They just wrapped up an investor call. The CEO took responsibility for making mistakes in forms but noted that other big pharma companies do the same all the time.
The FDA hold up was becuase of the needles that they include with the packaging not the drug it’s self. The FDA has also asked them to try 700MG does up from 350 and is not asking them to restart a whole new trial.
I’m not sure what the stock will do tomorrow and I’m not really concerned either way but that was the best call they have had that I have heard them do in the 3 Months I have been following.
The CEO also slipped up towards the end and said “when we are approved” and then had to go back and say “If”...... sounded like a slip.