FDA acceptance for the filing of new drug application

Polarean Imaging

23 December 2020 - The Directors are pleased to announce that Polarean has received notification of acceptance of the Company’s NDA by the FDA. 

The FDA has confirmed that the review will follow the standard review time frame with a target Prescription Drug User Fee Act action date of 5 October 2021. 

The Company plans to make full use of this time with regards to commercialisation and launch preparation.

Read Polarean Imaging press release

Michael Wonder

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Michael Wonder

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US , Dossier , Diagnostic agent