Here's an article that discusses RTF letters. The main excerpt that I wanted to point out is that " The majority of the applications receiving refuse-to-file letters were resubmitted to FDA by the study analysis, with nearly 72 percent of those resubmissions being approved. "

They gave us notes on all of the issues so as long as we can address all of the issues they noted we should be okay I think.

https://pink.pharmaintelligence.informa.com/P...%20minimal