Amarin Corp Plc (AMRN)

[Ajax133]

Kiwi: I am aware of that, and personally feel there are
no safety issues with Vascepa. That said FDA is malignant
when it comes to AMRN. There's a buzz I heard going back
to adcom, and have heard of some issues somewhat recently.
I wish I could pinpoint it, but I can't. The FDA has done
this in the past with company's they've been contentious
with, even without any safety signals that would raise
legitimate concerns. The relationship between AMRN and
FDA is as nasty as I can recall. The 30,000 patients on
V without safety concerns is a big positive. That said,
in a different indication, FDA can and does make arbitrary
decisions. The AMRN SPA decision was discussed at the highest levels and the decision to rescind was upheld. I believe
that AMRN dropping further appeals was smart as it could be
a step forward in making nice to Agency. Hopefully, this
will allow for an improved relationship. The only reason I
brought it up is that there apparently is precedence for this
in outcomes trials. I can't give you specific names, but it
is another potential blind side hit that FDA could deliver.
The DSMB only looks for safety issues to keep the trial blinded.
This is by far and away the most vindictive Biotech story I can
recall after 23 years. A few exceptions are an old Boston based Biotech named Organogenesis, and a San Diego based Biotech by the
name of Advanced Tissue Sciences. I believe the Co would have been well served getting JZ to resign from the BOD. That would
help making nice for sure.