The real potential of Vascepa may be realized very soon. The company currently has an application in with the FDA to expand the label of the drug, with a PDUFA date set at December 28, 2019.
Should AMRN achieve its goals here, the label will be expanded to include cardiac risk reduction in high risk patients. The data supporting the potential approval came from the REDUCE-IT cardiovascular outcomes study, the largest study of its kind, with data essentially proving that Vascepa has the potential to reduce cardiac risk as a long-term therapy.
This is incredibly important as there is a large population of patients that have high cardiac risk, but no options. To date, the FDA has not approved any medications for this indication, nor has any other regulatory body around the world.
In the past, the general idea was to take a baby aspirin per day. However, even this has been changed. The American Heart Association recently issued a statement warning that baby aspirin should not be used daily unless directed by your doctor.
Considering that there are LITERALLY NO OPTIONS available to this massive patient population, should the Vascepa label be approved, AMRN will be sitting on a gold mine! So, pay very close attention to this stock over the next couple of months!
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