1 year on basically since the denial, slow timing but i do understand COVID was in the way and as the vaccine rolls out they are re-engaging which makes sense.
Overall though this is still noise with Illara feedback Medgate trial starting the 2 key pieces for this month.
Ann: Pre-Submission package lodged with the US FDA, page-13
Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #