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Who has those patents
Why does the FDA NOT allow doctors the right to use Medicines that Work, for instance Leronlimab.
The tyrannical medical-media-government complex tries to force people to take unproven virus vaccines whose short-term/long-term safety is in question - while therapies such as Leronlimab, with proven safety and efficacy over years of testing, just sit on the shelf.
Is the FDA anything more than a criminal shakedown operation?
It appears that the Pfizer China-virus vaccine was only tested for a period of a few months - it’s long-term safety is still very questionable, yet it’s given an EUA by this corrupted and political FDA.
Meanwhile Anavex 2-73, with an unparalleled safety profile that has been proven over years of study, sits somewhere up on the shelf of some faceless DC bureaucrats.
How many people die of CNS diseases each year as a result of inept, corrupted FDA bureaucrats' failure to do the right thing. Maybe they're just too busy with calculating their lucrative retirement fund balances.
HOW MANY PATIENTS WORLDWIDE HAVE BEEN TAKING A2-73 FOR 5 PLUS YEARS
You sound like you have issues with handling the truth.
Linux provides all the tools necessary for total in-house security, without having to outsource to some questionable 3rd party. And, as we’ve seen with this voting fraud, outsourcing system security to who-knows-who WILL come back to bite you.
Many need to understand that MSFT Windoze is a dog-slow, full-of-holes marketing system – not an operating system. If you want a true, secure operating system you better use Linux.
... many will soon be wondering what the hell is taking them (regulatory bodies) so long?
It is indeed a battle to get A2-73 out to those who critically need it, with many dark forces aligned against it's success. Is Dr Missling a student of Sun Tzu:
-Appear weak when you are strong, and strong when you are weak.
-The general who wins the battle makes many calculations in his temple before the battle is fought. The general who loses makes but few calculations beforehand.
-Victorious warriors win first and then go to war, while defeated warriors go to war first and then seek to win.
-It is more important to out-think your enemy, than to outfight him.
-Do not engage an enemy more powerful than you. And if it is unavoidable and you do have to engage, then make sure you engage it on your terms, not on your enemy’s terms.
-Let your plans be dark and as impenetrable as night, and when you move, fall like a thunderbolt.
Keeping private companies from milking the market selling snake oil under unsubstantiated and false claims
The FDA is underfunded and isn't out looking for more workload
That's right - the FDA has devolved into a corrupt, political operation that does not work in the American people's best interests - quite the opposite, as we've seen these past several months.
Healthcare Systems WW (particularly FDA) are due for a major overhaul
Missling wants to fly in under the radar
To provide FDA with more resources and mitigate this cost, the voucher holder must pay the FDA an additional user fee ($2,116,167 in fiscal year 2020)
The voucher program is intended to reduce two types of inefficiency.
Thats right - I came up with that term to describe the deranged behavior of many Dims during the Kavanaugh hearings. It certainly fits those leftists who make up their own crazy stories and the lies to support them.
Lets see if the FDA has the courage and the process capability to call it for what it is.
If the delay is unavoidable, no such inferences can be drawn and a full range of outcomes should be in play.
If we rely on FDA-WHO-NIH-other's, we deserve exactly what we get.
That’s right, the FDA is a corrupted, UN-accountable, political outfit that operates not for the benefit of the American people, but selfishly for themselves. Expect them to do 180 deg from what they should be doing.
Based on the antics of Nader & company these past several weeks, I couldn’t disagree with your strategy.
OTHER THAN MISSLING WHO SAID THE ABOVE, WHO ELSE SHOULD BE BLAMED FOR THE CEO OF AVXL MSSING HIS OWN TIMELINE?????????????????????
Might I throw out the possible/probable reason for this long delay being due, to a large extent, to one bureaucratic agency or another’s ineptitude and bungling with the data, etc. Why give these nameless, faceless bureaucrats a free pass, when these types of involved bunglings are what they’re really good at and is their MO.
I’m sure that TGD has much high-powered company that has their pesky fingers in this on-going malaise.
I, like many here, have been invested I this company for quite a while, close to 5.5 years – it’s been a hell of a bumpy ride and a long drawn out process.
We are all speculating as to why the data has not been released by end of Q3/Sept 30th as promised. If I may speculate, I’m detecting the foul but unmistakable stench of bureaucratic activity, which stands to reason with Dr Missling having to deal with several different controlling governmental agencies throughout the world (what could go wrong there, huh). The bureaucratic boon-doggle is designed to slowly drive sane individuals BS crazy, if one can stand to live through their bureaucratic horse crap.
