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 Strategies & Market Trends : Sharck Soup

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To: sam_o who wrote (32060)7/27/2001 5:49:50 PM
From: CopelandRead Replies (1) of 37746
 
>AVIR... 'It would HAVE approval" if it excluded one year >olds..etc.. SO maybe the labeling needs to be changed >IMO.. see...Briefing.com and..

They would have had approval if they had submitted better safety data. They have a few safety studies that apparently weren't included in the BLA, likely due to deadlines.

What bothers me is the fact that the issues with the BLAlast time were manufacturing issues -- now safety. Why weren't the FDA's concerns with the safety issue brought up earlier?
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