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|European Medicines Agency Accepts Design of NeuroDerm’s ND0612 Phase III iNDiGO Efficacy Trial|
At any stage of development of a product candidate, developers can request Scientific Advice from the EMA, which provides a mechanism for the EMA to give developers advice on the appropriate tests and studies in the development of a product candidate. This process is designed to facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefit of patients.
NeuroDerm recently requested Scientific Advice from the EMA focused on the amended ND0612 iNDiGO trial protocol. The goal of this request was to reach agreement with the Agency on the content of this protocol, which is now being conducted as a pivotal efficacy and safety trial to support registration of ND0612 in the EU, and to confirm completeness of the development program intended to support the submission of a Marketing Authorisation Application (MAA).
“The acceptance of the main design elements for the iNDiGO trial protocol provided in the Scientific Advice Letter reaffirms
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