Where the FDA tox study sits exactly at the moment isn't crystal...

Where the FDA tox study sits exactly at the moment isn't crystal clear, and that is in part because what the FDA thinks and commits to is the knowledge of the FDA, and in their hands until it is shared in a non-confidential way with ANP.
Take into account the Ph2a trial was in a non-official way part of a tox study, and Ph2b/3 will be effectively a 12-month human tox study at up to 50mg.

What ANP and the FDA can turn that into is in part in the control of the FDA, and cant is clarified where its at by ANP because they cant quote the FDA if anything promising is encouraged by the FDA until the FDA commits to something concrete, which could then be quoted.

So, still, officially we need a 9-month monkey tox study, and that may be the case going forward, or, the FDA may allow EMA Ph2a/3 results (if positive) to effect requirements in the USA.

We will have to wait and see, the FDA for the most part is steering this aspect.
And it can be difficult for ANP to discuss non-defined, non-confirmed pathways to the market.

The tox aspect is quite important though as most appreciate, and it also can correlate to MS , and other indications with 1102, so doing things right is important.

I hope things go our way.