Kiwijuice,
I don't know where you are getting your information from.
If you are referring to the NMRC meeting that was held with the FDA:
The Type B meeting with the FDA discussed the Chemistry, Manufacturing and Controls including the proposed release testing specifications of the product as well as the planned clinical studies evaluating the safety and efficacy of the product which the company is developing to prevent Campylobacter and ETEC mediated moderate to severe diarrhea.
From what I can see there is no mention of FDA Approval.
That would come after the results of the planned clinical studies which will be conducted in 2021.
Unless, I am reading it wrong.
Chart, page-124
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