Examples of End of Phase 2 Meeting in a sentence
Larazotide successfully completed the End of Phase 2 Meeting with the FDA to prepare for expected Phase 3 clinical trials for larazotide in celiac disease in late 2017.
Following the last Phase 2 Clinical Trial for Type 2 diabetes, as determined by the JDC, XOMA agrees to schedule and attend an End of Phase 2 Meeting with the FDA with respect to the anticipated Phase 3 clinical program for Type 2 diabetes, should the data warrant.
For clarity, the submission by Targacept of documents, questions or other information or materials to, or other communication with, the FDA in contemplation of an End of Phase 2 Meeting to be conducted after the earlier of the Effective Date or ********, 2010 is expressly permitted and shall not be deemed to violate or breach this Section 12.19.1 or any other provision of this Agreement.
For Immediate Release: BioMarin Announces Fourth Quarter and Full Year 2012 Financial Results Total Revenue in 2012 Exceeds $500 Million PEG-PAL End of Phase 2 Meeting Completed, Phase 3 to Begin Next Quarter Conference Call and Webcast to Be Held Today at 5:00 p.m. ET Financial Highlights ($ in millions, except per share data, unaudited) * The cash balance at the end of 2012 includes net proceeds of $235.5 million from the public offering in June 2012.
This proposal was reviewed favorably at an End of Phase 2 Meeting with FDA on May 5, 2004 and through a Special Protocol Assessment that was initiated in December 2006 and completed in August 2008.