Media Updates, page-13053

It depends on a few things.

On the FDA side there are still all the same requirements a company has always had to go through. This includes clinical trials (at company's expense) to produce a dossier of evidence supporting its product's quality and nutritional benefits etc. I believe it's a fairly rigorous process.

A few years back, before the FDA's temporary exemptions, one NZ company (Munchkin) was applying for FDA approval through its producer Synlait. They withdrew for unstated reasons during this process of clinical trials. Interestingly, BUB was one of the earliest companies to receive a temporary exemption and, despite all the other issues they are having, is now currently running its clinical trials. They might be a good test case to see how likely it is for foreign companies to finally break through and get permanent access.

The other side of the equation is whether A2M feel it is worth it. Margins are likely to be very tight, meaning the sales growth would have to be phenomenal USA IF to meaningfully contribute to the bottom line. If it's not, they might pull the pin on the whole thing earlier. However, for now I think they will still be going through the process on the assumption that they will want permanent access.

The other interesting thing is that they would likely be expected to demonstrate, to the FDA' standards, that the A2-only aspect of A2 Platinum is beneficial for USA population in order to be able to market it as such in the long run. So it does mean more scientific scrutiny, which is a good thing in my opinion.