Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
July AAIC: pk/pd data release
September: Rett ph2 trial start
October: Parkinson's ph2 trial start
November: AD ph2/3 trial start
BP is (within the next year) about to have it's axx handed to it. Their structure, methods, investments and attitudes will all implode as the FDA (w/others) trial processes shift to the process approach. Assignable cause research away from a (tube-sock one size fits all) bunch of geniuses in a secret room R&D.
Great catch Xena...we want them IN the tent. Dr. M. was VERY low key when he mentioned their work. Small Bio CEO just don't pass up that kind of opportunity unless they are on a much bigger mission, IMO.
IMO, Dr. M is talking about processes working and not about events (as in trials). When we learn how to listen to him better we will get it. He is crafting the trials and the process of selecting his target to ensure a selected outcome. When you think about it, it's brilliant. Validation of such a process requires a deep understanding of the variables and risks and when executued correctly the outcome is certain. All my opinion of course.
Flakes, IMO you just hit the nail on the head.
The old days of waiting for the time square trial ball to fall so we all see if the win/lose light flashes pass/fail are over. (you know what I mean). The new FDA processes and precision science will drive solution development.
DR M has told us repeatedly he wants 3rd level trials to simply verify-confirm what has already been proven. That is exactly what we are witnessing with A2-73. Brilliant. I claim it will take a while for the street and Big P to figure out what just happened to them. Cuz, they are history...and there is nothing they can do about it. welcome to precision medicine dudes.
The transition from spending zillions of $$$ and taking years and massive risks based on dubious trials is about over. Such product development is not sustainable any more. Dr. M is making them obsolete overnight with A2-73 and his process b/c it works.
I do not think I am reading too much into this scenario. It makes me feel more secure when the share price wanders. As long as the science drives the process and integrity matters. The shorts, hedgers, liars and just crooks who have made life hell for Biotec investors are going to go off as a gas.
HUH....nice catch-thought. There's a pony in here somewhere.
Attila..agree with your observation.
The first few times were a little tough so I listened with an emphasis to understand his key messages...so many,and each one important chapter in this story.
IMO, it is critical that he is describing how all the CNS diseases are linked according to his Homeostasis (human body fixes itself if we let it) model and to date there are the two big shinning nuggets of...SAFETY and EFFICACY. His point on safety cannot be over emphasized as he comes out of his skin restating the latitude A2-73 has in future CNS studies. What a thrilling experience he and the team must be living through, we as well, vicariously.
Among my high points :slide 20 where he ref Biogen's testing again. His enthusiasm describing the next level of comprehensive analysis now underway and (hint) what that bodes for the Homeostasis thesis. Obviously this story is what he is all about. see#36. Lastly #44 when he begin to wrap up the sequence of results and how they(each)link to what is next in the story. Clearly he has a plan for 2017 (the next 6 mos) being the period when this phase of our learning process bears fruit. IMO we are witnessing history being made, these are not anecdotes.
The hippocampus is a small organ located within the brain's medial temporal lobe and forms an important part of the limbic system, the region that regulates emotions. The hippocampus is associated mainly with memory, in particular long-term memory. The organ also plays an important role in spatial navigation.
Damage to the hippocampus can lead to loss of memory and difficulty in establishing new memories. In Alzheimer's disease, the hippocampus is one of the first regions of the brain to be affected, leading to the confusion and loss of memory so commonly seen in the early stages of the disease.
The major functions of the hippocampus include:
Memory
Historically, the link between the hippocampus and long-term memory formation was first described by William Scoville and Brenda Milner who reported what happened to an epileptic individual who underwent surgery on the organ that was intended to relieve his seizures.
The patient had severe amnesia after the procedure as well as an inability to form new memories of events such as when or where a situation occurred (termed episodic memory). The only memories he did retain were those from many years earlier, as far back as childhood.
Related Stories
“Young” blood revitalizes elderly mice’s learning and memory skills, say researchers
Could pathogen infection really lead to Alzheimer’s?
