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Jimmy, I agree. There is nothing asynchronous about Dr. M. and the AVXL story.
"ANAVEX has a story to tell", that is what is going on here, IMO. Unlike other Bio's I have owned where every day hinges on the latest trial/rumors/hit pieces. We may be analogous to the story around the development of antibiotics back in the days when surgeons thought that washing their hands was a waste of time. Eventually medicine pieced a story together but it was RETROSPECTIVE as a rationalization for why sterile instruments made sense, and aseptic processes and suddenly it all made sense to everyone. It took a while to get all the dots connected.
Dr M. is telling a story, the facts are on the table and SO FAR they all say more or less the same thing. Not only does his story blow away all previous theories for effectively treating AD (The Plaque thing)but at least so far, ALL the evidence indicates the same conclusion. Homeostasis as a CNS cell state is a very good thing to establish. How good is to be proven but the thesis holds with zero failures or contradictions to this point. The evidence indicates the thesis is proven to be true.
So, at least in my mind, having a story to tell is far better than treating all of these trials as anecdotes, particularly since there have been no contradictions. It is for example always true that patients with AD die. No amount of testing for alternate theories has ever proven a thing. THE BP STORY HAS BEEN BADLY FLAWED, eventually they all failed.
This story is not yet finished. There will be a beginning, a middle and an end. I am not smart enough to write it, but someone will. As some very qualified people have noted here (A2-73) Anavex is about to change the practice of medicine, just like antibiotics did, maybe more.
Agree, it is not out of the question and politics matter. If a strong additional analysis shows efficacy then it is not a leap to move forward with recognition. When one considers what AD is and the dynamics of demonstrated A2-73 safety performance along with other pre clinical trial evidence the requirements appear to be met. Many unknowns of course.
) What are the benefits of a breakthrough therapy designation?
Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.
A breakthrough therapy designation conveys all of the fast track program features (see below for more details on fast track designation), more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review. Section 902 of FDASIA requires the following actions, as appropriate:
holding meetings with the sponsor and the review team throughout the development of the drug
providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the nonclinical and clinical data necessary for approval is as efficient as practicable
taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment
assigning a cross-disciplinary project lead for the FDA review team to facilitate an efficient review of the development program and to serve as a scientific liaison between the cross-discipline members of the review team (i.e., clinical, pharmacology-toxicology, chemistry, manufacturing and control, compliance) for coordinated internal interactions and communications with the sponsor through the review division’s Regulatory Health Project Manager
involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review
If the Shoe fits...
https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/significantamendmentstothefdcact/fdasia/ucm341027.htm
FDA Breakthrough Designation....all good
BTD for A2-73 is game over.
Just what I need, another biotec investment GUT CHECK. Now we will hear the WS crooks and shorts. Get ready (rats not humans, not enough pts, trials, etc).
Are the anecdotal patient testimonials considered inferential evidence in support of AVXL or lies? Has anything like these results ever been shown in any trial, anywhere? Is AD a death sentence, shouldn't those people be dead or turnips by now? Are the all the organizations willing to spend massive $$ for trials all fools? Or are they serious, educated people on a mission? Are successful animal trial results meaningful? Can this body of knowledge and experiences be used to prove by inference and deduction that Homeostasis restoration with A2-73 is an effective treatment for certain CNS disease? It is at least possible and supports continued investment, and I think YES.
On the other hand. If I owned ANY BP company stock which was continuing to try to prove the Tau-Plaque thing as the CAUSE for AD and I got news of dilution I would be upset. So then, AF and the boys who have refused to acknowledge the direct proof of failure for all other thesis over 30+ years will be critical of AVXL for sure. THAT, is their problem.
I am not selling.
Jimmy...helpful post thanks. In your experience does this scenario suggest that AVXL is about to drop some big news? Sure, they need to be viable to either start their own or act like it, I get that, but the systemic drama here is way up. Between changes at FDA, results in mini events, past due AD trial readouts, Retts links about to start and who knows what else.
Why did Dr. M act at this moment? Obviously a planned event...AF is gonna step in it and then KA-BBOOOMM, vapor.
Cit..what you say makes perfect sense and does explain timing.
"Saliors called this the "doldurums" and that term is now used in many different applications.
When we do get positive news ( and I believe we will) it will be "All hands on deck" and get ready for a wild ride.
[quote[quote]]"How many other Big Pharmas have spent billions testing both beta-amyloid and tau tangle removal drugs? Not a one has been successful in any way."
