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Post# of 257580
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jq1234

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jq1234

Re: DewDiligence post# 160700

Thursday, 05/02/2013 10:19:54 PM

Thursday, May 02, 2013 10:19:54 PM

Post# of 257580
I do, I think it will be a full and thorough review, not a simple reformulation sNDA. Otherwise, it wouldn't have taken this long to file. It could be like Myozyme sBLA that turned into a new Lumizyme BLA after FDA reviewed the filing.
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