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.
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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.
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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.
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Examples of Positive Data in a sentence

  • Contact: Kathleen Fredriksen Corporate Development(914) 789-2871kfredriksen@progenics.com PROGENICS PHARMACEUTICALS' NOVEL SMALL MOLECULE DRUGS TARGETING PSMA SUCCESSFULLY VISUALIZE PROSTATE CANCER— Positive Data Reported in The Journal of Nuclear Medicine —— Global Phase 2 Imaging Trial of Next Generation Molecule Underway —TARRYTOWN, N.Y., March 5, 2013 -- Progenics Pharmaceuticals, Inc.

  • Albuferon®: Positive Data Announced for First of Two Phase 3 Trials in Chronic Hepatitis C Patients; Results of Second Phase 3 Trial Expected in March 2009 In December 2008, HGS reported that Albuferon (albinterferon alfa-2b) met its primary endpoint of non-inferiority to peginterferon alfa-2a (Pegasys) in ACHIEVE 2/3, the Phase 3 clinical trial of Albuferon in treatment-naive patients with genotypes 2 and 3 chronic hepatitis C.

  • Consistent, Positive Data From Secondary Clinical Endpoints at 60/50 Dose NS = p>0,05; (1) Wilcoxon Rank Sum test vs.

  • Exelixis has shared these data with U.S. and EU regulators and intends to present the results at a major medical meeting this year.Additional Positive Data Presented from Subgroup Analyses from METEOR Trial.

  • For Immediate Release: BioMarin Announces Positive Data From Phase 1b Clinical Trial of Vibrilase for Serious Burns Novato, CA, August 25, 2004 – BioMarin Pharmaceutical Inc.


More Definitions of Positive Data

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.
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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.
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Positive Data is the release from the Data Monitoring Committee of study data from the HEAT Phase III trial in HCC, demonstrating clinical benefit with a thirty-three percent (33.00%) or greater improvement in Progression Free Survival with a p-value of less than or equal to five hundredths (0.05); or a DMC Recommendation to unblind the HEAT Phase III trial data based on equivalent or better clinical efficacy (ie overall survival improvement); in both cases, with publication of the results to the public markets (whether in the form of a press release or in an 8-K filing with the SEC).
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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).
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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.
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Related to Positive Data

  • Sensitive Data means information that is protected against unwarranted disclosure, to include Personally Identifiable Information (PII), Protected Health Information (PHI) or other private/confidential data, as specifically determined by the State. Sensitive Data includes information about an individual that (1) can be used to distinguish or trace an individual‘s identity, such as name, social security number, date and place of birth, mother‘s maiden name, or biometric records; (2) is linked or linkable to an individual, such as medical, educational, financial, and employment information; (3) falls within the definition of “personal information” under Md. Code Ann., Com. Law § 14-3501(d); or (4) falls within the definition of “personal information" under Md. Code Ann., State Govt. § 10-1301(c).

  • Positive identification means a method of identifying a person that does not rely on the use of a private personal identifier such as a password, but must use a secure means of identification that includes any of the following:

  • Positive Test Result means a finding of the presence of drugs, alcohol, or their metabolites in the sample tested in levels at or above the threshold detection levels contained in the standards of one of the programs listed in Minn. Stat. § 181.953, Subd. 1.

  • Directory information means information contained in an education record of a student which would not generally be considered harmful or an invasion of privacy if disclosed. It includes, but is not limited to: the student’s name, address, telephone listing, electronic mail address, photograph, date and place of birth, major field of study, dates of attendance, grade level, enrollment status (i.e., full-time or part-time), participation in officially recognized activities and sports, weight and height of members of athletic teams, degrees, honors and awards received, and the most recent educational agency or institution attended. It also includes the name, address, and telephone number of the student’s parent(s). Directory information does not include:

  • Regulatory Information Service means a service approved by the London Stock Exchange for the distribution to the public of announcements; and

  • Product Information has the meaning specified in Section 10.12(a).

  • DXC Sensitive Information means DXC Confidential Information, Intellectual Property, PHI, DXC Customer data, and Personal Information.

  • Benchmarking Information means information generated by Portfolio Manager, as herein defined including descriptive information about the physical building and its operational characteristics.

  • Development Data means any and all research data, pharmacology data, chemistry, manufacturing and control data, preclinical data, clinical data and all other documentation (including raw data) compiled, developed or generated with respect to the Compound or Product.

