(, ) 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”.
