Amarin Corp Plc (AMRN)

[Biobillionair]

HG-

Your post is offensive and ignores the facts, name calling is not a constructive use of bandwidth.

Here's what the 5-23-2017 opinion did not say:

Translate:
- available info / data / science ISN'T ENOUGH to determine efficacy ...
- it does not mean that "substantial scientific issue" required to "rescind an SPA agreement" ... the lack of proof (=substantial scientific issue essential) is enough

TG ISN'T a validated marker

Instead on page 6
"The decision to rescind, Dr. Jenkins added, "was based on the accumulation and totality of scientific data and information, including reevaluation and improved understanding of the relevant scientific knowledge, that have become available sine the ANCHOR trial began..." This is factually false there was no new science...FACT There was only FDA opinion of trials and this opinion contradicted new genetic science.

Regarding TG, page 8
This is the opinion of a three Judge panel: "Similarly, any statements allegedly implying that TG lowering was an accepted surrogate endpoint were not misleading because "under the facts alleged, it is clear that at the time the 2009 SPA and the 2011 SPA were executed, the reduction of TGs was still an accepted surrogate for the reduction of [major adverse cardiac events]....

and on page 11
""Viewed in their entirety, the SAC and documents incorporated by reference reveal that TG lowering, despite the open nature of the scientific question, remained a viable surrogate endpoint until 2013.""

and on page 12
""Dr. Jenkins confirmed that "at the time of the [2008 Meeting], (as well as at the time of the ANCHOR SPA agreement) [the FDA] was still willing to accept TG lowering as a valid surrogate for reducing CV risk..." Thus, the 2008 Minutes actually show that TG lowering was an accepted surrogate endpoint in 2008."...

Finally page 12-13
"The post-Class Period documents show that in reaching its decision to rescind, the FDA was swayed not only by ACCORD and AIM-HIGH, but also by third study not mentioned in the 2008 Minutes, HP2S-THRIVE. (noting in December 16th, 2013 meeting that three studies, ACCORD, AIM-HIGH, and HP2S-THRIVE, "reduced the [FDA's] level of confidence").

The three Judge panel concluded the above opinion, the FDA rescinded and maintained rescindment based on "reduced confidence". The FDA factually used opinion to enter the practice of medicine to cancel TG as a surrogate, then use this cancellation to rescind SPA. The FDA created the "wisdom" to rescind science.

G, don't let the facts confuse you, FDA was wrong and this opinion supports this assertion. Your prior opinion is clouding your judgement on what the facts now point to, the 3 Judge panel supports the FDA used opinion to cancel a prior accepted surrogate marker, then used this as "evidence" to rescind a SPA.

BB