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Once again legal question...
FDA delaying the PDUFA date because they decided they needed an adcom late for "some reason".
Could this possibly be considered "arbritary and capricious"?
Legal question...
Could the FDA's decision to extend the PDUFA date once granted be considered "arbritary and capricious" legally (it certainly was in the real sense) since they had plenty of time to schedule an Adcom in the normal timeframe and opted not to do so.
Would they be covered under Sovereign Immunity (which I think should be abolished for the FDA at this point) or not?
I wish it was simple incompetence (which would mean we at least wouldn't in the end face a CRL) but the cap raise, the FOIAs and the request to keep the adcom secret suggest conspiracy, malfeasance and corruption.
Corruption... the strange cap raise (JT did know at least something was going on), the FOIA, the FDA request to keep it secret. These do not fit the pattern of things being on the up and up.
People who think we should play nice with the FDA is going to work are like people who think playing nice with a bully is going to work.
MRC's petition was part of an excuse and I agree "grudges" had nothing to do with it, Astrazeneca's wish to acquire the company cheap likely has everything to do with it.
The most likely point of origin for the conspiracy lies with AstraZeneca given their links with our "friend" Dr. Nissen and his apparent relationship with our "friends" at MRC.
Objectives
1. Make AMRN accept a very lowball buyout price.
2. If they will not destroy them and destroy Vascepa, have their friends at the FDA issue a CRL.
This is an interesting idea...
AMRN unilaterally changing the label and claiming the label based on the Reduce-It results is truthful and non-misleading information. Its nuclear and risky and a last resort following a CRL but I like it... if the FDA conducts itself badly enough and say overrules their own ad-com I think it will holdup in court. Best to keep it in reserve until then.
Amarin management does not have their head in the sand.
I did not post on the board very much but after the cap raise I was very very angry with Thero suggesting that the cap raise could have only two reasons behind it.
1) AMRN and Thero through some source of information knew an FDA f***over was coming. In which case Thero was right to do it. Considering that this would be blatant open corruption on the level I'd expect to see in Mexico or Nigeria I thought this was unlikely... little did I know.
2) That Thero was stupid.
It turned out to be #1. AMRN also has submitted these FOIA requests... they are prepared for war.
I don't want a halt... I'm out of my margin position but took losses on it, I'm hoping it drops a bit so I can buy it back... and then around the time of the Adcom will hedge with puts I think the FDA intends a CRL and to demand another study... luckily I think this is a corrupt conspiracy and the cap raise and FOIA tells me that AMRN management has the goods on them.
Why the cap raise, why the FOIAs, why did the FDA want this kept secret?
This is a conspiracy theory with very good supporting evidence.
1. JT does a huge cap raise for what seemed like no good reason before it happened (and once again I apologize he was right and I was very very wrong).
2. AMRN's law firm has submitted all sorts of FOIA requests of individuals associated with MRC or otherwise opposed to Vascepa and their communications with the FDA. Seems to me they were looking for a conspiracy. Hopefully they'll find the equivalent of the Peter Strzok text most of these bureaucrats probably aren't all that bright.
3. The FDA despite the study passing with flying colors and despite the drug being a lifesaving indication with no safety issues and virtually no negative side effects, and despite support from the American medical establishment, decides that after granting priority review (months after) they need to hold an ad-com that will push back the date and furthermore the FDA shamed at their own corruption asks JT to keep it a secret until the last minute.
Looks like a corrupt conspiracy to me. There is probably some intention to find an excuse to throw out the whole Reduce-It study... luckily I think that they are going to get caught talking about it.
Why are you making excuses for them, obviously this was corrupt in nature otherwise why would the FDA want to keep it secret this is war and the FDA is the enemy. They will repeat 2013 on us unless the public expose of their corruption is such that they can't get away with it.
The reason why this is so worrisome even long term is that AMRN (quite rightly, I was very very wrong and JT did the right thing 100%*) did the cap raise beforehand, combined with the FOIA requests it is quite possible to suspect that the FDA (which it seems is corrupt on the level of Mexico and Nigeria) intends a repeat of 2013 here. One key thing is the FDA itself knew it stinked that is why they requested JT keep it secret. They wanted to steal Vascepa from us like a thief in the night and without public scrutinity.
This is war. All legal options, all nuclear options, all means of lobbying should be employed here. Trump I'm 100% sure would like to tear the FDA (which is greatly responsible for the high costs of drugs) apart, the FDA should be the drug equivalent of meat inspectors they certainly should not have any say on efficacy at all he would love a good corruption scandal so he has the excuse he needs to destroy them.
