in Clinical Field Efficacy Trials Prepared by:

Spawning aids such as Ovaplant ® (Salmon Gonadotropin-releasing Hormone Analogue, sGnRHa), luteinizing hormone-releasing hormone analogue (LHRHa), human chorionic gonadotropin, and common carp pituitary are routinely used in aquaculture to induce gamete maturation in fish to enhance fish propagation programs. The U.S. Food and Drug Administration has authorized the use of Ovaplant ® under the Compassionate Investigational New Animal Drug (INAD) Exemption #11-375 for the purpose of gathering efficacy data to support a new animal drug approval for Ovaplant®. In calendar year 2007 (CY07), seven trials were conducted under this INAD to evaluate the efficacy of Ovaplant ® to induce gamete maturation in a variety of fish species. Trials involved 772 treated fish and 834 control fish and were conducted at five different hatcheries, including two U.S. Fish and Wildlife Service fish hatcheries, two state hatcheries, and one tribal hatchery during this period. Efficacy was determined by whether or not treated fish produced or yielded more eggs or milt than untreated fish. 2Overall results from trials conducted in CY07 showed that treatments appeared efficacious in all trials