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The share price will be higher than it needs to be to stay above the Russell 3000 requirements by May 31. It is the reason for any promotions and buy ratings
Right to try sounds plausible, in particular for CNS diseases as long as FDA controls/facility licenses (define, document and do) on where and how drugs are made are still effective.
http://thehill.com/policy/healthcare/388871-house-passes-right-to-try-sends-bill-to-trumps-desk
This will indeed be a TIDAL WAVE, with success!!
from georgeiil Thursday Jun 07, 2018
9:00 AM 10:15 AM
Exposing Cracks in the Armor of Brain Diseases
Speakers: Christopher Missling,Dr. George Vlasuk, PhD,Dr. Jeff Gulcher, MD,PhD,Dr. Martin Tolar, MD, PhD,Mr. John Alam, ACHA
Brain Health Room 255, Level 2
Bios...great post, thanks.
Incidentally, the dichotomy between the two is even apparent on the message board as some see this investment through the lens of a business which should already be churning out profit and releasing PR’s every week or two, while others see it as a a medical entity attempting to produce a solution to multiple devastating diseases whose time will come when all things are in place.
Roger that Talon.
After Looking closely at the Precision Medicine model w/new IND C/l requirements we can see that someone has been asleep in the tower for a long time. I am no expert but it is actually embarrassing when you look at how they processed the trials. It looks like they were watching for something to produce results which (I guess) could then be universally analyzed/applied to some population of AD patients. They literally had no idea what the treatment process would produce. They all did more or less the same thing. So, a lot of AD patients got "treated", some had brain bleed, some had swelling, other reactions but not one ever recovered.
I agree w/you that Dr.G. has at least stopped the train. How he did that so effectively and quietly w/o one word of wonder/question across so many massive news/political, Medical PR's, pharma organizations w/ so many people impacted is impressive. Only now, months after they called it off, are we seeing the occasional (saw one here yesterday) news piece on the failed Amyloid plaque thing. Wait a minute, we just spent a decade ++, spent Billions of $$$, sucked up FDA resources, BP talent/resources WW, thousands of AD patients/w/families (at least DEFCON 3) and all they have to say is ..."Never Mind". Part of learning involves failure analysis and discussing what DOES NOT WORK. It's called readiness training. Kicking ass works even in our new PC world.
Thanks again for your Air Force service, great pass.
What is precision medicine?
According to the Precision Medicine Initiative, precision medicine is "an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person." This approach will allow doctors and researchers to predict more accurately which treatment and prevention strategies for a particular disease will work in which groups of people. It is in contrast to a one-size-fits-all approach, in which disease treatment and prevention strategies are developed for the average person, with less consideration for the differences between individuals.
Although the term "precision medicine" is relatively new, the concept has been a part of healthcare for many years. For example, a person who needs a blood transfusion is not given blood from a randomly selected donor; instead, the donor’s blood type is matched to the recipient to reduce the risk of complications. Although examples can be found in several areas of medicine, the role of precision medicine in day-to-day healthcare is relatively limited. Researchers hope that this approach will expand to many areas of health and healthcare in coming years.
https://ghr.nlm.nih.gov/primer/precisionmedicine/definition
Precision Medicine and the street? CNS disease complexity? Now What?
Now that the established research models for how to invest in CNS treatment Pharma have been nuked what are the street investors going to do? The IPO float/scam guys have to re-tool. Sad isn't it? BP's exclusive hold on max (n) trials w/massive $$$ WW sites and secret handshakes is ALL GONE. A game that only the privileged few could afford.
As far as we know, Dr. M. has been on the ("NO REALLY", FIND OUT WHAT CAUSES IT) trail for a few years now, while the rest of them were redefining their statistical model rationalizations. Then some fool in Oncology started a new process concept and (what do you know) it worked. (much to the concern of the toxic chemical/radiation bombardment crowd).
Precision medicine suggests the clinicians spend time to actually research what gut genom/environmental/other causa links exist. Then, after narrowing the chase, target specific patients based on science, not shot-gunning. The questions then become not "IF" the treatment works at all but "How on many patients". Ensure the study presents evidence of efficacy? Not IF but WHEN.
Will the STREET systems actually allow such investments to even happen or will they be compelled to JUST GO BUY or ATTACK?
