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Thanks for the guidance, she has been under doctors treatment-guidance for several years.
plexrec:why aren't BP jumping all over this ???? Just a ho-hum moment-----we have a drug that can help---and zero reaction from the people who can help !!!!! Unreal !!!!
Agree w/your reaction. I have a family member w/MS. She deserves some treatment that is safe and REALLY effective. Yes, I understand BIIB makes massive amounts money on MS drugs. As you say, who is helping here? Are MS patients supposed to expect the BIIB people to evaluate a treatment that will potentially undercut 70% of BIIB gross rev? Not gonna happen. I guess the FDA sees itself as a cop and not a leader. Dr.M. and staff have their work cut out.
Excellent:
it means that A2-73 (as the only of the tested Sr-1 agonists) restores (reverse) the ability of the immune system to block B-cells from activating T-cells attacking the myelin sheath that wraps and isolates axons to facilitate the signaling between nerve cells.
If so that seems quite important!
TOTALLY
From today's PR.
My emphasis bold) is about claims being made here and emphasis on being public w/the best of the best. This is definitely the kind of Comm. I have been looking for.
ANAVEX®2-73 activates the Sigma-1 receptor (S1R) protein, which serves as a molecular chaperone and functional modulator involved in restoring homeostasis. S1R activation has demonstrated ability to reduce key pathophysiological signs of Alzheimer’s disease: beta amyloid, hyperphosphorylated tau, and increased inflammation. In a Phase 2a Alzheimer’s disease study, ANAVEX®2-73 has shown dose dependent improvement in exploratory endpoints of cognition (MMSE) and function (ADCS-ADL). Whole DNA Exome Sequencing (WES) and RNA expression genomic analysis of ANAVEX®2-73 Phase 2a Alzheimer’s disease patients was performed. The ANAVEX®2-73 Phase 2b/3 study design includes genomic precision medicine biomarkers identified in the ANAVEX®2-73 Phase 2a study.
To para phrase falconer...and USMC..."AVXL is either BIIB's best friend or worst nightmare"..
blanka, very nice catch...thank you.
bear77...welcome back man....this sounds important to MS patients and to relations w/BIIB? Excellent find.
http://www.abc.net.au/news/2018-09-25/alzheimers-disease-research-questions-plaque-as-cause-of-disease/10299514
Are we looking at the A2-73 Precision Medicine poster child? Remember the advertisement...is he the first survivor?? God bless him if true.
The PM process as well as the outcome of this trial are(IMO) equally important. I hope we see each patient respond favorably as regards their treatment and results. That is an important numbers detail, the more the better and SP changes should correspond once everyone figures out what the results mean. We need to avoid the whole pass/fail thing as much as possible. BTW, it's gonna pass.
I hope we can avoid the old pass/fail day-long statistical discussions. The Precision Medicine process is about using the science (repeatedly)and engineering good science beginning to understand why those who did not respond as fully did what they did.
Sure, effective treatment is what we all want to see, but the science-knowledge building process is just as important. At some point, when the science has been understood, the whole placebo arm will not be done in future trials, except for the first 1 or 2 of a type/indication. The trials will be simple verification that the science predictions were correct. Like turning on a light switch. Massive trials and complex statistical analysis will all be a thing of the past.
Looking forward to trial results with large numbers of pts who responded well. Equally interested in what HH has to say about P.M. and what he and the team learned. IMO that is what future partners will pay for, the massive capability of AVXL and CNS cellular homeostasis.
Seriously????
A misunderstanding of terminology. My message meant repeating the same trial might be seen as redundant. Since we do not yet know what will be reported from safety trial(XXX weeks)we should not get too far out in front of the sponsors ongoing requirements (aside from being in compliance). They may be withholding trial plan detail prior to public release of results.
Will refer to the impressive portfolio of regs. you identified when needed.
Xena:
Talon, agree w/your observation on the Aussie's. If I am ever in a serious fight I want them on my side. They are smart, tough and a little bit nuts. I needed them one time and they performed with speed and accuracy. Just the best. If they say A2-73 is good to go that is all we need.
Powerwalker:
CK-Sorry for your recent family member loss. An effective treatment is long overdue. Appreciate the feedback and I agree things are moving.
This language is unambiguous:
JJ, I sense that you also have been through some technical analysis-discovery process where decisions must be taken based on new information. One alternative when that new information presents itself is to stop the train and restart later. That would have happened in cases if a new risk presenting, etc.
Now, as you suggest, if new important information makes a change clearly in the best interest of the pt. then (while in control) a risk based change decision may be taken. So, you might be right. It is pretty hard to schedule an invention but this is a learning process and things do happen.
JJ
[quotethe goose is cooked][/quote]
Life's a bitch and then you die.
Biostockclub, thanks for the valued feedback. Shewart (sp)the famous statistician said: " Data is worthless without context". BTW, he is the guy who did all the work for which Dr.Deming gets a lot of credit. They were both brilliant. But the point is made on process and context, which in this case may be the same thing. In this case Precision Medicine both enables and requires a technical-scientific skill set which may be already available today waiting to be properly directed by many private companies and academia. IMO, either private industry profit motivations or government funding must be added.
Sadly, the FDA are the last people on the planet to be asked to lead such a P.M. initiative, but, there it is. If we needed a bunch of rules written, then the FDA would be the place to go but we do not yet have the rules properly outlined. The Aus. A2-73 trials results will be the first example of what P.M. is capable of. P.M. rules must be politically sterile. The P.M. examples for verification and validation might be unique CNS disease indications. IMO, instead of proving that the Amyloid Thesis is valid the P.M. technical goal is to prove that CNS cellular homeostasis (restore and regen) is viable as a practice in medicine.
My, My, My...looks like W/S and others (BIIB, Roche, Lilly) and others in FDA-and the press are going to be seeing and hearing a lot about AVXL Precision medicine w/CNS disease potential over the next month or so.
We recognize new show and tells and we recognize that Dr.M. is delegating AVXL key appearances to SAB members with their reputations and expertise on the line. This little company with science leadership like you read about and Precision Medicine expertise are going to make some noise. Not only will the FDA be pleased but CNS disease patients and caregivers should have something to cheer about, for once. If the media is paying attention we will do well.
Maybe our long darkness is coming to an end. For the sake of every one of the tremendously skilled, well schooled and professional AVXL team here and all the CNS patients from the young Retts kids to the most feeble AD patient hang in there. Between now and the end of 2018 good things are going to happen.
We still have a long way t go but this feels like the end of the beginning in many respects. We just cannot know how the competition will handle this.
CTAD 2018 Sponsors. Stacked deck:
http://www.ctad-alzheimer.com/ctad-sponsors
http://www.arianapharma.com/2018/09/alzheimer-precision-medicine/
Just curious. Does this ref to an alternative platform present the BIIB CEO w/an opportunity to abandon his current AD path ,w/their rationale and AI suite, in favor of the AVXL path? Just connecting a few dots. Assuming he believes they are already on shaky ground and that he would be mistaken to continue. We'll see.
Too much of a good things...is just fine:
Too much of a good thing???...NAH..
https://www.anavex.com/anavex-life-sciences-presents-new-data-identifying-treatment-response-biomarkers-in-alzheimers-disease-patients-treated-with-investigational-anavex2-73-at-2018-alzheimers-assoc/
SEE Quote from HH and note how this next presentation in Barcelona has special (told ya) significance.
Biostock:
GOOD QUESTION:
tradeherpete:
Biostockclub...WOW.
cornflakes...riddle me this:
On Embargo@CTAD from google site: