RE:RE:RE:RE:A 3rd CR at 450 days?Rumpl3StiltSkin wrote: greaterfoolFred wrote: At 450 days we see 23-8=15 subjects. This is the 3 from phase one plus the screwed up 12 from phase two. If we remove the 1 nr and 2 cr from phase one, that leaves 1 cr, 1 pr, and 10 nr for the screwed up 12. I say leave them out of the analysis. If they weren't treated properly then their results should not be counted. Start the analysis at patient 13.
I agree, I think TLT will only have to treat ~ 40 patients before we will see the CR % up where it should be, especially if they are allowed to remove the 12 that didn't get this new 'optimized' procedure. Phase 1 patients didn't recieve this procedure, yet 2 were lucky to have CRs at 450 days.
Yes, and it shouldn't take too much longer to treat one or two dozen more patients when all sites are treating. The regulators would want to see patients treated at all (or at least many) sites before looking at data anyway. As far as the treatment protocol goes, study 1b was very similar to what they are doing now; no fancy reflectance measurement / monte carlo simulation, just light dosage based on bladder surface area. And now two treatments instead of just one.
I think that in the long run we will be very happy. GLTA