RE:RE:75 to 100 patientsHere is what Mr. Dumoulin-White said in today's video:
"We've been able to enrol and treat 72 patients to date - with another 3 coming up in the next 4 to 6 weeks - gives us around 75 patients. Why that's exciting is one of our competitors just achieved FDA approval in May with 77 patients. So we're very, very close. We expect to enrol anther 10 patients by the end of the year. I think we're going to be completed our study. With that we have a data lock in about mid-2026, and hopefully an FDA and Health Canada approval by the end of 2026." This statement could be interpreted as they are going to treat 85 patients and then call it a day. Or maybe they're hoping for accelerated approval based on the results of the first 75 patients. Hopefully they will clarify at next week's conference call (Wed. August 21)
By the way, the competitive 77 patient treatment approved by the FDA in April was the combo treatment N803/Anktiva plus BCG.
Their 18 month CR was 33%
Their 24 month CR rate was 25%
toade1313 wrote: The. Number 75 is what we will have when those recently registered become patients. The FDA has not chaged the 100 number.