Jaydeezy23z : Any day in December
yesyesyes : it could take time, enjoy the ride if you took profits
M J582 OP Jaydeezy23z : Shouldn’t it be before 60 days?
M J582 OP yesyesyes : No that’s not true. As per FDA rule, they should get a feedback within 30-60 days.
老实和尚 : Submitted for fast track on October 16th, it has now been over 60 days.
Arrayfunction : The FDA approval news is still a few months away. The news everyone is talking about for December is whether they reject the NDA or not. If they don't reject it, it is a couple months till final approval
Jaydeezy23z : Any day in December
yesyesyes : it could take time, enjoy the ride if you took profits
M J582 OP Jaydeezy23z : Shouldn’t it be before 60 days?
M J582 OP yesyesyes : No that’s not true. As per FDA rule, they should get a feedback within 30-60 days.
老实和尚 : Submitted for fast track on October 16th, it has now been over 60 days.
Arrayfunction : The FDA approval news is still a few months away. The news everyone is talking about for December is whether they reject the NDA or not. If they don't reject it, it is a couple months till final approval