RE:RE:RE:Breakthrough Therapy You're statement there just speaks to the idea that the first approval brings along more than just the value of sales in that first indication. They have to be seeing it doing other things like move up the treatment pipeline for TNBC, into new indications etc. Did they buy the molecule or the patent? Maybe they see a family of molecules based on the IP. This would be part of the argument for thtx being laser focused on getting 1902 over the line and not split their resourses in bringing other molecules forward, even 1904.
It does raise questions about defining NPV based on just the indication that are showing in the program at the present time.
Wino115 wrote:
It seems it is when you show preliminary clinical evidence it is safe and an improvement over existing therapies. Trodelvy (the ADC targeting TROP2 on TNBC that is refractory that Gilead bought for $21bil) got priority review and BTD after Phase 1 data given both the unmet need and a response rate of 33% and additional 7.7 months survival. Then they got accelerated approval midway through P2 trial with around 110 patients confirming the rough 33% ORR and 7 months PFS. If TH1902 followed this pattern,perhaps you'd get Priority Review and BTD end of year and Accellerated Approval 1H 2021. That would be the most optimistic reading.
We should note that the FDA actually sent back the original BLA on Trodelvy based on some concerns. They refilled a year later and did it have fast track in Phase 1. This TNBC does suffer from patients getting neutropenia and other SAEs so it's still a rough drug to use, but the target seems to work for a third of patients. Most analysts don't think Gilead will make the kind of revenues needed from it to justify the price they paid (it would need something like $6.5bil annual revenues to get a decent ROI). The thought is maybe there's other things on the pipeline to supplement it and make it a decent acquisition.
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