Today, my bullish opinion received further validation with the submission of a supplemental new drug application, also known as an sNDA, that was submitted to the FDA. In my view, this is the next step on the road to turn Vascepa, the company’s fish oil pill, into a blockbuster with the potential to make millionaires.
What Is Vascepa?
AMRN has been working on Vascepa for years, and back in 2012 the treatment was approved by the Food and Drug Administration (FDA). The approval covered the use of the refined fish oil pill as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.
Why Is Today’s News Such A Big Deal
Sure, it’s great that Vascepa was approved in 2012 for the reduction of trigliceride levels in adults with severe hypertriglyceridemia. However, this was never where the real value of Vascepa lied, and long-time AMRN investors knew it. After all, severe hypertriglyceridemia only affects just over 1% of the American population.
The supplemental new drug application submitted will greatly increase the company’s target audience, should the application be approved. After all, the application surrounds the indication of reducing residual cardiovascular risk in patients with statin-managed LDL-C cholesteral, but persistent elevated triglycerides.
Think about it this way. At the moment, it is estimated that more than 35 million Americans or more than 10% of the United States population are using statin-based treatments. A large percentage of these see persistent high cholesterol levels.
In the past, the American Heart Association recommended the use of baby aspirin to control risk of cardiovascular events in this population. However, the AHA has pulled its recommendation. Moreover, there are absolutely no treatments on the market with this indication, leading to a vast medical need.
Considering everything that Vascepa has going for it, should the sNDA be approved, AMRN could be sitting on a blockbuster drug that is quickly adopted by the high cardiovascular risk community in the United States and around the world.
This could propel the value of the stock to new heights, and it could all happen soon.
In fact, the FDA granted Priority Review designation for the sNDA, reducing the time to a decision by several months. In fact, at the moment, we’re just a few months away, with a decision from the FDA expected in late-September.
At the end of the day, while the stock is up about 14% on the news so far today, in the long run, the gains will likely be in multiples should Vascepa be approved to reduce cardiovascular risk in this patient population.
What Do You Think?
Where do you think AMRN stock is headed moving forward? Join the discussion in the comments below!