Filing of Marketing Authorisation Application on accelerated basis with EMA
“Following the filing for accelerated approval with the FDA in Q1, we filed our submission for conditional approval with EMA in May. Both FDA and EMA applications are being processed on an accelerated basis and in the U.S our target PDUFA date is September 15th.
During the 2nd quarter we significantly ramped up our pre commercial activities in the US following the strengthening of the team announced in Q1. We have added significant internal resources as well as entered into some key partnerships, in order to ensure that we are well positioned to initiate commercialization in Q4, subject to a positive outcome of the FDA approval process.