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Re: biomaven0 post# 116522

Wednesday, 03/16/2011 11:58:00 AM

Wednesday, March 16, 2011 11:58:00 AM

Post# of 257253

What do you make of the fact that the FDA argument here rests solely on the lack of a good and stable raw material supplier - not one word in there about lack of "sameness" or failure to meet their 5 criteria?



How can they comment on Amphastar meeting the sameness criterion when they have yet to receive evaluable material?

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