is to gain experience
Our current focus
Presently, we are focused on the development of a medication in cardiovascular medicine which is available in the EU but not yet the US. Introducing it into the US market in an optimized, reformulated format presents a sizable market opportunity. We are reformulating the product from twice-daily to once-daily dosing which we believe will substantially improve adherence rates while maximizing benefits and outcomes for patients with this common chronic condition with combined EU and US prevalence exceeding 20 million patients.
A sound regulatory strategy is the key factor of our commercial planning. We intend to introduce our reformulated product into the EU market via a well-established regulatory pathway and into the US market using a 505(b)2 filing. FDA has expressed preliminary interest in our project, and we are currently in the process of planning our pre-IND meeting with the agency.