Fennec receives FDA Complete Response Letter for PEDMARK NDA citing manufacturing deficiencies

FENNEC PHARMACEUTICALS INC.

FDA issued CRL on Nov 29, 2021, after PDUFA date of Nov 27, citing manufacturing deficiencies for PEDMARK NDA.
PEDMARK is intended to prevent cisplatin-induced ototoxicity in pediatric patients 1 month to <18 years with localized solid tumors.
Company plans to request a Type A meeting with FDA to discuss deficiencies and path to resubmission.
Fennec had approximately $24M in cash and cash equivalents as of Sept 30, 2021.
No approved therapy currently exists for this condition; company is committed to addressing CRL issues.

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