Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Re: abner: It's simple: FDA no longer allows surrogate
endpoints for approval.
Simplify your thinking on this, the FDA had a contract involving a substansial investment of capital which they violated with malice and bad faith and as a federal government agency they have deep pockets which to pay compensation for all the damage they caused.
Fda is untouchable
Not if they are in breach of contract... federal law waives sovereign immunity in such cases.
Since the SPA is a contract
And will most likely be found to be one in federal court... how can Amarin lose in a lawsuit???
It seems to me that the stock is a great giveaway at this price when it will be able to fund itself for years when it cleans out the FDA in federal court.
Is the SPA a contract or is it not, that is the legal question...
If the SPA is a contract I don't see how AMRN loses in federal court.
The Tucker Act
http://en.wikipedia.org/wiki/Tucker_Act
The FDA has NO SOVERIGN IMMUNITY when it comes to breach of contract.
Patrick Byrne (former CEO of overstock)... took a personal interest in DNDN's FDA rejection and has had a longstanding vendetta against "thestreet.com" (which at least knew what the FDA was going to do in advance).
He probably knows the right way to approach this.
Gentlemen don't be so despondent, given that the price has already dropped so much this is good news. All the bad stuff is on the table.
The FDA has announced that they have broken a contract which represented on AMRN's part a large investment of capital, the sooner the better in my opinion.
They broke their agreement based on studies of other substances, studies which were known before the reduce it trial began. This will not look good for the FDA in federal court.
Now AMRN can prepare for the lawsuit and file it the second after the FDA rejects the expanded indication in December.
More imporantly TV ads can market off label
The 9th circuit decision is only for FALSE STATEMENTS made in off label marketing. Ie the FDA or whoever else would have to prove fraud.
http://www.lanepowell.com/16037/ninth-circuit-affirms-prosecution-for-off-label-marketing/
Over the past two years, courts began to recognize that at least some off-label marketing is protected lawful commercial speech under the First Amendment. Specifically, the Second Circuit in New York in a case called United States v. Caronia held that truthful off-label marketing is a form of protected First Amendment commercial speech that cannot be prosecuted under 21 U.S.C. §333 of the Food, Drug and Cosmetic Act (“FDCA”). The Ninth Circuit issued an opinion last week that reaffirmed the ability of federal authorities to prosecute false statements concerning off-label promotion. In truth, despite the decision in Caronia, prosecution for off-label marketing remains a high priority for the FDA and the U.S. Department of Justice and companies are well-advised to thoroughly vet such materials before they are communicated to the public.
If the FDA denies Anchor in December the company has to focus on achieving profitability with the current indication... not spending its limited resources dealing with more FDA bull****
This means
1) Cutting unnecessary cost - which will include running the Reduce It study. The company should discontinue immediately the minute it becomes certain there is no hope of the FDA overruling its advisory panel.
2) Marketing to all expanded indications anyway.
I think they probably should sue the FDA even if they can't win for reasons of publicity... cockroaches and corrupt FDA employees in bed with big pharma will both run for cover from the light. Hell they might win if it surfaces that someone really was paid off (I'm almost certain payoffs were involved, what I don't know is how well the tracks were covered if they weren't covered too well it might come out in a court case). In any case Vascepa will get favorable publicity.
They don't need to worry about generic competition till their patents expire either, and the FDA and the patent office are two entirely different groups.
Glad to know I am not the only cynical realist on this AMRN board.
The same people (GS-whatevers) who run this govt from inside all the ineffective bureaucracies so incompetently...
Off Label Drug Marketing was Ruled Free Speech
And this was upheld on appeal
http://www.prweb.com/releases/2013/3/prweb10523505.htm
I am not enough of a legal expert to determine whether or not Amarin would have any realistic chance of suing the FDA for breaking their SPA because I don't know what the precedents are if any, but based on the free speech ruling Amarin could market itself openly as preventive cardiovascular drug. The main downside being it would have a lot more trouble getting expanded insurance coverage.
Based on this I think Amarin should inform the FDA (at the level of commissioner Hamburg if possible) that if they don't overrule their advisory panel their financial situation will give them no choice but to
1) Drop the reduce it study to conserve money, seeing that there is no point in continuing it for them if the company goes bankrupt or has to be sold at bargain basement prices.
2) Market Vascepa as a preventive cardiac and anti diabetes drug anyway.
If the FDA agrees with Amarin they overrule the adcomm panel we get the anchor indication.
If not we have a superior product which we market as a preventive cardiac drug anyway. No more dealing with corrupt FDA bullshit.
And no I don't think the FDA will pull it from the market, that risks all sorts of outside investigations.
6. In April '09 GTC gets a partnership w/ $35M up front cash
(*)(**)
With Cox this is at best a remote prospect.
In a position of cash weakness to get anything close to fair he needs to get two companies or more in a bidding war over the IP. Difficult to say the least im sure but its what he needs to be able to do, since he can't he should be fired and replaced with someone who can.
but then I see Cox as having much more information, to work with, than myself or, probably, others on this board. Maybe someone could contact Cox and show him all of the better deals he overlooked
Then he should start telling it all to the stockholders. His secrecy has not helped the company at all.
Furthermore I think someone who makes as much as he does from a company thats still losing money should be able to MAKE IT HAPPEN. Ie if we do have someone in charge who keeps on just providing shitty deals we should at least have someone willing to forego a salary.
