This is very big news. And now a press release from the FDA: FDA...

This is very big news.

And now a press release from the FDA:

FDA Developing New Framework for Continued, Expanded Access to Infant Formula Options for U.S. Parents and Caregivers

https://www.fda.gov/news-events/press-announcements/fda-developing-new-framework-continued-expanded-access-infant-formula-options-us-parents-and

Of course it would be more signficant to A2M if they had already achieved temporary access. However, the announcement also signals that they are trying to open up access more broadly to encourage any foreign companies to enter. For instance:

- Provide a single technical assistance contact at the FDA for any company aiming to enter the U.S. infant formula market, making it easier for potential new entrants to navigate the FDA’s regulatory review process. This is similar to a practice commonly used by other FDA centers that has resulted in novel medical therapeutics entering the U.S. market in a more efficient manner. The FDA hopes to encourage more entrants into the market, including new domestic firms.

I think A2M will be granted the temporary access, but at this stage it sounds like the whole system will be changing anyway.