Positive Data definition
Positive Data means achieving the primary endpoint for either the 6 or 12 week arm (as defined in Borrower’s clinical trial protocol dated March 8, 2021) of Borrower’s clinical trials with statistical significance, sufficient to advance clinical studies or filing of a new drug application with the FDA, and with a safety profile consistent with Borrower’s recent clinical data showing an overall favorable safety profile relative to other currently FDA approved oral therapies, which shall be reviewed in consultation with Borrower, and in each case as determined by Agent in its sole but reasonable discretion.
Positive Data means, with respect to any Phase 1 or Phase 2 clinical trial, positive safety and efficacy results which, at Lender’s reasonable discretion, support progression into the next immediate planned step in development.
Positive Data means, with respect to a clinical study, that such study has completed enrollment and has met the primary safety and efficacy endpoints set forth in the applicable study protocol, in each case subject to reasonable verification by Collateral Agent.
Examples of Positive Data in a sentence
Positive Data Value Color Set the color of the positive value labels.
More Definitions of Positive Data
Positive Data means data from a clinical study pursuant to an IND first showing statistically significant efficacy between a Licensed Product in an active patient group compared to a placebo patient group based upon either (i) statistically significant achievement of the primary endpoint of the study or (ii) Somaxon's determination to proceed with clinical development based on any secondary analysis of the clinical study data.
Positive Data means that PRX-00023, PRX-03140, PRX-08066 or PRX-07034, as the case may be, shall have demonstrated statistically significant final results (meaning a p-value of less than 0.05) against the primary endpoints of the clinical trial in question as set forth in the applicable protocols of such clinical trial.
Positive Data means data that either (x) meets the primary end points for the relevant clinical trial, or (y) upon which the FDA bases its consent to initiate: (I) the second phase 3 trial in Acute Schizophrenia upon completion of the first phase 3 trial in Acute Schizophrenia, and (II) a phase 3 trial in one of PAH or IPF upon completion of a phase 2 clinical trial in either of PAH or IPF, respectively. In the event that either Earnout Milestone is not met, the Company Stockholders shall not be entitled to receive the Earnout Shares.
Positive Data means Borrower’s achievement of (i) both co-primary endpoints (statistically significant improvements in median progression free survival for Arm A vs. Arm C and Arm B vs. Arm C) and (ii) Arm A generating a median progression free survival of at least 3 months longer than Arm C.
Positive Data means, with respect to the clinical trial of a drug candidate, achievement of statistically significant primary endpoints and key secondary endpoints with an acceptable safety profile sufficient and necessary to support the advancement to the Phase 3 clinical trial (if the applicable trial is a Phase 2 clinical trial) or to receive the final approval by the FDA with a label that is generally consistent with what Borrower sought (if the applicable trial is a Phase 3 clinical trial). “Prepayment Fee” is, with respect to any Term Loan subject to prepayment prior to the Maturity Date, whether by mandatory or voluntary prepayment, acceleration or otherwise, an additional fee payable to the Lenders in amount equal to: (i) for a prepayment made on or after the Funding Date of such Term Loan through and including the first anniversary of the Funding Date of such Term Loan, three percent (3.00%) of the principal amount of such Term Loan prepaid; (ii) for a prepayment made after the date which is after the first anniversary of the Funding Date of such Term Loan through and including the second anniversary of the Funding Date of such Term Loan, two percent (2.00%) of the principal amount of the Term Loans prepaid; and
Positive Data means favourable information relating to a data subject on contractual or legally compliant behaviour;
Positive Data means with respect to a clinical trial, that (i) such clinical trial has achieved its protocol-specified primary efficacy endpoint with statistical significance; and (ii) that the Borrower Product investigated in such clinical trial has demonstrated an acceptable safety profile, in each case subject to verification by Agent (including supporting documentation requested by Agent, to the extent such documentation is available to Borrower).