It is usual for two Phase 3 studies to be required for filing. However, depending on data from the first Phase 3 study, we may explore with Regulatory bodies in Europe filing with one Phase 3 study which could occur during 2020. US FDA have been clear that two studies are required, and filing will await results from the second study. Because of this process, the product will not be available for sale before 2021
As part of the Phase 3 programme, Futura is required by regulators to run an open label extension study. After patients complete their 12 week double blind, they are invited to enter the open label extension study (“OLE”) to assess safety at the highest dose (0.6% GTN). This OLE is a normal requirement of regulators for pharmaceutical products to provide additional reassurance on safety for longer term use of MED2005.