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Re: jb_118 post# 113476

Friday, 01/28/2011 2:47:05 PM

Friday, January 28, 2011 2:47:05 PM

Post# of 252783
jb,

<I don't recall ever having a company announce a date when they will respond to the FDA upon making the announcement that they have received an FDA letter. >

So how many deficiency letters have you read, and more importantly, how many company responses have you read? We do know TEVA had no problem talking about specific dates when they expected approval as they mentioned August 2010 or that they would be disappointed if it didn't occur by the end of 2010. These precise timing expectations were given WITHOUT specific input from the FDA. Now TEVA gets a deficiency letter from the FDA and all they can say is they will respond in the near future. That is a change in tone.
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