July 30, 2020, Of the 4 patients that were removed from Study II, the clinical protocol in effect at the time stated in the patient withdrawal criteria that “Patients found to have at Day 90 new T1 high-grade disease, with or without CIS” and “Patients found to have unchanged or worsening CIS at 3 months” will be removed from Study II. Of the 4 patients removed from the Study, they presented with “unchanged CIS at 3 months”.
This was an oversight on behalf of the Company and the clinical protocol has since been updated to remove these two specific patient withdrawal criteria, maintaining the key patient withdrawal criteria of NMIBC progression,
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Looks like 8 of the First 12 from phase 2 are up for the 2nd treatment at full dose!
67% CR @ 18 months. Patients removed after 24 moths from the study.
Only the doc knows about the 24 mo results from the phase 2 but.... but he diald back the first dozen to lower dose levels....
Before 409 was on the market it was 410 but it was so strong they had to dial it back. just sayin.
TLTFF GOLD STANDARD FOR NMIBC NONRESPONSE