Newron submitted their NDA for Safinamide to the FDA this past May. The normal time period for approval, assuming everything goes ok, would be about 12 months. So, they are expecting to receive FDA approval sometime in mid-2015. As the data of the last two studies was very favorable, there has been extensive testing over the past few years, and the EU approval is imminent, I am expecting this to move smoothly through the FDA review process. I don't see what MJFF could do at this time as it is already well into FDA review.