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Thursday, July 03, 2025 7:09:12 PM
Dennis, I still hope that at some time they may be able to obtain patient level data in the future, perhaps from the GBM agile program.
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
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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