(Total Views: 494)
Posted On: 03/22/2021 4:31:52 PM
Post# of 154119

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.

