Replies to post #8380 on Amarin Corp Plc (AMRN)

[BaaBaa45]

Once more:

"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.

Don't quite understand how anything other than an NCE (designated as such by the FDA) can be discussed at an ADCOMM. Are you saying that an ADCOMMs remit is broader than the section quoted. If so please provide relevant section.

Thanks