EOP2 Meeting definition

EOP2 Meeting has the meaning set forth in Section 4.10.3.
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EOP2 Meeting has the meaning set forth in the Evaluation Agreement.
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EOP2 Meeting means a Type B meeting with the FDA [*], to evaluate the plans for the Phase 3 Clinical Trial program and protocols, and to identify any additional information necessary to support a marketing application for the uses under investigation.
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Examples of EOP2 Meeting in a sentence

  • Coordination Regarding Water SupplyCurrent Florida Statutes require coordination between water supply planning and future land use planning in order to ensure an adequate supply of water to support future development.

  • We also found that the station did not fully comply with the open meeting requirements of the Act and CPB guidance nor did it fully comply with the discrete accounting requirements of the grant.We also found that the allegation that the station failed to adhere to EEO requirements in a 2017 hiring of a part-time employee was not a violation of FCC requirements because they did not apply.

  • The company expects to present data from these patients at a medical meeting in Q3 2018.• SEL-212 End of Phase 2 (EOP2) Meeting Planned for Mid-2018 and Plans for Phase 3 Program Initiation in 2018: The Selecta team is currently compiling the data package for an EOP2 meeting with the FDA, targeted for mid-2018, which will define the company’s design for the Phase 3 program.

  • Notwithstanding the foregoing, Spark’s obligations to provide personnel support to Pfizer as required in Section 4.10.2 shall not be subject to the foregoing limitations until the EOP2 Meeting has been completed.

  • No later than [**] days following the EOP2 Meeting with the FDA and EMA, Pfizer shall provide Spark with [**] (the “Pivotal Trial Development Plan”), [**].

  • Enquiry Authority, authorising them to have access to information about Your Account, but not to provide Proper Instructions, transact or withdraw from Your Account; orii.

  • Unmet need Life-threatening condition Long-term data needed Only feasible to conduct post-approval Prior clinical experience indicates safety Small subpopulation affected Theoretical concern Other: PREA Onychomycosis is primarily a disease of adults, and Phase 3 studies were conducted in population 18 years and older as agreed upon during EOP2 Meeting 10/8/2009 and SPA review 9/13/2010.

  • Lavin, Ph.D., a biostatistician, FDA panel member, and pharmaceutical consultant, to opine on interactions between the FDA and Esperion preceding the August 11, 2015 EOP2 Meeting andDefendants’ August 17, 2015 public statements.

  • Andrew Haughwout, Donghoon Lee, Joelle Scally, Wilbert van der Klaauw(2015), “Student Loan Borrowing and Repayment Trends, 2015”, Federal Reserve Bank of New York.

  • PREVIOUS DOCUMENTS: Previous Documents Document DatePIND meeting minutes EOP2 Meeting MinutesSafety review IND 69,190 and IND Amendment Pre-NDA meeting MinutesAug.


More Definitions of EOP2 Meeting

EOP2 Meeting means the end-of-phase 2 meeting with the FDA and/or the equivalent meeting with the EMA to be conducted at the end of the Phase 2a Clinical Trials for a particular Product to discuss the requirements of the FDA or EMA (as applicable) for a Registration Program for such Product to support Marketing Approval. * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission
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Related to EOP2 Meeting

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

  • 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;

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

  • 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;

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

  • Meeting means any meeting of:

  • Board Meeting means a meeting of the Board;

  • Scheme Meeting means the meeting or meetings of the INM Shareholders or, if applicable, any class or classes of INM Shareholders (including as may be directed by the High Court pursuant to Section 450(5) of the Act) (and any adjournment of any such meeting or meetings) convened by (i) resolution of the INM Board or (ii) order of the High Court, in either case pursuant to Section 450 of the Act, to consider and vote on the Scheme Meeting Resolution;

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

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

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

  • Special Meeting means a special meeting of the holders of Voting Shares, called by the Board of Directors for the purpose of approving a supplement or amendment to this Agreement pursuant to Subsection 5.4(b);

  • 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.

  • 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;