First Interim Analysis definition

First Interim Analysis means, with respect to a clinical trial, the date on which the data from such clinical trial has undergone an interim analysis and such interim analysis has been finalized by Biotest and received by ImmunoGen.
Sample 1Sample 2Sample 3
First Interim Analysis means the first interim analysis described in the DSMB Charter.
Sample 1

Examples of First Interim Analysis in a sentence

  • Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study.

  • The estimated number of cases for each interim analysis equates to the number of cases observed in each vaccination schedule and the placebo group: First Interim Analysis 1Second Interim AnalysisFinal AnalysisExperimental group 1≈ 53 cases (starting on≈106 cases (starting on≈151 cases Day 42) acrossDay 42) across(starting on Day subjects treated in thissubjects treated in this42) across group and the Placebogroup and the Placebosubjects treated group.group.in this group and the Placebo group.

  • For clarity, GSK shall have the right under this Section 1.c.i to terminate its Option to the TTR Program irrespective of the outcome of the First Interim Analysis.

  • Press Release, “Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study,” Businesswire.com (Nov.

  • In accordance with the DSMB Charter, the Parties expect the Independent Statistician will perform the First Interim Analysis and provide the data from such First Interim Analysis (the “Interim Data Package”) to the DSMB and to each Partner Firewalled Staff.

  • Exhibit Number DescriptionPress Release, dated March 7, 2014, entitled “NewLink Genetics' Independent Review Committee Recommends Study99.1 Continuation Without Modification after Completion of First Interim Analysis of IMPRESS Phase 3 Pancreatic Cancer Trial with Algenpantucel-L”SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

  • Press Release: Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study.

  • Pfizer and BioNTech Announce Vaccine Candidate against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study.

  • Press Release: Pfizer And BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success In First Interim Analysis From Phase 3 Study.

  • Key secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2.” Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study | Moderna, Inc.

Related to First Interim Analysis

  • Forensic analysis means the practice of gathering, retaining, and analyzing computer-related data for investigative purposes in a manner that maintains the integrity of the data.

  • risk analysis the analysis required under Rule 17f-7(a)(1)(i)(A).

  • Operating Statement Analysis Report format substantially in the form of and containing the information called for therein for the Mortgage Loans, or such other form for the presentation of such information as may be approved from time to time by the CREFC® for commercial mortgage securities transactions generally.

  • CMSA Operating Statement Analysis Report means a report substantially in the form of, and containing the information called for in, the downloadable form of the "Operating Statement Analysis Report" available as of the Closing Date on the CMSA Website or in such other form for the presentation of such information and containing such additional information as may from time to time be approved by the CMSA for commercial mortgage-backed securities transactions generally.

  • CREFC® Operating Statement Analysis Report The monthly report in the “Operating Statement Analysis Report” format substantially in the form of and containing the information called for therein for the Mortgage Loans, or such other form for the presentation of such information as may be approved from time to time by the CREFC® for commercial mortgage securities transactions generally.

  • Market Analysis means a technique used to identify market characteristics for specific goods or services “National Treasury” has the meaning assigned to it in section 1 of the Municipal Finance Management Act, 2003 (Act No. 56 of 2003);

  • Credential analysis means a process or service by which a third party affirms the validity of an identity document described in section 25(6)(c) through a review of public and proprietary data sources conducted remotely.

  • Phase 1 means the phase of the ATP comprised of: (1) improvements to the State Street Substation; (2) construction of the Proposed Line; (3) the rebuilding of NYSEG’s existing Lines 971 and 000 xxxxx xx Xxxxxxxx Xxxx xx the NYSEG ROW to allow for construction of the Proposed Line as intended; (4) improvements to the Elbridge Substation to accept the Proposed Line; and (5) National Grid’s conveyance to NYSEG of the NYSEG Acquired ROW and such other land interests as contemplated by the Purchase and Sale Agreement.

  • Total resource cost test or "TRC test" means a standard that is met if, for an investment in energy efficiency or demand-response measures, the benefit-cost ratio is greater than one. The benefit-cost ratio is the ratio of the net present value of the total benefits of the program to the net present value of the total costs as calculated over the lifetime of the measures. A total resource cost test compares the sum of avoided electric utility costs, representing the benefits that accrue to the system and the participant in the delivery of those efficiency measures, as well as other quantifiable societal benefits, including avoided natural gas utility costs, to the sum of all incremental costs of end-use measures that are implemented due to the program (including both utility and participant contributions), plus costs to administer, deliver, and evaluate each demand-side program, to quantify the net savings obtained by substituting the demand-side program for supply resources. In calculating avoided costs of power and energy that an electric utility would otherwise have had to acquire, reasonable estimates shall be included of financial costs likely to be imposed by future regulations and legislation on emissions of greenhouse gases.

  • Guaranteed analysis means the minimum percentage of each plant nutrient guaranteed or claimed to be present.

  • Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on Appendix B.

  • Commissioning test means tests applied to a distributed generation facility by the applicant after construction is completed to verify that the facility does not create adverse system impacts and performs to the submitted specifications. At a minimum, the scope of the commissioning tests performed shall include the commissioning test specified in Institute of Electrical and Electronics Engineers, Inc. (IEEE) Standard 1547 Section 5.4 "Commissioning tests".

  • Feasibility Study means the evaluation and analysis of the potential of a project, which aims at supporting the process of decision-making by objectively and rationally uncovering its strengths and weaknesses, opportunities and threats, as well as identifying the resources required to carry it through and ultimately its prospects for success;

  • Research Analyst means any individual employed by Loomis Sayles who has been designated as a Research Analyst or Research Associate by Loomis Sayles. A person is considered a Research Analyst only as to those Covered Securities which he or she is assigned to cover and about which he or she issues research reports to other Investment Persons or otherwise makes recommendations to Investment Persons beyond publishing their research. As to other securities, he or she is simply an Access Person.

  • Applied behavior analysis means the design, implementation, and evaluation of environmental modifications, using behavioral stimuli and consequences, to produce socially significant improvement in human behavior, including the use of direct observation, measurement, and functional analysis of the relationship between environment and behavior.

  • Comprehensive resource analysis means an analysis including,

  • Root Cause Analysis Report means a report addressing a problem or non-conformance, in order to get to the ‘root cause’ of the problem, which thereby assists in correcting or eliminating the cause, and prevent the problem from recurring.

  • Project Management Report means each report prepared in accordance with Section 4.02 of this Agreement;

  • Value Engineering (VE) means a discipline of engineering that studies the relative monetary values of various materials and construction techniques, including the intial cost, maintenance cost, energy usage, replacement cost, and life expectancy of the materials, equipment or systems under consideration.

  • Forecast GDP means the average forecast for British Columbia’s real GDP growth made by the Economic Forecast Council and as reported in the annual February budget of the government;

  • Generation Interconnection Feasibility Study means a study conducted by the Transmission Provider (in coordination with the affected Transmission Owner(s)) in accordance with Tariff, Part IV, section 36.

  • Commissioning Tests means all of the procedures and tests which, in accordance with the Reasonable and Prudent Standard, and in compliance with industry guidelines, practices and standards, are:

  • Commissioning means the process for determining the need for and for obtaining the supply of healthcare and related services by the Trust within available resources.

  • Interconnection Feasibility Study means either a Generation Interconnection Feasibility Study or Transmission Interconnection Feasibility Study.

  • Asset adequacy analysis means an analysis that meets the standards and other requirements referred to in 5.34(5)“d.”

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.