Amarin Corp Plc (AMRN)

[Biobillionair]

Why a decision is likely tomorrow.

New FDA MAPP policy's Manual of Policies & Procedures (CDER)
MAPP 5000.6R1 posted 5-7 and effective 5-2 Office of Pharmaceutical Science Coordinating Committee (OPS CC)
Purpose:
? This document describes the organization, membership, responsibilities, and procedures of the Office of Pharmaceutical Science Coordinating Committee (OPS CC) in the Center for Drug Evaluation and Research (CDER). OPS CC serves as a forum for identifying and discussing scientific, technical, and regulatory issues that may require OPS to develop and implement applicable policy.

MAPP 4512.2 posted 5-13 effective 6-10 Conducting Effective Meetings in CDER: Remote Access Considerations


http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/default.htm

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Both new CDER policy relate to meeting and making decisions that are difficult, like Vacsepa's NCE status. It looks to be the wrap up on the over haul of CDER MAPPs.

Well why is this the end? Both policy's relate to being efficiant with the FDA deciding difficult policy procedures and then actually have the time to meet, thus we have the 4512.2 policy going into effect and oraganizing teleconference meetings. It would truly be pathetic for the FDA to submit such policy's without the Vascepa decision being made...as Amarin waits for a decision CDER has met and revised pages of policy.

Tomorrow finally....???

NCE/NME only provides short term valuation and security for Amarin to follow through on business plans, without the decision Amarin and shareholders are on their own.

Williams