Replies to post #146406 on Biotech Values

[jq1234]

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.