Bio-Gene Technology's progress with Flavocide registration plans

Bio-Gene Technology Limited (ASX: $BGT) has received feedback from the Australian Pesticides and Veterinary Medicines Authority (APVMA) on studies required to support the Company's planned submission for regulatory approval of Flavocide active ingredient, currently expected to be filed with the APVMA in December 2025.

Executive commentary on Flavocide registration progress

We have taken this opportunity to proactively engage with the APVMA to pressure test our study plans for Flavocide. Engaging with the regulator now assists us to confirm and streamline the work that we need to do as part of the registration process. Based on the feedback received, we are currently on track to submit the regulatory information dossier for Flavocide as an active ingredient by the end of 2025. The APVMA's feedback has clarified the range of studies required and also assisted in fine-tuning our existing strategy for regulatory approval. It is very reassuring to receive this feedback from the APVMA at this time. It ensures our Flavocide regulatory development path in Australia is optimized and will include the range of studies required, based on all of the data on Flavocide we have generated so far.

Summary of Bio-Gene Technology's progress and outlook

Bio-Gene Technology Limited (ASX: $BGT) has made progress in its registration plans for Flavocide, a novel insecticidal active ingredient. The feedback received from the APVMA has helped the company to confirm and streamline its work for the registration process, ensuring that the regulatory studies planned are consistent with the regulator's expectations. The company is currently on track to submit the regulatory information dossier for Flavocide by the end of 2025. This development is significant as Flavocide is being developed as a new insecticide derived from nature for various applications, addressing the global challenges of insecticide resistance. The company's focus on overcoming insecticide resistance and providing safe pest management solutions aligns with market demand for effective and environmentally friendly products.