Posted by Michael Wonder on 05 Apr 2018
Aradigm announces the EMA has completed its validation of the MAA submission
5 April 2018 - Aradigm Corporation today announced the completed formal validation by the EMA of the marketing authorisation application for Linhaliq for the treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa.
The completion of the MAA validation is commensurate with the start date of the review procedure on 29 March 2018.
The EMA review of the application for Linhaliq will be according to standard timelines, with an opinion of the CHMP expected within 210 days (less any clock-stops for the applicant to provide answers to question(s) from the CHMP). After the adoption of a CHMP opinion, a final decision regarding the application assessment is carried out by the European Commission on Day 277 of the procedure.
