Replies to post #23939 on Amarin Corp Plc (AMRN)

[slowmover]

nutsy here u go



Specifically, consistent with discussion at the Advisory Committee meeting, the FDA cited results from the ACCORD-Lipid and
AIM-HIGH outcome trials, as well as the publicly presented results from the HPS2-THRIVE outcome trial, which the FDA stated in its
October 29, 2013 notice to Amarin, fail to support the hypothesis that a triglyceride-lowering drug significantly reduces the risk for
cardiovascular events among statin-treated patients with mixed dyslipidemia and residually high serum triglyceride levels (200-499 mg/dL).
Thus, the FDA stated that it no longer considers a change in serum triglyceride levels as sufficient to establish the effectiveness of a drug
intended to reduce cardiovascular risk in subjects with serum triglyceride levels below 500 mg/dL.

[Dancing in the dark]

mile wide, inch deep.

[DeepBreath]

"the FDA has rescinded the ANCHOR study special protocol assessment agreement because the FDA has determined that a substantial scientific issue essential to determining the effectiveness of Vascepa in the studied population was identified after testing began"

There was no, none, zilch, zero....studies that determined a substantial scientific issue relating to mineral oil. Unless I am mistaken, at which point you will provide a link to show one does. Otherwise, issue of mineral oil is moot.

[chas1232123]

Just want to cordially offer some information (previously discussed):


Regarding niacin:
THRIVE results were released on March 9, 2013[51]. THRIVE principal investigator Prof. Jane Armitage said about niacin “…the unwanted side-effects outweighed the benefits. This is important information for all the people who have been using this or similar medicines for many years.” From the THRIVE press release headline[52]: “NIACIN CAUSES SERIOUS UNEXPECTED SIDE-EFFECTS, BUT NO WORTHWHILE BENEFITS”

[51] THRIVE trial website (niacin): http://www.thrivestudy.org/
[52] THRIVE trial press release: http://www.thrivestudy.org/press_release.htm

Vascepa vs Lovaza: http://www.buyvascepa.com/why-vascepa/vascepa-vs-lovaza-which-is-better-safer-more-effective/

What has a lot of us up in arms is that the so-called new science is bogus, they cite failure of some outside trials to strongly support V efficacy. That is an excuse for FDA to justify their anti-Vascepa agenda, those trials are mostly irrelevant and to the small extent they are slightly relevant they are supportive. If FDA wants to cite outside trials to break the SPA, they need something that succeeds at supporting that V is ineffective or the Anchor trial design (that FDA approved) is inadequate. They don't have that. Their lack of justification is why they turned the adcom into an ambush, and minimized the possibility of properly focused discussion (changed the goal post after discussion was over).

[BioChica]

Facts about mineral oil placebo

[AfroChicken]

What scientific issue would that be? The placebo that they agreed upon for both ANCHOR and Reduce-it? Or maybe the failed trials of completely different substances to Vascepa being used to discredit its effects on the ANCHOR population?

Please enlighten us with your short thesis.