Primary Endpoint definition

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 Holders, such other endpoint as the Requisite Holders 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 Commission.

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Primary Endpoint means the primary endpoint specified in the protocol for […***…], as the same may be amended from time-to-time.

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.

Examples of Primary Endpoint in a sentence

• EXHIBIT A CUBIST CLINICAL TRIALS ----------------------- --------------------- -------------------------------------------- ---------------------------- Protocol Number Country(ies) in which conducted Primary Endpoint Core Trials and Trial Phase ----------------------- --------------------- -------------------------------------------- ---------------------------- [ ]* [ ]* [ ]* [ ]* *CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION.

• Study Duration 1 Year Assessment Tools Ankle Brachial Index HbA1c Monofilament test for neuropathy Photograph E-Z Graph Wound Assessment System Sf-36v2 Health Survey Primary Endpoint Proportion of subjects who have a closed wound at or before 12 weeks after the index procedure.

• For purposes of clarity, the milestone that refers to the Achievement of the Primary Endpoint in the Global Pivotal Clinical Study (Milestone event iv) shall not be payable by Eurofarma if this Agreement is terminated pursuant to this Section 13.2.2(c).

• NN shall conduct Phase III Clinical Trials for the [ * ] Indication and [ * ] Indication using the Phase III Development Candidates established pursuant to Section 3.6. Each Phase III Clinical Trial shall be conducted using a two (2) arm parallel design and shall include an adequate number of study subjects based on the Primary Endpoint.

• PHASE II CLINICAL TRIALS means any human clinical trials for which a Primary Endpoint is a preliminary determination of safety, biological activity, efficacy or dose ranges in patients with the disease target being studied as required by the relevant Regulatory Authorities.

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, 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 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 that ▇▇▇▇▇▇▇▇’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.”

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 a change in Total Maximal Chorea Score (TMC) from Baseline (defined for each subject as the average of values from the Screening and Day 0 visits) to maintenance therapy (defined for each subject as the average of values from the Week 9 and Week 12 visits).