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Friday, September 05, 2014 1:42:11 PM
The committee has already addressed these concerns in their recommendations to FDA. This is really no news except for the possibility of a delay in FDA action caused by the "petition". But since this was fully hashed out in AdCom, I'd think the FDA will give the petition a quick glance and then move along towards approval with the modifications as recommended by AdCom.
Thus, after all is said and done, I think we hear from FDA before the end of September. This also accounts for the fact that quite a few of FDA staffers likely just returned from summer vacations and have to clear the assorted routine memos, papers and emails from their desks that inevitably accumulated in their absence.
Good luck!
-Fritz
The more you know, the less you don't know.
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