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. As used in the preceding sentence, the term “Phase 2 Trial” shall mean a human clinical trial that would satisfy the requirements for a Phase 2 study as defined in 21 CFR § 312.21(b) (or its successor regulation); and

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.

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).

Examples of Phase 2b Trial in a sentence

• Following the completion of the KaloBios Phase 2b Trial, KaloBios shall furnish to Sanofi the final clinical study report from such trial, together with such other information then existing as Sanofi may reasonably request in connection with the evaluation of such trial results in order for Sanofi to determine whether it will exercise the Option.

• The Warrant Shares shall vest upon, and the Holder shall not be entitled to exercise this Warrant with respect to such Warrant Shares until, the Phase 2b Trial Completion Date.

• For the avoidance of doubt, if the Expiration Date occurs prior to the Phase 2b Trial Completion Date, this Warrant shall not be exercisable.

• At least six (6) weeks before Synosia expects to have generated, or to have received from a contract services organization (as applicable), the tables and listings data from the first SYN115 Phase 2b Trial, Synosia shall provide written notice to Roche of the expected date of availability of such tables and listings data (the “First Notice”).

• For Investor Use Only AR-15512 Phase 2b Trial Design Objective: To evaluate the safety, tolerability, and efficacy of AR-15512 compared to vehicle administered twice daily in subjects with dry eye disease.

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 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 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 has the meaning set forth in Section 3.1.3.

Phase 2b Trial means, with respect to the US, the second phase of human clinical trials of a Licensed Product to gain evidence of the efficacy in one or more indications and expanded evidence of the safety of such Licensed Product and an indication of the dosage regimen required, as described in 21 C.F.R.§ 312.21(b), as may be amended, or, with respect to any other country or jurisdiction, the equivalent of such a clinical trial in such other country or jurisdiction.

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.

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