Fennec Plunges As FDA Is Expected To Deny Approval For Pedmark Yet Again

(RTTNews) - Fennec Pharmaceuticals Inc. (FENC) said on Monday that it expects to receive a Complete Response Letter from the FDA for its lead drug candidate Pedmark.

Pedmark, proposed as a treatment for the prevention of Ototoxicity from Cisplatin in pediatric patients, is under FDA review and a decision was due on November 27, 2021.

With the FDA having identified deficiencies in the manufacturing facility of the PEDMARK manufacturer, Fennec has been able to read the writing on the wall.

The company noted that once the official Complete Response Letter is received, it will request a Type A meeting to discuss the deficiencies and steps required for the resubmission of the NDA for PEDMARK.

Last August too, the U.S. regulatory agency had declined to approve PEDMARK due to deficiencies in the facility of the drug product manufacturer. No clinical safety or efficacy issues were identified then.