Suji Jeong

Suji Jeong from Jefferies asked whether the trial design for IMPALA 2 would be different for the European Union and if the company has had any discussions about the design with the European Medicines Agency (EMA).

Answer

Chief Medical Officer Badrul Chowdhury responded that conceptually, the trial design is unlikely to differ for the E.U. because the original IMPALA study design was consistent globally. He noted that the company will provide updates on interactions with other regulatory bodies once those discussions have occurred and the protocol is finalized.

Suji Jeong from Jefferies LLC asked about the potential impact on statistical power from reducing the AeroVanc Phase 3 trial enrollment to approximately 140 patients. She also inquired about interactions with the EMA for the second IMPALA study and whether the number of deaths in the OPTIMA study was expected.

Answer

CEO Rob Neville stated that the reduced enrollment for the AeroVanc trial would have a minimal impact of a few percentage points on the study's power. Chief Medical Officer Badrul Chowdhury clarified that their priority is to agree on a study design with the FDA for IMPALA 2 before engaging with the EMA. He also confirmed that the three deaths in the OPTIMA study were reflective of the severe, advanced disease in that patient population.