Fennec Pharma Stock Plunges On Expected FDA CRL For Pedmark For Chemo-Induced Hearing Issues

Fennec Pharmaceuticals Inc FENC said it expects to receive a Complete Response Letter (CRL) from the FDA regarding its marketing application for Pedmark.

• Related Link: Fennec Pharma Stock Is Trading Higher As Pedmark Is Under FDA Review For Chemo-Induced Toxicity.
• The FDA has indicated that, following a recent inspection of the manufacturing facility of the drug product manufacturer, deficiencies have been identified. 
• Pedmark is under review for intravenous administration to prevent ototoxicity associated with cisplatin chemotherapy in pediatric patients over 1 month to 18 years of age with localized, non-metastatic, solid tumors.
• Once the official CRL is received, the company plans to request a Type A meeting to discuss the deficiencies and steps required for the resubmission.
• The marketing authorization for sodium thiosulfate (tradename Pedmarqsi) is currently under evaluation in Europe. 
• Pedmark received Breakthrough Therapy and Fast Track Designation by the FDA in March 2018. 
• See here Benzinga's Full FDA Calendar.
• Price Action: FENC shares are down 49.7% at $4.85 during the premarket session on the last check Monday.