Preliminary regulatory assessment obtained for Metvix® photodynamic therapy for treatment of actinic keratosis
Vidar Hansson, President and CEO, commenting on the response from the MPA said: The authorities have taken slightly longer than they originally expected to provide us with their initial feedback. However, we are happy that we have received the first written response, and that we are now able to continue the work needed to finalise our application in order to gain marketing authorisation for Metvix® PDT. We believe we can answer the MPAs initial questions appropriately and keep the approval process on track.