Replies to post #22158 on Amarin Corp Plc (AMRN)

[sts66]

Nice to have friends in high places that allow the fox to guard the henhouse!

The FDA also required GSK to convene an independent group of scientists to readjudicate key aspects of RECORD, which studied the cardiovascular safety of Avandia compared to standard diabetes drugs to provide clarity about the integrity of the study findings.

On June 5 and 6, 2013, the readjudicated results of RECORD, which were consistent with the original findings of the trial, were discussed at a joint meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. Committee members generally agreed that the readjudication was well conducted and provided reassurance that the original study findings were accurate. A majority of the committee members voted to recommend that the REMS for rosiglitazone be eliminated or modified to lessen restrictions to use.