There's more bad news for Encysive Pharmaceuticals. The developer received its second "approvable" letter for the blood pressure therapy Thelin, rather than the simple approval that investors were looking for. The announcement sent Encysive shares down 43 percent. The company said that one item from the FDA's March approvable letter remained unresolved, but added that the agency had indicated its willingness to listen to new arguments on what Encysive characterized as a "matter of judgment." Encysive also has the option of mounting a new clinical study. Encysive has been looking to gain the FDA's approval to market Thelin for pulmonary arterial hypertension.
- here's the AP report on Encysive