This article is a perfect example of the kind of Ahead of the Curve Analysis that we specialize in at Red Acre Investments. Five days before the FDA Orange Book was due out, we indicated through this article that Amarin Pharmaceuticals (#AMRN) might still have a delay in their New Chemical Entity (NCE) Decision from the FDA. The NCE decision is a binary event for the stock because it grants extra market exclusivity for their drug Vascepa. The article was published at 7:00 AM on September 10th. After the market closed that same day, the company confirmed via an 8-K filing that, based on their discussions with the FDA, the NCE decision for Vascepa would not be settled when the FDA Orange Book update issued in 5 days.
Our analysis was accurate, and we were the ONLY investment analysts who put out a view BEFORE the company's 8-K SEC filing. Last month, AMRN waited until the day that the Orange Book update was published to disclose (via an 8-k filing) that the NCE decision would not be in the Orange Book. It is quite possible that our analysis, published in the article linked below, may have prompted the company to issued their 8-k disclosure 5 days earlier than they had originally planned. This is the kind of analysis that let's you Get Ahead of the Curve.
This article was published on seekingalpha.com on September 10, 2012
Investors in Amarin Corporation (AMRN) are once again anticipating news on Vascepa's new chemical entity (NCE) status. The FDA's August update to the Orange Book comes out on Friday September 14th. In a previous article published just before last month's orange book update, we wrote about how the NCE status is not likely to matter one way or another in terms of long term marketing potential of Vascepa. In this article we outline reasons why the NCE issue might still not be cleared up during this month's orange book update.
Read the full article on Seeking Alpha
