RE:RE:RE:Another look at the dataDJDawg wrote:
I know everyone is hopeful that that 25 is the magic number for BTD submission but I would argue that it is not so simple. The FDA info says that as you get closer you can request a meeting to discuss whether the data is enough to get BTD. Kind of a way of checking in and getting a preliminary thumbs up vs being told that should aim for another x number of patients and a total CR of x %.
As such, I believe that 25 is the point where they will check in and utilize this pre-BTD application meeting option. If they get told to collect a few more patient data points it is not necessarily a bad thing as it means that when apply for BTD it is more likely to succeed. Or maybe they have already had this meeting check in. Who knows?
I would like to see them take those 12 "undertreated" patients out of the data base completely and write them off as what they are - a mistake! That is very unlikely to happen but their numbers muck up all numbers for evermore, whether it be 12 out of 25 or 12 out of 100 they distort the true result.
Question then is - do the reviewers work around them? imho.