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I also own NVIV. What news is there? Nothing obvious. AVXL will have it's day, soon I hope.
agree 100%
Some one should do some thing......
HUH..small world...
United States House of Representatives Special Committee on Un-American Activities (the "McCormack-Dickstein Committee")
The longer people live
They are still going to get sick.
IMO - that is why Anavex has in international footprint
Excellent observation
Riddle me this: If your own personal well being and your massive personal fortune were dependent on the Healthcare "System" continuing to FUNCTION as it is then why would you want an effort like this one to even exist, much less succeed?
Who is responsible?For example, we have laws to watch/prevent monopolies in communications. Can a small company with the possible no risk solution to major health costs ever get through the swamp? What if some fool proves they can actually treat CNS diseases when such treatments will nuke a big part of existing medical system revenue generators?
If the spending for military over the past 50 years had been used as effectively as it has been for healthcare and entitlements we would all be speaking Chinese right now and eating worms.
Ask yourself: just exactly who gets fired if no effective CNS disease treatments(AD/RS/MS/PD...) are developed over the next 20 years? Answer-NO ONE. BTW, in case you had not noticed, the ROW looks to U.S. for leadership, whether they admit it or not. WE OWN IT. My bet is this IHUB board is the closest you will find to a leadership focus in the universe, since the first step in solving a problem is recognizing that one exists.
ENJOY:
Once again I predict genomic markers will relate to the many genes with potential links to AD pathophysiology and not 2-73 pharmacokinetic-specific activity. I'm sure they'll have some nice correlations and associated tasty p-values for the unwary. I'm also sure it will all be BS.
https://endpts.com/two-more-top-fda-officials-hit-the-exits-as-an-exodus-of-senior-regulators-continues/
Cannot help but think the revolving door in FDA management is also a factor in apparent inability to get decisions and trial process support. They have been in the middle of significant process structural changes now for months. We have seen multiple BP's pull the plug on major initiatives they have had for years (AD) closing facilities and just seemingly walking away. WTF?. New trials protocol process rules are in flux or at least that is how it looks. AVXL has no sponsors in the room thx to the whole IPO-massive undetermined corruption links. We do not have to geniuses to figure out the consequences of chaos (must be playing out). Restructuring will be working the rounds of trials changes which will most likely reset the entire CNS drug approval process (IMO). No one spits in this country unless the FDA approves it and then relabels it, again and again following repeated AE reports(never mind). Evidence of past irresponsible decisions are everywhere.
My question is when is DR.G. going to do/say something definitive about the plan/schedule/rule set and roll out issues. Are we all supposed to sit around and act like everything is cool when it obviously is not. No wonder Dr.M. linked w/other countries he could but mark this post b/c until the FDA gets it's shat in one pile nothing of consequence will get done WW. like it or not the FDA is the gold standard and my frustration is running high.
Me either, but that is how I read it. Cellular Regen and recon is what the man says A2-73 does do. Thx.
Either inject stem cells periodically or w/A2-73 you can just GROW YOUR OWN.
Can you imagine how deep the hole is that BP/FDA/NIH and others have put the pharma development process in? All these execs bailing out according to the links posted earlier is evidence of the periodic BP-FDA recycling we have seen in the past. Well, at least they finally stopped digging.
The good news might be that any promised use of AI tools to manage the protocol and logic will require hard data and traceable inference links w/logic. Science matters. It looks like Dr.M. and maybe a few others are the only/best CNS game in town for now. If this is done correctly they will be able to quickly identify marker links to avoid repeated CNS unintended consequences by using a continuously growing scientific body of knowledge and RWE.
They should also have insights into what does not work and, with any luck, why it did not work. They need to quickly catch some breaks here to get this thing going. Right now I get the sense many BP are deep in their foxholes after the Amyloid washout. I still get the sense there is a lot more to this than we will ever know.
Alzheon steps back from an IPO, further than ever from a PhIII Alzheimer’s study
by john carroll — on April 27, 2018 01:16 PM EDT
Alzheon won’t be profiting from an IPO soon.
