Product development over the past quarter has focussed on our most advanced product, the proven Poultry Productivity Enhancer. We have advanced our key commercial objectives: • Significantly improved production scale-up processes to better suit internationally approved commercial production methods • Establishing the source of approved material for use in final regulatory trials and commercial release • Finalising the global sub-license arrangements for the product • Planning the development path of the product under the sub-license arrangements • Progressing the dossier for Office of the Gene Technology Regulator (OGTR) approvals for commercial product release During the last quarter promising advances were made to improve the commercial production processes for the Poultry Productivity Enhancer. The new production process is better suited to large scale production and is compatible with production methodology currently used by multinational animal health companies. Preparations are underway for initial production of product material for registration in the major global markets. A final optimisation step is required before production of initial batches commences. We expect this material to be available for the upcoming intentional release trials. The timing of these trials depends on regulatory approval timing of the OGTR. Our application for the ‘Intentional release license’ from the Commonwealth Government’s OGTR has advanced. This license is a precursor to large commercial field trials and commercial sales of the Poultry Productivity Enhancer in Australia. While regulatory trials can proceed without this license, Imugene has identified significant marketing value in obtaining this license early to enable trials to be undertaken by commercial poultry producers to boost the products marketing value. Importantly, the product development timetable is proceeding while the OGTR considers the terms of the license.
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