H.C. Wainwright's Andrew S. Fein reiterated a Buy rating on Amarin Corporation plc (ADR) AMRN, with a price target of $10.
The DMC decision is expected July–August 2016, and Fein believes that the study is likely to be recommended to be continued as planned.
However, management emphasized a potentially prolonged time frame for data analysis "due to the need to adjudicate MACE primary events and the large-scale, international reach of the study," the analyst said.
In addition, Amarin indicated that the 967th event (of the total 1,612 events that lead to the interim look) was expected "sometime in 1H16," while the data readout was likely "several months after."
Fein expects the event to occur in February–March. However, the analyst mentioned that due to the variable time frame for data analysis, it could be difficult to interpret the implications of the later than anticipated interim readout.
According to the H.C. Wainwright report, the delay in the time frame is likely to have been due to either higher RRR or a longer data analysis time, given that the placebo event race has already been revised down after discussions with the FDA.
"While we cannot tease apart the relative contribution of a higher RRR and a longer analysis time to a delayed interim readout, we do believe that the full study readout will benefit from a tighter timing estimate once we gain the interim information," the report added.
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