Analyst Research

Report Title Price
Provider: Thomson Reuters Stock Report
Provider: Reuters Investment Profile
Provider: Edison Investment Research
Provider: GlobalData

NYSE and AMEX quotes delayed by at least 20 minutes. NASDAQ delayed by at least 15 minutes. For a complete list of exchanges and delays, please click here.

Circadian Technologies Ltd completes Pre-IND meeting with FDA for OPT-302 for the treatment of Wet AMD

Sunday, 11 May 2014 07:30pm EDT 

Circadian Technologies Ltd:Says through its 100 pct. owned subsidiary Opthea Pty Ltd it has completed Type B pre-investigational new drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA).The meetinng for OPT-302 for the treatment of wet age-related macular degeneration.Opthea requested the meeting which was held on May 9 with the FDA division of Transplant and Ophthalmology Products, Centre for Drug Evaluation and Research.The purpose of the meeting was to obtain CDER’s guidance for the regulatory and clinical path for OPT-302 and clarity on the steps required for IND submission.The discussions included manufacturing criteria, scope and design of IND-enabling preclinical studies, and the scope and design of Phase 1/2a clinical trials.The FDA agreed to Opthea’s proposed clinical indication for OPT-302 as a drug for the treatment of wet AMD, which represents an important unmet medical need. 

Company Quote

0.02 +11.43%
31 Jul 2014