Falconer, like the others I appreciate your knowledge and your contributions here. Having spent time getting funding for programs and projects over time I wonder how these organizations can possibly justify spending billions more dollars after 3+ decades of consistent failures expecting that somehow THEY found the solution. In fact now when I read of yet another Plaque attack theory/attempt I feel relief as an Anavex investor.
I also see some kind of BTD designation for A2-73, which cannot come soon enough for me. Possibly the delays we see here are not only due to analysis of results to this point. We may be seeing thoughtful planning over the dynamics (FDA+AVXL+others+politics) of a BT.
Think positive. Thank a Veteran. Pray that A2-73 is conclusively proven to be what we think it is, today. Everyone buy a Red Sox hat, and wear it.
Thanks Mike
Mikesc...cannot link to text, can you please post the part on AVXL?
Many thanks
Sixpack,
"A lot of diseases no one ever heard of..."
This testing is a strategy (possibly) based on "death by 1000 cuts" to big P. Many, many rare disease patients adds up to a lot of sick kids and adults WW. These trial results provide some evidence that Big P is and has been on the wrong track for decades with harmful and ineffective treatments. In the meantime we all have lost the one thing we have very little of...TIME.
I believe AVXL is on the right track and hope to see more results (including AD) soon. Hang in there.
17...Saw that and thought the same thing. ( I am not qualified in medical science to say this..but) I do have some limited experience with BT (in semiconductor physics). When BT happens new plausible explanations jump to the surface. The BT then becomes the bridge to other solutions previously not considered. Maybe we are will see some of that with A2-73.
The "black box" is of course Homeostasis. The evidence is building around CNS diseases and the efficacy models being shown in mouse trials. It is not a leap to say this is more than just chance/luck of the draw. Independent self funding trials seem certain at this point as a broadly implemented next step. The whole FDA new structure thing could not be better planned, even it is only millions of little family prayers being answered. This whole thing may just flash over at any moment, that is what BT's do.
Dr. M has bigger issues and I would like to think he has anticipated the enormous negative power of combined big P, various tutes, some media when they realize (probably already have) the scope of the threat that A2-73 (etal) presents. There are those who will say that just b/c A2-73 works it's not (fill in the blank).
Could it be that Dr. M sees this Big P threat and is surrounding his opponents(as a good Ninja would, silently) with many small self funded trails on rare diseases. The time for the AD solution will come at it's best speed, we can sense that. We have seen many times in Bio that just b/c something is right does not mean it is successful. If we can see this coming then we can be certain that Big P does also and that they will/are bring(ing) on massive/negative resources to crush AVXL. This is my own read of the current situation. I am not being negative just aware of what to expect in the systems dynamics about to play out if A2-73 continues to prove the thesis which will destroy big P. If this does happen for Anavex then I predict they and the FDA fast track program will sweep the field.
T-38
["Your key point that 2-73 is showing that the Sigma 1 mechanics is treating the pathology of a wide number of diseases within the brain is a critical point. The point being that neural restoration is elemental to the brains function or lack of function. It seems to work when there are genetic or process inadequacies in the young as well as failure of normal neural functioning as we age. The Sigma 1 role is starting to come under increased medical focus.....it certainly may have extremely far reaching implications to the health of society!"
quote][/quote].
Talon this is a brilliant observation. Dr M. is showing links/findings between and among many thought to be different CNS diseases in patients of all ages. Many have been told there is no cure/treatment. And, AVXL has presented evidence of at least changes in both clinical and pre clinical studies with A2-73. After decades of dry holes a beam of light. Like the man said, "it's like turning the light on in a dark room". Dr. M. is proving the Homeostasis thesis with multiple examples. Certainly a candidate for BTD.
"i don't get it! with all this good stuff going on why's it down in premarket?"
Denial is one explanation. Decades of BP massively expensive trial and error studies are about to be blown to bits by a tiny company. Some tutes are on board (sort of). See what happens next.
You just don't see this kind of language used very often, nice. Would like to see more of this describing appropriate/corresponding results in humans.
" The experiments demonstrated that ANAVEX 2-73 restored hippocampal BDNF expression to normal levels (p<0.05). BDNF under-expression has been observed in many neurodevelopmental and neurodegenerative pathologies."
The body of knowledge (read the string of breadcrumbs) continues to build indicating a clearer path for so many who suffer. Bless these kids.
From FDA definitions(something to keep in mind)
"On July 9, 2012 the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed. FDASIA Section 902 provides for a new designation - Breakthrough Therapy Designation. A breakthrough therapy is a drug:
intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition and
preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
If a drug is designated as breakthrough therapy, FDA will expedite the development and review of such drug. All requests for breakthrough therapy designation will be reviewed within 60 days of receipt, and FDA will either grant or deny the request.
