A2M 8.89% $6.25 the a2 milk company limited

FDA Approval, page-121

  1. 4,266 Posts.
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    Bellamy's is a bit of a surprise to me, but also suggests that approvals probably come down to product availability ahead of anything related to brand, quality, or even country of ownership in this case (assuming the FDA understand that Bellamy's is Chinese owned and not Australian owned - one would hope so..).

    I recall reading somewhere in the FDA documentation that preference would be given to companies that with already FDA-approved production facilities (which Synlait and Mataura both are) as well as the capacity to supply large volumes quickly.

    A2M is currently in the process of transitioning from an old English label product to a new line, through a soft phase in - phase out transition. They also appear to be experiencing much stronger demand for sales in China then all of the companies that have received approvals, with the exception of Danone / Aptamil. So it is possible that A2M management has prioritised the higher margin sales first, then offered to supply USA IF from late July/August onwards following their label transition.

    So if I'm the FDA, I'm approving companies in order of how soon they can supply and how much they can supply. If I'm a company seeking approval, I can probably get in a better position to achieve this: a) through good planning and management or b) if I have less demand for your products in other markets.
 
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