Bellerophon Therapeutics, Inc. announced that it received confirmation from the U.S. Food and Drug Administration (FDA) of the Agency's acceptance of all modifications proposed by the Company to its Phase 3 program for INOpulse in Pulmonary Arterial Hypertension (PAH). Under the newly modified Phase 3 program, the ongoing one-year INOvation-1 study, and a second confirmatory randomized withdrawal study with approximately 40 patients who will be crossing over from the INOvation-1 study, can serve as the two adequate and well-controlled studies to support a New Drug Application filing for INOpulse in PAH subjects on long term oxygen treatment (LTOT). INOvation-1 and the randomized withdrawal study are planned to be conducted on near parallel timelines, which could reduce the time to market for INOpulse in PAH by approximately two years. Both studies include an interim analysis approximately half-way through each study, estimated to occur by the end 2017 for the INOvation-1 study and in the second half of 2018 for the withdrawal study. The interim analysis will allow both studies to be stopped early if efficacy is demonstrated. The original Phase 3 program called for two studies, the INOvation-1 study (n=188; placebo arm and iNO 75 arm), followed by the INOvation-2 study (n=282; placebo arm, iNO 50 arm and iNO 75 arm). Based on these parameters, the Company anticipated that INOpulse could receive regulatory approval in 2022. With the approved modifications to the Phase 3 program, the INOvation-2 study will be replaced with the randomized withdrawal study, a much smaller study in approximately 40 subjects over a four-month enrichment period and two month randomized withdrawal. Under this revised clinical trial protocol, INOpulse could receive regulatory approval as early as 2020. In the modified Phase 3 program, following completion of INOvation-1, subjects will receive at least four months of active, open-label iNO treatment with a dose of 75 mcg/kg IBW/hr (iNO75). Those subjects who demonstrate 30 meter improvement in six minute walk distance, the primary endpoint of INOvation-1, and can tolerate the iNO, will constitute an "enriched" population of iNO responders who will be randomized to either placebo or iNO75 in the withdrawal study. Changes in clinical status (defined as clinical worsening) within an individual patient during the randomized withdrawal period will provide the necessary evidence of whether the improvements observed during the enrichment phase were related or non-related to iNO therapy. The proposed study design, therefore, provides the formal confirmatory evidence of whether iNO at a dose of 75 mcg/kg IBW/hr delivered via the INOpulse delivery device for up to 24 hours per day is efficacious in subjects with PAH concomitantly using approved PAH medication and LTOT.