- Date of occurrence: June 11, 2017
- Company name: OBI Pharma, Inc.
- Relationship to the Company (please enter ”head office” or ”affiliated company”): N/A
- Reciprocal shareholding ratios: N/A
- Name of mass media: CNA News E-Paper
- Content reported: During the preparation court hearing on OBI’s insider trading case on June 9, Michael Chang emphasized that OBI’s novel breast cancer drug, OBI-822, has been approved for China, US, and EU Phase III clinical trial, which attests the success of its multi-center/multi-country Phase II clinical trial (Phase II/III in Taiwan). In addition, the scientific significance of the clinical data has been published and recognized in international conferences. OBI is accelerating the process of research and development.
- Cause of occurrence: OBI attended the End of Phase 2 (EOP2) Meeting with the FDA in January of this year; in April, a written response was provided by EU EMA in regards to OBI-822 Global Phase III clinical trial design inquiries. In January, CFDA has also agreed on the multi-center Phase III clinical trial in Asia. Based on the above meeting conclusions, OBI is actively planning OBI-822’s Global Phase III clinical trial.
- Countermeasures: Relevant announcements on OBI-822’s Global Phase III clinical trial will be made available to the public according to relevant laws and regulations.
- Any other matters that need to be specified: None