RE:RE:RE:RE:RE:Our newfound US financial muscle..two issues of note:Ahah, I see, thanks for the explanation! Yep, that must indeed be a pretty poor position to be in...
Only came across the story within the last 12 months, at which point believe stock looks great imo... but I have to retrospectively educate myself on the history! To have held it all the way down through Bioniche implosion, however, must suck.
Agree, new leadership and execution has been impressive.
I'm increasingly certain they can achieve a first pass approval here.
The acceptance of filing/RTF is (simplistically) purely a bureaucratic check of the documents. These should be in order following three pre-filing meetings and an initial 3 month delay to triple check everything is in order.
AdCom should not be an issue given results and clinical setting, and approval should be a formality following that.
My 2 cents anyway :-)