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Manpower as a constraint , even when it is just for making plans. Very good point. Clearly/quickly develops to some kind of shared responsibility when results show obligations are self evident. He will need to deal. Great point.
[quote"Wouldn't the body, at that point, be able to heal itself?" ][/quote]
Trade...now you let the cat out of the bag. What if the best clinical minds and tools were to work with that concept? It too easy to get out in front of oneself w/this but you gotta love the concept at least. I suppose now we will get the people who will rave on about how such a thing is impossible, so far no takers.
Best to all AVXL longs today.
Penny,
I agree. IMO, the FDA is probably not being very helpful b/c they have to do two things at once. They have to change their methods and practices while simultaneously continuing to chew gum. Their structure and methods are in the way. We ain't going anywhere w/o them. Hope 45' gets their attention.
I have noted over time what a great job the FDA has done of saving chimneys after the house is burned to the ground. Most of the rules they have in place are retrospective reactions to the obvious. They are not the people who should be deciding what new treatment to use. They actually stop change. When their efforts are combined with the mixed political interests of DC and BP sponsors who hate competition, then we get what we get. It is what it is.
Dr. M. is a cautious guy like any competent Bio person. He is sitting on a BTD which will change everything about medical practices, FDA methods, BP futures and, it will be demonstrated in a explosive manner when finally Retts trials done. He says the science predicts a certain outcome and it looks like he is right(we hope). Lots of nervous cats in the room full of rocking chairs.
can you say BTD boys and girls?
Penny, you have it exactly right IMO.
According to my model of the dynamics here there at least least 3 major variables. The media, politicians(politics includes FDA leaders until now) and science. I make no claims at being an expert in any of these areas, but that does not stop me from having opinions.
The FDA model of how the world works is about to get nuked. Change will happen at the speed of light. A2-73 will be an example and it's about time.
Penny..thx,
Could this explain some of our VERY quiet time????
sokol...excellent catch, thanks for noting. We know there must be closely held knowledge. Considering the potential of this information (expressed in $$$) it amazes me more has not been escaping. I prefer our quiet state to incomplete rumors being floated and bashed. It is the end of Q2 and 1/2 convention dictates there MUST BE SOME NEWS.
Raja...Sounds like a plan to me.
Skin...appreciate the new information. I would normally be unaware of NZ TV. If you have other relevant RGIN news pls pass it along. I do own a lot of this and hope it works out for all, including the patients who benefit.
Jimmy...Semper fi, well done.
Stop me if you have heard this before...medicalexpress.com 8hrs ago
Do you recall reading WHY any AD drug did not work, failed trials? I don't. We are told end points not achieved b/c patients did not respond...blah, blah..some died...move on, do not collect $$. Das Ende.
The difference of course is Dr. M. has said WHY A2-73 works in great detail and also why the same thesis applies in other CNS diseases. Others have said..."Well , the plaque thing did not work out...again"...99.4% of the time over the past 3+ decades, definitely not good. Trials and animal pre-clinical results do not contradict the "Why it works" story. So far so good. So, if one applied that logic to the "plaque thesis", only a fool would expect passing future trial results.
I would be among those who say that long periods of silence by Dr. M. are worrying. But, I take some comfort that no claims of proof the CNS cell Homeostasis theory is wrong have been made. Which seemingly would be easy enough to do, as I am certain Dr. M has studied before he went there. He says the science is there and most of the rest of the Pharma world is basically still saying the earth is flat.
I do agree with another posters suggestion here on why the silence on ANYTHING of consequence from AVXL. He suggests and I agree that AVXL are in final discussions/planning w/FDA/DC/2nd parties to begin fast-track/BTD trials and any hint/public statements would step on the process and break the trust. Re-watching the last Dr. M. show observing the throw away BIIB MS testing comment and other dismissive gestures helped me to see this point. Bottom line for me is until the BTD story is proven wrong I am a believer.
Attila...thx, what you describe makes sense as it fits the time cycle and the underlying sense that I have that the market does whatever it wants and that retailers like me are road kill. Appreciate the insights, I never would have figured the cycle out it would be nice if it turned faster though. What will happen if we get positive news over the next week or so before they finish their cycle. Will sp respond to news or follow the MM first?
Curiouser and curiouser , several of my Bio stocks have hit serious downdrafts starting last week before the options thing. Best feedback I have from an inside contact is wait a couple of weeks, things will get cleared up. Not suggesting THAT came from AVXL but from a credible source in a different Bio. Considering EOQ and end of 1st 1/2 are at end of June is anyone aware of any recurring market cycle that might explain the drop before an end of qtr. Are players getting sucked in to an EOQ news release scramble? Is this a shake the bushes scramble/exercise w/o news? Is this normal for all Bio's or is it my imagination? Lots of red all of a sudden with no direct cause in sight. Is this the establishment shaking out retailers?
I am and remain a believer. Just need calibration on timing, according to my clock we are soon getting into Q3 which is later than I expected based on milestones and other plans.
T-38 , agree with your process thought and suggest the debates on trial results, with all respect to process, miss the point of Dr. M.'s mission.
