Novus Therapeutics Receives FDA Guidance on OP0201 Phase 2a Study in Patients with Chronic Otitis Media with Effusion
Study C-009 is designed to explore the effect of daily administration of OP0201 in patients with COME, a non-infectious form of otitis media. The study will enroll infants and children with three months or longer of bilateral middle ear effusion and hearing loss. The primary endpoints of study C-009 will be the resolution of middle ear effusion and/or restoration of hearing.
“We are pleased to have alignment with the
About
Forward-Looking Statements
This press release contains forward‐looking statements that involves substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about its strategy, future operations, development of its product candidates, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward‐looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, although not all forward‐looking statements include such identifying words. Forward‐looking statements include, but are not limited to statements regarding: risks related to market conditions, the completion of the common stock and warrant financing, including the satisfaction of the closing conditions, and the use of anticipated proceeds; expectations regarding the timing for the commencement and completion of product development or clinical trials, including the four ongoing OP0201 clinical trials; expectations regarding the success of clinical trials; the rate and degree of market acceptance and clinical utility of the company’s products; the company’s commercialization, marketing and manufacturing capabilities and strategy; the company’s intellectual property position and strategy; the company’s ability to identify additional products or product candidates with significant commercial potential; the company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; developments relating to the company’s competitors and industry; and the impact of government laws and regulations. Actual results may differ materially from those indicated by such forward‐looking statements as a result of various important factors, including: the ability to develop commercially viable product formulations; the sufficiency of the company’s cash resources; the ability to obtain necessary regulatory and ethics approvals to commence additional clinical trials; whether data from early clinical trials will be indicative of the data that will be obtained from future clinical trials; whether the results of clinical trials will warrant submission for regulatory approval of any investigational product; whether any such submission will receive approval from the
View source version on businesswire.com: https://www.businesswire.com/news/home/20191029005257/en/
Source:
Investor Contacts
Timothy McCarthy
LifeSci Advisors, LLC
Tel: 212-915-2564
tim@lifesciadvisors.com