22nd Sep 2022 10:32
(Alliance News) - Polarean Imaging PLC on Thursday said that the US Food & Drug Administration had requested more information from Polarean's drug manufacturing partner.
Shares in Polarean were trading 18% lower at 45.01 pence in London on Thursday morning.
Polarean's partner is working on the xenon-129 gas which enhances magnetic resonance imaging.
Under current good manufacturing practice regulations, designed to ensure the quality of drug products, the FDA is requesting an inspection of the partner's production facility prior to the approval of the product.
The FDA has suggested that the required information would constitute a "major amendment" to the new drug application. If the information is submitted promptly, it would allow the FDA to grant a 90-day extension to the review timeline.
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.
Polarean says it has "received assurances" from its drug manufacturing partner that they will address the concerns.
By Chris Dorrell; [email protected]
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