Chem - thanks for your post. I wish you and your family a happy holiday season and a healthy new year. To all - I3 longs I wish the same. See ya in the circle.
It does state..up to 60 days...so it could come at any time before that, unless they take the entire period. That is also for se-nse decision letters. We don't know if they have decided se and are ironing out the label? JMO
Re: DECISION DATE HAS NEVER CHANGED! (60) DAYS) 24-Dec-09 12:19 pm
Lets take this one step further. If you take a look at the guidance performance for the FDA that is posted on the site, you will see how they have performed in the past few years to meet these guidelines (dates).
After the second or Additional Information request: 60 days
2005 70% received notice by this timeframe 2006 80% 2007 90% 2008 ? 2009 ? With recent concern of FDA dragging their feet you would think this percentage would get better! Rating :
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