The tiny biotech, which has been trying to fund a late-stage trial for a once-failed drug called ALZ-801 (tramiprosate), notified investors on Friday that they’re postponing the IPO they filed in search of about $70 million or $80 million, according to an alert from Renaissance Capital.
We’ll have to wait and see if they try it again.
Martin Tolar, Alzheon CEO
Alzheon’s timing was bad. Its strategy involved getting an amyloid beta drug that had failed at Bellus, then relying on post hoc analysis to spotlight a success in a subset of patients with two copies of the APOE4 gene and better trial design to argue they had a shot at winning the lottery in Alzheimer’s.
After 15 years of near universal failure with nothing on the market to influence the course of the disease, a win would be worth a fortune.
eagle8...the point is... "watch your six"....b/c no one else is.
My simple model of what Dr.M. is saying is the answer to this tremendously complex CNS disease mess is...untangle it by getting back to basics. We better hope he is right.
An observation...assessment:
The recent back and forth started by Firemen's note on his MOM's RA presented an interesting high level view of the healthcare/pharma/patient/regulatory universe. IMO, we have a mix of well informed/independent thinkers here who are not at all impressed with the state of our current (WW) healthcare system.
I have spent 20+ yrs doing investigations of WW supply chains Pharma/medical devices/H/W-/SW (sand to finished products) and I can tell you it ain't pretty. I am scared shatless of how hospitals do things. Our family have great GP but he is the only strong link in my own H/C system.
After reading people's stories and putting a few facts in place w/links like the recent one from CNN about known significant pts losses being ignored by the system, the inference being it's all about money. Inputs from So many skilled and informed people here, you know who you are. Thanks. Stop and look around. The system is broken.
We better hope Dr.M.& G. and co. are able to lead/pull this one off and any others like it b/c if we have to depend on the existing healthcare system(BP-WS-FDA-other) we are in trouble IMO. Someone better start to call it the way it is or it will not be fixed properly.
All the best.
Thanks. I have recently started taking D3 and agree it has been a positive step.
Have you found anything for relief for your RA?
I am also expecting a hook up with either Takeda or Eisai for manufacturing and trials and distribution in Asia
Anavex 2-73 supports holistic self healing.
BIIB interests might be different if they turn on their TV or read a MAG/PR. NUPLAZID got some splainin to do...
http://www.wpsdlocal6.com/2018/04/25/fda-re-examines-safety-of-new-parkinsons-drug/
Xena...Commendations for excellent insight and follow up on this.
I was once involved in a consent decree follow up where pts were being overdosed by a device which had a fundamental design flaw (missed during reviews and then denied by management). Bottom line is, someone always knows but has to decide to keep their mouth shut (or else). A part of the management rationale was ... "these people were old/very sick and their deaths were not directly caused by the device...prove it.?"BTW, the company leadership were sued.
Rubyred, Thanks for posting this link. It is truly amazing and serious stuff. Comments on the efficacy of current drug acceptance processes and adverse event reporting process, including BP/FDA corrective action effectiveness. Dr. G. inherited a mess.
If this kind of information gets widely reported there will be consequences. A MUST READ.
http://www.wpsdlocal6.com/2018/04/25/fda-re-examines-safety-of-new-parkinsons-drug/
Thanks Xena. These are amazing statistics.
The researchers found that people who used certain types of anticholinergics, such as those used to treat depression, Parkinson's and urinary incontinence, for a year or more had about a 30% increased risk of developing dementia down the road.
(CNN)Many older adults know that long-term use of certain medications can negatively affect cognition and increase one's risk of dementia.
Xena-Investor 2014. It looks to me like Doc has called a DOUBLE DOG DARE ...on the debate. Impressive as it was, hugs all round.
11:25 eastern time 04/26/18
Empowered educated patients influencing pre-clinical development and working with industry to optimize drug discovery
Rare Disease Advocacy World
Patient groups role guiding research, disease understanding, supporting pre-clinical development and follow up experiments
Driving translational research and the influence on formulation, routes to delivery and overall clinical development
Effective partnerships between advocacy and industry to expand collaborations that can support enrollment and physician engagement
Christopher Missling,
President and CEO,
Anavex Life Sciences
Steven Kaminsky,
Chief Science Officer,
International Rett Syndrome Foundation
What happens if the EU adds conditional approval for Parkinson's shortly afterward?
