Amarin (AMRN) says the FDA's Division of Metabolism and Endocrinology Products has delayed a decision on the reinstatement of the ANCHOR SPA.
There is currently "no definitive date for [a] planned response."
Although the company says that "based on dialogue with DMEP, [it] does not expect the delay to be for a significant period of time ... there can be no assurance that AMRN will be successful." (PR)
The shares, which had run up in the regular session, are down 9% AH.