RE: RNS out 12 noon14 Jan 2020 12:08
This is big news , "We believe these additional endpoint data, together with the totality of the 12-month topline data and trend in fracture rate reduction in the high dose cohort, are fully supportive of moving forward with our planned pivotal trial in children with OI. To this end, we have made additional progress on the regulatory front, including a positive recent meeting with the European Medicines Agency ("EMA"), and are currently preparing for a Type B End-of-Phase 2 meeting with the FDA, scheduled for the first quarter of 2020."