Amarin Corp Plc (AMRN)

[Biobillionair]

"FDA Preliminary Response: Under 505(s) of the FD&C Act, all new chemical entities must either be discussed at an Advisory Committee Meeting or a justification provided as to why it will not be discussed. A final decision on whether AMR101 is a new chemical entity has not been made.
Meeting Discussion: The firm pressed for a more definitive response given the limited resources of the company. The sponsor was informed that, based on what is known about the compound at this time, and in our opinion it was less likely that AMR101 would go to an Advisory Committee. Final decision on the question of an Advisory Committee would be made after submission of the NDA"

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Amarin should have had an Advisory Committee for Marine, the FDA did not understand the Omega 3 situation.
Likely the June 22, 2012 meeting save the miss branded 3 yr NME at PDUFA date.