Why does appetite loss occur during illness? An interview with Prof. Conti and Prof. Francesconi
Experts generally agree that the hippocampus plays a role in the formation of new memories and in the detection of new surroundings, occurrences and stimuli. Some also believe the organ is involved in declarative memory; that is memories that can be stated verbally such as facts and figures. However, studies have shown that damage to the hippocampus does not affect a person's ability to learn a new skill such as playing a musical instrument or solving certain types of puzzles which suggests that the memories involved in learning a procedure are governed by brain areas other than the hippocampus.
Spatial navigation and spatial memory
Neuroscientist John O' Keefe and psychology professor Lynn Nadel studied the involvement of the hippocampus in memory formation and learning behaviors in the 1960's and 1970's. Together, they wrote the landmark 1978 book "The Hippocampus as a Cognitive map," which outlines the role of the hippocampus in learning and storing information referring to portions of space, in the form of cognitive maps.
Behavioral inhibition
Animal experiments investigating the effects of hippocampal damage have previously suggested that, firstly, the damage causes hyperactivity and, secondly, that it affects the ability to inhibit responses that have previously been learnt.
Reviewed by Sally Robertson, BSc
Sources
http://www.caam.rice.edu/~cox/wrap/hippocampus.pdf
http://www.cognitivemap.net/
http://www.icn.ucl.ac.uk/nburgess/papers/Kingetal04.pdf
http://www.uv.es/revispsi/articulos1.02/M6Good.pdf
http://www.richardhill.com.au/HippocampusMemory.pdf
I think we witnessed a data drive man with an abundance of integrity doing all he could to not get too far out in front of the process. Most weaker people would be tempted to give bigger explanations. So far we are making progress.
NEW YORK — June 5, 2017 — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer, today announced that Christopher U. Missling, PhD, President and Chief Executive Officer, is scheduled to present on Friday, June 9, 2017, at 10:00 a.m. Eastern Daylight Time, at the Jefferies 2017 Global Healthcare Conference in New York City.
A live webcast including audio and slides and subsequent archived replay presentation can be accessed at http://wsw.com/webcast/jeff105/avxl or via the investor material page of the Company’s website at http://www.anavex.com/investors/investor-material/.
My hopes are not exactly up either but I do rely on the fact that he is at least speaking which presents the opportunity for new information, no matter how thin it might be. Been there, done that.
Here is tele link...https://www.globenewswire.com/Tracker?data=NpDCz4Sxompcyv5m1Tgzsssy-1cbF26QA572o6oWSdmHSYEeJYD4bJwpsJTMrBTbkBabHLTQMhFnrErfOKEKIa1lfRKFjKl6bTw5aKf1skXTDn_7XTyc7XZOaBImJTr1ZFpz-QHrH7htlV08TO_O_vScmo6oNFZLoyxqpYXZqV0=
Trial news is of course needed. We should/do expect SOME KIND OF NEWS (new information). Maybe that's a royal "WE". I do not see this a just another day at the office, maybe no BOOOM but at least some kind of clearer ..."STAND BY", message. Or is that just me.
OK...Harvard promotes a method in selected programs called "Breakthrough Thinking". A definition posted below, I believe it is relevant in AVXL-FDA trials context. If Homeostasis is what Dr M says then all bets off. I also think the FDA will act accordingly.
"Deliberate, focused effort aimed at developing radically new approaches that overcome constraints, instead of making incremental changes in the older ways of working"
trend
Completely agree, that's why they call it breakthrough....previous rules are not relevant when the entire book is thrown out, based on data/proof of course.
Dr. M has a thesis which would be more correctly stated by himself. My version is he claims cell homeostasis in CNS appears to impact a number of previously incurable CNS diseases, such as Rett, AD, autistic spectrum, Parkinson's and more. Evidence supporting his claims include AD human trials and animal preclinical trials for other indications. No failures have been reported to date to disprove this Homeostasis stability theory.
There is no record that we know of on any human ever maintaining cognitive skills much less recovering as some claim to have with A2-73. Some stories have been largely dismissed as anecdotal, possibly false claims. So, we debate. I claim that unless these claims are lies and the data to date is false the thesis is proven true. Who knows what level of exhaustive testing the medical/regulatory universe needs. In the meantime we are caught in some unprovable hell where only a saint could be calm.