The company will get liquidated immediately if the agreement is voted against, I am however strongly in favor of any and all measures to oust Cox and his puppet board of directors.
No, not criminal, merely tortious.
Yet merely tortious might be good enough.
We can't squeeze blood from a stone and we can't (unfortunately) go after the personal assets (as far as I know about the law and limited liability) of any managers or directors no matter they did. Even if we could get something Im sure the lawyers would get nearly all of it anyway.
I much prefer it be criminal, that serves the purpose of removing the Coxa Nostra from the management of the company.
I'll tell you a news item that would send the stock up at least to 60cents a share immediately, board fires Geoffrey Cox and everyone in the management except for Meade.
That they have not done so is a criminal violation of their fiduciary responsibility.
The 1st indication (hereditary deficiency) was crap. Your 1st indication needs to make you profitable.
Cox compounded the problem through his incompetence though to get a good deal with partners (from a position of financial weakness) you need to get two or more of them simeltaneously competing over your IP. Cox has never been able to do this, whether its a case of corruption (in the case of the board of directors this is certainly the case) or incompetence he needs to go.
Yes, your point?
Mine was that Cox track record is no better then a ficticious paragon of stupidity?
Looking through your post you mentioned Jim Carrey's character in Dumb and Dumber in ref to GTC and Nabi. A relevant analogy to how he spends money.
Actually I think a more relevant analogy to GTCB may be the movie the Hudsucker proxy. LFB's management is pretty clever for a government run entity.
The bottom line is Cox can't negotiate, he may have a bad hand but he also had the IP rights. If he was any good he could have gotten a good deal by getting two or more partners into a bidding war.
The board of directors should all be thrown in the slammer for not firing his ass, at best its criminal negligence on their part. The entire management should have been shitcanned when Woloshen and Liposky sold stock earlier this year.
Geoffrey Cox's strategy is great... for Geoffrey Cox, not for you.
There are no excuses at his salary level IMHO... Homer Simpson could do a better job negotiating.
He thinks hes done a good job, is he a narcissist or a sociopath?
The right thing for Cox to do would be to commit seppuku.
Jesse is saying that if they can't dilute its not an issue thats a blessing, I hope they can't find anyone willing to accept a private placement. In the eyes of GTC's partners GTC is too big* to fail. That means they'll be ponying up the money (as Cox should have gotten them too long ago).
*From a regulatory perspective
So far, though, the FDA has fallen short on its goal to recruit more cancer specialists.
Is there a greater then 5% probability this is due to pure chance?
If you don't get the joke lookup Richard Pazdur.
Wouldn't skimming be more intelligent if they were gonna run that kind of fraud...
Relax there are only two scenarios...
1) GXPI is legit, the mine is legit.
2) GXPI is a fraud, and the corporate officers must dissapear and get new identities in some other country or go to jail.
Commiting fraud with a publically traded company (that isn't on the pink sheets even if it is a penny stock) is not the best way to go about it. So I think even if they structured the news creatively... they weren't lying about the mineral concentrations.
Peak oil will come eventually but not any time soon. Too many reserves have been discovered lately and shale becomes economical once oil goes over a certain price.
J, is it your opinion that a gold collapse (im very glad they found silver) will NOT follow a collapse in oil prices?
Joe, so why is the price not going up. On three consecutive items of good news?
Unless we're talking a case of fraud... the claim seems to be verified at least to the point where its profitable (they haven't struck the veins of pure gold or silver, thats a possibility btw, but they have profitable ore concentrations).
They can borrow against the claim now... No need for dilution. They have collateral.
I find it unlikely that they merge with a French government company...
Doesn't make sense to sell the company now
LFB has started to put up money to fund them till they get to profitability. This likely means no more dilutions (the tricky part with that is if the price goes too high) and an upward trend in momentum (which will be helped by what I anticipate is a total crash in oil prices after labor day). After the election the idiotic attempts to prop up the housing bubble (which should die a horrible death) may end as well. Leaving stocks the only place for money to go.
Why sell now (I despise the management as well)... the worst looks to be over.
He was right about the partnership.
For the next few months we actually want the share price to stay low so that GTCB can't dilute, their partners will have to bail them out (and they won't want to buy them out would mean them going into a new business they don't understand or dealing with a much better negotiator then the incompetent Geoffrey Cox and the rest of Jerry's kids). Thus if the share price goes up due to something besides them getting their money from their partners it could indeed screw things up.
If Cox and GTCB doesn't know about whatever goldmine GTCB is sitting on, we don't want them to until the partners cough up the money.
to announce that it wasn't
going to happen would be the same as saying the firm would
rather trade pink
Market cap rule, they can't avoid trading pink anyway lest they get their market cap anyway.
I'd rather have them trade pink then do the RS regardless, but there isn't any way out of it besides extremely good news in the meantime. Barring that GTC is heading to the pink sheets period.
The worry people have with the RS is that it will be used to set up a MASSIVE dilution to raise that money (luckily the low market cap could make this unfeasible and their partners who need GTCB to survive will provide the funding they need).
Thats why I'd be very happy to hear they have abandoned the reverse split... as that likely signals the abandonment of the dilution plan and their partners will have to cough up.
LFB was included in "institutions".
It'd go over a dollar if they announced no RS, then they wouldn't have to do it...
Who the f*** (besides institutions which rubber stamp the management's proposals) was stupid enough to vote for it?
And did they say (maintaining GTCB's record for management stupidly following up good news with bad) that they were going through with it.