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(The document can be found on the Public Health Law Centers website.) After the additional information was submitted, the parties agreed to extend the FDAs deadline to issue a final response to April 29

While we did not observe any high levels of acute toxicity associated with short-term CSE-EV exposure in this study, we did find that over the course of the 16-week long-term treatment period, CSE-EV-treated SV-HUC cells tended to grow increasingly slowly, ultimately exhibiting near-total growth arrest 4 weeks after the completion of the long-term colony formation assay (data not shown)

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Which didn't sit very well at that time