Amarin Corp Plc (AMRN)

[MedResCollab]

Inasmuch as your [Citizen Petition] contains information that has already become public, it is already known to FDA. -north40000

When did a citizen petition ever contain non-public information? You should know that, apart from thinly veiled attempts by industry at delaying generic entry (the majority of Citizen Petitions), CPs can and have been effective in changing or influencing regulatory opinion and decision making. The FDA is a massively burdened federal agency that cannot spend huge amounts of time and resources on every decision. It allocates what resources it reasonably can. If those outside the agency have spent considerable time and attention to certain details beyond what can be reasonably expected from the agency, then their work can be of use to the agency. It’s as simple as that. And the FDA is no respecter of persons. A petition will stand or fall based on its own merits, depending upon the strength of the argument presented within it, not based on who presented it.

Now, we do think that what we request in our petition was likely to happen anyway, but submitting it makes those actions all the more likely, and helps ensure the agency doesn’t miss some important detail, which an overburdened FDA might very well overlook.

Regards,
-MRC