We'll see. In my opinion, that kind of process is what we will see. How will it play out, what will it look like? Look for change everywhere. As Musashi would say, "the Pen and the sword, in accord."
Not clear how we will know who is on first in this new model, we can say that change is happening though. The FDA should lead but I doubt they will. The good news is, the bad old days in CNS disease treatment development/research are likely gone. Change cannot be too soon for many.
Missling is getting cement overshoes ready for his opponents. The scientific evidence will be irrefutable in the end.
Powerwalker...
Also, might the MSM not want Anavex (with its safety and efficacy) to be known to the public because the public might demand immediate access?
[quote Let us all hope through change at the FDA, drugs from Anavex, and increased personal responsibility that we can start to reverse the downward trend in the cost/average age @death curve. ][/quote]
A number of people on this thread present a theme which I happen to also agree with. The FDA represents the healthcare "system" for lack of better term. An old Irish expression comes to mind when I think of the system after listening to the long text of everything that might go wrong (i.e., AE commercial labeling is laughable if it were not so serious)when using pharma products. Try this instead," Unconstrained by knowledge we moved on.". In spite of the best efforts of some of the smartest people on the planet, the system must be fed. The system uses and produces money and it is not a perpetual motion device. The curve that Xena posts on life expectancy in U.S. vs. cost is telling us that if that is the metric (I believe it might be) then the system has failed badly. There must be a better way. Who will declare that and when? Then what...take no meds?
Just maybe, somewhere buried in Dr.M.'s thesis on (re)establishing CNS cellular homeostasis the truth will surface from the wasted efforts and on AD and other CNS diseases. Wouldn't it be great if we learned that in all the possible subatomic/microbiologic combinations and permutations re-establishing cellular homeostasis is the solution and AVXL has such available now. No wonder BP and the system are scared, they can see it coming.
Or postponing the bad news till they can follow it quickly with partnership news to negate some of the effect.
treden...agree w/your sentiment and w/your thoughts on how the FDA-BP system works. Not sure how it explains the cost/average age @death curve.
I have close relatives who are very familiar w/the cycles in DC and w/personalities. Let's just say the original design plan was for these people to go to DC for a couple of cycles and then go back to the farm. But, now when they get to DC they quickly learn it is the BEST GIG around and they hang out for decades. All of them seem to acquire great wealth somehow in the process. Beyond just good luck many have attributed their genius for wealth to getting and using good investment information.
I also see the president as you described him, he is kicking axx and they cannot stand it. Anyone who has ever worked for a living understands his actions pretty well. Let's hope he cleans the place out.
OK...fare enough. I have some personal evidence I will review for possible linkage. Until then, delete as appropriate.
Not at the moment...will look and let you know. My example referred to reported practices in Canada and obviously anecdotal V.A. reports in U.S..
Rubyred--Thx
Although the IRB must follow written procedures for functions and operations specifically described at 45 CFR 46.103(b)(4) and (5), and/or 21 CFR 56.108(a) and (b), there are other IRB activities that require findings and determinations for which the underlying regulations do not explicitly require the IRB to follow a written procedure. The Checklist includes footnotes that identify these underlying regulations, as well as other relevant regulations that we recommend institutions and IRBs consider when preparing written procedures.
For example, an IRB that reviews studies involving children must follow the regulatory requirements for additional safeguards for children at 45 CFR part 46, subpart D, and/or 21 CFR part 50, subpart D, and approve only those studies that satisfy the conditions of all applicable sections of those subparts. Although the subpart D regulations do not explicitly require an IRB to follow a written procedure for review of studies involving children, OHRP and FDA recommend that written procedures for the IRB address the review of such studies (see recommendation #10 in the Checklist under the regulatory requirement regarding written procedures for conducting initial and continuing review).
Thanks for the information. My first read says cost of U.S. Healthcare and efficacy do not compare favorably many other countries. Could it be that making someone wait for 6 months to get an x-ray is simply good financial management practices? Are we overly cautious?
This chart is mind blowing. If everyone is measuring the same thing then we got a YYYHHHUGGGEEE problem in U.S.
Moving forward and looking better with each passing day
samk...NP...BTW, whoever set it as a sticky (Likely Xena) gets the credit.
https://www.nbcsandiego.com/news/local/Illumina-Buys-Edico-Genome-for-100M-482807301.html
check out who Illumina just bought 2 days ago, like to think this will help Avxl move quicker.
running with those index funds selling, don't like it much.
