Investigational Device Exemption (IDE) for the development of Adagloxad Simolenin (OBI-822) was approved by the US Food and Drug Administration (FDA) for its use in OBI-822 Phase III Clinical TrialJuly 27, 2018
- Date of occurrence of the event: Jul 28, 2018
- Company name: OBI Pharma Inc.
- Relationship to the Company (please enter “head office” or “subsidiaries”): Head office
- Reciprocal shareholding ratios: N/A
- Name of mass media: Commercial Times
- Content reported: “OBI…immunohistochemistry (IHC), received the safe to proceed letter from the FDA to be used for OBI-822 Phase III study. “it is estimated that the Phase III study may start in the third quarter, and complete in 2025 with total enrollment of 668 subjects.”
- Cause of occurrence: Clarification on news articles
- Countermeasures: The aforementioned timeline is an unofficial estimation by the mass media. The actual progress of the study will be announced based on the company’s schedule and planning.
- Any other matters that need to be specified: new drug development is a long process associated with high costs. It is not a guaranteed success, which may increase the risk of investment. Investors shall make prudent judgments and investments