Morphocell Technologies Inc. held a successful pre-pre-Clinical Trial Application (CTA) meeting with Health Canada in August 2019.

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Health Canada agreed in principle to the proposed non-clinical plan in support of a first in human clinical trial. The discussion focused on the acceptability of our non-clinical and quality development plans for ReLiver®ELT. A high-level discussion on the potential design of our first-in-human clinical trial that provided great direction for fine-tuning our approach.

 

Health Canada’s Biologics and Genetic Therapies Directorate and Medical Devices Bureau offered valuable guidance on data that would be considered acceptable to support our initial CTA.

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The Morphocell team is looking forward to using Health Canada’s input to further refine ReLiver®ELT development plans. More to come – follow us on Twitter for updates.