Yeah exactly. It's not clear what hurdle Munchkin fell down at but they are what underscored the difficulty for me, especially since they had a large supplier like Synlait guiding them through it.
That said, it sounds like MVM has some accreditation to assist with 21 CFR 106. It may be a long process but I assume A2M will undertake it eventually. In the meantime, there is no hurdle to them selling what is their most popular product - Stage 3 - other than they need a canning facility first (although they could always outsource this until it is complete).
However, if they want to be able to offer all stages at once, they would be waiting awhile to navigate the FDA. So they have a decision to make, do they hold off in order to be able to offer a progression through all stages, or do they follow the BUB route and get a product to market quicker.
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