data. Additionally, I am expecting RWE/RWD to be shown which will blow the room away. BTW, it would be nice to see BIIB join up, am not counting on that. But, if they do then this phase of the investigation is done, the next phase will present a massive success.
Suggests Moving the horizon? Wouldn't it be refreshing to have a regulatory body move something in?
Investor2014:
The most generous comment I can make about the FDA's collaborative performance w/respect to their working positively to produce medical devices, pharma's and combination products that are both safe and effective is their organizational/work structure is wrong and their regulatory emphasis is often ill advised or politically driven.
plexrec:
Steady t:
KUND:M.
Thanks Doc328.
Thanks falconer:
Will it matter if patients are now living normal lives after being treated with A2-73?
falconer, thanks for your read. This was a new path (I thought) for BIIB and they used the "Precision Medicine" word. IMO, it is pretty hard to figure them out but for sure they do have a big investment PR budget . Thanks again.
Biostockclub; exceptional information as usual. Will study and get back w/any follow up questions. BR
Falconer, Biostockclub, doc328, others. Any thoughts or comments on this PR from BIIB today. Curious if you see any possible ref link to A2-73 research @BIIB . IMHO this is the type of work I would have expected w/PM methods-protocols, positive links to measurable test criteria. TIA
https://finance.yahoo.com/news/biogen-advances-research-improve-outcomes-113000794.html
Biomarker Could Guide MS Treatment Decisions
Biogen is engaged in research to evaluate sNfL, a protein that reflects neuronal damage and is elevated in the blood of people with MS, as a biomarker of disease activity. Results from a retrospective analysis of more than 1,000 patients support the clinical relevance of sNfL levels in the blood to predict disease severity and monitor treatment response in MS patients. Data indicate that sNfL levels above a certain threshold are associated with ongoing disease activity and negative clinical and radiologic outcomes, such as more disability progression and brain atrophy. Researchers also found that introducing disease-modifying therapies significantly reduced sNfL levels, and greater reduction was associated with better treatment outcomes.
“Our research suggests that serum neurofilament light is a promising biomarker that may predict a person’s disease course and help guide treatment decisions in MS,” said Peter Calabresi, M.D., director of the division of neuroimmunology and neuro-infectious diseases at the Johns Hopkins University School of Medicine. “These findings support sNfL as a clinically useful biomarker to help predict whether a person with MS is likely to have a fast-progressing or milder disease course. They also open the possibility of using a simple blood test to monitor whether a patient is responding to a specific treatment. The strong predictive power of sNfL may ultimately provide physicians with additional information beyond what is currently measured by MRIs to help guide treatment decisions.”
Looks like the Precision Medicine path will change how much BIIB makes on MS. Doing retrospective analysis is a certain sign of RWE at work.
Xena:[quoteAssociate Professor Stephen Macfarlane, Head of HammondCare Clinical Services, is the principal investigator of the trial.
“We’re still not sure what causes Alzheimer’s disease, but the prevailing theory is the brain is damaged by a build-up of toxic proteins,” A/Prof Macfarlane said.
“There have been many failed trials attempting to remove these proteins or prevent them being produced.
“The theory behind Anavex 2-73 is that it targets a receptor that, when activated, leads to the removal of these abnormal proteins from brain cells.”
The Phase II trial of the drug, featuring 32 patients across Victoria, found their mini mental state exam (MMSE) score remained essentially unchanged after 18 months. The degree of decline expected in a person at a similar stage of Alzheimer’s disease is about two MMSE points per year.
Six of the patients also improved their MMSE scores significantly – an unprecedented outcome in Alzheimer’s treatment. This trial was extended from an initial six months to five years on the basis of the strength of the results and at the request of trial participants and their carers. ][/quote]
flashing back to the outputs from the BIIB PR team where the message has been …"still going downhill but at a slower pace"...my para...Cannot help but think what the BIIB PR team would do with the Dr. Mc F. quote above.
Questions? Will NYY sell all their goonies and move on now that the BOS. RED SOX destroyed them?
And, will this be the day the AVXL retail holders are rewarded?
BIIB just blinked again. They do this b/c it works for them, AD Patients...not so much. Musashi says..."When being pursued by a powerful and confident opponent you must stop and hit them between the eyes as hard as you can." The CTAD show is important for BIIB and everyone else. We should expect more of the same, IMO.
https://finance.yahoo.com/m/2ed8afcb-d672-315c-8442-54b00b74f957/a-look-at-biogen’s.html
dia76ca.Thank you for the response.
M. did say during this recent Cantor presentation that an IND for RS had been submitted. He did not say when or make any other qualifying comment. It sounded clear enough although he did not say when and no one asked.
https://seekingalpha.com/article/4186314-biogen-alzheimers-disease-reasons-caution
REALLY?
Nice: