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Good points. I believe that Doc Missling, coming from the socialist “democratic” nation of Germany, understands the bureaucratic “mind” and sees Australia as a lessor of bureaucratic-evils, with a relatively small population and maybe a government that isn’t such a huge monolith to deal with.
God help us and the poor people who are suffering
Trump signed the 'Right to Try Act' that aimed at helping terminally ill patients back a while ago. Seems not much has happened regarding this legislation and seems likely that FDA bureaucrats are diligently working to undermine this necessary legislation or at least to water it down to the point of being ineffectual – these swamp creatures are going to show the president who is boss, aren’t they.
Since A2-73 has passed Phase-1 safety studies, I would think that the ball would be rolling forward on providing it to those who are in need – is the FDA working for or against us.
Any break-down of this stifling bureaucratic control and red-tape is a good thing.
What we are seeing here, boys and girls, is a good example of why you do not let these big, fat government bureaucracies gain this degree of power and control over our lives in the first place.
The criminal-collusion between these Big Pharma companies and the FDA is providing ample opportunity for Anavex to fail, one way or another. The swamp is deep.
The bureaucrat’s primary purpose is to not rock the boat and to wait things out until they can collect their exceedingly lucrative pension funds – they do not work for us, but against us.
Said capitalist enterprises must have a conscience.
You should remember that Anavex is a capitalist enterprise, which is a good thing. Businesses such as this provide all the goods and services that we demand.
The government is a huge driver of increased costs in about everything they touch – to expect government to turn around and reduce costs is folly. Free market innovation and competition by “evil corporations”, such as Anavex, is what actually reduces costs.
Between the ambulance chasing lawyers and over-controlling bureaucrats it’s a wonder that anything gets done in the US anymore – the country has turned into one massive socialist welfare system – I guess that’s why our focus is on Australian trials right now.
You are 100% correct – the profit motive in the real world creates a competitive environment in which efficiencies are created and costs are lowered -- competition = less cost.
A socialized/government system creates inefficiencies and shortages that only serve to drive up the costs to deliver health care – government activity is, by far, the biggest driver of health-care costs, period.
And, why are there more sellers than buyers for Anavex stock?
We suffer yet another week in which the SP is played with and manipulated with impunity. The FDA has fostered this environment in which these games can be played and you should understand that the root cause of this nonsense is inexcusable bureaucratic ineptitude and red tape - not Dr Evil as some suggest.
It's not what I "think" - it's what I know - it's time to gut the SOB and it's draconian regulations!
AVXL will be sub-penny soon. Sell Sell Sell.
Things seem to going nowhere fast for Anavex – which leads me to wonder if the self-serving bureaucratic-drones, who inhabit the FDA, actually received the memo about actually doing positive work FOR the American people.
Maybe it’s time for Anavex to take the FDA out to the woodshed – who’s watching these watchers anyway?
It’s a whole different ball game in transforming a company from principally an R&D organization to one able to manufacture, market and distribute product – a different skill set and a much larger organization is required.
I see that the only response to my last post was probably an ad hominem attack by one of those who has been indoctrinated into thinking that these massive government agencies function as their own personal savior and cash machine – that’s the problem.
I submit to you that these alphabet administrative agencies do more harm to people than good – believe me I speak from first-hand experience.
You have to ask yourself, where would Anavex be today without the heavy hand of the FDA to deal with?
We sit here and wonder why our precious little stock is going nowhere fast:
The administrative-state has become so omnipotent and so over-powering that it is completely out-of-control of the people and of our elected representatives. This administrative-state is now brazen enough to believe that they can operate outside the law, in fact they create their own laws to ensure their continuing survival and to thrive to the detriment of those for whom they are supposed to serve.
We are seeing a good example of this out-of-control administrative-state in the form of the FDA, with it’s death-grip on medicine in this country. We cannot expect this federal bureaucracy to somehow evolve and now do the right thing and actually work for the people.
These big-government types talk of “affordability” and “sustainability”. Well, the only thing that’s truly UN-affordable and UN-sustainable is this massive government state that’s been built up and has become rancid with graft and corruption.
We’re in the beginning stages of a revolution in this country (and is spreading to Europe), whereby these fat, corrupt big-government agencies are being exposed as the phony entities that they really are and they are running scared. In the coming months, lets see this exposure result in the breakup/shakeup of outfits such as the FDA, along with all of these fake alphabet administrative agencies.
Lets have medicine return to being a beneficial relationship between a doctor and patient and not some kind of sick political game that is has become.
We’ve seen the building of the administrative state for over 50 years, which has recently been dubbed the “deep state”. There are those who feel that calling this administrative state the welfare state is taboo - you decide.
You got it - just another self-serving bureaucracy. We cannot expect these children of this massive social-welfare system to do the right thing - they're just swamp denizens of a system that's geared to maintaining the same ineffectual status-quo.
