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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:
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.
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.
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.
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
Biostck wrote:
McM wrote:
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.
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...
Xena..
Thursday April 26---11:25 AM MD time
Could it be that new information will be brought forward this week?
AB-E-NORMAL trades
xena...
OK...thanks ...that's about what I see. Agree, we are due.