Management Comment "We made significant progress with our lead program in both the U.S. and European Union. Our first New Drug Application (NDA) for Mycapssa™ in acromegaly was accepted for filing by the FDA in August, and our Prescription Drug User Fee Act (PDUFA) target date was set for April 15, 2016," Mr. Leuchtenberger continued. "The European Medicines Agency (EMA) also just recently accepted the protocol for our Phase 3 acromegaly trial of octreotide capsules, which we now expect to initiate by early in the second quarter of 2016. In addition, we have continued to explore additional indications that we might address utilizing Mycapssa™ and our Transient Permeability Enhancer (TPE®) platform."