Fennec Pharmaceuticals Inc

-0.06 (-1.28%)

Fennec Pharma Expects To Receive CRL From FDA For Solid Tumors Treatment NDA

Published: 11/29/2021 11:12 GMT
Fennec Pharmaceuticals Inc (FENC) - Fennec Pharmaceuticals Expects to Receive Complete Response Letter From the FDA for Its New Drug Application for Pedmark™ to Prevent Ototoxicity Associated With Cisplatin in Pediatric Patients With Localized, Non-metastatic, Solid Tumors.
Fennec - Once Official Crl is Received, Co Plans to Request Type a Meeting to Discuss Deficiencies, Steps Required for Resubmission of NDA for Pedmark.
Fennec Pharmaceuticals - Expects to Receive Crl After PDUFA Target Action Date of Nov 27, 2021 From U.S. FDA Regarding NDA for Pedmark.
Fennec - FDA Indicated, Post Completion of Pre-approval Inspection of Manufacturing Facility of Drug Product Maker, Deficiencies Have Been Identified.