Primary Endpoint means, with respect to a clinical trial, the point at which equivalence to the comparator agent has been achieved with respect to a clinical or microbiological outcome as specified in the protocol for such trial as set forth in Exhibit A, unless otherwise agreed by the Parties in writing.
Primary Endpoint means, with respect to a Phase II Clinical Trial, the point at which positive statistical significance has been achieved with respect to the primary endpoint specified in the protocol for such trial.
Primary Endpoint means the primary endpoint specified in the protocol for […***…], as the same may be amended from time-to-time.
Examples of Primary Endpoint in a sentence
Subject perceptions about experimental sessions will be collected from each active dose subject at the Primary Endpoint after unblinding and the two-month follow-up in Stage 1.
Recruitment and enrollment will continue until 76 participants have completed the Primary Endpoint.
For this and more comprehensive risks related to Innovate’s intellectual property, please see “Risk Factors — Risks Related to Innovate’s Intellectual Property.” CeD PRO: Copyrighted Primary Endpoint for Celiac Disease Tested in a Successful Clinical Trial The patient reported outcome (PRO) primary end point for celiac disease (CeD PRO).
Formulas for Correcting the Mean and Variance of the Full-data Sample Mean of the Primary Endpoint Under the Dose Selected at Stage One in a Two-stage Trial with Selection Between Two Active Doses.
Primary Endpoint: Improvement in NAS by ≥ Two Points with no Worsening of Fibrosis * p < 0.05, *** p < 0.001.
More Definitions of Primary Endpoint
Primary Endpoint means, with respect to a clinical trial, the point at which the primary efficacy objective has been achieved with respect to a clinical or microbiological outcome as specified in the protocol for such trial, unless otherwise agreed by the Parties in writing.
Primary Endpoint means the main result that is measured at the end of a Clinical Trial to determine whether a given treatment has worked (e.g., the difference in survival between a treatment group and a control group), which shall be predefined in the protocol for such Clinical Trial.
Primary Endpoint means, with respect to Part 2 of the PERSIST Trial, [ * * *].
Primary Endpoint means, upon an analysis of the intent-to-treat population, either (a) (i) with respect to XPORT-MF-034 (NCT04562389), the proportion of participants with spleen volume reduction shall be at least 35% at week 24 and the proportion of participants with total symptom score reduction shall be at least 50% at week 24 (as measured by Myelofibrosis Symptom Assessment Form V4.0) and (ii) with respect to XPORT-EC-042 (NCT05611931), the investigator has assessed Progression Free Survival in accordance with Response Evaluation Criteria in Solid Tumors v1.1., (b) prior to the statistical analysis assessment and upon written request by the Company to the Lenders, such other endpoint as the Requisite Lenders may agree or (c) with respect to XPORT-MF-034 (NCT04562389) and prior to the statistical analysis assessment, such other primary endpoint that the Company has publicly updated pursuant to a Form 8-K filed with or furnished to the SEC.
Primary Endpoint. To evaluate the effect of two dose levels of CERC-501 on tobacco reinstatement in subjects who have previously failed abstinence and experienced dysphoria and / or anxiety during quitting attempts • Anticipated study start-up and first subject randomized by 4Q2015 CMC • [**] • [**] • [**] • [**] • [**] Regulatory • Meeting/communication with FDA regarding planned study by 3Q2015 Non-Clinical • [**] Intellectual Property • [**] ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. 44 Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request.
Primary Endpoint means the primary endpoint specified in the protocol for [*], as the same may be amended from time-to-time. (b) Notwithstanding the foregoing, if following the achievement of milestone [*], ASLAN elects to discontinue all further development of the Product for [*], then provided that ASLAN promptly notifies Array of such decision (which notice must in any event be provided prior to the date upon which the payment for milestone [*] is due), then ASLAN’s payment obligation with respect to such milestone will be suspended, provided that should ASLAN elect at any point in the future to resume development of the Product [*], the corresponding $[*] payment associated with such milestone shall become immediately due and payable.
Primary Endpoint means that Borrower’s EDP 2939 Product demonstrates superiority over a placebo on the portion of patients participating in Borrower’s EDP Trial who achieve a fifty percent (50%) improvement over the baseline in Psoriasis Area and Severity Index score (also known as a PASI-50 response) after sixteen (16) weeks of administration of such EDP 2939 Product in the EDP Trial for at least one dose level evaluated.”