I think it is clear at this point (just based on their handling of the Abbott contamination) that the FDA as an organisation is incompetent when it comes to infant formula. The timeline of the saga also suggests there was possibly some wilful ignorance / corruption at work, as whistleblower reports received by the FDA got 'lost in the mailroom' to explain why they were not acted on.
So it is no surprise they are lacking when it comes to this application process as well. The fact that the FDA and everything about the IF regulation system is being reviewed and potentially overhauled suggests that things are seriously broken. Usually these 'reviews' are also about getting ahead of bad news that is going to emerge. Most likely we are about to hear more about failings at the FDA in relation to Abbott IMO.
Either way, reform is a good thing for any foreign company looking to enter USA.
A2M Price at posting:
$4.46 Sentiment: Buy Disclosure: Held
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