Amarin Corp Plc (AMRN)

[johnking29]

STS66: I spoke to Amarin's Joe Bruno (Amarin's PR person) today and asked that very question...

Again I ask - WHEN WAS ANCHOR MODIFIED TO INCLUDE THE WORDS "REDUCE CV RISK"!?!?! AND WHO DID IT!?!?

He said: It is typical that the Intended Testing Targeted Endpoint Group be listed in the Application... (Yet I add that they did not do that in the Marine application!)

His comment to meant to me that Amarin did...


I also asked him if Amarin will request a modification in their Anchor application to just get approved for the reduction in Trigs in the 199 to 499 group and move on with that.

I ask anyone again: How could they say NO to that request?!?

He said Amarin is and will be in contact with the FDA thru December 20th covering any and all options to get some form if not all of Anchor approved whether intact or modified.

In effect No Comment on my direct question...

I also have to ask anyone on this board if they do apply for this treatment, do they have to list a targeted group?

Based on the Marine application I have to say NO because they did not use the CVE language (in that process!) I also do not believe they listed an intended target group... I KNOW they noted in their Marine Application that the product was not proven to reduce Inflammation in the Pancreas nor is it proven to Reduce CVE's...

NOW THERE IS A NOVEL APPROACH:

LET'S ASK FOR A MODIFICATION IN THE ANCHOR APPLICATION LANGUAGE NOTING THE EXACT SAME LANGUAGE IN THE MARINE APPLICATION!