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Executive Summary - FC1122 Malachite Green Alternative Scientific Progress Demonstrated the target animal safety of salmonid eggs to Pyceze treatment in a GLP tolerance stydy. Test model for Saprolegnia developed for artificial infection of salmonid eggs in incubators. Performed a dose titration study in salmonid eggs to establish the proposed dose. Complete dose confirmation study in Rainbow trout to illustrate the efficacy of the proposed dose. Performed a GLP tolerance trial in salmon and trout which demonstrated that Pyceze is well tolerated by the target species. Conducted a pilot radio labelled study at the contract laboratory to identify the marker residue in fish tissue. Performed in vitro minimum inhibitory concentration (MIC) study of Pyceze to Saprolegnia parasitica. Completed two ecotoxicological studies to determine the effects of Pyceze and bronopol on the growth of Scenedesmus subspicatus. Established the proposed treatment recommendations following homogeneity testing of Pyceze in water. Developed a tissue residue method suitable for residue monitoring in the EU. Industrial Progress Close liaison with industrial partner to enable manufacturing process and controls to be developed for manufacturing of Pyceze in-house. Three pilot batches manufactured for stability studies. Six months product stability data has been generated. Submitted an application for an Animal Test Certificate (ATC) to conduct field efficacy studies with Pyceze in fish in the UK> Submitted an application for an Investigational New Animal Drug (INAD) to conduct field efficacy studies with Pyceze in eggs in the USA. Response s to Environment Agency and SEPA questions regarding environmental impact of Pyceze and been prepared. Respond to efficacy and tolerance points raised by the Veterinary Assessor at the VMD. Pyceze may be a suitable product for other indications such as Rainbow Trout Fry Syndrome (RTFS), Bacterial Gill Disease and other bacterial infections. Simple look-see studies have been or are being performed in Canada on ornamental fish. These are external but complimentary to the project. A potential screening trial against Amoebic Gill Disease has been set up in Eire. This project also links with FC1123 ‘Malachite Green Alternative - CEFAS Component’ and FC1124 ‘Improving the efficacy of medicines in aquaculture’.