Fennec Pharmaceuticals Inc

NASDAQ:FENC  
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Fennec Pharmaceuticals Receives Complete Response Letter From The FDA For Its New Drug Application For Pedmark™ To Prevent Ototoxicity Associated With Cisplatin In Pediatric Patients With Locali

Published: 11/30/2021 12:42 GMT
Fennec Pharmaceuticals Inc (FENC) - Fennec Pharmaceuticals Receives 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 - Crl Issued As Result of Identified Manufacturing Deficiencies Which Need to Be Satisfactorily Resolved Before Pedmark NDA Can Be Approved.
Fennec Pharmaceuticals Inc - Plans to Request a Type a Meeting With FDA to Discuss These Deficiencies and Other Matters Described in Crl.
Fennec Pharmaceuticals Inc - Plans to Discuss Steps Required for Resubmission of NDA for Pedmark With FDA.