So, unless and until some contradictory evidence is shown I believe the claim is proven and suggest the FDA or other such body must step up and lead. Then we all get on with life. The FDA must work to define a test process which will put this to rest. Since no human has ever recovered it seems obvious the risk is low. Massive, exhaustive, expensive testing seems a waste since the thesis can easily be proven by logic. A2-73 presents no risk considering the alternatives. If it were my little girl I would at least try instead of bowing to BP. It is clearly the FDA's call.
Definition:
plural noun: theses
1. a statement or theory that is put forward as a premise to be maintained or proved.
synonyms:
theory, contention, argument, line of argument, proposal, proposition, idea, claim, premise, assumption, hypothesis, postulation, supposition
His positive Bloomberg message was about the ," The Anavex Homeostasis Story". The interviewer did not pick up on it. He tells the world the human body is doing OK but we need to get our act together on understanding CNS diseases, then he lists them. He is clearly leading the parade and BP has no choice but to get in step or they will die. If they just ignore him then maybe he will go away....NOT. He is/was very cautious about ref to Big P. Clearly when the 1st Big P goes with the "H" story the others are then watching the parade go by. We are awaiting a condition known in semiconductor physics as avalanche breakdown. Like the man said, "It will be like turning on the light in a dark room".
He is being very low key.
I would like to see him re-state/repeat or expand on results they have from first trial. Yes, we all know (small sample/confused dose stories and so forth). Did AD patients actually recover cognitive skills? The whole patient sleep/insomnia story .
Would love new/different trial information along with additional confirmations of real life recoveries. Expand on where original patients are today. Have they continued to improve? You know, A bone or two for the crew here. BTW, I believe we will have more news before Friday.
benny, Dr. M is low key guy, going live is ab-e-normal. It may signal nothing but it is different.
Thanks Squid...makes sense.
Thanks Sokol. I read this then as a non trivial conference/investment session but maybe we are not in the BIG (science) tent. We'll see I guess.
Curious...Is this significant or is it "So What"? Do small companies fight to get to speak or not? I have no interest in chasing any vapor trail, just wondering if anyone with real knowledge can respond.TIA.
Anyone know why this thing poped 40% today? Been waiting a long time to see it move. Hope this means they have FDA action or funding support...green is good
Is it possible that the "Homeostasis Story" that Dr M is authoring continues to grow and develop daily at a rate that is faster than he can manage. Each day we see new clinical news releases describing how normal cell functioning or not is linked to some previously thought to be unrelated disease. We all recognize the now long list of CNS trials and theories being floated, all are plausible.
Has Dr M got a dilemma where he cannot spill the beans before he is ready/able to control or deal with the consequences? I am a believer who wants to understand. A possible explanation is we (owners) do not get just how massive this story is and how difficult it will be to publish. I believe all the various diseases may be linked in some way with a common root cause. We may all sense the explosive nature of the A2-73 story. Is it a conventional kinetic device we are sitting on or thermal run away device ? If so, how to you describe it w/o looking nuts? And, if you owned it would you want to? We may just have a much bigger story here than $15 SP by EOY.
falconer...Thanks again. This AVXL concept certainly is beginning to come together thanks to people like you with the skill and training to publicly articulate their model.
I am hoping the FDA will review and consider BTD for A2-73. There are no alternative, viable initiatives on the table that we know of.
It is almost too good to be true.
It is my own theory that Dr. M. already has additional final proof in his pocket or he is just a few clicks away. I also agree that the Retts work will help to quickly resolve any remaining A2-73 Homeostasis efficacy questions. Wouldn't it be great to have some families little girl recover, what better proof is there.
Stop me if you have heard this before...
“If we could do this in one disease, it’s a good bet the therapy would be effective in the other two diseases.”
https://alzheimersnewstoday.com/2017/05/26/protein-clumps-in-alzheimers-share-features-with-those-of-parkinsons-huntingtons-study-reports/?utm_source=Alzheimer%27s+List&utm_campaign=d6154c2121-RSS_EMAIL_CAMPAIGN&utm_medium=email&utm_term=0_94425accb7-d6154c2121-72173229
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