Liquidia Technologies Says On Nov. 15 Received Notice From FDA In Response To Pre-NDA Submission Questions; Co. Says Not Believes Pre-NDA Submission Meeting Is No Longer Necessary

As previously disclosed, Liquidia Technologies, a Delaware corporation (the “Company”), anticipated a pre-New Drug Application (NDA) submission meeting in the fourth quarter of 2019 with the U.S.

Benzinga · 11/18/2019 21:39

As previously disclosed, Liquidia Technologies, a Delaware corporation (the “Company”), anticipated a pre-New Drug Application (NDA) submission meeting in the fourth quarter of 2019 with the U.S. Food and Drug Administration (the “FDA”) to discuss the nonclinical and clinical contents of the planned NDA for LIQ861. On November15, 2019, the Company received written correspondence from the FDA in response to the Company’s pre-NDA submission questions. Given that the Company deemed the written responses provided by the FDA to sufficiently answer its pre-submission questions and that the FDA did not provide the Company with any unanticipated requirements for the NDA submission, the Company now believes that a pre-NDA submission meeting is no longer necessary.

 

The Company continues to target a first quarter 2020 NDA submission for LIQ861. However, there can be no assurances that the FDA will accept the NDA for filing once submitted or, if accepted for filing and subject to substantive review by the FDA, that the FDA will ultimately approve LIQ861.