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Re: Lykiri post# 583898

Sunday, 04/09/2023 9:58:06 PM

Sunday, April 09, 2023 9:58:06 PM

Post# of 823203
Thank you Lykiri for your info. Here are some of my thoughts.

1. I mentioned that there were 29 permanent placebos at the end of the trial because some time ago in I believe Al Muzella's Q and A Webinar segment, Dr. LL stated that 7 of those 35 dropped out before the end of the trial. However, if I understood you correctly, except for one drop out, 5 of those placebos were among the 81 with documented progression and that would add up to at least 98 patients (92+5+1=98). That means that those patients were recorded as having progressed before they dropped out and if this is correct we have at least 98 of the 99 accounted for.

2. However, I am still uncertain about the following: You counted 81 progression events of which 48 occurred before 7.6 months on trial and 33 progression events thereafter which would add up to an mPFS below 7.6 months. Fortunately if there were only 81 recorded progression events in that group of 98-99 patients, there must have been 17-18 patients whose progression was never established. If let's say15-18 of those patients were judged as not having progressed during the trial and were added to the 33 who progressed after 7.6 months, then 48-51 such patients match the 48 patients that progressed before 7.6 months and that would approximately legitimize the mPFS of 7.6 months.

3. Finally, is it not likely that most of those 48 who progressed after 7.6 months were crossovers and that a large proportion of the earlier progressors were permanent placebos?
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