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ghmm

03/16/11 9:53 AM

#116512 RE: DewDiligence #116510

Wow! I guess they are not too happy with Amphastar. Should be an interesting read. Thanks for posting the doc and thanks also to mouton29.
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biomaven0

03/16/11 11:40 AM

#116522 RE: DewDiligence #116510

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?

Peter