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Going to the senate probably won't work, at least not before the elections (and it will MAYBE work after the elections only if the republicans win) because in all likelihood a high ranking senator or two are behind the FDA's stance on the matter...
Ajax what makes you think the FDA gives a damn about JZ's trading activity???!!!
You've asserted in the past that Amarin contrary to their public statements has turned down compromise offers from the FDA. Something that could see their management sent to jail for securities fraud.
Now you are asserting the FDA big shots are infurited about trading activity, and furthermore that JZ's inside sales were made on the day marine was approved. You forget the fact that if insiders want to sell on the same day as something they need to do it illegally and clandestinally via intermediaries anyway (their announced stock sales have to be part of annual or quarterly financial plans).
Yes the FDA has been f***ing over Amarin but there is none zero zilch evidence its because of trading activity and its an absurd motive to suggest. For one thing the FDA is not the SEC. For the other it would imply they have integrity (which they do not) and yet would violate it due to the lack of financial integrity of the insiders (which they don't care about unless it adversely impacts them).
Most likely its because of the machination of a big pharma with influence within the FDA (and/or congress).
The 2nd most likely explanation is bueracratic incompetence or simply to set a precedent that they don't have to abide by agreements.
the FDA has to issue a "No you can't market this drug" before you can claim they're surpressing your freedom of speech.
The questions are
1) How long can the FDA stall the appeals (afterwords is the layup breach of contract suit), your point that the FDA is now going to stall IS a worry.
2) How long before (it appears from JL's post Amarin is going 1st amendment and marketing off label already) a 1st amendment case ends up in court
And in the distance
3) How long before a peak at R-IT data comes
- it was not a classical contract, it is an agreement and it just a primary base of the claim, not the one and only
Why would they not appeal to higher levels...
They have to go through the entire FDA appeals before they can sue the FDA for breach of contract (a case that is a slam dunk and guarantees they will have plenty of money to complete reduce it)...
I generally agree with management but if they stop the appeals I would not...
Yes Changing management is a bad idea.
Management's only serious error was not hiring fixers/paying bribes... and given whatever big pharma they may be up against it might not have been feasible.
Management
1. Got an approval
2. Got an SPA
3. When the phony FDA appeals are completed they'll have a hell of a lawsuit in federal court.
I'll confess I don't know why they haven't ordered their sales people to start marketing off label (in order to also setup a 1st Amendment case which they will also win) but there may be reasons there I don't understand which pertain to the SPA or some other legal issue.
People here despair far too much...
These appeals never had much chance of success since a decision to void something like an SPA was likely taken at the highest level of the FDA, Amarin is going through because they have to before they sue the FDA in federal court.
The case should be a slam dunk breach of contract case... I suppose whatever big pharma etc that is behind Amarin's treatment can try to rig the case but IMHO its hard to rig elementary breach of contract.
FDA gag rule won't be an issue in breach of contract suit once the phony appeals finish
The SPA will speak for itself, they won't need anyone to confess that they ordered the code red if you will...
AFTER all the phony agency appeals are exhausted they will lose breach of contract via the SPA.
I tend to agree the NCE lawsuit is a loser though.
I just don't see the angle...
Nobody would want a generic of vascepa right now its not worth the money regardless if the patents are strong or not... and this lawsuit unlike the breach of contract (which apparently they can't launch without going through the stalling FDA appeals process) and free speech marketing (which they don't have standing to launch until they actually market off label and the FDA tells them not to) is not an open and shut winner...
This is worrisome...
Why are they suing over the NCE (which their patents make a non issue) they should sue for
1) Free speech off label marketing rights
2) Breach of contract in regards to the SPA (though I don't know to what extent they have to wait till the fda appeal process is done).
NCE is practically irrelevant
I mean how many patents do they have? They only need one to hold up against any competitors to have a longer exclusivity period?
Relax the FDA will get trounced in federal court...
They can't breach contracts.
