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news.Encysive Pharmaceuticals has reported that it will move forward with plans to conduct an additional Phase III study evaluating Thelin in patients with pulmonary arterial hypertension.
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Encysive has been discussing possible protocols for the trial, to be called Stride 5, with its scientific advisory board and other experts. The company will now work with the FDA to finalize the protocol. After it has concluded its protocol discussions with the FDA, it will announce the details of the study, including timing and the number of patients.
The company believes it had successfully addressed all of the questions raised by the FDA in its new drug application for Thelin in pulmonary arterial hypertension (PAH). However, it has concluded after consulting with external experts that the best path forward for commercializing Thelin in the US is to conduct an additional Phase III study. As a result, Encysive will not continue to pursue the formal dispute resolution process with the FDA.