Regulatory Pathway

The Company will seek regulatory approval and labeling indications for ZS-9 in both the acute and chronic hyperkalemia patient populations.  We believe the most expedient and effective approach to regulatory approval is to first complete the necessary efficacy and safety study in acute hyperkalemia patients.  The hospital market provides an ideal environment to conduct the approrpriate clinical trial.  Due to the high incidence of acute hyperkalemia patients (up to 8% of all hospitalized patients) available for study and an unimpressive de facto standard of care, we believe that the protocol development, site and patient recruitment and trial execution will be straight forward and produce compelling data.  Clinical development for the chronic hyperkalemia indication will occur concurrently beginning with additional toxicity and animal studies.  Upon completion, the company will conduct the appropriate human trial.  The company will pursue an expedited development and regulatory pathway as we believe ZS-9 is a significant advancement over existing therapies thereby addressing a significant and poorly met healthcare need.