$CRMD Announces SPA Agreement With FDA For Pivotal Phase 3 Trial Of CRMD001

CorMedix Announces SPA Agreement With FDA For Pivotal Phase 3 Trial Of CRMD001:

"(RTTNews) - CorMedix Inc. (CRMD: News ) said it received a Special Protocol - Agreement letter from the U.S. Food and Drug Administration, or FDA, regarding a Special Protocol Assessment, or SPA, on the design of a pivotal Phase 3 trial for the company's oral formulation of CRMD001 in the prevention of Contrast-Induced Acute Kidney Injury. The SPA takes into consideration a modification to the dosing regimen contained in the previously submitted protocol.

The Phase 3 clinical study of CRMD001 will assess the efficacy and safety of CRMD001 in the reduction of morbidity and mortality in patients with Chronic Kidney Disease undergoing diagnostic or interventional cardiac procedures and receiving an iodinated radiocontrast agent."