
"As a result of the supportive feedback from the FDA, we have established a clear development plan for AHRO-001, including Phase I and Phase II human clinical studies." said Thomas W. Gardner , CEO of AtheroNova. "Based on the success of our interactions with the FDA, AtheroNova plans to move forward with the submission of the IND application during 2012, as planned."
"The imaging of plaque lesions has made significant strides in the last few years and AtheroNova is planning to use the state of the art combination of intravascular/near-infrared spectroscopy as a critical measurement tool for the regression of coronary artery disease when moving forward with its Phase I and Phase II studies," said Balbir Brar , DVM, PhD; SVP, Drug Development of AtheroNova. "Critical information of the coronary plaque morphology and lipid content will assist in the measurement of clinical progress of this and future therapies in plaque management. We appreciate FDA's suggestions in AtheroNova's study outlines and acceptance of intravascular/near-infrared spectroscopy use in evaluating plaque reversibility."
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