Polarean Imaging PLC (AIM:POLX, OTC:PLLWF) said it has been granted a 90-day extension by the US Food and Drug Administration (FDA) to 30 December 2022 in order for the regulator to review the company’s new drug application.
Polarean has developed a drug-device system that provides enhanced imagery of the lungs using hyperpolarised xenon-129 gas.
“The FDA will conduct periodic meetings during the extended review period to ensure that any questions that arise during the remaining review can be rapidly addressed to provide the best chance at a positive review decision by the extended date,” investors were told.
From the announcement they also learned the company’s cash balance remains strong. As of June 30, it held US$22.7mln – enough to see it into 2024.