Phase 2b Trial Completion Date definition

Phase 2b Trial Completion Date means the date of the completion of the final study report of a clinical trial in which KRN5500 is demonstrated to meet the pre-specified endpoints contained in the final Statistical Analysis Plan with a well-tolerated dose demonstrated to have clinical significance (change in NRS score of > 2) and statistical significance (p < 0.05) over placebo.

Examples of Phase 2b Trial Completion Date in a sentence

  • For the avoidance of doubt, if the Expiration Date occurs prior to the Phase 2b Trial Completion Date, this Warrant shall not be exercisable.

  • The Warrant Shares shall vest upon, and the Holder shall not be entitled to exercise this Warrant with respect to such Warrant Shares until, the Phase 2b Trial Completion Date.

Related to Phase 2b Trial Completion Date

  • Substantial Completion Date means the required date for Substantial Completion of the Project. The Substantial Completion Date can be adjusted only by written Change Order.

  • Project Completion Date means the date on which the Completion Certificate is issued;

  • Target Completion Date has the meaning given such term in Section 3.3(b).

  • Final Completion Date means the date on which Final Completion occurs.

  • Substantial Completion means the stage in the progress of the work as determined and certified by the Contracting Officer in writing to the Contractor, on which the work (or a portion designated by the Government) is sufficiently complete and satisfactory. Substantial completion means that the property may be occupied or used for the purpose for which it is intended, and only minor items such as touch-up, adjustments, and minor replacements or installations remain to be completed or corrected which:

  • Completion Date means the date of completion of the Services by the Service Provider as certified by the Procuring Entity

  • Completion Period means the period starting from the date of issue of "Order" and required to complete the work in all respect.

  • The Completion Date means the date of completion of the Works as certified by the Employer’s Representative.

  • Construction Completion Date means the date by which the overall development of the Project is completed in accordance with the provisions of this Agreement and when the Construction Completion Certificate is issued by the Independent Engineer as per Article 14.1.

  • Final Completion means the date determined and certified by A/E and Owner on which the Work is fully and satisfactorily complete in accordance with the Contract.

  • Project Completion means completion of the Redevelopment in accordance with this Agreement to the state where the whole of the Morley Shopping Centre, as so redeveloped, is capable of occupation for its intended purpose;

  • Guaranteed Substantial Completion Date or “Guaranteed Substantial Completion Dates” has the meaning set forth in Section 5.3B.

  • Scheduled Completion Date shall be the date set forth in Clause 10.3;

  • Milestone Date means the date set against the relevant Milestone in the Implementation Plan;

  • Phase 1 means the first implementation phase of this section, beginning June 1, 2018 and ending May 31, 2022.

  • Successful Completion means that in the reasonable opinion of the Customer, Deliverables completed by the Supplier are fit for purpose, completed on time and otherwise meet all the criteria defined under this Contract;

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

  • Project Milestone means the project milestone set forth in Schedule-J;

  • Development Milestone Event shall have the meaning set forth in Section 9.2(a).

  • Mechanical Completion means that (a) all components and systems of the Project have been properly constructed, installed and functionally tested according to EPC Contract requirements in a safe and prudent manner that does not void any equipment or system warranties or violate any permits, approvals or Laws; (b) the Project is ready for testing and commissioning, as applicable; (c) Seller has provided written acceptance to the EPC Contractor of mechanical completion as that term is specifically defined in the EPC Contract.