Amarin Corporation plc (ADR) (NASDAQ:AMRN) announced that the independent data monitoring committee (DMC) has recommended the Phase 3 study of its drug candidate Vascepa to continue. The late-stage trial of Vascepa has been dubbed REDUCE-IT study and it is designed to evaluate the efficacy of the drug in reducing cardiovascular risks in patients.

Amarin said it had expected the DMC to recommend the REDUCE-IT continue. However, some investors could be seen heading for the exit in Amarin stock immediately as it became clear that REDUCE-IT study would indeed continue.

Did the market misinterpret DMC’s recommendation regarding the late-stage study of Vascepa? Misinterpretation doesn’t seem to be the case, but the trigger of the selloff in the stock lay somewhere between what Amarin expected from the DMC’s assessment of preliminary data from REDUCE-IT study and what its shareholders wanted to hear.

Robust clinical data

Amarin is looking to approach regulators for Vascepa approval with the backing of robust clinical data. However, investors have been focused on a more rapid approval process for Vascepa. As such, they were expecting DMC to recommend an early end to the REDUCE-IT study so that Amarin can immediately seek marketing clearance for the drug.

Therefore, some investors were disappointed when DMC said the study should run its full course, thus delaying approval and increasing uncertainty over the drug’s approval.

Trial data inflow

The final results from REDUCE-IT study are expected in 2018, though there will be some interim analysis of the study around mid-2017. Amarin will be kept in the dark about the progress of REDUCE-IT study until the study is stopped.

Add-on to statin

Amarin’s Vascepa is being developed as an add-on therapy to statin treatment. It is specifically geared toward patients whose cardiovascular risks have persisted despite prior statin treatment. As such, the REDUCE-IT study seeks to find out whether Vascepa can reduce cardiovascular events and other heart diseases in the group of patients who have failed to see positive outcomes with statin therapy.