RE:RE:Breakthrough TherapyI am not an expert on this but I think at the end of phase I is likely most common. If the fDA thinks you ahve somethign important, they likely want to identify it early and speed its progress through the trials. But BTD can come anytime the FDA thinks they see something worthwhile.
Lee430 wrote: Historically at what point in a trial has the FDA typically granted BTD status?
jeffm34 wrote: Criteria to apply for BTD
"A significantly improved safety profile compared to available therapy (e.g., less dose-limiting toxicity for an oncology agent), with evidence of similar efficacy"
They should know if this is the case with TH1902 within a couple months and could apply for a BTD