Please refer to section 902 of FDASIA for more specific information about this provision. Additionally, a Guidance for Industry: Expedited Programs for Serious Conditions––Drugs and Biologics was published on May 30, 2014, providing a single resource for information on FDA’s policies and procedures as well as threshold criteria generally applicable to conclude that a drug is a candidate for one or more of the expedited development and review programs: fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation. ."
K9...excellent point, had not thought of it that way. Dr. M. has better things to do w/his time. If I were him and I KNEW I had the goods but needed time to make the soup why would I try to impress anyone? Huh? And, BTW it seems the tutes are happy...what could go wrong?
McM...you are correct, that was a breadcrumb of sorts...I was thinking more of oatmeal-raison bread, toasted w/butter...I get your point...it is what it is... eventually I still expect the whole loaf.
"[The silence is deafening]"[/quote]
Agree.
All we really need is a hint that we are on the right track...nothing earth shattering, just a few facts, breadcrumbs on the path to scientific/discovery milestone...that's all I need. There are those here who are very good at connecting the dots for the rest of us.
Skan...Saw that, pathetic analysis and reasoning. Bottom line he claims..."It's just too hard". So every patient with a CNS disease is just supposed to "suck it up" and say goodbye. You tell that to the little girl with Retts..... axxhole.
The author says AVXL is too small, no one has ever survived, there is not enough money in the universe to help AVXL, the trial they did is no good ...blah, blah.
I offer this article as evidence that some people will do anything for a few bucks.
Friday May 19-FLA
May 17-19, 2017 | Turnberry Isle Miami Hotel | Aventura, Florida
Antiepileptic Drug Trials XIV Conference | May 2017
Friday, May 19, 2017
3:10pm ET
ANAVEX 2-73, A Clinical Candidate for Neurodevelopmental Disorders
Christopher Missling, PhD, Anavex Life Sciences Corp.
There are seemingly obvious contradictions here. If A2-73 has as much potential as many of us believe then what are we (or they) missing? Either the published reports by AVXL are complete fabrications or they really have for the first time ever shown evidence of effective CNS treatment, at least for AD. BTW, all the rest have always failed so it's not like the results are so ambiguous that failure is not measureable. Smart people have trialed and tested their asses off for 40 years and they all failed (99.6%).
Why would Biogen not buy in. Agree, times up.
[quote:There are many interested parties (BP, WS, etc.) that want to make sure Anavex does not succeed as a disruptive innovation/force in healthcare, much like those groups lined up against President Trump][/quote]
Agree completely. Nidan
Someone needs to tell them about Homeostasis.
I guess(in the end) it's really only all about money. These are critical times in a lot of ways. Even sideways is OK today and then kick some ass Friday.
Hope you are right...way overdue now.
Raja,
Agree with your comment that watching from the sidelines is more comfortable, evenso most of us are in the game. If the options for Dr. M are linked to some event and not just time then I missed it also. I am none the less here to stay having reviewed 40+ years consistent BP failure to find any effective treatment for AD or other major CNS diseases. If his thesis on Homeostasis is proven true then I am happy to be in the game. The timing of the options thing today is at least curious, but this guy has been several moves ahead of the pack on everything else so far. The BP/FDA/economic systemic dynamics are intense. I would rather be in the game.
Bio,
Been thinking about the market dynamics developing around AVXL. If the AD+ thesis on homeostasis is proven (soon I hope) then BP are in a bind. If BP partners w/AVXL then they get a piece of some kind of pie while they simultaneously start to eat their young...but, they get to fight another day. If BP does not partner w/AVXL and the thesis is proven then they are gone, along with any fake pharma cures of today's BP market.
Also consider the new FDA rapid development initiatives and repatriated $$$ one sees the ingredients for explosive change. They are compelled to act one way or another IMO.
Biotech, it seems clear that some kind of partnering must happen, either soon or eventually. What also seems clear , considering the facts in our most recent 10Q, is that the real scope (read impact) of the Anavex Homeostasis thesis is massively beyond our understanding or any practice we know of today. It's easy for me to say I do not know what I am talking about in this context. I barely know what I don't know, but I get it. BP is in a tight spot with AVXL. It is clear to even me that if the thesis is proven then every hospital, clinic, nursing home, many medical devices and service now associated with healthcare will be obsolete w/in 10 years.
That is what is going on here and we have to deal with it as shareholders and BP must surely see that. As parents, families and as a culture our lives have been based on the process of people getting older, weaker, sicker and then passing. Some BP certainly may have some insights into what we know we do not know? As Dr Senge, "The Fifth discipline", would say what about the stuff we don't know we don't know? BP is in a tough spot.
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