Oh yeah, Misiu’s questions ! Regarding finishing GvHD after 20 patients, it seemed to be vague optimism on Nader’s part when I first heard this. It didn’t sink in that “why in the heck would he be optimistic about THAT unless the FDA said something specific to encourage that belief”. That wouldn’t even be a possibility unless the first 10 patient results were STUNNING ! The next 10 can be enrolled quickly (whenever that starts again ... he didn’t say ARE BEING enrolled). Hopefully before Labor Day we Weill hear something !
This is incorrect. The IDMC has already reviewed the first 10 patients, and they are recruiting 10 more. They loosened the requirements for the next 10 patients and are upping the dose. Pourhassan suggested the second cohort of 10 could be enrolled quickly. The FDA is going to review again after the next 10 (patients 11-20) complete 30 days post-treatment. He did suggest that if data was strong, they may not need to finish enrolling the trial.
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