Feb 19, 2009 (Datamonitor via COMTEX) –
— Cordex Pharma, a developer of new cardiovascular medicines, has submitted to the FDA an amended Phase III protocol for ATPace to be reviewed as a special protocol assessment.
According to Cordex, the amendment addresses written comments recently received from the FDA in response to the company’s initial special protocol assessment (SPA) submission to the FDA in November 2008.
Amir Pelleg, Cordex’s president and chief scientific officer, said: “We are very pleased with the FDA’s timely response to our initial ATPace SPA submission. We now believe that the written correspondence from the FDA, which clearly outlines all study-design requirements and clinical endpoints, would enable us to generate the efficacy and safety data required for the marketing approval of ATPace.
“We look forward to initiating the pivotal Phase III clinical trial for ATPace in paroxysmal supraventricular tachycardia patients.”

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