Dr. Lee S. Simon, a Rheumatologist and former Director of the Food and Drug Administration's Analgesic, Anti-Inflammatory and Ophthalmic Drug Products Division, and a consultant to the companies, commented,"The results of this initial clinical trial provide supportive evidence for the efficacy and safety of Indaflex(TM). This therapeutic product candidate has the potential to fulfill the need for an effective, tolerable and safer alternative to either oral non-selective NSAIDs or COX-2 selective inhibitors for the treatment of osteoarthritis of the knee, as well as other diseases and disorders which are associated with localized pain and inflammation."