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Re: rafunrafun post# 206999

Thursday, 08/08/2019 11:28:40 PM

Thursday, August 08, 2019 11:28:40 PM

Post# of 448110
I’ve searched and searched and cannot find one example of a drug that was given priority review, then scheduled for an ADCOM after the pdufa date.

There are plenty of PDUFA extensions with no ADCOMS. But I can’t find one example where the PDUFA was extended because an ADCOM couldn’t be scheduled in time.

The FDA is a joke!! They need to explain why they waited so long to issue their ADCOM. If there isn’t a good reason, Amarin needs to take them to court 100%!

Can anyone find ONE example? Or is this the only time it happened in the history of the FDA.
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