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Re: Keep in Mind TamifluIn this case, I think it means sometime during Oct, Nov or Dec (not by end of Q3). Even if we have responded by now, it will take some time for the FDA to review and (hopefully) lift the hold. Because they have partially lifted the clinical hold, freeing up TKM-EBOV for other trials, I don't think they will feel that their response has to be rushed. I could easily be wrong, as the FDA can be unpredictable! |
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