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Posted On: 03/27/2019 11:33:49 PM
Post# of 150065
Higher dose reguire clearance with FDA.
For 700 mg for combo they didn’t ask for separate trial just for
100 patients for safety evaluation .
So one never really know what they will ask for , but yes they will need to ask for something for higher dose .
For 700 mg for combo they didn’t ask for separate trial just for
100 patients for safety evaluation .
So one never really know what they will ask for , but yes they will need to ask for something for higher dose .
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