Thursday, October 10, 2013 3:04:48 PM
sorry, but its standard protocol to call an adcom for a first in class drug for a large new indication. nothing has been approved previously for Anchor indication. That is why they are calling the adcom. I think people get nervous as the open and shut nature of Anchor results really begs the question as to why the adcom is needed but the fact are its standard protocol for something this big and this new.
At the end of the day, fda wants the reduce it outcomes data. no one in the US has ever done such a study. they know that amrn needs anchor to pay for reduce it. that is the deal between the two - you hit anchor spa and we give you anchor, and in return you give us reduce it data.... thats the deal, period.
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