Fennec Pharmaceuticals Inc.’s (FENC) Pedmark, proposed for the prevention of ototoxicity induced by Cisplatin chemotherapy in patients one month to less than 18 years of age with localized, non-metastatic, solid tumors, awaits the FDA decision on November 27, 2021.Last August, the FDA had declined to approve Pedmark after identifying deficiencies in a manufacturing facility of the company’s drug product manufacturer.Cisplatin is the standard of care for pediatric solid tumors and is often associated with ototoxicity. It is estimated that about 60% of children on Cisplatin therapy develop irreversible ototoxicity, which manifests itself as hearing loss, sometimes accompanied by tinnitus.There is currently no established preventive agent for this hearing loss due to chemotherapy and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. If approved, Pedmark has the potential to prevent chemotherapy-induced hearing loss and be the first available agent approved for this condition.If approved, Pedmark could achieve peak sales of $200 million, according to analysts.FENC closed Thursday’s trading at $8.97, down 0.88%.