RE:RE:RE:RE:RE:pre-BTD and BTD
I'm not really sure. My area of work doesn't work with FDA but we do recruit for thyroid cancer trials.
My personal gut feeling is that frequent communication with the FDA seems a bit fluffy. The FDA is a beauracracy so when I read that I don't know if I imagine a dedicated phone line back and forth. My hunch is that the BTD review committee is its own silo and they can just look at things and say what the personally want in the applications. And then the companies have to dig around for those details.
I'm not ever sure that the 15 m timeline was a mistake that just happened. Didn't they start the study doing just one treatment and then modify it for a 2nd maint treatment at 6m after the first 12? I can't recall the timeline. If so, then the original one and done protocol would have mean that they would have had follow up for 15m from last/only treatment. With the 6 m protocol for a second treatment it now means that the 15 m follow up is only 9 m from last treatment.
I'm guessing completely.....