Positive Topline Data definition
Positive Topline Data means the achievement of “Statistical Significance” in two primary and/or secondary endpoints. Statistical Significance will be declared if the lower bound of the two-sided 95% confidence interval (CI) is greater than 20%.
Positive Topline Data means data showing that the RINGSIDE Part B Study met its primary endpoint of improving progression-free survival of patients with progressive desmoid tumors, as assessed by blinded independent central review, demonstrating a statistically significant improvement for AL102 over placebo as defined by the clinical protocol, specifically a hazard ratio of 0.35 or better.
Positive Topline Data means the achievement of “Statistical Significance” for the primary efficacy analysis of major response rate. Statistical Significance will be declared if the lower bound of the two-sided 95% confidence interval (CI) is greater than 20%.
Examples of Positive Topline Data in a sentence
At the earliest, Inventiva shall send this invoice on the day of publication of the Positive Topline Data.
More Definitions of Positive Topline Data
Positive Topline Data means the primary objectives of the trial have been met, which include safety and tolerability.
Positive Topline Data means (a) with respect to the ChonDRAgon Trial achieving both (i) the primary endpoint with at least a 3-month longer median PFS (progression-free survival) relative to placebo and (ii) has observed a safety profile which is generally consistent with the safety profile observed as of the Effective Date of the Loan Agreement and (b) Borrower making a public announcement that, based on the results from the ChonDragon Trial, Borrower intends to submit a BLA to FDA for such drug candidate.
Positive Topline Data means the release by Inventiva of topline data announcing that any key primary endpoint or key secondary endpoint of the Phase III Global Trial, with any dosage regimen tested in the trial, have been met and that would support an NDA approval by the U.S. FDA. Key primary endpoint and key secondary endpoint are those defined in the Phase III Global Trial’s Protocol.