Aradigm Corporation 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 before the FDA could draw any conclusions regarding the safety and efficacy of Apulmiq from these trials. Aradigm believes the independent TPE results verify the significant treatment effects of Apulmiq in ORBIT-4 for the pre-specified primary endpoint and secondary endpoints as previously reported in the NDA submitted on 26 July 2017. The TPE results also verify the already reported non-significant primary and secondary PE endpoint results of ORBIT-3. A meeting has been scheduled with the FDA to discuss these TPE verified Phase 3 trial results. Based on the TPE results, in ORBIT-4 the primary endpoint of median time to first PE was 231 days in the Apulmiq group and 158 days in the placebo group, a difference of 73 days. The treatment effect, based on a stratified unweighted log-rank test (stratified by sex and previous number of exacerbations in the past 12 months prior to randomization), was statistically significant (HR: 0.70; 95% CI: 0.52-0.96; p = 0.024). For the first secondary efficacy endpoint, there was a 37% reduction in the frequency of PEs over the 48-week treatment period in the Apulmiq treatment group as compared to the placebo group (negative binomial model; RR: 0.63; 95% CI: 0.48-0.82). This result was statistically significant (p=0.0007). In the analysis of the second secondary endpoint, a statistically significant 61% reduction in the frequency of severe PEs in the Apulmiq group compared with placebo was found (using the negative binomial model; RR: 0.39 (95% CI: 0.21-0.72; p=0.0024).