* And yes JT knew about this somehow in advance but I'm not mad he did the right thing by getting a warchest ready in advance and he could hardly due that if he blabbed about this in advance
For what it is worth write the White House (I referenced my RNC # I got for donating). I was sure wrong about JT's cap raise but he needs to hire lobbyists, lawyers... potentially more unsavoury characters and go to the mattresses.
I'll admit when I'm wrong I did say that there were two possibilities with the capital raise.
1) Thero knows that there is a very good chance of an FDA screwjob coming.
2) Hes an idiot with an intellect that matches his public speaking ability.
So since #1 is true the good news about this catastrophe is that I now have renewed faith in Thero and in this case I was the idiot because if I had bet on #2 I would have sold my entire position far in advance...
I did not believe #2 was very likely because this is a level of corruption that I did not expect even from the FDA (and I've long basically thought of them much the way Biobill does), that they would pull this crap with a major lifesaving drug with no side effects, an outcome study and backed by the American medical establishment... incredible. JT still seems willing to play nice with the FDA but now given that he was right to take the street for 400 million I'm confident that he has a plan to fight this dark corrupt effort against us (I believe the FOIA request are part of it).
I think we get the label but given the size of the cap raise I think JT knew and knows that there are dark forces against us that don't want Amarin to have this indication and want the company sold off cheap. Its possible that Dew is correct and the FDA is just pulling this as some chickenshit form of revenge because we've sued the FDA twice (what makes me think otherwise is the FOIA requests on our friends).
FFS completely agree.
Spite from a government agency is a form of corruption, they are supposed to do their duty in the public interest not settle private scores. AMRN was quite justified in suing the FDA anyway.
If they are settling private scores at the expense of the public that is a form of corruption.
"Very unfortunate for FDA to delay 3 months, killer for longs in the short term and just adds more stressful days to wait, but in the end no reason to believe this won't be approved. What are they going to say, run a new 6 year trial? Deny the drug despite science saying it works regardless of any placebo effect? "
The thing that makes me think very very dark thoughts about the implications of this adcom was that JT raised so much cash.
I WAS very very angry with JT for doing so and said the only good reason for doing so was that JT had good reason to fear an FDA screw over... well we know we at least have a delay and I now forgive JT but given the size of the cash raise I have to worry that they whatever the FDA was planning to do... would put the company in bigger financial shit then delaying the label for three months.
Its inexcusably corrupt for the FDA to announce priority review not convene an adcom during the regular time for priority review and then announce opps we should have had one we're extending your time.
China did the right thing with their own FDA head back in 2007 and it would be a great thing if it happened here, that is how you discourage this kind of corruption.
Trump is almost certainly far too busy to directly intervene on our behalf but Trump has long wanted to tear the FDA (which let none now doubt is the most corrupt agency in our entire very corrupt government) apart, the FDA and the government in general should not be in the business of evaluating drug efficacy anyway the government should only evaluate purity and safety. The FDA should be the drug equivalent of a meat inspector.
This will give him ammo against the FDA and perhaps there is a small chance the White House might intervene. There are some big important people who own shares...
Complained to the WH with my Trump donor number for what its worth.
I suggest we ALL do the same... especially if you donated to Trump. He is not on good terms either with the permanent bureaucracy or big pharma and this case if investigated would give him very good ammo to tear the FDA apart.
JT was very right to raise the money and I apologize for my strong criticism of him... this is a level of corruption I did not find believable but he apparently knew it was coming.
The company does need to stop playing nice with the FDA, direct to consumer marketing should start in areas with good tier coverage never again should we adhere to their marketing restrictions, the ANCHOR appeals process should immediately resume with the idea of suing the FDA in Federal Court for breach of contract.
AMRN also needs to reach out to Malpractice lawyers about the Type 2 diabetes standard of care with the idea that if they don't prescribe it even off label it is standard of care and the doctors can be sued for not prescribing it, we need to start playing hardball with doctors who don't want to prescribe off label.
I take back everything I said about JT.
I did say the only good reason for the cash raise was if he suspected an FDA fuckover was coming and indeed it very much was and did come so JT did the right thing. JT has my full confidence now... but the company needs to actively start doing things to hurt its enemies the FOIA requests are good but I mean private investigators, "contributing" to congressmen.
They need to hurt people involved in this decision... in uh legal ways of course.
Thank John "Dilutin Tootin" Thero.
We'd probably be at 25 now if we had a CEO who believed in the stock and the product enough to wait for approval and then finance with debt instead of dilution. The remaining options sellers and shorts would have been burned after approval but as things are... who knows if we even see upside on label expansion now.
I really hope he didn't consult the Baker Brothers, because if not there is hopefully some chance they'll fire him after approval.
