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Re: friendofthedevil post# 3415

Friday, 09/05/2014 1:42:11 PM

Friday, September 05, 2014 1:42:11 PM

Post# of 9142
These are the same arguments raised during the AdCom hearing. They were most prominently argued by a woman on the committee whose name and industry ties I never got.
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

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