  • Assistive technology service means any service that directly assists a child with a disability in the selection, acquisition, or use of an assistive technology device. The term includes:

  • Development Works means the external development works and internal development works on immovable property;

  • SAP Technology Solution(s means SAP NetWeaver Foundation for Third Party Applications, SAP Business Technology Platform (excluding when used solely as a Connectivity App between an SAP Application and ERP), SAP Signavio Solutions and SAP Process Insights (including any renamed, prior and/or successor versions of any of the foregoing made generally available by SAP if any but excluding when any of the foregoing are used as a User Interface for ERP.

  • Fugitive dust means a particulate emission made airborne by forces of wind, man's activity, or both. Unpaved roads, construction sites, and tilled land are examples of areas that originate fugitive dust. Fugitive dust is a type of fugitive emission.

  • Biometrics means a technique of personal identification that is based on physical, physiological or behavioural characterisation including blood typing, fingerprinting, DNA analysis, retinal scanning and voice recognition;

  • information gathering measures means laws and administrative or judicial procedures that enable a Contracting Party to obtain and provide the requested information;

  • Research Data means documents in a digital form, other than scientific publications, which are collected or produced in the course of scientific research activities and are used as evidence in the research process, or are commonly accepted in the research community as necessary to validate research findings and results;

  • Price Sensitive Information means any information which relates, directly or indirectly, to a company and which if published is likely to materially affect the price of securities of the company.

  • Feedback means input regarding the SAP Products, services, business or technology plans, including, without limitation, comments or suggestions regarding the possible creation, modification, correction, improvement or enhancement of the SAP Products and/or services, or input as to whether Partner believes SAP’s development direction is consistent with their own business and IT needs.

  • Confidential commercial information means records provided to the govern- ment by a submitter that arguably contain material exempt from release under Exemption 4 of the Freedom of Information Act, 5 U.S.C. 552(b)(4), be- cause disclosure could reasonably be expected to cause substantial competi- tive harm.

  • Clinical Data means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

  • Staffing Information in relation to all persons identified on the Supplier's Provisional Supplier Personnel List or Supplier's Final Supplier Personnel List, as the case may be, such information as the Department may reasonably request (subject to all applicable provisions of the DPA), but including in an anonymised format: (a) their ages, dates of commencement of employment or engagement, gender and place of work; (b) details of whether they are employed, self employed contractors or consultants, agency workers or otherwise; (c) the identity of the employer or relevant contracting Party; (d) their relevant contractual notice periods and any other terms relating to termination of employment, including redundancy procedures, and redundancy payments; (e) their wages, salaries, bonuses and profit sharing arrangements as applicable; (f) details of other employment-related benefits, including (without limitation) medical insurance, life assurance, pension or other retirement benefit schemes, share option schemes and company car schedules applicable to them; (g) any outstanding or potential contractual, statutory or other liabilities in respect of such individuals (including in respect of personal injury claims); (h) details of any such individuals on long term sickness absence, parental leave, maternity leave or other authorised long term absence; (i) copies of all relevant documents and materials relating to such information, including copies of relevant Agreements of employment (or relevant standard Agreements if applied generally in respect of such employees); and (j) any other “employee liability information” as such term is defined in regulation 11 of the Employment Regulations;

  • Pseudonymous data means personal data that cannot be attributed to a specific natural person

  • Fugitive dust emissions means particulate matter from process operations that does not pass through a process stack or vent and that is generated within plant property boundaries from activities such as: unloading and loading areas, process areas, stockpiles, stock pile working, plant parking lots, and plant roads (including access roads and haul roads).

  • Modern biotechnology means the application of:

  • Development Tool Kit means a DS Offering specifically designed for application or content development. A Development Tool Kit is either identified (i) with “CAA” or “ENOVIA Studio” in the DS Offering name, or (ii) in the Transaction Document and/or the Product Portfolio. Extended Enterprise User means an employee of Customer’s affiliate(s), supplier(s) and/or customer(s) authorized to use Customer’s DS Offering for the sole and exclusive purpose of enabling the Extended Enterprise User(s) to conduct business with Customer. The use of the DS Offering by any such Extended Enterprise User(s) (1) shall be solely limited to use (a) as configured and deployed by Customer and (b) in connection with the Extended Enterprise User’s performance of services for and on behalf of Customer, and (2) shall exclude any use by Extended Enterprise User (a) for its own account or a third party’s account, or (b) for the purpose of modifying, otherwise using, maintaining or hosting the DS Offering. Extended Enterprise Users are authorized if so specified in the Product Portfolio.