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They might be able to leverage a conditional approval with threats of a SPA lawsuit. What conditions?
Call phone number
I don't know was going to ask same, need to say something
They have to have a buyout $10 sounds good
We'll see what Joe's attorneys say tonight
The can still prescribe off label, questions answered today very limited
Wait for CC. I think they anticipated this, have prepared for manufacturing, they must have a plan B. I bought at less than $10, so that sounds good.
Tanks I feel like a blind guy trying to watch Dodger game
I can't get on limit exceeded at FDA, is there another link?
I don't get what you're saying, if it's negative?
I'm not listening but 4g sounds good because the Italian study used less. The emphasis on CV is expected that's the only real question. If they vote yes on this FDA won't have cover to breach the SPA
Bays won't get as much credibility if they think he's working for Amarin but he's gotten research grants from GSK also.
But couldn't you tell by looking at a translucent capsule which is which?
Is there any kind of closed captioning or transcript of Adcomm?
No one is denying the code but you have no evidence how it's been or will be interpreted by the courts. Common law is just as important as a code section.
Nope, "special protocal assessment and agreement" is at the FDA SPA website in several places, it's an agreement with very specific rules to not be in breach. I can't put link with my cell phone but you can Google it.
Not true there is not one single lawsuit against Amarin.
Not true, manufacturing and quality are what distinguish Vascepa. LOVENOX is basically filtered heparin which is from pig gut or cow lung, it's a natural product. So it's pig oil, cow oil, or maybe even snake oil.
Not really, the wouldn't ask the question if intended on ignoring the answer
That's not true, the "A" in SPA stands for "agreement."
NPH insulin is made from trout semen, I guess some would call fish oil but they sure made a lot of money on it, got patents, and FDA approval.
That's not true, we'd still have a better drug than Lovaza. Vascepa's approved, doctors can prescribe for anything they or you want without restrictions, that's the hard part. Plus most analysts now predict Anchor approval.
You said it made you $30000, congratulations.
Lawsuits are very expensive, too expensive for individuals to sue a corporation. That's why they have class action suits to spread the costs among many.
No lawyer will take a case for one shareholder
Aren't they referencing the Italian study and didn't that use olive oil as a placebo?
Right I contacted one of those law firms back when Facebook had that ipo debacle, they asked for every other holding I owned. Everytime one of my stocks went down or was bought out they called me, nothing ever happened
I think best to wait for Joe's opinion on this. He has some very good attorneys at least with the patents. He was very optimistic last time.
I think you're giving too much absolute power to the FDA, it gets sued all the time for interpreting the law incorrectly or abusing its power. Ultimately a court has the final decision.
Never saw any post with that many thumbs up. He seems to be saying who needs Anchor, Vascepa already approved for any use a doctor can think up and doctors wouldn't be doctors if not prescribe Vascepa to pretty much anyone.
Right but they have an agreement with damages if not honored, can't change rules mid game, FDA subject to laws like anyone else.
Maybe you're wrong. Joe stated at the last conference that SPA would be honored. I'm sure he will say the same this week after consulting his seemingly very good attorneys. True the FDA can choose to not follow but must follow the law. Changing the agreement from requiring triglycerides to be lowered to be lowered and also prevent CAD might be a breach of the agreement and denied by a court.
But wasn't the agreement with the FDA that Vascepa had to reduce triglycerides not necessarily benefit in any other way. This triglycerides don't matter but need to stuff was added later
Right, but with the SPA the close vote wouldn't necessarily be a no vote as some have pointed out.
Unless you can show some mal intent like linking it to the put buyer.
Right but they wouldn't allow you to submit the document.
AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS’
GUIDELINES FOR MANAGEMENT OF DYSLIPIDEMIA AND
PREVENTION OF ATHEROSCLEROSIS
Thus, elevated triglycerides in a nonfasting state can
no longer be ignored as indicative of no increased CHD risk. The treatment of hypertriglyceridemia,
however, demands they be measured in a standard fasting state to
assess the effect of therapy.
Table 12
Lipid Goals for Patients at Risk for Coronary Artery Disease
(20 [EL 4], 37 [EL 1], 38 [EL 1], 39 [EL 1], 40 [EL1], 41 [EL 4])
Lipid Parameter Goal
EL 1
TG, mg/dL ?150
EL 1
Yeah but we can discuss all the studies here but unless it's the ones they're looking at it doesn't matter, that study was from Japan maybe not pay attention to it
But he's wrong, FDA stated it was for concomitant use with stations, not diet
If the endocrinology society thinks lowering triglycerides benefits CAD how could the endocrinology committee think any differently?