25 October 2007, London, UK - Ark Therapeutics Group plc (‘Ark’ or the ‘Company’) today provides an update on the Special Protocol Assessment (SPA) process with the FDA relating to the Phase III programme for VitorTM, its product for weight loss and muscle wasting (cachexia) associated with cancer. An SPA is a written agreement between the trial’s sponsor and the FDA regarding the design, endpoints and planned conduct and analysis of a trial to be used in support of regulatory approval. It therefore provides greater clarity and certainty that, if the trial’s endpoints are met, approval from the FDA will be forthcoming.
