Published in Medical Letter on the CDC and FDA, August 10th, 2008
Based on recent communications with the FDA, including a face-to-face meeting held on April 16, 2008, Duska believes that the proposed single, prospective, placebo-controlled, and randomized trial in patients presenting to the emergency room with paroxysmal supraventricular tachycardia (PSVT) should be sufficient to demonstrate clinical safety and efficacy. The proposed primary endpoint of...
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