RE:pre-BTD and BTDI thought the news release was pretty clear on this; the 15 month data is all they want, but the cytology results from all of the study centre labs have to be confirmed in a central lab. This means selecting an accredited lab, having samples sent there from the study labs, getting the work done, and then paying for it. Not to mention proving that the samples were stored properly the whole time, and shipped properly. Might take a while.
DJDawg wrote: For those of you who were wondering what is the missing data for BTD application.
My hunch is that the main detail that makes BTD on hold at the moment is that FDA is wanting 18 m data vs current 15 m data.
Interesting fact (from my area of work) is that if you are doing a research trial and want to find out how patient is doing you are not allowed to just look up the chart or email the investigator or physician. If the protocol covered up to 15 m then you have to apply for approval to go and get more detail about how patients are doing.
The prevailing pattern of immune drugs is that they work (to a degree) while you are taking them and then once you stop, the cancer comes back for many, given a bit of time. From other companies I follow I get the sense that the FDA wants longer follow ups to make sure the CR is being held.
So, if TLT was told by FDA that the BTD needs 18 m data then they cannot submit BTD till they get the protocol modification approved and then they can call the research sites and get the 18m data.