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sts66

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sts66

Re: ziploc_1 post# 208464

Wednesday, 08/14/2019 12:50:45 PM

Wednesday, August 14, 2019 12:50:45 PM

Post# of 428178
It makes zero sense - when FDA approves an sNDA it means they have approved a label change - so what's the point of having an AC afterward to discuss what should be on the label? If FDA intends to hold an AC they WILL delay the PDUFA, they have no choice - just because they haven't publicly said it will be delayed doesn't mean they won't do it - hell, they still haven't admitted there's going to be an AC.

The Thought Police: To censor and protect. Craig Bruce

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