Monday is the day
Nov 13 Dec 14 Jan 13.
With all these FDA meetings, we were told a no go mid nov, working on a fix mid dec and now a re issue mid jan.
Its do or die. my bets in and its minimum 50-50.
If they are indeed in conversation with the fda its a go. If they were leading us on its bankruptcy.
With the fda team online in the discussions, approval is days away from submission of the 510 submission on monday.
Next week will be the most interesting in this companies history one way or the other.
Good luck to everyone!