Ventura/Hikma Advair Diskus6 Sep 2017 12:46
Ventura today...The biggest event during the period was perhaps the complete response letter in May that Vectura and partner Hikma received from the US Food & Drug Administration in relation to the pair's proposed generic version of Advair Diskus, which is likely to require significant amendments to the drug application.
Vectura, as device and drug formulation designer, and Hikma, as the drug maker, have said a number of the questions raised have been clarified and resolved, leading management to expect to be able to "confirm the regulatory timetable before the end of 2017.