The True Value of a SPA: An Inside Look at CorMedix
With its new Special Protocol Assessment with the U.S. Food and Drug Administration, CorMedix will be conducting Phase III research for Deferiprone as an indication for Contrast-Induced Acute Kidney Injury. Often times, the importance or value of an SPA is overlooked, but it the case of CorMedix, it certainly warrants a closer look.
A portion of the article:
CorMedix Receives SPA from FDA for Deferiprone Phase 3 trial
CorMedix (AMEX: CRMD) announced that it received a Special Protocol Assessment approval letter from the FDA on the design of a pivotal Phase 3 trial for Deferiprone. Deferiprone is indicated for Contrast-Induced Acute Kidney Injury. The “SPA” takes into consideration a modification to the dosing regimen contained in the previously submitted protocol.