Additional Relevant Details Based on discussions at the CHMP meeting and the Food and Drug Administration Complete Response Letter in January, BioMarin intends to discontinue clinical and regulatory development of Kyndrisa as well as the three other first-generation follow-on products, BMN 044, BMN 045 and BMN 053, currently in Phase 2 studies for distinct forms of Duchenne muscular dystrophy. Notwithstanding this outcome for Kyndrisa in Europe, the Company continues to expect to achieve non-GAAP break-even or better in 2017.  BioMarin plans to work with physicians, patient groups, and regulatory authorities to develop a transition plan for those patients currently being treated with Kyndrisa, BMN 044, BMN 045 and BMN 053. The Company will continue to explore the development of next generation oligonucleotides for the treatment of Duchenne muscular dystrophy.