Since trying to get the hold lifted it sounds like

Since trying to get the hold lifted it sounds like we have been filing things correctly. It just sounds like the FDA has continually moved the goal posts and asked for additional info. I'm somewhat concerned that they can just continue doing this into perpetuity to companies and there's no recourse that the company has. The FDA should tell you everything that they need up front to address your hold, not piece meal it and drag stuff out.