In December 2010 Lorcaserin Regulatory Update, Arena reported on its discussions with the US Food and Drug Administration at the end-of-review meeting for the lorcaserin New Medication Application , including Arena and Eisai’s plans to handle the lorcaserin Complete Response Letter and the expectation to resubmit the NDA to the FDA by the end of 2011. Arena is certainly continuing its discussions with the FDA to finalize protocols for actions that are designed to address the issues raised by the FDA or that usually are linked to the assessment of the benefit-risk profile of lorcaserin.Holden has built and led regulatory and compliance functions and obtained approval for a number of products in the U.S., Canada and Europe. From 2005 until 2012, Dr. Holden was Senior Vice President of Regulatory Affairs and Compliance at Nereus Pharmaceuticals. Proprietary Development Programs ARRY-614 – Dual p38/Tie2 inhibitor for Myelodysplastic Syndromes : A fresh formulation of ARRY-614 with improved plasma exposure and lower inter-subject matter variability is currently advancing in a Stage 1 scientific trial in patients with MDS. In the second half of 2012, we intend to meet the FDA to discuss the primary endpoints for a registration trial. ARRY-520 – KSP inhibitor for Multiple Myeloma : ARRY-520 happens to be advancing in three clinical trials: 1. Stage 2 trial in combination with dexamethasone in individuals with MM refractory to lenalidomide, bortezomib and dexamethasone therapy; ARRY-520 exceeded the response criteria in stage 1 of this trial and is definitely advancing into stage 2 2.