Replies to post #305759 on Amarin Corp Plc (AMRN)

[couldbebetter]

Gary, Thanks for posting. I hope someone knowledgeable can opine on this.

Obviously, other medications are more effective in reducing very high
Triglyceride levels than Vascepa is. As to the "safety" issue, one
could argue that Vascepa should not be thought of or labeled as a drug
to reduce very high Triglyceride levels, but as a drug to reduce CV
events! Of course, if it were that simple would not AMRN's "crack"
management team have already pursued this avenue with the FDA? If not,
why not?

The FDA is supposed to protect the health of its citizens from scams
or ineffective drugs and supplements. The FDA certainly wanted AMRN
to complete the R-I study, and now they allow the fruits of that
endeavor to be taken away due to a dysfunctional judiciary?

If the FDA has the power to make this right, and in the process save
lives of its citizens by doing so, why wouldn't they? Is human life
not that important to them? I can only hope that John Thero is on
this as a very high priority item. (Right up there with selling the
company...maybe one will help to facilitate the other. Right, Kiwi?)

[lizzy241]

gary, does this mean that the vascepa label for high trigs will be pulled from the mkt thus invalidating it's use thereby preventing Hikma to launch GV.

[bigkahuna2006]

It mentions that voluntary withdrawal of a listed drug must be done "prior to approving an abbreviated new drug application that refers to the listed drug". Does that mean we might have lost our chance if Amarin hasn't made the application before Hikma's approval?