(Total Views: 607)
Posted On: 07/15/2020 6:56:23 PM
Post# of 154115
Quote:Agreed
The FDA is in breach of its own guidelines. At the pre-submission meeting it was established that the FDA wanted safety data from 50 more 700mg patients in the monotherapy trial. When the company achieved that the FDA changed its mind and has now done so once again.
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