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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.
Right, each individual must make their own choice here.
My issue is M. has a particular management style which will not work where we want to go.(although we recognize it how the some manage in EU) While, yes he is the CEO and calls it as he wants, his acting like the silent giant on the hill has run out of understanding. My experience w/some EU management acting as imperial (do not question me) aloof paragons. Get over it, your style is open to question, start to ACT LIKE YOU HAVE THE GOODS. The silence thing is done, it is time to lead.
It's OK, you can do it, just lead. There are millions of sick CNS patients (Kids and adults) who need AVXL to execute. Do it.
Suggest you start w/IR. If I get a better answer I will post it here. Keep trying.
Hello longs, does anyone give any thought to “the tip of the iceberg” comment Missling has said in the past?
Hi Investor,
Re: the con call yesterday. What did I expect?
To me the science remain intact and increasingly supported. That the Aussie AD patients will now continue on A2-73 for an additional two years can't be negative. When was the last time patients, caregivers and physicians requested extended use of a Phase 2 AD drug?
Talon, Thanks for another great effort w/your post. I am also a believer but am running out of any PC/nice guy tolerance juice. If we do believe we have the goods (I do think it is at least possible) then we HAVE TO ACT LIKE IT.
Millions of people around the world are suffering some kind of lousy sub life existence with a CNS disease that we may have the (at least partial) solution to. it is time to do an attitude adjustment at AVXL. I get the fact that many factors are at work, including huge powerful anti-AVXL Big P. who would like to see AVXL decompose right now. SO WHAT?We are on short final.
In case we had not noticed, PC has very limited efficacy. Dr. M. needs to put his big boy pants on and execute. I was unhappy with the last con call and would hope that many others will contact him directly to express their position. I am not talking about 24x7 whining here. We cannot accept that kind of con call performance.
Thanks for the effort....whatever works...it is time to get a little pissed off.
Con Call was not what I expected today. I think he has the goods and that AVXL is a solid investment although it is an adventure. If I did not think that I would be gone.
try mailing them in. Tell them we were not able to get on the link.
Upcoming technical conference?
Thoughts? What? when? where? Why?
He sounded enthusiastic on the marker info they have at least.
Biostock...excellent message.
People know the difference. I think the continued desire for this drug is far from haphazard behavior. Time matters to people who are suffering from an incurable state of dementia with all the savage concomitant symptoms and decline.
At the very least some would spare their family members from going through the motions.
If these trials we are designing continue to compress into two highly precision designed 12 week trials, we are off to the races when they start.
This post by Rubyred shows everything we need to know about where CNS trials are going. All we need to do is read and map the new process guidance to AVXL trials plans. The great opportunity that Dr.M. has today is to show some of the link applications.
http://www.pharmexec.com/fda-moves-overhaul-new-drug-review-process-0
Commissioner Scott Gottlieb similarly highlighted how OND modernization will help FDA adapt to important scientific changes in medicine. The overall aim, he explained in a keynote speech at the FDLI meeting, is to better align new drug development and review with new types of medicines designed to target molecular changes that initiate disease, and “not just the symptoms of illness.” This shift will require new approaches to documenting and evaluating applications, including a team-based review process that brings together staff with expertise in areas such as statistics, modeling, simulation, and advanced manufacturing to assess novel trial designs and drug development approaches.
“We want it to be easier to innovate the way drugs are developed,” Gottlieb commented. Our professional staff members are “thought leaders in their disciplines,” he observed, “and we want to give them more time to collaborate with academic medical scientists and patients, to analyze scientific and commercial developments, and to strategically foster drug development.”
New templates
The process for documenting reviews will be revised to highlight issues and data of greatest importance, while also reducing the sometimes-redundant memos generated by multiple review processes. Woodcock noted that CDER staffers are developing a new template for documenting multiple aspects of a review, including toxicology, clinical pharmacology, and clinical review.
A new Office of Policy in OND will play a key role in developing more consistent policies and procedures across disease areas, Woodcock added. This office will facilitate the development of more “bullet guidances” that provide short, timely advice on specific topics involved in developing certain therapies. Such guidances are faster to draft and to finalize, and CDER hopes to issue 30-40 such advisories a year.
Gottlieb further described the OND changes at the annual meeting of the Reagan-Udall Foundation the next day, noting that he expects CDER to begin unveiling these initiatives by the end of this summer. The OND reorganization will establish more focused therapeutic divisions, he explained, such as separating the current Division of Gastroenterology and Inborn Errors Products into divisions for gastroenterology and for liver disease. He also anticipated that a common review template would reduce the multiple memos developed by each review discipline.
pineapple...my pleasure. If he responds to any of those questions (particularly #1) we should/will see a pop.
Going all in
My Questions:
1. Compared to previous FDA guidance, describe in detail how the new FDA precision science process rules have impacted/influenced the A2-73 trials structure, metrics and planning process milestones for RS, AD, PD.? (eg. Timelines, metrics, including measurement devices/tools, RWE guidelines, pass/fail criteria).
2. How and How much will AI be used in planning, conducting and measuring trials results?
3. What specifically will you evaluate to validate that the claim of CNS Homeostasis restoration has been achieved with A2-73?
4. Do you have specific CNS cellular restoration or regeneration targets?
Just because someone is disabled doesn't mean they are stupid.
Trust the process, even though it can be frustrating.
GrassyKnoll...many of us have had similar experiences in business and also with regulatory bodies. The entrenched resistance is everywhere, usually taking strength from each other/the herd . "They have seen them come and seen them go" crowd. The resistance to change in such cases is real and is HOW things are done, unless they are eliminated. I would like to think that Dr. G knows all about them as he seems to have given them fair warning.
