End of Phase 2 Meeting definition

End of Phase 2 Meeting means the first end of Phase 2 meeting with the FDA, as defined in 21 CFR Section 312.47, intended to determine the safety of proceeding to Phase 3, evaluate the Phase 3 plan and protocols and identify any additional information necessary to support an NDA for Product.
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End of Phase 2 Meeting means a meeting with FDA, the purpose of which is to determine the safety of initiating a first Phase III Clinical Study, to evaluate the Phase III Clinical Study plan and protocols and the adequacy of current studies and plans to assess pediatric safety and effectiveness, and to identify any additional information necessary to support a Drug Approval Application for the uses under investigation, as further defined in 21 C.F.R. 312.47(b)(1), as amended from time to time, or the corresponding foreign equivalent.
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End of Phase 2 Meeting means the end-of-Phase 2 meeting with FDA as described in 21 CFR 312.47(b).
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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.


More Definitions of End of Phase 2 Meeting

End of Phase 2 Meeting means the receipt by Somaxon of the FDA's minutes from the meeting to be held between Somaxon and the FDA to discuss the results of the Phase 2 Clinical Trials.
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End of Phase 2 Meeting means any “End-of-Phase 2 Meeting” as described in 21 CFR 312.47, or, with respect to the EU, a similar meeting with the EMA.
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End of Phase 2 Meeting means the end of Phase 2 meeting with the FDA, as described in 21 C.F.R. § 312.47(b), intended to determine the safety of proceeding to Phase 3, to evaluate
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End of Phase 2 Meeting means the first end of Phase 2 meeting with the FDA, as defined in 21 CFR Section 312.47, intended to determine the safety of proceeding to Phase 3, evaluate the Phase 3
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End of Phase 2 Meeting means the first end of Phase 2 meeting with the FDA, as defined in 21 CFR Section 312.47, intended to determine the safety of proceeding to ** CERTAIN INFORMATION (INDICATED BY ASTERISKS) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. AN UNREDACTED VERSION OF THIS DOCUMENT HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. Phase 3, evaluate the Phase 3 plan and protocols and identify any additional information necessary to support an NDA for Product.
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End of Phase 2 Meeting means an end-of-phase 2 meeting with the FDA as described in 21 CFR §312.47(b), or the equivalent meeting with the EMA.
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End of Phase 2 Meeting means the end of Phase 2 meeting with the FDA, as described in 21 C.F.R. § 312.47(b), intended to determine the safety of proceeding to Phase 3, to evaluate CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED. the Phase 3 plan and protocols, and to identify any additional information necessary to support a marketing application for the uses under investigation.
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