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Circassia's AirNOvent drug a step closer to market with FDA pre-submission meeting

Circassia Pharmaceuticals PLC (LON:CIR) CEO Steve Harris tells Proactive London's Andrew Scott their partner, AIT Therapeutics Inc. has successfully completed a pre-submission meeting with the US FDA for the ventilator-compatible nitric oxide product AirNOvent.

AIT anticipates submitting a Premarket Approval application (PMA) for AirNOvent in the second quarter of 2019 for use in the treatment of hypoxic respiratory failure associated with persistent pulmonary hypertension of the newborn (PPHN).

Circassia intends launching the product in the first half of 2020, once approved.

 

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