Amarin Corp Plc (AMRN)

[ggwpq]

Guys, Red Acre discovered the following nugget in its twit @redacre :

$AMRN From: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000MedR.pdf

"It was agreed that a non-inferiority test for percent change from baseline in LDL-
C would be performed between AMR101 and placebo using a non-inferiority margin of 6% and a significance level at 0.05."

VS

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM370985.pdf

"The sponsor performed non-inferiority tests for percent change from baseline in LDL-C between each of the AMR101 doses and placebo using a non-inferiority (NI) margin of 6% and a 1-sided significance level of 0.025. This reviewer thinks that the non-inferiority test was not suitable in this setting [for an efficacy claim] because the study was a placebo-controlled trial."

Sorry FDA - you can't have it both ways - if you agree to it in the SPA - you cant change your mind later regarding whether or not the test is the right one.