Also, much speculation regarding a possible buyout or partnership, as details could still be a work in process, taking much more time and effort to nail everything down.
Dr Missling seems to be holding his cards close to his chest, after having to deal with all the legal nonsense a couple of years ago, but I think we’re still moving toward the promised land with this wonderfully promising A2-73.
Thinking that Anavex 2-73 would fit nicely into Lilly’s portfolio of products for CNS diseases.
Could I summarize your statement, that the FDA is a Big-bureaucratic boon-doggle, in which the left hand doesn’t know what the right hand is doing – maybe both hands don’t know what the hell they’re doing.
Nader definitely has his work cut out for himself in dealing with Big-bureaucracy - I know from experience that it's not easy. These bureaucrats don't live in the real world.
Another kook-aid drinking, big-government mongering bureaucrat you are. Do you feel that if WHO, FDA, CDC, NIH were anything more than one gigantic, feckless, self-serving bureaucratic boon-doggle that we’d even be dealing with this massive economic, social and health debacle right now – wake up.
Crazy detrimental FDA regulations only serve to stifle new life-saving products such as Leronlimab.
The FDA employs over 15,000 drones and has a budget of almost $6-Billion – what the heck does this bastion of graft, corruption and crony capitalism really do, other than to feather their nest with tax money.
Time for the president to finally hold these UN-accountable bureaucracies, accountable and cut them down to size, allowing the free market finally work.
These petty bureaucrats “think” that the world revolves around themselves – once you’re in their boon-doggled system, you’re going nowhere, fast. Sad situation that needs a 180 deg rectification.
Long investors have a right to be upset with Nader’s planned CC performance this week. With his 6-day telegraphing of the event, the only thing he really accomplished was to set up these shorting-gamers to make some coin. I hope that he doesn’t pull this kind of stunt in the future, unless he really has something to say that couldn’t be simply handled by a PR update.
He needs to calm down and think before he speaks, and deliver PR in a more organized, professional manner that’s easily understandable.
$20+/per share
That’s right – of course the cork in the bottle here is not NP, but the FDA. Archaic, arcane, massive rules and regulations, and mountains of paper work are the problem. Large companies hire entire departments in order to deal with asinine government horse crap.
We all should be pushing for a complete gutting/overhaul of these fat, corrupted, self-serving bureaucracies, such as the FDA, that do more harm than good – they DO NOT work for the American people.
September 9th meeting will be about manufacturing, marketing and licensing.
Big-government in general and the FDA in particular have demonstrated, time and again, that they screw up most everything they touch. Hell, they’d screw up time if you’d let them – wait – they’ve already screwed with that too.
Let’s hope that Cytodyn/Leronlimab can survive and thrive despite this unconscionable FDA.
I’d say cut NP some slack. Many of you probably have not started nor run an entrepreneurial business – it’s NOT easy and NOT pleasant, and requires an extreme mount of time, drive and diligence that many aren’t willing to invest.
Struggle and sacrifice are the name of the game for successful entrepreneurs. There are a 1000 reasons for failure and one 1 reason for success, that being if one can successfully navigate past those nasty 1000 – nothing is ever certain.
It’s tough enough just starting and running a successful business, but when you have a big-government bureaucracy breathing down your back, such as the FDA, it makes things many times more difficult. And, as we’ve seen, the amount of bureaucratic red-tape and the insanely long time factor can be a real killer of success – not to mention the arbitrary government corruption factor.
It seems to me that NP has the vision and drive to see this thing through.
Based on what we’ve been experiencing, the FDA is past TBO and is way overdue for a major overhaul. This agency with shaky, decades old methodology/technology now requires a major tear-down – no way around it at this point.
Much agency sludge that's been built-up over the years needs to be thoroughly dunged out. Many old, worn, unreliable parts need to be replaced with newly engineered components that will give us the integrity and reliability that we need in order to move forward from point A to point B in the 21st century.
We’re seeing that much dirt needs to be sifted through in order for the golden nugget (Leronlimab) to finally appear - this ain't easy folks - silence is golden.
Maybe, just maybe, the FDA is more concerned with CYA than EUA.
Right you are - the FDA is just like any other fat, self-serving bureaucracy - it's all about feeling really, really good about yourself and not having to work too damn hard while doing it. That big retirement stash it just around the corner, just need to tough it out a bit longer.