New drug application resubmission update

Polarean Imaging

20 April 2022 - Polarean Imaging announces that further to the RNS issued on 31 March 2022, the Company can confirm that the US FDA has accepted the resubmission of its new drug application as a complete response, and has established a user fee goal date of 30 September 2022, designating it Type 2.

Read Polarean Imaging press release

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Medicine , US , Dossier , Device