Phase 2b Trial definition

Phase 2b Trial means a Phase 2 Trial constituting a dose exploration, dose response, duration of effect and kinetic/dynamic relationship study of a candidate drug in the target patient population; and

Phase 2b Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purposes of achieving a preliminary determination of efficacy or appropriate dosage ranges of any product, as described in 21 C.F.R. § 312.21(b) (including any such clinical study in any country other than the United States).

Phase 2b Trial means a Phase 2 Trial, the results of which, alone or in combination with the results of the Phase 2a Trial, would demonstrate the effectiveness of a Product for a particular Indication in patients with the Indication or that would otherwise satisfy the requirements of Part 312 of Title 21 of the United States Code of Federal Regulations or its foreign equivalent.

Examples of Phase 2b Trial in a sentence

• Whereas the Phase 2b Trial had excluded patients with pure occult lesions, by requiring only the presence of SHRM for enrollment in the Phase 3 Trials, Ophthotech was permitting patients with pure occult lesions to be included in the Phase 3 Trials.

• Phase 2b Trial Results Parameter Mino - Lok Arm N ( % ) Control Arm N ( % ) Patients 30 (100%) 60 (100%) Cancer Type - Hematologic 20 (67) 48 (80) - Solid tumor 10 (33) 12 (20) ICU Admission 4 (13) 4 (7) Mech.

• FDA BLA Pathway: • Confirmatory Phase 3 Study • Submission to FDA x No increase in Adverse Events compared to Placebo x No increase in Hypoglycemic Events compared to Placebo x No weight gain compared to Placebo FDA Phase 2b Trial Results - Primary Endpoint Successfully Met Safe and well tolerated Significant HbA 1 c lowering with 1 X/daily treatment: Gain 12 - year marketing exclusivity upon FDA approval Pivotal Phase 3 Factors considered by the FDA in a pivotal Phase 3 program 1.

• In looking back to discuss the results from the Translarna Phase 2b Trial and their import for the Company, Peltz also noted: And a confirmatory trial to be able to get it in the US is well underway, and it’s already fully enrolled.

• There were no deaths, no systemic AEs, no serious AEs or withdrawals due to AEs. Nyxol RM: MIRA-1 Phase 2b Trial (Completed) MIRA-1 (NYXRM-201) was a double-masked, randomized, placebo-controlled, multicenter, cross-over trial of Nyxol compared with vehicle (placebo) ophthalmic solution in normal healthy patients with eyes dilated using a mydriatic agent (phenylephrine or tropicamide).

More Definitions of Phase 2b Trial

Phase 2b Trial means a Phase 2 Trial, designed to support and immediately precede the initiation of a Phase 3 Trial program without any further Phase 2 Trials, to evaluate the dose-dependent effectiveness of a pharmaceutical product for a particular indication or indications in patients with the disease or condition under study and to determine the common side effects and risks associated with the pharmaceutical product.

Phase 2b Trial means a controlled phase 2b clinical study carried out prior to the

Phase 2b Trial means a Phase 2 Trial, the results of which, alone or in combination with the results of an earlier trial, would demonstrate the efficacy and safety of a Fluorinov Product for a particular indication in patients with the indication or that would otherwise satisfy the requirements of Part 312 of Title 21 of the United States Code of Federal Regulations or its Canadian, European or foreign equivalent.

Phase 2b Trial means a Phase 2 Trial of a Program Product, the principal purpose of which is a determination of safety and sufficient potential efficacy to progress such Program Product to a Phase 3 Trial. For purposes of this Agreement, "start of a Xxxxx 0x Xxxxx" for a Program Product means the first dosing of such Program Product in a human patient in a Phase 2b Trial.

Phase 2b Trial means a Phase 2b Clinical Trial evaluating a [***] Product; Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. Confidential Treatment Requested by Sienna Biopharmaceuticals, Inc.

Phase 2b Trial means that portion of a Phase 2 Trial constituting confirmation of the dose and regimen established in the first Phase 2 Trial, and exploration of efficacy.

Phase 2b Trial means a controlled phase 2b clinical study carried out prior to the initiation of pivotal Phase 3 Trials (described below) that is intended to be the definitive dose range finding study in patients with efficacy as primary endpoint, as well as safety, initiated after determination of the recommended phase 2 dose of the relevant Licensed Product, that will evaluate the dose-dependent effectiveness of a pharmaceutical product for a particular indication or indications in patients with the disease or condition under study, as well as to collect further adverse effects and safety data to assess the risks associated with the pharmaceutical product, and further pharmacokinetic data. The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents and a Phase 2b Trial shall be deemed commenced upon FPFD.