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Thursday, July 03, 2025 7:09:12 PM
But at least for now FDA requires patient level data for comparison
oh yeah let's see as far as the control group goes was
33:36
there any thought or discussion with the FDA about using external controls instead of randomization to receive both
33:43
yes we we looked at that briefly FDA would not accept any external control plan that we presented to them
33:50
um what they had offered was that we had to look at patient level external controls what that means is that every
33:56
patient on study would have to be matched with a patient from a database and as we pursued the databases that
34:03
were out there which is kind of surprising to us there's not enough data to match these individual patients
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