These corrupt, self-serving bureaucracies need to be gutted – they've gotten away with their scam for way too long. These PhD's of Ignorance sorely need a big dose of reality.
Let's see Missling make an end run into Australian and Asian markets and bypass this boon-doggle – teaching these bureaucratic-children a well deserved lesson.
The positive here is: Missling, coming from Germany, seems to understand how to operate within the confines created by these big bureaucracies and is exercising extreme patience in that regard. His European roots seem to have given him the know-how to work his way through this government-imposed boon-doggle maze.
The FDA, as with all bureaucracies, operates primarily for their own benefit, not necessarily yours. Even if Missling is able to partner with overseas companies and pursue markets outside the US, he still must kowtow to the FDA if he hopes to make the product available in the US. The FDA has had a strangle-hold on any progress up to this point and will not easily let go.
Therefore, we should hope that the new administration can get rid of many of these government imposed road blocks with a good bureaucratic dunging-out, which will immensely help we-who-live here in the real world.
We are now seeing the fraudulent “deep state” in a panicked frenzy - attempting to hold onto their strangle-hold on the people and power at all costs.
We know that government only excels at creating detrimental regulations and out-of-control taxation, which is evidenced by this big-government Obama-care system that is sinking under it’s own weight of funding demands.
We see that the FDA is not much more than a revolving door in which big-pharma execs can push for special favors, in a sort of incestuous relationship that greatly benefits those on the inside who know how the game is played.
This dirty/corrupt system is in dire need of a good dunging-out and I think it’s in the works, but progress is currently slow because the fraudulent “deep state” is going down kicking and screaming.
I believe that these Utopian big-government bureaucrats are in for a big-awakening and a well deserved slap-in-the-face by reality – stay tuned!
Has anyone yet spoken of taking pure MSM as a powerful anti-inflammatory as well as many other life-sustaining properties?
You’re exactly right – these farcical government agencies, such as the FDA, are not good at anything other than creating boon-doggle regulations and taxation. How are these bureaucrats, who have created and operate in an environment of corruption, now supposed to correctly analyze data and objectively determine which drugs are beneficial. These myopic, self-serving bureaucrats are simply not capable of doing what should be done for the benefit of the people.
Hurdles for the sake of hurdles are one thing (as we see with all bureaucracy including the FDA), necessary and justifiable hurdles are another.
And lets not forget that due to FDA activity or lack thereof, the cabal of shorts and game-players have had a heyday with this stock’s share price for 2.5 years – they know how to play the game in an environment nurtured by big bureaucracy.
We’ve all seen government’s inability to do anything well….
In fact everything they touch seems to turn into a mess, one way or another – witness Anavex – and that is why the Founding Fathers drafted the Constitution to severely limit what the federal government is supposed to do.
We’ve seen our promising new drug, A2-73, delayed by burdensome FDA regulations and an overly cumbersome approval process that takes years. Even with the mandate given by the Trump Administration to cut unnecessary regulation and streamline the approval process, this fat, clumsy bureaucracy can’t even get out of its own way in order to step forward and save lives.
A2-73 has been proven safe, so why is there not a streamlined and much quicker process already in place to make this drug available to those who have needed it – yesterday!
FDA bureaucrats are overly-concerned and way too cautious in making sure that drugs have no adverse consequences and we’re all paying dearly for their extreme need to control the process, thereby denying timely access to life saving drugs.
Are people no longer responsible for their own lives? Why can’t the FDA grant approval for drugs, that have proven safety, to be given to people in need by signing an informed assumption of risk form?
I realize that Missling and company are under the thumb of these power-hungry FDA bureaucrats, but wouldn’t it be great if he did an end run into markets that are not controlled and burdened by draconian FDA regulations, thereby letting free market forces work in a meaningful way and allowing people to live their own lives again by getting the inept bureaucracy off our back.
I must say, excellent insights and note-taking/recall of this valuable information – very well done.
FDA while has it’s own drawback, actually works faster than EMEA agencies.
Have you considered that co did not files completely and correctly? That could be the reason for all the delays
As we sit here and languish with our struggling little biotech, this all reeks of big-government (in)activity and with this government (in)activity our wheels are spinning in the mud – going nowhere fast.
It should disturb everyone, greatly, that an inept bureaucracy, that can’t even get its act together, is calling all the shots, and who can predict what kinds of nonsense these FDA bureaucrats will conjure-up next - hence we sit here and speculate.
Missling and crew are struggling to move forward under the heavy thumb and running scared, you can bet on it.
Everyone should understand that the FDA is just another big, self-serving government bureaucracy. These bureaucrat’s primary concern is for keeping their fat paychecks and exceedingly lucrative retirement plans intact - to actually work FOR the people/patients is of secondary importance - it's all about money, power and control for them – that’s their stock-in-trade.
Now it should all make sense to us that the FDA’s slogan is,
“We here at the FDA are here to protect you – even if we have to kill you” -
- leave it to government bureaucrats to come up with a catchy phrase.
