Polarean Imaging PLC (AIM:POLX, OTC:PLLWF) said it will continue to work with the US medical regulator after receiving a list of issues to be addressed in response to the new drug application (NDA) for its drug-device combination product.
The AIM-listed company submitted the NDA in respect of its investigational drug-device combination product using hyper-polarised xenon gas to enhance pulmonary MRI scans.
It has now received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA), where the regulator said it is unable to approve the NDA in its present form.
However, Polarean said the list of issues provided by FDA are “attainable” and “mostly technical or manufacturing-related in nature and centre around the Xenon hyperpolariser system”.
The company said it will urgently seek additional discussions with the FDA and work to address the issues identified in the CRL with a view to resubmitting the NDA and securing approval as quickly as possible, with the subsequent FDA review process expected to take two to six months following resubmission.
Richard Hullihen, chief executive officer of Polarean, said, “We are obviously disappointed that we have not received FDA approval within this review cycle, and we will continue to work diligently with the FDA to understand their recommendations to address the issues that have led to the CRL being issued. We remain confident in the safety and efficacy profile of hyperpolarised noble gas imaging and Polarean’s ability to accomplish its goals.”
Polarean noted that it had a net cash balance of US$38.2mln at the end of June 2021 that should allow it to fund operations “comfortably” through its response to the CRL and the FDA review period.
In the meantime, it pledged to continue to collaborate with current and future research investigators in continued exploration of potential clinical applications of this technology, with its 9820 Xenon Polariser system installed in the world-renowned University of Texas MD Anderson Cancer Center in July and a follow-up order from the system from the University of British Columbia in May.