(Total Views: 462)
Posted On: 03/22/2021 4:31:52 PM
Post# of 145247
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The FDA wanted us to submit for 700mg and now the FDA wants us to justify using a higher dose with a RO test. The justification is in the efficacy not the RO test. We could have went in with 525mg and had all the data necessary. Complete garbage from the FDA.
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