The reality is the court is going to say
You (the FDA) signed an agreement and the other party held up their end of the bargain. You did not meet your own withdrawal clauses . Test of different drugs don't count as new science and you acted improperly by not informing AMRN of your change in opinion regarding the new science immediately.
Unless someone can "get to" the court the case is a slam dunk. Let alone whatever shennanigans revolved around the option's trade (which AMRN's law firm will be investigating) or Feurstein's advanced knowledge of the outcome months before.
bottom line is the FDA wont lose!
Contract? I don't think so.
They will need to convince the Court that the decision was somehow improper or such.
I think you shall be surprised then.
The FDA broke contract...
And are going to lose quickly and badly in federal court...
The FDA lost their absolute power when they signed a contract.
Which won't happen
1. Amarin won't sue (they prettymuch have to)
2. Amarin won't win the suit (pretty simple breach of contract in essence)
3. The law firm involved won't uncover any corruption during their investigation... (I think they will but its more speculative)
Do not despair...
The company had a CONTRACT with the FDA with the FDA breached without meeting any of their withdrawal clauses...
They will lose QUICKLY and BADLY in the federal court of claims. Whatever law firm the company hires for this will also do some investigation as to the finances of those involved (and the questionable options trade beforehand) bet they get someone... and once they get something firm on one person that person will flip.
Mary Parks will likely be in jail by the end of next year :D.
Why have the lawsuits fingered antitrust...
There is no basis to sue a government agency for violations of the Sherman act...
What Amarin has is a breach of contract case in regards to the SPA.
The Sherman act will be a legal stretch.
Far better to use breach of contract...
Maybe not to FDA employees...
But you can make "campaign contributions" to senator so and so...
I don't blame management I blame the corrupt FDA but I do think they should have had some political cover on this... JMHO.
If there is any grounds to criticize management on its that.
They should have had their own spies, been making their own payoffs etc... Probably should have rented a senator to threaten to raise holy hell if anything goes wrong.
Congressional hearings are more likely to follow a successful lawsuit then the other way around.
I would like to see a congressional investigation immediately... but better to file the lawsuit 1st.
Anyone NOT demanding a lawsuit is commiting sabotage IMHO.
These FDA employees should be fired
In China they'd be shot like the head of China's FDA. I'd like to see that but I'd settle for jail.
Thats not true the company can and almost certainly will sue them and almost certainly will win.
Kinda an open and shut case actually.
SHAREHOLDERS CAN'T SUE THE FDA
Let me repeat... the FDA has SOVEREIGN IMMUNITY
The COMPANY can sue the FDA as FEDERAL LAW WAIVES SOVEREIGN IMMUNITY in the event of breach of contract.
Shareholders can't sue the FDA.
Only the company can.
The FDA's arguement in such a court case is going to sound like something Jack Thompson (the guy who was always trying to sue the video game industry and who sued Janet Reno for sexual harassment) would come up with...
Its not going to go well for them.
Contact Pat Byrne of Overstock if possible...
He took a personal interest in Denedron's rejection when he found out Milken, Cramer, and Fuerstein were involved.
Then the judge will be tougher then the clerks because they wasted his time...
The federal court of claims generally doesn't bring things with trial, clerks generally here testimony from both parties 1st decide who they think won and tell them to settle...
I don't think a breach of contract case will take forever...
Its pretty open and shut actually. They broke their contract without meeting their withdrawal clauses.
1. No the shareholders would not have "standing" to sue the FDA or any "in" against a soverign immunity.
2. The company however could sue the FDA for breach of contract.
There will be no real talk of strategies, discussions with the FDA, lawsuits, broken SPA's or anything else. We will be told they are still exploring all options. We will not be told what those options are.
Lets see....a speculative mini bio company suing an agency from the most powerful government in the world?
The FDA doesn't have a public health out
They are on record during the adcomm saying the drug is safe, that rules out public safety as a reason for reneging on the SPA.
Why don't you think AMRN will sue the FDA???
I mean barring a surprise positive decision in December (they will not announce a lawsuit before then).
Re:Easy. It is not a contract.