Thinly traded micro cap Fennec Pharmaceuticals (NASDAQ:FENC) slumps 32% premarket on average volume in response to its announcement that it received a Complete Response Letter (CRL) from the FDA regarding its marketing application seeking approval of Pedmark (sodium thiosulfate) for intravenous administration for the prevention of ototoxicity associated with cisplatin chemotherapy in pediatric patients ≥1 month to 18 years of age with localized, non-metastatic, solid tumors.
The CRL cited deficiencies at its manufacturing facility. The review team noted no issues with safety or efficacy.
The company plans to meet with the agency to clarify the necessary steps to resolve the issues.
Management will host a conference call this morning at 8:30 am ET to discuss the matter.
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