Aradigm Announces Submission of Responses to EMA Day 120 Questions and Meeting with FDA
ARADIGM CORP COMMON STOCK (ARDM)
US:NASDAQ Investor Relations:
investor.aradigm.com
Company Research
Source: Business Wire
HAYWARD, Calif.--(BUSINESS WIRE)-- Aradigm Corporation (OTCQB: ARDM) (“Aradigm” or the “Company”) submitted responses to the European Medicines Agency (EMA) Day 120 questions on 23 January 2019. The due date for response to the questions was 25 January. The submission of the responses to the questions triggers the restart of the regulatory clock. As part of the EMA regulatory review calendar for marketing authorization application submissions to the EMA for approval, Aradigm will expect a Day 180 List of Outstanding Issues in late March. The clock will stop again until Aradigm responds to those issues, usually within thirty to sixty days. One month later, Aradigm could expect an opinion by the Committee for Medicinal Products for Human Use (CHMP) to our request for approval or a presentation to the CHMP during a formal hearing, which will be followed by the CHMP opinion a month later. As previously annou
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