Unfortunately he doesn't really have to care what anyone except the Baker Brothers thinks.
I strongly hope you are right.
I agree its good to pretend to go along with this blatantly unconstitution Office of Prescription Drug Promotion for now... but if we don't ignore the OPDP after we do get the label JT is beyond stupid and needs to be replaced.
JT's conservatism to the point of cowardice makes me think he is telling the FDA the truth though and plans to let this bureaucracy dictate his marketing.
LOL at the idea that Goldman Sachs and JPM care about the law.
The worst that ever happens to them is lower level people get a slap on the wrist, we need to adopt the Chinese system. They get caught doing something really bad and the Chinese government has their CEO (and maybe other top level and involved people) executed. That actually effectively deters misconduct.
But all that being said... I do not think AMRN was manipulated up to 23, when JT started talking to them about the secondary they shorted the hell out of the stock so the secondary closing price was as low as possible so if anything it was manipulated down.
JT has not explained why he had to do it now, not really. It was very very vague.
I thought AMRN was GIA and so did JL.
We just did not see why he needed to raise so much money and even if he did (and yes I concede there might be reasons why such as to buyout the EPA suppliers and vertically integrate, though I suspect after the label he could have paid off Pharmakon and then borrowed) why not wait for the label to do so.
Re: Markipeach and other's who think a big pharma is best...
The problem is not AMRN's size the problem is that JT has made some very very bad decisions lately which suggest that he is incompetent or even worse doing some Hudsucker Proxy type scam (not that I think he could buyout the stock but to let institutions buy nearly all the stock with an understanding he'll be rewarded for it later at our expense).
1. A totally premature and unnecessary dilution that if things weren't so perfect otherwise with the drug... and the medical establishment backing the drug and ITER backing the drug I would say its because they suspect an FDA screw job is imminent.
2. Even after the label... he plans to allow this OPDP to dictate his marketing rather then saying we won the 1st amendment case f*** you.
I would be for going it alone if we had a competent or trustworthy CEO, but I'm no longer for GIA with JT at the helm. One bad decision is human... two in quick succession suggest that he is going to keep making bad decisions.
I think direct to consumer advertising should have started one day after results were publicized... Now on the other hand there is some argument for playing nice with the FDA before the label is granted (though I don't the FDA wants to screw AMRN totally this time) but there is zero reason to play nice with them once we have it.
I apologize you are right... I guess I had forgotten the previous dilution being 230 million... I thought it was around 100 million.
So they needed to do it... eventually sure... but probably only for 100 million.
Now that they are profitable they didn't need to do this one.
They were stupid to do it if they do not intend to use the 1st amendment to aggressively market the truthful and non misleading Reduce-It information which apparently JT f***head that he is does not intend to do.
We had no information to suggest JT was this incompetent before the capital raise.
There were some questionable decisions made before this (and some really good things management did like getting Mochida not to dispute their IP).
1. The decision to stop appealing anchor all the way up the FDA chain so they could then sue the FDA in federal court for breach of contract and damages. I think they should have done this. The court might not have approved the label (saying such was beyond their competence) but I think the court would have ordered the government to make good their financial losses for breaching the SPA contract.
2. The ITC suit... predictably the ITC and FDA didn't want to go to war with dietary supplement makers (a war they would almost certainly lose).
But raising this much money now... and for... sales reps. And he is going to wait to do DTC ads until this Office of Prescription Drug Promotion approves rather then ignoring them and asserting the companies 1st amendment rights... makes me think hes incompetent. Perhaps competent enough for the Reduce-It auto pilot phase but as far as the drug launch in over his head.
The 1st amendment court case reaffirmed the right of any citizen or corporate entity (I love Citizens United here) to tell truthful and non-misleading claims the 1st amendment does not make any reference to medical doctors only. The FDA may not like this but if they challenge it in court they will lose again.
The so called reasons they need this incredible amount of extra cash prior to approval are vague non-specific bull***.
Sure hate Goldman.
But the ocean has sharks and sharks do what they do because its their nature...
I reserve my hatred for the idiot stammering skipper who sunk the boat on us in shark infested waters.
I hope the company is sold (but a publically traded company only) because while GIA would be ideal if the management was competent we'd be better off as part of a company (even if Vascepa is partially weighed down by other things) that has a competent CEO.
We wouldn't be going through this at all without the "brilliant" cash raise from our "brilliant" stammering bean counter CEO because you know can't wait two months until approval.
Don't like borrowing money myself but if its a question of borrowing against an extremely profitable income stream at a low interest rate (as Vascepa should be) vs diluting ownership in it... better to borrow. Diluting instead of borrowing also sends a message to the market that the management thinks the shares are overvalued...