Bios...Thanks for your service. (hate ice)
I am also an ex Navy aviator.
As we get ready to launch everyone will feel the ship heel over (10-20 degrees) as it turns into the wind to get requisite wind over the deck. The entire ship (all xxx,XXX tons) vibrates under foot as everyone on the ship knows..."Game On".
sokol...this is an example of a leadership thought...commendations to you. Older people being warehoused in care facilities is not a priority in our society. This while our current thinking treats illegals/homeless/etc. as another form of entitlement.
Maybe more old people will die being independent and active rather than wasting away in a care facility. If aging is recognized as a disease (and it should be), the medical community should be taking a close look at the drugs Anavex is developing to treat that disease.
Just in case you missed this...read it and imagine what we are about to witness. Posted by Biostockclub on 2/16/18. Enjoy.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=138624771
Not our first rodeo. Just in case anyone would like to review the conference-publication history of (5yrs or so) Anavex do a quick review. Not a flash in the pan. One might look around for comparable history from any microbio.
http://anavex.com/category/anavex-2-73-publications/
Let's get past $3.00 before we start quoting $10.00 share price. Missling can't even get us to three, much less ten.
HUH? Just one of those routine days where volume is up 3-4X normal and sp jumps by XX%. Now we get back to about $10 where it should have been all along.
Have a good one everyone.
Maxim group raises PT from 5.00 to 7.00
https://www.benzinga.com/stock/avxl/ratings
Kevli33 thx...we have been in need of news like this..BR
Results will be announced June 15 and go into effect June 22. If AVXL is deleted from the R3K as I have predicted,
Excellent resource ref. Thanks again Xena.
All of this new trials thinking is of course in recognition that not one effective CNS disease treatment has been developed by the FDA or BP. To put a positive spin on it one could claim that they have proven that unless effective science is being evaluated the statistical modeling is meaningless.
If Dr.M. can present a science case for A2-73 w/biomarkers based on Aussie trials or other science (gut for example)we are golden. If not, we are stuck in the vacuum created by the FDA-BP star implosion along w/every other loser. Desperate is not too big a word to describe the WW CNS disease situation as I see it.
To be positive about this, the bar could not be set any lower.
https://alzheimersnewstoday.com/2018/05/14/failed-verubecestat-trial-in-alzheimers-patients-may-call-into-question-beta-amyloid-theory-study-suggests/
Ya Think, maybe the causal relationship was just missing? It went off as a gas. After decades and billions being spent and many sick patients being "treated" the statisticians have concluded...."Never mind".
The real issue here IMO is the time that has been lost.
This process has clearly been broken for a while. Let's just hope that the same people who screwed that up are not in the way of A2-73 trials.
Interesting quote from billionaire Ron Baron about his investment in Tesla, which kind of reminds me of my investment in AVXL:
If we are correct, they are managing a fine line. It looks like he has set a plan that includes collaboration w/a very few selected-trusted bodies, some 3rd party (RS-Lund-others). Demonstration of clinical concepts using AI and the validation of the homeostasis thesis could occur in one sequence of selected planned and sequenced trials. It is obvious but worth noting that RS-PD results may present dramatic changes in patients in minimal et.
He does not need or want a cast of thousands around him in order to succeed in the next stage of development/proof. In fact a bigger cast adds weight but not lift. The dark side of that thinking is it takes longer to get things done w/thin resources, hence the need for silence I guess.
We will probably know before the fall time. Semper fi.
or an autocrat who has to do things his way which implies he can’t work with others.
And so we are using really the same path of clinical study of [rigor] to applying to the CNS indications Rett Syndrome, Parkinson's with dementia and Alzheimer's disease, which so far has been only applied to oncology and that's also something which Anavex believes is at the forefront in that regard.”
OK, we have different opinions. NP. I have in the past judged silence to be appropriate if avoiding legal attention required such. Silence can also be read as..."I'll do this MY WAY". He calls the shots at AVXL. Being open and demonstrative about the Aussie extension would be an example of no risk-WELL DONE- message that should be emphasized.
I believe we have the goods and will succeed but the sp dragging along the bottom needs help which he is best positioned to provide.