Phase IIb definition

Phase IIb means a Phase II study in any country, the principal purpose of which is to explore the dose relationship of a Product against some efficacy measure for the Indication in patients with the disease or Indication under study.

Phase IIb means a placebo or active drug controlled, randomized human clinical trial performed to gain evidence of the efficacy of a pharmaceutical product in a target population, and/or to establish the optimal dosing regimen for such product.

Phase IIb means a Phase II designed to support and immediately precede the initiation of a Phase III without any further Phase II, on a sufficient number of patients that is designed to provide a preliminary determination of safety and efficacy of the applicable Product or New Collaboration Compound in the target patient population over a range of dose and dose regimes.

Examples of Phase IIb in a sentence

• Peyronie’s Phase IIb Trial Utilizes a Novel Patient Reported Outcome (PRO) • Study is designed to validate Auxilium’s proprietary Peyronie’s Patient Reported Outcome (PRO) questionnaire.

• Peyronie’s Phase IIb Study Design Arm Study Drug Plaque Modeling Targeted Number of Patients A XIAFLEX yes 45 B Placebo yes 15 C XIAFLEX no 45 D Placebo no 15 120 • Patients will be randomized in a 3:1 ratio of XIAFLEX to placebo and a 1:1 ratio to receive penile plaque modeling or no modeling.

• Under the terms of the agreement, at no cost to the Company, Schering has supplied PEGETRONTM and certain technical and laboratory support and other services for the Company’s recently completed MX-3253 Phase IIb non-responder combination study in chronic HCV patients.

• Reimbursement of such pre-Effective Date expenses shall be due within thirty (30) days after the first patient is dosed in the first Phase IIb Clinical Study for rheumatoid arthritis using such Clinical Study Supplies.

• For example, if a Phase IIb Clinical Trial is initiated without payment of the Successful Completion of Phase Clinical Study, then the Successful Completion of Phase Ib/IIa Clinical Study will be deemed to have occurred and will be paid in full upon payment of the milestone payable upon the submission of the first NDA filing.

More Definitions of Phase IIb

Phase IIb means such studies in humans of the safety, dose ranging and efficacy of a Product designed to generate sufficient data to make a decision about whether to commence a Pivotal Trial, as more specifically defined by the rules and regulations of the FDA and corresponding rules and regulations in other countries or jurisdictions.

Phase IIb means a Phase II clinical trial in human patients, the primary objective of which is to collect data on dosages and demonstrate clinical safety and efficacy in a target population for a specific disease or condition under study with a demonstration of efficacy (i.e. statistically significant differences between groups for clinical endpoints considered as a basis for registration, which may include generally accepted surrogate pharmacodynamic endpoints).

Phase IIb means human clinical trials, for which the primary endpoints include a determination of dose ranges, if not already determined, and a preliminary determination of efficacy in patients with the Indication being studied as required in 21 C.F.R. §312.21, or similar clinical study in a country other than the United States which design is intended to enable the Initiation of the Phase III or Pivotal clinical trial. 35. “Phase III” or “Pivotal” shall mean human clinical trials, the principal purpose of which is to establish safety and efficacy of one or more particular doses in patients with the Indication being studied in a manner designed to be sufficient to support Marketing Approval for such Indication, as required in 21 C.F.R. §312.21(c), or similar clinical study in a country other than the United States. For purposes of clarity, in the event that a Phase IIb has not already occurred with respect to the Indication being studied, upon the Initiation of a Phase III or Pivotal clinical trial, such clinical trial shall also be considered the Initiation of a Phase IIb clinical trial. 36. “Preexisting Third Party Intellectual Property” shall mean any intellectual property rights, including without limitation all patents, trademarks, copyrights, and any applications therefor, including any applications for registration, issuance, or grant thereof, that are owned or Controlled by a third party and that are necessary for the practice of the license granted hereunder, the existence of which was discoverable or otherwise could have been known on or prior to the Effective Date and were not owned or Controlled by FibroGen as of the Effective Date. 37. “Product” or “Products” shall mean any HIF Compound designated by FibroGen for clinical development in an Anemia Indication in accordance with the terms herein. As of the Effective Date, each of FG-2216 and FG-4592 shall be deemed to be a Product. For the avoidance of doubt, Product shall include the finished form of a pharmaceutical product containing such a HIF Compound described above, whether or not other ingredients (active or otherwise) are contained in such product. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

Phase IIb means a human clinical trial of a Licensed Compound or Licensed Product, the principal purpose of which is a determination of safety and appropriate dose-ranges for efficacy in the target patient population, which is prospectively designed to generate sufficient data that may permit commencement of pivotal clinical trials, or a similar clinical study prescribed by the Regulatory Authorities, from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(b), as amended.

Phase IIb means the construction of two or more buildings on the Phase IIB Property consisting of at least 12,500 gross leasable square feet of commercial space accommodating retail, restaurant, or service tenants.

Phase IIb means a [**] of a Licensed Product [**].

Phase IIb shall have the meaning attributed to such term in 21 CFR 312.21.