Remodulin Phase IV
Executive Summary
Postmarketing study for Remodulin now due in December 2005 after FDA grants 18-month extension. Sample size is also reduced from 100 to 39 patients. Remodulin was cleared in May 2002 under accelerated approval regs for the "treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise" (1"The Pink Sheet" May 27, 2002, p. 32)...