Amarin Corp Plc (AMRN)

[alternatepatel]

Why would Jenkins wait to approve Anchor if he is in favor of an approval ? I think he has got enough of Authority to reverse lower level decisions without taking 'advise' from MPC.

Thoughts please...


Pasting lines from AMRN CC for ready reference:

" Dr. Jenkins informed us that before reaching a determination on our appeal, he has asked to seek advice from a CDER Medical Policy Council. As you may know CEDR is an acronym for the FDA’s Center for Drug Evaluation and Research. The CEDR Medical Policy Council which includes Dr. Janet Woodcock and Robert Temple and other senior FDA officials provides a senior level form to establish medical policy to ensure it’s implemented in a consistent manner throughout the center.

Given ongoing dialogue with FDA, we have no further substantive updates on the FDA appeal this time. We repeat that why we believe that approval of the ANCHOR indication is in the best interest of patient care in that we have strong legal, regulatory and clinical arguments for reinstating the SPA for the anchor indication. Existing levels when the FDA have not agreed, then there can be no assurance that the appending response from the FDA will be any different. We continue to see this effort as an upcoming battle."