The initial costing estimate for AYR+ path to marketing authorisation is outlined below.
One product refers to 1 formulation and strength. Four products would be two nicotine strengths in an unflavoured and flavoured variation. We have included these two ranges to highlight the impact of formulation on cost.
At the time of releasing this draft program to the board, we are still expecting the quotation for the clinical studies and CE marking. We have estimated the clinical costs based on previous studies that Monica V has been involved in. Once these are all received then we can easily make adaptations to the project timeline and total estimated costs.