Wil Helmus schreef op 19 oktober 2018 16:00:
At the beginning of October, Acacia Pharma's contract manufacturer told the company it had received a post-inspection notification from FDA, and that the facility complied with current good manufacturing practices.
Yet a few days later, regulators sent the unnamed contract manufacturer a copy of an "untitled letter" — a request to correct issues not significant enough to merit a warning letter — that included details of a single deficiency which need to be corrected before Barhemsys (amisulpride injection) could be approved.
een enkele tekortkoming, niet erg genoeg voor een waarschuwingsbrief kost je bijna 70 miljoen aan beurswaarde. Het is toch te gek voor woorden...