Quote:I am kind of thinking they want want to apply for btd using the backbone only and would prefer to not even have the backbone attached to it.
Thing is, Jay will need to provide evidence of clinical efficacy to get a BTD. In CLOVER there was no leron cohort without the backbone. So I don't think he can offer evidence of Leron's clinical efficacy without the backbone, even though it is surely real.
Nader applied for BTD for TNBC using the same trials where the five women lived on for six years... but when they'd only been alive a year. So his application didn't better the SOC, at the time. I don't know if Jay could reapply using the same trials. I doubt he would.