“What I remember to qualify for BTD. You have to have two terminal patients and extend life for two months to qualify for the BTD.”

I don’t believe this is an official requirement for BTD in regards to cancer. This may have been a comment made by NP, but the first BTD filed earlier this year only had data from a few patients and it was rejected, so the above qualifications are most likely inaccurate.

Here’s the FDA’s general definition of BTD and what a potential BTD drug candidate needs to show in order to receive BTD:

https://www.fda.gov/patients/fast-track-break...gh-therapy