Vascepa’s sNDA is requesting a label expansion to include the reduction of cardiac risk in high-risk patients. Should the drug be approved, it will be the first and only on the market, not only in the United States, but around the world.
In general, during the review of New Drug Applications, or supplemental New Drug Applications, the FDA will lean on an Advisory Committee. These Committees are made up of experts in the area of the indication that the drug is intended to treat.
On November 14, 2019, the FDA Advisory Committee meeting will take place at the FDA’s offices in White Oak, Maryland. Information on the meeting is available here.
While advisory committees do not have the ability to approve or reject treatments, the FDA takes their views into account and regards them very highly. In fact, when we see a landslide vote from advisory committees in favor or against approval, we tend to see the same result when the FDA makes its decision.
Should the FDA Advisory Committee vote for the approval of Vascepa’s label expansion, AMRN Could see dramatic gains in value. After all, a strong vote would signal a strong chance of approval.
If Vascepa were approved, it could be a massive win. The truth of the matter is that there are no approved treatments to reduce cardiac risk in high risk patients. Moreover, the AHA recently advised against the use of daily baby aspirin to control cardiac risk, leaving patients with no options either prescription or over the counter.
Should the FDA approve Vascepa’s label change, it will be the ONLY OPTION for a LARGE PATIENT POPULATION. That is a recipe for extreme profitability.
Stop wasting your time! Start finding winning trades in minutes with Trade Ideas!
Don’t Miss The Next Big Story
Join our free mailing list below to receive real-time news alerts!