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jq1234

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jq1234

Re: pcrutch post# 146406

Wednesday, 08/01/2012 7:00:52 PM

Wednesday, August 01, 2012 7:00:52 PM

Post# of 257580

After reviewing the data, CDER has confirmed that there is no need for actions against Hylenex or clinical programs in the Hylenex IND.



Why is this worse? CDER doesn't find a need to suspend approved product Hylenex after reviewing the non-neutralizing antibody data. To me it shows this is pre-caution by CBER rather than alarming non-neutralizing antibody data that caused CBER's decision.
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