Dr. Peter Senge introduces the concept of "Mental Models". "“Mental models are deeply held internal images of how the world works, images that limit us to familiar ways of thinking and acting. Very often, we are not consciously aware of our mental models or the effects they have on our behavior” Each person here has posted their interpretation of results based on held beliefs (Mental Models), we all do this.
BUT, Dr. M. is not about this endless #'s debate. He knows there will be change. IMO he wants to have the process discussion on his Homeostasis thesis. While everyone wants to have a trials debate based on their own "Mental Model". He is saying if the H. story is proven true then the solution is always clear and no apples/oranges discussions are relevant. We do not need to spend zillions of $$$ and years of exhaustive trials based on historical models and methods. IMO, he is about examining the variables in well controlled trials/testing to prove the thesis. I think that his, " Tip of the iceberg" comment may be interpreted to have many possible applications. He is saying this represents the beginning/continuation of a learning process in medical science where the scale/scope of tests/evaluations is based on what it takes to prove a CNS point. He is saying we will apply newly acquired knowledge of Homeostasis in CNS disease context. Some pt's will/will not respond in the same time period or manifest as they will based on other variables, such as genetics.
As the details of results so far are debated by all the smart people here. With all respects would the CNS/investment discussion be better served by reviewing the real story and trust the expedited necessary trials outcome. The only real fear we have is will the thesis be proven wrong by contradiction, otherwise we are golden.
Slice...EXCELLENT POST...factual, positive, informative, rational, well though out, certain to give everyone something to feel better about. Please continue to contribute as possible.
"
Parse This...."“I am very pleased to be joining Anavex at this important and exciting time for the company,” stated Dr. Fadiran. “There are tremendous opportunities ahead, and I look forward to working with the Anavex team to deliver on the corporate objectives for 2017 and beyond.”
falcon, agree. I think There are many important variables involved in the model of Avanex's future. These include Politics (politicians)pushing FDA, the A2-73 science story itself (if Retts happens), BP's conflicting interests, FDA's ability to do a process change and chew gum, severe patient needs, precision medicine evolution unknowns, massive financial interests. This leap must be made, the existing processes by themselves will not get us to where society needs be in the time period required. If A2-73 does not do this then something else will. The media will play a key role.
Tred, if you called it right, that is the kind of hand you play to win. Read em' and weep, big P...now go do another zillion dollar plaque test run.
Well Kid...guess you will have to just wait and see. I think he just does not want to see the SP rocket to $1000 right out of the gate. Rockets are hard to throttle once they fire.
Apple...hope you are right. I have confidence in the team but some days it is tough. Can you say at milestones in particular that you expect to see action on?
I liked the way they were laid out and the emphasis.
Thanks Mike
I predict that AVXL and associated/partner firms have been working with the FDA on Rett, AD, PD, MS and other fast track trials to be executed during half 2 of 2017.
Dr. M. has been intentionally not dramatizing A2-73 results in his presentations to not compromise or call attention to ongoing FDA and partner )BIIB MS planning. He has said these trials will start shortly. I believe the only explanation as to how the hell that can happen is as described above. If I were a short I would be throwing up.
Thanks falcon.
I would also point out that we all understand if someone REALLY wanted to lie, make up research facts, present a false solution based on obtuse facts that they claim but which are truly FAKE, then they will. We all run a sort of micro mini risk assessment app when we see these things every day. No big deal. You either believe or you do not depending on your biases. Always try to keep an open mind.
If Dr. M was a complete liar then people like Adam F would be heros. The world is full of people who see absolutely nothing wrong with stealing. In fact most of the worlds population would kill the average American for his belt buckle.
Unless and until a scientific argument is made and facts are presented which contradict his A2-73 Homeostasis story I will remain a believer. The key word is contradicting.
IMO the days of massive trial and error testing are about over . Political, scientific and financial common sense will eventually prevail. Some day people will look back on this FDA trial and error process period as we look back today on surgery w/o even washing one's hands 100 years ago.
IMO, AVXL will be front runner with the new FDA quick turn trials process starting probably w/Retts followed quickly by Parkinson's, MS and AD. IMO, the template has already been built, BIIB is on board (maybe others).
Sitting around speculating/waiting for the old "do or die" trials routine is just not a good use of time.
"T"..my sense is that Dr.M. knows he has A2-73 results which should reset CNS pts natural cell self healing processes but that is only chapter one in his story. Even though we mortals would call that a life's work and miraculous, I predict not so with this process for him.
I do also think he has a deal w/BIIB on MS and adjunct A2-73 to salvage their work, as pointed out by Xena. Another poster here has pointed out that he stepped back from expanding in his slides on that so as to save the new CEO as a trusted partner. I agree, we'll see soon enough. If that is all true then it is another sign of integrity. We all win.
Why do some get AD and others not? People like M. do not simply accept what is. He is compelled to find out WHY what is, is. He has opened a door which he cannot shut. The genetic/DNA path is an obvious logical path to answer the why question. Will homeostasis bring everyone all the way back? If the answer is N then that will drive him nuts. IMO.
That kind of genetic patient selection is a doubled edged sword
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.
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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.