If ency/Given had started this trial when the fda first requested, would they be finished by now?
Press Release Source: Encysive Pharmaceuticals Inc.
Encysive Pharmaceuticals to Conduct Phase III Study With Thelin (Sitaxsentan Sodium) in Pulmonary Arterial Hypertension
Monday September 24, 7:00 am ET
HOUSTON, Sept. 24, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals Inc. (NasdaqGM:ENCY - News) today announced that the Company will move forward with plans to conduct an additional Phase III study evaluating Thelin(tm) (sitaxsentan sodium) in patients with Pulmonary Arterial Hypertension (PAH).
The company 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 the Company has concluded its protocol discussions with the FDA, it will announce the details of the study, including timing and the number of patients.
Encysive believes it had successfully addressed all of the questions raised by the U.S. FDA in its New Drug Application (NDA) for Thelin in PAH. However, the Company has concluded after consulting with external experts that the best path forward for commercializing Thelin in the U.S. 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.
Background
Following receipt of the June 15, 2007 ``approvable'' letter from the FDA, the Company filed a request for formal dispute resolution with the FDA over its decision. Dispute resolution is a process where companies can challenge regulatory decisions by bringing the dispute to the attention of FDA supervisors. In September of 2007 the Agency replied that, while the data in the NDA are suggestive of the effectiveness of Thelin, it did not provide the substantial evidence of effectiveness needed for approval, and recommended an additional Phase III trial as the best path forward.
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