And as a quick follow up, I also asked the below to IR on Jan 6th:

"And in regards to the filing itself, would that be an event that the company intends to announce, or will they only be announcing the relevant authorities' decision(s) in regards to breakthrough status?"

And they responded with the below boilerplate that is received when most questions regarding BT are asked:

"At this time, we cannot comment on any potential announcements with respect to the breakthrough status filing. All material developments will be disclosed in due course."