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MaaT’s FDA Woes Highlight Rocky Regulatory Path For Microbiome-Based Therapies

Clinical Hold Remains On Graft-Versus Host Disease Drug

Executive Summary

The French firm's lead microbiome therapy has been on clinical hold in the US for a year and continuing concerns about MaaT's 'pooling' approach (mixing donations from multiple donors) suggests the wait to restart trials will not be a short one.

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