FDA Acknowledges Receipt of Bronchitol NDA Resubmission - Decision Review Date 1 November 2020
Release Date: 13/05/2020 9:33am
Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today announced its US licensee Chiesi Farmaceutici S.p.A. (Chiesi) has received acknowledgement of receipt of the Bronchitol NDA resubmission from the US Food and Drug Administration (FDA). The receipt of this communication from the FDA indicates that the submission responds to all issues raised in the complete response letter received in June 2019.
However, the FDA have classified the resubmission as Class 2 which changes the FDA review period from an expected two months to six months and sets a Goal Action Date of 1 November 2020.
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