Biostck wrote:
McMagyar,
I agree with your posts this morning re the line of thinking that the Parkinson’s trial should be our main focus, now that it will be concentrated on Parkinson dementia as opposed to motor skills.
Further, you are correct that a “win” in that trial will reveal the vast majority of the iceberg which lies beneath the surface of the “tip” which we all have our eyes trained upon.
McM wrote:
Many positives relational to clinical participants and clinical success for Trial targets..
Often times it’s not the answer to the question..
It is WHAT is the RIGHT question!
It's not IF, But WHEN. Transition our thinking.
We can move on from will A2-73 be effective to WHEN A2-73 is finally introduced to the world. Why it is effective will also be important but for now it is all about when (how).
Posts by some # 145269(sticky), #148653 JJ, many others to include Falcon t-38, Investor 2014, Xena and many others present the evidence well. I also believe that DR.M. has correctly identified our biggest risk to retail investors and is working it, that being an AVXL take over by unfriendly forces.
I suggest we consider the transition in perspective from NOT IF we succeed in CNS trials and all that follows but WHEN will that and other developments play out. The terror of CNS diseases will be scientifically resolved, patients will begin to recover. That fact is what is not playing out. There is no scientific contradiction. Hang on.
Jon, thanks again for an excellent read-back of what is going on. Yes, of course this kind of investment is all about trust-belief. Dr. M.'s action are saying...trust me, we have the goods.
When all this starts to become more obvious (will not be flawless IMO) AVXL patients/results/data will speak for itself. Statistical rationalization will be minimal or as required.
Thanks again for your excellent perspective and explanation.
Yep, haven’t been locked up - yet!
There has been hardly any silly posts today - bit worrying
perhaps everyone went out to find more money
http://www.terrapinn.com/conference/world-orphan-drug-congress-usa/speakers.stm
Dr. M. identified as a speaker in this PR. I guess panel participant and speaker mean the same thing. In any case the possible opportunity for any trials status review is still notable.
IMO, this talks to the level of desperation PD patients are living with.
https://www.gocovrihcp.com/moa/?QCkkxxaaOgUhC0pR.99
CNS disease treatments will flourish of A2-73 is safe and effective.
from link...
Results showed that by the end of the two-year treatment, patients’ scores on the MDS-UPDRS Part IV, assessing motor complications, showed a change of -2.4 units in patients previously treated with placebo, -3.5 units in patients who took amantadine immediate release, and -3.6 units in patients who had deep brain stimulation.
In patients who were already on Gocovri, changes in MDS-UPDRS, Part IV scores were less pronounced — only 0.4 units — confirming the therapy’s effectiveness even before long-term treatment.
“The completed Phase 3 open-label study further expands our understanding of the benefit/risk profile of GOCOVRI,” said Rajiv Patni, MD, chief medical officer of Adamas Pharmaceuticals. “The large reduction in dyskinesia and OFF, as assessed by the Part IV score of the MDS-UPDRS, was observed by the first visit at Week 8 and was sustained for two years. This durability is noteworthy given the known progression of motor complications.”
Gocovri’s safety profile is in line with previous reports. The most common adverse reactions included falls, hallucinations, peripheral edemas, constipation, and urinary tract infections, but these were generally mild to moderate. During the two-year study, 9% of the patients discontinued the treatment due to adverse effects, and nine patients died, although no death was linked to Gocovri.
Xena..
[if they discuss any aspect of trial structure it may have an impact on price.
/quote]
Agree with this point and would add M.'s appearance and attitude will mean a lot. Since another one of the Amyloid crew spiraled in today, AVXL looks HYUUUGE. I have heard that attitude is everything, such as was reported by Jon from the recent ASM. He cannot be sued for presenting a positive attitude.