End of Phase 2b Meeting definition

End of Phase 2b Meeting means the first meeting with the FDA following Completion of the Phase 2 Dose-Ranging Trial and pertaining to the clinical program for a Product. In the case where FDA declines Akcea’s request for a face-to-face End of Phase 2b Meeting, such meeting will be deemed to have occurred upon Akcea’s or its Affiliate’s receipt of a written response from FDA to the questions posed by Akcea or its Affiliate for such meeting and Akcea having provided to the FDA any additional information in the possession of or readily available to Akcea requested by the FDA as the case may be.
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Examples of End of Phase 2b Meeting in a sentence

  • Akcea will invite Novartis representatives to attend the End of Phase 2b Meeting and such representatives will participate in such meeting under the direction of Akcea.

  • The Parties will update such draft documents after the primary endpoint and key safety data generated based on the database lock under the statistical analysis plan for such study are available and, within [***] ([***]) calendar days after Completion of the Phase 2 Dose-Ranging Trial for such Product, will promptly convene a special meeting of the CSC for the CSC to mutually agree on the final contents of all such documents prior to Akcea requesting an End of Phase 2b Meeting.

  • Akcea will invite Novartis to participate in any key internal Akcea meetings Akcea holds to prepare and discuss strategy for the first End of Phase 2b Meeting for such Product.

  • The Parties will mutually agree on a plan and strategy (including key messages) for the conduct of the End of Phase 2b Meeting that reflects Akcea’s role as IND-holder for such Product and facilitates Novartis’ active participation as the Party potentially responsible for conducting the CVOT and IND and MAA/NDA-Holder in the event of Option exercise.

  • Once such documents are finalized, Akcea will use Commercially Reasonable Efforts to schedule and conduct an End of Phase 2b Meeting.

  • Prior to, but no later than [***] months before the anticipated Completion of the Phase 2 Dose-Ranging Trial for a Product, in preparation for the End of Phase 2b Meeting, Novartis will deliver to Akcea drafts of all documents Novartis reasonably determines are necessary for the End of Phase 2b Meeting, including, at a minimum, a draft [***] for the CVOT and the Cardiovascular Risk Reduction (or “CVRR”) Indication Novartis will pursue for such Product, draft [***] and [***].

  • Any interactions Akcea has or plans to have with a Regulatory Authority for a Product before Option Exercise (other than the End of Phase 2b Meeting under Section 1.2.5), including any meetings, correspondence and submissions, shall be the sole responsibility of Akcea.

  • IASEny interactions Akcea has or plans to have with a Regulatory Authority for a Product before Option Exercise (other than the End of Phase 2b Meeting under Section 1.2.5), including any meetings, correspondence and submissions, shall be the sole responsibility of Akcea.

  • The order must establish a visitation plan for parents unless the trial court finds “that the parent has forfeited their right to visitation or that it is in the child’s best interest to deny visitation.” In re Г.ff., 232 N.C. App.

Related to End of Phase 2b Meeting

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

  • Board Meeting means a meeting of the Board;

  • 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.

  • 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;

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

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

  • 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;

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

  • Public meeting means a meeting that is required to be open to the public under Title 52, Chapter 4, Open and Public Meetings Act.

  • Shareholders Meeting has the meaning provided in Section 6.3.

  • JRC has the meaning set forth in Section 2.2.

  • 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.

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

  • Special Meeting shall have the meaning set forth in Section 23(c)(i) hereof.

  • special meeting in lieu of an annual meeting means a special meeting called by Directors for the purpose of electing Directors in the event that an annual meeting is not held on or before such date as may be required by the NYSE Amex, New York Stock Exchange or such other exchange or trading system on which shares are principally traded, if applicable.

  • physical meeting means a general meeting held and conducted by physical attendance and participation by shareholders and/or proxies at the Principal Meeting Place and/or where applicable, one or more Meeting Locations;

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

  • Annual Meeting means the annual meeting of the stockholders of the Company.

  • special meeting of shareholders means a meeting of any particular class or classes of shareholders and a meeting of all shareholders entitled to vote at any annual meeting of shareholders at which special business is to be transacted.

  • Shareholder Meeting means an annual general meeting of shareholders or special meeting of shareholders of the Company called for the purpose of electing directors to the board of directors of the Company.

  • JDC has the meaning set forth in Section 3.2.

  • Annual General Meeting means the meeting held by the Society in the first four months (or such other period as permitted by the Statutes) of each Financial Year at which the Annual Accounts are presented and which is specified as such in the notice convening the meeting;

  • JSC has the meaning set forth in Section 3.1.

  • Meeting means any meeting of:

  • Meeting of Members means an annual meeting of members or a special meeting of members;

  • relevant meeting means a meeting of the authority to consider whether or not to approve a proposal to dismiss a relevant officer; and