Daily decisions on what and who gets resourced are controlled by the "System" in such instances. The in place system is run by names and powerbases. Names are often the old school who established and live off the existing processes, they control from behind the curtain. They will run into a wall if Dr.G just shatcans the existing stuff. Powerbases are connected silos where budgets get approved and where people go to get favors and make deals. We all know that some variation of this model is how the FDA also gets things done.
Signs of change are easily detected as published in recent mass old FDA school turnovers by those heading back to BP's. Rewriting the FDA processes based on "Precision Science" requires some new thinking and someone's going to have to throw their weight around. Old timers are not stupid enough to piss off the new guy while they figure out what works for them. Trouble is we do not have time and they better get their asses in gear now.
If AVXL can send some kind of new science message to give the establishment something to hold on to then they will all switch overnight and become precision science advocates, overnight. (insert binary event here) Timing and power base moves will be visible to the outside world. Top Down decisions are getting the ball moving. it looks real to me at this point.
This has also provided cover for BP to abandon (except BIIB) AD trials based on Amyloid...
This shift to smaller review divisions should reduce bottlenecks in the review process, she explained at the annual meeting of the Food and Drug Law Institute (FDLI) last week in Washington, D.C. An OND reorganization steering committee heads up the effort, and, she emphasized, the review program modernization effort is “proceeding according to plan.”
Commissioner Scott Gottlieb similarly highlighted how OND modernization will help FDA adapt to important scientific changes in medicine. The overall aim, he explained in a keynote speech at the FDLI meeting, is to better align new drug development and review with new types of medicines designed to target molecular changes that initiate disease, and “not just the symptoms of illness.” This shift will require new approaches to documenting and evaluating applications, including a team-based review process that brings together staff with expertise in areas such as statistics, modeling, simulation, and advanced manufacturing to assess novel trial designs and drug development approaches.
ihidfromthex...
then there is the resist to change within the organization which slows down the processes even more.
Anyone trying to get work done while an org is in the middle of major rethinking is going to have to wait. Typically, no one will move until done. Thx Ruby...
[quote FDA Moves to Overhaul New Drug Review Process
May 07, 2018
By Jill Wechsler
Pharmaceutical Executive
To better manage a growing number of applications for new drugs that treat disease in innovative ways and involve new kinds of clinical research programs, FDA officials are mapping plans to restructure the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER). A main goal is to “flatten the organization,” explained CDER director Janet Woodcock, with more reviewers authorized to make decisions on
Jill Wechsler
review findings. This shift to smaller review divisions should reduce bottlenecks in the review process, she explained at the annual meeting of the Food and Drug Law Institute (FDLI) last week in Washington, D.C. An OND reorganization steering committee heads up the effort, and, she emphasized, the review program modernization effort is “proceeding according to plan.”
Commissioner Scott Gottlieb similarly highlighted how OND modernization will help FDA adapt to important scientific changes in medicine. The overall aim, he explained in a keynote speech at the FDLI meeting, is to better align new drug development and review with new types of medicines designed to target molecular changes that initiate disease, and “not just the symptoms of illness.” This shift will require new approaches to documenting and evaluating applications, including a team-based review process that brings together staff with expertise in areas such as statistics, modeling, simulation, and advanced manufacturing to assess novel trial designs and drug development approaches.
“We want it to be easier to innovate the way drugs are developed,” Gottlieb commented. Our professional staff members are “thought leaders in their disciplines,” he observed, “and we want to give them more time to collaborate with academic medical scientists and patients, to analyze scientific and commercial developments, and to strategically foster drug development.”
New templates
The process for documenting reviews will be revised to highlight issues and data of greatest importance, while also reducing the sometimes-redundant memos generated by multiple review processes. Woodcock noted that CDER staffers are developing a new template for documenting multiple aspects of a review, including toxicology, clinical pharmacology, and clinical review.
A new Office of Policy in OND will play a key role in developing more consistent policies and procedures across disease areas, Woodcock added. This office will facilitate the development of more “bullet guidances” that provide short, timely advice on specific topics involved in developing certain therapies. Such guidances are faster to draft and to finalize, and CDER hopes to issue 30-40 such advisories a year.
Gottlieb further described the OND changes at the annual meeting of the Reagan-Udall Foundation the next day, noting that he expects CDER to begin unveiling these initiatives by the end of this summer. The OND reorganization will establish more focused therapeutic divisions, he explained, such as separating the current Division of Gastroenterology and Inborn Errors Products into divisions for gastroenterology and for liver disease. He also anticipated that a common review template would reduce the multiple memos developed by each review discipline.
Such a broad and complex reorganization of this important CDER operation, involving the formation of new review divisions and a new policy office, will take time to move through the formal federal government review process, Woodcock pointed out. Yet, she and her staff have orchestrated such restructuring efforts for generic drugs and for drug quality oversight in recent years, and she anticipates a similarly successful modernization effort for the new drug review process.
][/quote]
THAT, BOYS AND GIRLS, is LEADERSHIP....also code for delays
It looks like we have been especially blessed here starting last week and building today. These people have not taken the time to understand their opponents (longs w/impressive credentials who are serious people). Too bad as Musashi would they have chosen badly.
The recent new offensives are obvious and may indicate a change. Longs, study your art well.
CONCLUSION:
Sig-1R agonists have been used in the treatment of different neurodegenerative diseases, e.g. Alzheimer's and Parkinson's diseases (AD and PD) and amyotrophic lateral sclerosis. Utilization of Sig-1R agents early in AD and similar other diseases has remained an overlooked therapeutic opportunity.
the state of the Pharmaceutical industry today
F1ash' Thanks for your informed/value added ref and the link.