09:54 AM EST - Fennec Pharmaceuticals Inc. : Following a pre-submission meeting with the oncology division of the U.S. Food and Drug Administration (FDA), has initiated a rolling New Drug Application (NDA) for PEDMARKTM (a unique formulation of sodium thiosulfate (STS) to be administered by infusion) for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors. The Company is targeting U.S. approval of PEDMARKTM in the second half of 2019. PEDMARKTM has been granted Orphan Drug, Breakthrough Therapy and Fast Track designations from the FDA. Fennec Pharmaceuticals Inc.
shares T.FRX are trading up $0.53 at $7.75.
