1.Date of occurrence of the event: December 22, 2016
2.Company name: OBI Pharma, Inc.
3.Relationship to the Company (please enter ”head office” or ”affiliated company”): N/A
4.Reciprocal shareholding ratios: N/A
5.Name of the mass media: Page A5 of the Economic Daily News
6.Content reported: Page A5 of the Economic Daily News stated that “The design of US Phase III clinical trial for OBI-822, OBI’s novel anti-breast cancer drug, has been submitted to the FDA for Investigational New Drug (IND) in mid-October. Experts pointed out that the scale of the clinical study will depend on the discussion between OBI and the FDA. If an ‘adaptive Phase III’ is approved, the length of the study will be significantly reduced.”
7.Cause of occurrence: Clarification on the news article by Economic Daily News
8.Countermeasures:(1)OBI-822, the novel anti-breast cancer drug, has been approved to for IND during Phase I clinical trial. The statement of “[…] has been submitted to the FDA for Investigational New Drug (IND) in mid-October” is inaccurate. In addition, regarding the study design of Phase III clinical trial for OBI-822 in the news article, OBI has been actively planning on the design. Any major progress will be made available to the public according to relevant laws and regulations.(2)The statement of “Experts point out that the scale of the clinical study will depend on the discussion between OBI and the FDA. The statement of my-antidepressant.com is approved, the length of the study will be significantly reduced” was solely a speculation by the mass media without any factual basis. The statement did not originate from OBI and therefore is unofficial. Investors should make prudent judgment. Any official response from the FDA will be made available to the public according to relevant laws and regulations.
9.Any other matters that need to be specified: The results of a single clinical trial do not sufficiently reflect the outcome of a new drug entering into the market. Investors should make carful judgment and prudent investment. New drug development is a long journey associated with high cost. It is not a guaranteed success, which may increase the risk of investment. Investors shall make prudent judgments and investments.