That's the interesting point that I think a lot of people may...

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werdplaya58

4,079 Posts.

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07/11/22

16:15

Post #: 64631691
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Originally posted by CarlosG: ↑

I think it was already mentioned earlier in this thread, but any way, main point is "Manufacturers currently marketing their products in the U.S. under enforcement discretion should send a letter to the FDA by Dec. 5, 2022, outlining their intent to pursue completion of all regulatory requirements. Upon receipt, the agency intends to evaluate the request to determine whether to extend the period of enforcement discretion and issue a new letter of enforcement discretion by Jan. 6, 2023. For manufacturers that receive a new letter of enforcement discretion, the FDA does not intend to object to the continued marketing of covered infant formulas in the U.S. through October 2025"https://www.fda.gov/news-events/press-announcements/fda-pathway-supports-long-term-stability-diversity-safe-and-nutritious-infant-formula-supply-us

Guidance on Transition Plan for Covered Exempt Infant Formula Products to ensure they meet regulatory requirements can be found here https://www.fda.gov/media/161904/download

Here is timeline to comply with from that document

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That's the interesting point that I think a lot of people may have missed - the approval until 2025 would actually be another 'temporary' exemption, and the next step after that would be to receive permanent approval.

While it is possible that A2M receives an approval only up until 2025, the likelier option to me is that they are able to successfully obtain the permanent approval that is available beyond this. It's definitely not a given but having an initial foothold + lobbyists who seem to get results certainly helps.

So for me it is now less a question about whether they will have long-term access to the market, and more one of whether they are able to achieve an USA IF business that is profitable enough that they actually want to remain there in the longer term.

Last edited by werdplaya58: 07/11/22

A2M Price at posting: $5.51 Sentiment: Buy Disclosure: Held
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0 Great analysis

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