Current Formulation

Current Formulation. Means Valrubicin at a concentration of 40 mg/ml in 50% Cremophor(R) EL (polyoxyethyleneglycol triricinoleate)/ 50% dehydrated alcohol or other formulations that are accepted by the FDA without the regulatory requirement for a formal clinical study to be submitted in support of such change in formulation.

Current Formulation. The formulation of nimodipine microspheres, including the drug substance, biodegradable polymer as described further in the table below