The US Food & Drug Administration (FDA) said the review of the company’s drug‑device combination product using hyperpolarised xenon-129 gas to enhance magnetic resonance imaging in pulmonary medicine will follow a “standard time frame”.
That means the target Prescription Drug User Fee Act or PDUFA date is October 5, 2021. This is the deadline by which the FDA must review all new drug applications and is traditionally 10 months from submission.
“The company plans to make full use of this time with regards to commercialisation and launch preparation,” Polarean said in a statement.
Chief executive Richard Hullihen added: "FDA acceptance for the filing of Polarean's NDA represents another important step forward for the Company's platform. If approved, Polarean's drug-device technology could provide a new diagnostic option for patients with pulmonary disease.”
In the same announcement, the company confirmed the planned retirement of chief operating officer Ken West, who will continue as a consultant and a non-executive director of Polarean.
“The board would like to thank Ken for his expert and untiring contributions, particularly in managing the NDA submission and its successful acceptance by FDA for review,” added Hullihen.
“I look forward to Ken's continued support at both the board level and in relation to special projects."