Before any company can begin a clinical trial, the Food and Drug Administration has to know how they’re going to make their “drug.” For some microbiome companies, that’s not really a problem; to put it delicately, the active ingredient for their drug comes from the guts of willing volunteers. All that’s left to do is process it.

But as more attention and hope is placed on bacteria specifically selected or designed to be therapeutic, the companies testing them may hit a roadblock that could cost them millions or slow their progress.

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