The producing company of the Brilacidin wouldn't have a QMS at the manufacturing site that would meet the requirements?
In other areas of business, the manufacturer of the product has the responsibility of being fully certified that they can produce to specifications of the industry or government requirements.
Think this is a "non-problem".
I highly doubt IPIX had any form of testing done by themselves as to the B used in the human trial.
If another level of testing to back up the mfr's testing is needed IPIX could always hire a testing facility to run spot checks on the B.
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