Just stating the fact. Still well ahead of the June 30 date that was on the .gov site. Should begin seeing some upward movement again as study comes to a close.
I vaguely remember someone saying that humanitarian org will likely sign up when US trial results are released and are strong, but don't quote me on that.
Good signs and momentum is coming into the FDA de novo app.
Just stating the fact. Still well ahead of the June 30 date that...
Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #