Aradigm Announces Detailed Third Party Evaluation Results for Apulmiq (FDA)/Linhaliq (EMA)
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") today announced specific, detailed results of an independent third party evaluation (TPE) of the Phase 3 clinical trial results for Apulmiq. As previously reported, Aradigm received a Complete Response Letter (CRL) on 26 January 2018, from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Apulmiq as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infection with Pseudomonas aeruginosa (P. aeruginosa). The CRL identified issues related to a manual re-review of patient-level pulmonary exacerbation (PE) data conducted by Aradigm after errors were discovered in the analyses performed by a contract research organization. The CRL stated that an independent third party would need to verify the results of the ORBIT-3 and ORBIT-4 Phase 3 trials befo
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