Top-Line Data definition

Top-Line Data means, with respect to a Clinical Trial, a summary of demographic data, the data for the primary endpoint(s), the data for any secondary endpoint(s), if such secondary endpoint(s) are applicable, and a summary of safety data, in each case which are based on an unblinded, locked database and wherein all data are collected in a 21 CFR 11 validated database with a complete audit trail.
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Top-Line Data means, with respect to a clinical study, a summary of patient demographic data, data for the primary endpoint, and safety data derived from the unblinded, locked clinical trial database.
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Top-Line Data from a Clinical Trial shall mean the audited, quality-controlled tables, listings and figures in reasonable and customary form reflecting all results of the Clinical Trial.
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Examples of Top-Line Data in a sentence

  • Onyx to Host Investor Teleconference and Webcast Today at 8:00 a.m. Eastern Time to Review Top-Line Data Emeryville, CA – July 26, 2010 – Onyx Pharmaceuticals, Inc.

  • FOR IMMEDIATE RELEASE BIOTA PROVIDES AN UPDATE ON THE DEVELOPMENT OF LANINAMIVIR OCTANOATE - Stop-Work Order Received Pending In Process Review Decision from BARDA -- Phase 2 IGLOO Top-Line Data Anticipated in Q3 2014 -ATLANTA, GA – April 29, 2014 — Biota Pharmaceuticals, Inc.

  • FOR IMMEDIATE RELEASE BIOTA ANNOUNCES POSITIVE PHASE 1 DATA FOR DIRECT-ACTING RSV ANTIVIRAL BTA585 - Commences Dosing in Phase 1 Multiple Ascending Dose Study with Top-Line Data Expected in 1H 2016 –ATLANTA, GA – December 18, 2015 - Biota Pharmaceuticals, Inc.

  • IONIS-HTTRX (RG6042) Top-Line Data Demonstrate Significant Reductions of Disease-Causing Mutant Huntingtin Protein in People with Huntington’s Disease [Internet].

  • Dated: March 30, 2020 By: /s/ Jeffrey Nau, Ph.D., M.M.S. Jeffrey Nau, Ph.D., M.M.S.President, Chief Executive Officer and DirectorExhibit 99.1 Oyster Point Pharma Completes Enrollment in ONSET-2 Pivotal Phase 3 Clinical Trial of OC-01 Nasal Spray for Dry Eye Disease and Provides COVID-19 Business UpdateONSET-2 Phase 3 Top-Line Data Expected by End of Q2 2020 NDA Submission Expected During 2H 2020 PRINCETON, N.J., March 30, 2020 [BUSINESS WIRE] -- Oyster Point Pharma, Inc.


More Definitions of Top-Line Data

Top-Line Data has the meaning set forth in Section 3.8.3.
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Top-Line Data means, with respect to a clinical trial, major efficacy data from such trial in reasonable and customary form, including p-values and measures of the magnitude of the effect with respect to the trial’s primary endpoint and each of its secondary endpoints, and any material safety data, in each case, derived from the locked clinical trial database.
Sample 1
Top-Line Data means, with respect to a clinical trial, major efficacy data from such trial in reasonable and customary form, including p-values and measures of the magnitude of the effect with respect to the trial’s primary endpoint and each of its secondary endpoints, and any material safety data, in each case, derived from the locked clinical trial database. [Signature Page Follows] IN WITNESS WHEREOF, the Company has caused this Warrant to Purchase Common Stock to be duly executed as of the Issuance Date set outabove. CERVOMED INC. By: Name: Title: -20- EXHIBIT A EXERCISE NOTICE TO BE EXECUTED BY THE REGISTERED HOLDER TO EXERCISE THIS WARRANT TO PURCHASE COMMON STOCK CERVOMED INC. The undersigned holder hereby exercises the right to purchase shares of Common Stock (“Warrant Shares”) and/or warrants to purchase shares of Common Stock at a purchase price of $0.001 (the “Pre-Funded Warrants”) of CervoMed Inc., a company organized under the laws of Delaware (the “Company”), evidenced by the attached Warrant to Purchase Common Stock (the “Warrant”). Capitalized terms used herein and not otherwise defined shall have the respective meanings set forth in the Warrant.
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Top-Line Data means the study data from a clean and locked data base that are available within 30 days of the date of a formally executed data-base lock memorandum. Any such Top Line Data []*.
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Top-Line Data means with respect to a PCT a summary of demographic data, the data for the primary endpoint and key secondary endpoints as well as a summary of safety data, which are based on an unblinded, locked database. Top Line Data can comprise tables, listings and figures, which reflect in a reasonable and customary form the PCT results at the timepoint of database look prior to the availability of the final PCT report. The timepoint of availability of Top Line Data is expected to be mutually agreed between AZ and NNBL, to enable both parties to comply adequately with the responsibilities of publicly listed companies related to the publication of relevant new information.
Sample 1
Top-Line Data means total sales per country, number of products sold per country, as well as reference to the fact whether sales are being realized through Licensee directly or via a Distributor;
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Top-Line Data means with respect to a clinical study, a summary of demographic data, the data for the primary endpoint and a summary of safety data. 1. 127 “Top Line Data Date” means the date on which Mereo provides AstraZeneca with a copy of its Top Line Data from the first [***] for a Product.
Sample 1