Following a recent meeting with the Therapeutic Products Directorate (TPD) of Health Canada, and after the receipt of the positive decision on eligibility, Santhera now has 60 days to submit the NDS to the Canadian regulatory authorities.
Klaus Schollmeier, CEO said: “We are excited about Health Canada's decision. We will seek Canadian market approval with a safety and efficacy package that is equivalent to the file currently under review at the EMEA. If everything goes according to plan, we may be able to launch SNT-MC17 in the Canadian market in late 2008, thus providing FRDA patients with the first approved pharmaceutical product for the treatment of this devastating disease.”