Interim Analysis definition

Interim Analysis means the Interim Efficacy Analysis, as described in Section 5.3 of the DSMB Charter.

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Interim Analysis is defined in Subsection 4.1.2.

Interim Analysis means the pre-specified futility and safety analysis, as defined in the Special Protocol Assessment, on the first 70 adjudicated events which evaluate the probability of the PRESENT Trial to achieve its pre-specified objectives.

Examples of Interim Analysis in a sentence

• Institution and/or Principal Investigator agree to conduct expedited data entry and query resolution for Interim Analysis as defined in the Protocol in addition to final database lock.

• Promptly after receipt of the Data and Safety Monitoring Committee’s recommendation regarding the continued conduct of the Pancreatic Cancer Phase 2/3 Clinical Trial after the ONTRAC Interim Analysis has occurred, Onconova shall notify ▇▇▇▇▇▇ of such recommendation.

• Upon the Successful Completion of the Interim Analysis of the Pivotal Clinical Trial/Phase IIb Proof of Concept, or, failing that, upon the Successful Completion of the Pivotal Clinical Trial, Ikaria shall, within [***] days thereafter, submit a formal written request for a reimbursement price for one or more Product(s) to the applicable governmental agency in one or more of the following countries: [***].

• Safety and effectiveness will be evaluated at the Interim Analysis and at 1 year.

• For clarity, GSK shall have the right under this Section 1.c.i to terminate its Option to the TTR Program irrespective of the outcome of the First Interim Analysis.

• Full details of the interim analysis procedure and steps to maintain treatment blinding of the study team will be described in the SAP and the Interim Analysis Charter and finalized prior to execution of the interim analysis.

• CPP must secure the preparation and delivery of one or more written reports of the Interim Analysis, including the statement of the DMC (such reports, collectively, the “Interim Analysis Report”) that CPP must at the latest ten days after receipt deliver to all the members of the JSC after receipt.

• For the avoidance of doubt, if the Successful Phase 3 Interim Analysis is not achieved, SFJ shall have no obligation to pay or incur any further Development Costs.

• Not later than three (3) Trading Days after the Company publicly announces (the date of such public announcement, the “Announcement Date”) the results of the Interim Analysis (as defined in the Debenture), the Company shall issue to each Purchaser the Series B Warrant to purchase the number of shares of Common Stock as set forth on such Purchaser’s signature page hereto.

• Interim Analysis An interim analysis of the efficacy data may be performed when up to 30 patients have completed 12 weeks of treatment (up to 10 patients in each of the three treatment groups).

More Definitions of Interim Analysis

Interim Analysis means the completion of either of the two interim analyses for efficacy (to be performed when approximately 150 and 250 subjects have had a positively adjudicated primary endpoint event) as described in Borrower’s Clinical Study Protocol TRCA-303 (VALOR- CKD) for TRC 101 (a/k/a “Veverimer”), Amendment 2, dated November 18, 2020. “Investment” means any beneficial ownership (including stock, partnership or limited liability company interests) of or in any Person, or any loan, advance or capital contribution to any Person or the acquisition of any asset of another Person. “Joinder Agreements” means for each Qualified Subsidiary, a completed and executed Joinder Agreement in substantially the form attached hereto as Exhibit G. “Lender” has the meaning given to it in the preamble to this Agreement. “License” means any Copyright License, Patent License, Trademark License or other license of rights or interests. “Lien” means any mortgage, deed of trust, pledge, hypothecation, assignment for security, security interest, encumbrance, ▇▇▇▇, ▇▇▇▇ or charge of any kind, whether voluntarily incurred or arising by operation of law or otherwise, against any property, any conditional sale or other title retention agreement, and any lease in the nature of a security interest. “Loan” means the Advances made under this Agreement. “Loan Documents” means this Agreement, the Notes (if any), the ACH Authorization, the Account Control Agreements, the Joinder Agreements, all UCC financing statements, the Warrant and any other documents executed in connection with the Secured Obligations or the transactions contemplated hereby, as the same may from time to time be amended, modified, supplemented or restated. “Material Adverse Effect” means a material adverse effect upon:

Interim Analysis has the meaning set forth in Section 3.10.

Interim Analysis means the Required Top Line Data corresponding to a potential six (6) month analysis of new surgically eligible tumor development in all vehicle-treated vs. all patidegib topical gel-treated subjects, as defined in the Phase III Protocol [***] and Statistical Analysis Plan.