“What I remember to qualify for BTD. You have to
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Posted On: 07/22/2020 2:14:06 PM
Re: Goosebumps #44534
“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
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
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