11 months ago, the U.S. Food and Drug Administration (FDA) shut down Solid Biosciences’ (SLDB) “IGNITE DMD” Phase I/II clinical trial after one of the young patients involved in the trial suffered a “serious adverse event.” Despite the patient in question recovering, no new patients suffering such serious adverse events, and the company providing the FDA with “information and measures intended to improve patient safety” and “data related to manufacturing process improvements,” the FDA declined to allow trials to resume in July, and asked Solid Biosciences to provide even more information on its trials, and on the safety measures it …read more
Source:: Yahoo Finance
