Topline Data definition

Topline Data means the results of the primary and pre-specified secondary analyses and all key safety information available as of the date of such primary and pre-specified secondary analyses (consisting, at a minimum, of baseline demographics, subject disposition, adverse events, serious adverse events, and discontinuations) for Part B of the GI Tolerability Clinical Trial.
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Examples of Topline Data in a sentence

  • La Jolla shall promptly notify BioMarin CF in writing following the occurrence of each of the following events: (i) the First Efficacy Analysis; (ii) the Second Efficacy Analysis; (iii) Non-Futile Determination; (iv) Futile Determination; (v) a P-Value Achievement; (vi) La Jolla’s receipt of the 128 Flare Topline Data; and (vii) receipt of recommendation from the Data Mentoring Board to terminate any portion of the 90-14 portion of the ASPEN Study for any reason.

  • La Jolla shall have the right to deploy a portion of the total number of Sales Representatives for the Products in the United States (“Sales Force Deployment Option”) in accordance with this Section 6.2. To exercise the Sales Force Deployment Option, La Jolla shall notify BioMarin CF in writing no later than [****] after La Jolla’s receipt of the 128 Flare Topline Data as described in Section 7.6(e) below or earlier completion of the efficacy portion of the ASPEN Study.

  • The foregoing diligence obligations shall not apply if there is a Futile Determination or, if based upon receipt of the 128 Flare Topline Data, the ASPEN Study does not result in a P-Value Achievement.

  • At the earliest, Inventiva shall send this invoice on the day of publication of the Positive Topline Data.

  • The Company shall provide written notice to each Holder within one Business Day of the Topline Data Announcement.

Related to Topline Data

  • Baseline data means information gathered at a selected point in time and used thereafter as a basis from which to monitor change.

  • Radiation therapy simulation system means a radiographic or fluoroscopic x-ray system intended for localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field.

  • Service Data means a subset of Confidential Information comprised of electronic data, text, messages, communications or other materials submitted to and stored within a Service by You, Agents and End-Users in connection with Your use of such Service, which may include, without limitation, Personal Data (but shall not include the Personal Data of Your Agents in the context of Account Information as described in the Privacy Policy).

  • Dataset means the data specified in Appendix 1 (Environmental Information) to Schedule 11.2 (Management Information) as the same may be amended from time to time by the Secretary of State (acting reasonably);

  • Claims processing services means the administrative services performed in connection with the processing and adjudicating of claims relating to pharmacist services that include: