FDA requires a fairly high bar in terms of clinical trail evidence - it is definitely not just a formality.
There have been other IF companies who had to abandon their applications at this stage. Munchkin Grassfed Formula from NZ comes to mind.
I'm not expecting this would happen, but they're not going to be waved through just because they already had temporary access.
Ann: Bubs Q2 FY24 Quarterly Activity and Cashflow Statement, page-21
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