Everything in bureaucracy can be a double edged sword
You might be on to something – if we could just get robots and AI introduced into some of these government agencies, such as the FDA, that would be a quantum leap forward!
If AI could speed up the glacial bureaucratic process and bring about a better intelligence that is more relevant to solving real world issues, then bring it on. It couldn't be any worse than the artificial intelligence that currently exists in these agencies.
And, look at the cost saving long run – no fat salaries and pension plans.
You may be right - but this scenario's high level of risk and uncertainty, and wading through the sludge of government bureaucracy is resulting in this heavy beat-down of current SP.
However, if Missling truly knows that he has the goods, then I'm sure that his focus is also on much more than quick $$$.
Things are awfully quiet, so it appears something is brewing behind the curtain – we're only left to speculate.
Right - I think in the effort to keep things as simple and straight forward as possible (KISS method) it makes sense to buy/sell the entire company lock, stock and barrel.
Yes, situations such as this require doing what one must do in order to get things moving forward.
I think Missling and crew, if they really know what they have, must undertake alternative measures in order to break this stalemate imposed in no small degree by our wonderful FDA – the stodgy bureaucrats will wonder what the hell happened.
Getting the ball rolling on new business venture is not easy – no slam-dunk, as you all are witnessing here with our struggling little bio-tech. Then, figure in the travails of dealing with an over-zealous big-government regulation environment and it's a wonder anything ever gets done.
This country has been too gummed-up with outrageous regulations from massive layers of government bureaucrats who's primary purpose is to justify their over-lucrative paychecks and benefits. This country is like a thoroughbred race horse with a fat 350lb government-jockey on board.
Therefore, as others have talked about, I think it would behoove Missling to seriously look at overseas markets. An end-run into Asia and/or Europe would definitely be a good thing and probably needs to happen soon.
Yes Turner, I'm sure that's what's currently happening – but, I think there is a big difference between doing everything right and doing everything the bureaucratic “right” way.
You know that things would move along much faster if not having to deal with the bureaucratic way – we have no choice but to be patient.
I read much banter back and forth about why the trials have not started, etc and why this company seems to be stuck in the mud.
Well, you try dealing with a big over-blown federal bureaucracy and see how you do. Dealing with government bureaucrats is akin to having a tooth pulled (I've recently had the dis-pleasure of both), but the tooth pain goes away quickly. The pain goes on and on when you are attempting to deal with the children of these big-government welfare societies who have very little regard for dealing with critical issues that impact normal people's lives in a timely manner or doing the right thing - after all, they have to attend to their all-important, exceedingly lucrative retirement programs.
Give Missling and crew a break here, I think they're on our side – direct your ire at the FDA.
You can bet that at least 99% of the blame for these phase-3 studies not moving forward in any degree of timely manner lays at the feet of a slovenly, inept bureaucracy.
You know that Missling and crew are working as diligently as possible to move things forward, however, they are forced to contend with government bureaucrats who are passionately concerned with justifying their lavish paychecks and excessive retirement program - which has become a big, big problem for many of us here.
You are right, these big-government politicians and bureaucrats never let a good disaster go to waste do they - but use it to foster more regulations and more control over people's lives.
How many new lifesaving therapies are buried under mountains of FDA regulations and never see the light of day – only your friendly bureaucrat knows for sure.
The FDA's motto should be: “We're going to protect you, even if it kills you”.
This is why we need to push for the gutting of detrimental regulations that only make sense to the bureaucratic “mind”. These massive governmental agencies have become out-of-control fiefdoms, unaccountable to the people and outside of purview by our representatives.
“Thalidomide was a catastrophic drug with tragic side effects” - are you comparing this to A2-73 with over two years of demonstrated safety in FDA studies – do you know something that we do not?
You've posted some useful information in the past, but I think this is an apples and oranges argument.
You people need to understand that the big cork in the bottle here is the FDA, with its draconian rules and regulations. We now have over two years of data demonstrating safety and efficacy for 2-73 – so, why don't the fat bureaucrats get out of the way and let the free market work to some small degree.
At this point, I can see no reason why Anavex should not be able to market their life saving products (patients have ZERO to lose) - other than we have to overcome a fat bureaucracy that moves at a snails pace and only works diligently to preserve their existence and control over the peasants for whom they are supposed to serve.
Rather than blaming Missling and Co for holding up the show - they're having to deal with government bureaucrats and red tape in order to get the studies moving forward, so that's where the blame should be placed. From experience, dealing with bureaucratic boondoggles ain't a pretty picture.
Remember that these government agencies aren't necessarily there to do the right thing or to work in the people's best interest – they exist to build a very nice retirement fund for themselves. We've given these burdensome bureaucracies way too much control in our lives.
Excellent point – most people have no idea of the amount of manpower, capital, time and effort required to successfully get a new product to market – a company such as Biogen would have all of these requirements covered.