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Moving forward and looking better with each passing day
Exactly correct. Would like to think AVXL team has done sufficiently complete Genomic analysis of the Aussie trial patients thereby providing evidence in retrospect of who responded and how much. Even the precision medicine differences between those who responded robustly and those that responded less becomes critically important going forward. Knowing the exact differences between these distributed populations may be possible and may be critical in CNS diagnostics going forward.
IMO, we should also note the references made about continuously improving Aussie patients. Not much has been mentioned here on this topic but it is possible and additional extension of the trial w/all involved is a good sign. So to speak, that is the opposite of the Amyloid AD efforts of the past.
running with those index funds selling, don't like it much.
Well bud, get used to it. Any assessment of AVXL science and history shows green. I would like to think that our worst days are behind us. I am certain we will not end as the FDA/BP have on the Amyloid trail where they discounted contradictory evidence for years. All the best.
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.
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.
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.
11:15 GLOBAL THINk Must be a mistake given Anavex is a one man company. Ahhh-Yes, but it is a Precision Medicine Mistake.
K TANK Brainstorm Challenges and Troubleshoot Solutions for Global Managed Access Programmes Moderator: Brian J. Fisher Vice President, Operations and Corporate Partnerships The Sturge-Weber Foundation Panelists: Patrick Hopkinson Executive Director, WWHEOR Markets Bristol-Myers Squibb Pharmaceuticals Stephan Toutain Senior Vice President, Operations Anavex Life Sciences Corp
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.
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.
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.
So that my comments are not misunderstood. I think I am not qualified to judge Dr.M.'s competence as the AVXL CEO. But, if I had to I have said he has performed brilliantly as the CEO.
My point/observation is based on many years of working directly with multiple German BP CEO's and their staffs. Any one who has spent time doing such work will tell you that German top management does not do help well. Not positive or negative, they do not do help. That is the style they have been trained in and they execute accordingly. No one near top management will seriously question/argue very long, they find a way to get along and are exceptionally loyal. On the other hand there will be strong respect shared for technical talent and knowledge. Credentials really matter.
The distinction is clear. Doing business interfacing with the FDA is a big challenge for and/most CEO's and staff. Americans have learned how to bend and make deals and stay cool when it is not going their way. The FDA has for the most part has taken a position that they must inspect and approve what is done before any device or pharma/bioscience will be approved by them for sale in US. This is changing/evolving a little in last 5 years or so but old ways die hard. (see MDSAP)
Dr.M. may/may not be more open than some to influence. This is not a criticism as much as it is my rationalization for why AVXL staff are so low key with some very important information. They are sitting on a gold mine of information. I think, he knows they have the goods and that he will let us all in on it when he thinks we are ready. If I were on his staff I would encourage him to find a way to get comfortable with the concept that "half a pie is a lot better than no pie"....prove the concept then the FDA system will find a way to work with him. The FDA needs wins as much as anyone.
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.”
Excellent, this is a perfect example of what I have been looking for. Also, at some point someone has to point out that NO ONE HAS EVER (fill in the blank). Now that gets support from even the most cynical.
Anavex is leading down the same path that has shown success in onocology....exactly what we want investors to be aware of. No risk, just facts.
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.
Hello longs, does anyone give any thought to “the tip of the iceberg” comment Missling has said in the past?
All the time, would be my response. Also note the new just posted by Xena as a potential example of this concept. I also see A2-73 as a potential "REBOOT" for each patients CNS disease.
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?
Agree, we have evidence the science is effective w/trials information and any/numerous academic and med pub articles, not one of which contradicts our claims. We have humans who are willing to testify, let them as RWE.
I expected AVXL to project a positive-take the hill attitude. We know there is work to do and we daily get our ass kicked by the statistical morons who point out the size of the trial. Kick back, no one has ever, ever done this before. If the facts are there then use them. No more deferring to some process political BS.
That is a hint at what I expected. Stop being so nice, people are sick and dying. Go kick some ass.
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.
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.
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.
In the FWIW dept.. Not long ago during a 1x1 conversation w/the previous PR spokesman he mentioned that, not only were the Aus. patients still using A2-73 but some impressive results were being reported anecdotally. I do not want to repeat what he said to me b/c it might inadvertently misrepresent what he was authorized to say. Good news.
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.
IMO, we need to keep another factor in mind. If trial results show effective treatments for CNS diseases which have NEVER been treatable then a serious discussion on the validation of restored Homeostasis and it's consequences must follow. HHYYYUUUGE.
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.
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.
IMO, if there are links to new processes at work then Dr.M. has been given the license here by Dr.G. to expand on them as context presents an opportunity.I would like to think that these guys are really that good. We'll see, if the links are there they should jump off the page at us. They could not really come out and say that just about everything the FDA did in the CNS disease space for the past 2+ decades was very sloppy and produced almost nothing considering the massive investments made. But, we all understand that in the not too distant future it all will become painfully obvious. In the meantime all the attack dogs criticizing lack of progress to a set of rules (which they do not recognize have already been shatcanned) will need to develop a new line of metrics on why things are screwed up. Good luck w/that. My suggestion is to mark this down as a learning opportunity and move on.
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?
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.
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