Polarean Imaging PLC (AIM:POLX, OTC:PLLWF) has announced that the US Food and Drug Administration (FDA) has requested additional information from the manufacturing partner for the company's xenon-129 gas blend drug.
The company said this request is related to the recent cGMP (Current Good Manufacturing Practice) pre-approval inspection at the partner's production facility. The FDA has suggested that the required information would constitute a major amendment to the New Drug Application (NDA) that, if timely submitted, would allow for the FDA to grant a 90-day extension to the review timeline.
Polarean noted that the FDA has proposed frequent meetings to occur during the extended review period to ensure that any questions that arise during the review can be rapidly addressed to provide the best chance at a positive review decision by the extended date.
The company said it has received assurances from its drug manufacturing partner that they will address the concerns. Polarean said it will provide an additional update on the status of its NDA in due course.
Polarean noted that its net cash balance was US$22.7mln as of June 30, 2022, which, based on strategic decisions, could finance the company into 2024.
Polarean and its wholly owned subsidiary, Polarean Inc, are revenue-generating, investigational drug-device combination companies operating in the high-resolution medical imaging research space.
The group develops equipment that enables existing MRI systems to achieve an improved level of pulmonary function imaging and specialises in the use of hyperpolarised xenon gas (129Xe) as an imaging agent to visualise ventilation. 129Xe gas is currently being studied for visualisation of gas exchange regionally in the smallest airways of the lungs, across the alveolar tissue membrane, and into the pulmonary bloodstream.