Apr. 18 at 12:29 PM
$LPCN i have personal experience of a company whose drug received breakthrough status after a trial in which the primary objective was not met. That was Durect's Phase 2 trial of larsucosterol for alcohol-related hepatitis. Failed because European sites didn't follow protocol and admitted patients who were too old and too sick. And there was also the questionable decision to count patients who chose to have transplants as dead. Promising results in the American patients led to the FDA decision. But Durect was unable to finance the required Phase 3, and they were acquired by BHC, who is now running their own larsucosterol trial, having presumably learned a lot of things not to do from Durect.
