Tuesday, April 23, 2013 1:25:53 PM
The application will be subject to a standard review and has been assigned a Prescription Drug User Fee Act (PDUFA) date of December 20, 2013. The PDUFA date is the target date for the FDA to complete its review of the sNDA.
I think people were hoping for earlier in 4Q but they are taking the full 10 months from submission
Though AMRN management said all along 10 months from submission so unclear if there was an expectation of sooner that has not been met and thus the stock being down?
8 Months to Anchor Approval, 2014, however they launch Anchor should ramp up very fast as they have plenty of time to figure out how to launch.
Realistically management keeps checking off the boxes, seems everyone is waiting for Anchor to get closer before putting in positions.
Can you imagine NCE granted next month, after all this time, and the stock would go down: LOL or cry?
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