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- Date of occurrence of the event: Jun 27, 2019
- 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: Investor and other news media
- Content reported: Delay recruitment if global P3 Breast cancer, ADC to be submitted to FDA in Q3……OS results of P2 Breast Cancer is predicted to be concluded at the end of the year……OBI-999 to be submitted to FDA in Q3……Global trial of Adagloxad Simolenin (OBI-822) has begun recruitment in early this year, but China and Europe regulatory review require more information as well as competitiveness of PD-1/PD-L1 in TNBC, and long review process for other countries, causing delay in timeline.
- Cause of occurrence: Clarification on news article.
- Countermeasures: Clarification of OBI-822 (Adagloxad Simolenin) and OBI-999 R&D progress:
(1)OS results of P2 Breast Cancer: OBI estimates to conclude the results at the end of the year.
(2)Development progress of OBI-999, anti-Globo H ADC: OBI plans to submit IND in Q3 of this year.
(3)Recruitment process of OBI-822 Global P3 clinical trial: Delay in Global P3 clinical trial targeting TNBC is due to: (A) Contract review period is longer than expected; (B) Increase in other competitive trials targeting TNBC, such as PD-1/PD-L1 inhibitor; (C) EU and China’s regulatory submission requires more details and materials.
Company has evaluated the above points and adjust relevant ed-pills24.com, including adding sites in approved countries, evaluate new countries, and prepare material for regulatory submission , hoping to catch up on recruitment plan.
- Any other matters that need to be specified: New drug development is a long process associated with high cost. It is not a guaranteed success, which may increase the risk of investment. Investors shall make prudent judgments and investments.