Approaching commercialisation of our veterinary oncology pharmaceutical
April, 2018 Update
All final sections of the Canine Mast Cell Tumour (MCT) US Food and Drug Administration-Centre for Veterinary Medicine (FDA-CVM) application for tigilanol tiglate are currently being drafted, with the complete application planned for submission in the third quarter of 2018.
The European Medicines Agency (EMA) route we will take for European veterinary registration of the drug is Centralised. Following a positive regulatory review, this approach enables us to gain marketing authorisation for tigilanol tiglate with all EU countries. The European programme is on track and the application will be submitted based on the core USA-FDA package.