Phase II definition

Phase II means the second part of the tuition incentive assistance program which provides assistance in the third and fourth year of 4-year degree programs.

Phase II means the acid rain program period beginning January 1, 2000, and continuing into the future thereafter.

Phase II means a human clinical trial of a Licensed Product, the principal purpose of which is a determination of safety and 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.

Examples of Phase II in a sentence

• We have also previously conducted Phase II studies with vilobelimab in other diseases, including hidradenitis suppurativa, or HS, a chronic debilitating systemic inflammatory skin disease and ANCA-associated vasculitis, or AAV, a rare and life-threatening autoimmune disease.

• We are studying the potential benefit of vilobelimab treatment in PD-1/PD-L1 inhibitor resistant/refractory locally advanced or metastatic cutaneous squamous cell carcinoma (cSCC) in an ongoing clinical Phase II proof of concept study.

• We are also developing INF904, an orally administered, small-molecule inhibitor of C5aR, for which we have completed a Phase I study in healthy volunteers and plan to initiate Phase II clinical studies in the future.

• Up to November 2023, we were also developing vilobelimab in cutaneous squamous cell carcinoma, or cSCC, in which we were running a Phase II clinical study.

• Beyond PG, we are developing vilobelimab to address a wide array of complement-mediated diseases with significant unmet medical needs, including severe COVID-19, in which we recently received an EUA from the FDA, and cutaneous squamous cell carcinoma, or cSCC, in which we are currently conducting a Phase II study.

More Definitions of Phase II

Phase II shall have the meaning set forth in Section 6.3.2.

Phase II as defined in CC Docket 94-102. Phase II data includes XY coordinates, confidence factor and certainty.

Phase II means the period of the national acid rain

Phase II means human clinical trials conducted on a limited number of patients for the primary purpose of evaluation of both clinical efficacy and safety, and/or to obtain a preliminary evaluation of the dosage regimen, as more fully defined in 21 C.F.R. §312.21(b).

Phase II means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(b) conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including Phase IIa studies.

Phase II means human clinical trials, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as required in 21 C.F.R. §312, or similar clinical study in a country other than the United States.

Phase II and "Phase III" shall mean Phase I (or Phase ------- -------- --------- I/II), Phase II, and Phase III clinical trials, respectively, in each case as prescribed by the U.S. Food and Drug Administration or a corresponding foreign entity.