RE:RE:RE:Heads Should Rollenriquesuave wrote: "
Conclusion: Study II has delivered significant clinical results to date for the primary, secondary and tertiary objectives."
Hopefully what the FDA wants to see for BTD. Novelty of a One-and-Done single treatment with high efficacy and safe.
I think I understand what they mean here
"The Study II optimized treatment patients, who received either an optimized primary study treatment or optimized maintenance study treatment consisted of: 23 patients at 90 days, 26 patients at 180 days and 27 patients at each of 270, 360 and 450 days."
23 patients got an Optimized primary (1st) treatment on day 1 and will get maintenance treatment at 6 months.
3 of the 4 patients from 1st set of 12 got optimized maintenance treatment, got treatment at day 180 and the 4th of that group got his late at day 270. ( maybe because of COVID?). Sounds right but just reading between the lines.
Agree....re: the "optimized'" data (collected post August 1, 2020), the 23 patients reported at 90 days appear to include only those who received an optimized "primary" treatment, & they would be getting a subsequent optimized maintenance treatment at 6 months. Looking at all Ph 1b & Ph 2 patients, there are a total of 38 patients. For Ph 2 (total of 35 patients), there are 12 patients who didn't receive an optimized "primary" treatment, which leaves a total of 23 patients who received an optimized primary treatment.
I also agree that based on the data as shown, 3 of the first 12 treated (those who got only an optimized "maintenance" treatment) are represented in the 180 day data, & all 4 of the first 12 are reflected in the 270 day (with one getting the optimized maintenance treatment late due to whatever reason). What is encouraging in the 180 day data is the significant jump in CR for evaluable patients, indicating many PRs are converting to CR after further analysis. By the 180 day mark, it appears that ~4 patients didn't respond (were NR). However, if three of the NRs can be attributed to the 3 patients who only received an optimized maintenance treatment (the 3 who were part of the first 12 treated), that would mean a potentially > 90% CR rate being achieved at 180 days by those patients who are "fully" optimized.
Any CR data > 90 days has little significance at this time imo due to the high number of pending patients...& the fact that they are including the 4 patients of the first 12 who did not receive a full "two-dose" optimization. Good luck...