RE:RE:RE:RE:Keytruda = $265,000 (17 doses per year)
N0taP00p wrote: Slayer, what are your thoughts on the smaller sample size with Theralase? Obviously, the FDA gave the green light for phase 1b completion with a very small sample size and then said 20-25 with similar efficacy and safety is good enough for BTD. These other ones you referenced above had higher sample sizes, correct? Thoughts appreciated.
Re: sample sizes required for BTD, I don't think our 20-25 patient threshold is an unusually low number, especially when you consider it involves a highly unmet indication. Re: other referenced drugs, I have not followed the precise patient numbers that were required for a given accelerated pathway....perhaps others can chime in on this. But historically, investigational drugs for high-unmet need cancers have not uncommonly been granted BTDs based on even less data &/or based solely on promising Ph 1 results.
To date, our Ph 2 efficacy rate has not reproduced our Ph 1 rate; however, one should not worry as the updated guidelines in 2018 had set a significantly lower efficacy bar when compared to our Ph 1 results. Experts continue to move the bar substantially lower based on the lack of patient-friendly treatment options & the lackluster historical efficacy rates of the currently approved drugs...as noted in my earlier post.
Imo, a high 20s-low 30s durable response rate is well within our reach, & ultimately, any response rate that exceeds the relatively low bar set by the competition (low 20s) should receive an AA. All imo.