End of Phase II Meeting definition

End of Phase II Meeting. End of Phase II Meeting means that certain end of phase II meeting between Adamas and the FDA with respect to Adamas’ IND for the Memantine-Donepezil FDC Product[*].
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End of Phase II Meeting means a meeting with a Regulatory Authority in which AbbVie’s plan to commence a Phase III that would be the subject of a Drug Approval Application for a First Licensed Product are reviewed.
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End of Phase II Meeting means the meeting with Acologix and the FDA to review the data and results of any Phase II Trials conducted for a Product, and to discuss with the FDA Acologix’ plan to commence further clinical Development of such Product with the intent of achieving Regulatory Approval thereafter.
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Examples of End of Phase II Meeting in a sentence

  • Records of these interactions can be found in an End of Phase II Advice letter issued December 8, 2009, End of Phase II Meeting Minutes issued June 3, 2010, Written Responses to proposed analyses issued May 22, 2012 and pre-NDA Meeting Minutes issued December 17, 2012.

  • It has completed the End of Phase II Meeting in US Food and Drug Administration (FDA), and approved by China CFDA to carry out phase III clinical trial in several centers in Asia.

  • Borrower shall fail to have the End of Phase II Meeting by June 30, 2013.

  • The CD71 Phase II Development Plan shall be designed with the goal of AbbVie being able to hold a Successful End of Phase II Meeting; provided, however, the Parties acknowledge that a Successful End of Phase II Meeting cannot be guaranteed and that an End of Phase II Meeting may not occur following completion of the CD71 Phase II Development Plan.

  • AstraZeneca shall provide Nektar with an opportunity to reasonably review any materials to be submitted to FDA in response to the End of Phase II Meeting, and shall reasonably consider Nektar’s comments with respect to any such submission in good faith.


More Definitions of End of Phase II Meeting

End of Phase II Meeting means Teva’s meeting with the FDA consistent with 21 C.F.R. Section 312.47(b)(1).
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End of Phase II Meeting has the meaning set forth in Section 6.7(e).
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End of Phase II Meeting means a meeting with a Regulatory Authority in which AbbVie’s plan to commence a Phase III that would be the subject of a Drug Approval Application for a First Licensed Product are reviewed. 1. 105“E.U. Major Market Country” means each of the following: [***].
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End of Phase II Meeting is a positive End of Phase II meeting with the FDA on the bavituximab second-line NSCLC program (defined as moving into Phase III design); and evidence of the same in form and content reasonably acceptable to the Lenders.
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Related to End of Phase II Meeting

  • Scoping meeting means a meeting between representatives of the applicant and the EDU conducted for but not limited to the following purposes:

  • Court Meeting means the meeting(s) of the Scheme Shareholders to be convened by order of the Court pursuant to section 896 of the Companies Act, notice of which will be set out in the Scheme Document, for the purpose of approving the Scheme, including any adjournment thereof;

  • JMC has the meaning set forth in Section 3.01.

  • Open meeting or "public meeting" means a meeting at which the public may be present.

  • JRC has the meaning set forth in Section 2.2.

  • Ordinary meeting means a meeting held by determination of the Board (SER r.115(1)).

  • JSC has the meaning set forth in Section 3.1.

  • Board Meeting means a meeting of the Board;

  • JDC has the meaning set forth in Section 3.2.

  • Company Meeting means the special meeting of Company Shareholders, including any adjournment or postponement of such special meeting in accordance with the terms of the Arrangement Agreement, to be called and held in accordance with the Interim Order to consider the Arrangement Resolution.

  • Public meeting means a meeting that is required to be open to the public

  • General Meeting means the annual or any special general meeting of the Association.

  • Virtual Meeting means any general meeting of the Shareholders (or any meeting of the holders of any Class of Shares) at which the Shareholders (and any other permitted participants of such meeting, including without limitation the chairman of the meeting and any Directors) are permitted to attend and participate solely by means of Communication Facilities.

  • Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • hybrid meeting means a general meeting convened for the (i) physical attendance by shareholders and/or proxies at the Principal Meeting Place and where applicable, one or more Meeting Locations and (ii) virtual attendance and participation by shareholders and/or proxies by means of electronic facilities;

  • Shareholders Meeting shall have the meaning set forth in Section 5.1.

  • Bondholders’ Meeting means a meeting among the Bondholders held in accordance with Clause 17 (Bondholders’ Meeting).

  • Joint Remediation Committee has the meaning set forth in Section II.A.2.

  • Steering Committee shall have the meaning set forth in Section 3.1.

  • Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • meeting of shareholders means an annual meeting of shareholders or a special meeting of shareholders;

  • JCC has the meaning set forth in Section 3.1.

  • Committee Meeting means a meeting of the Committee.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Pre-bid Meeting means Pre-bid meeting to be held as per the schedule indicated in the Schedule for the Tender hereof;

  • Project Proposal has the meaning set forth in Section 2.2(b).