Monday, July 15, 2024 8:06:37 AM
I got it now
The FDA says they want to see patient level data (not summary data) for ECAs. The JAMA paper notes lack of this as a limitation. LL bemoanes the fact that this lack of data creates an issue.
Yet you and Senti think the FDA is wrong because nobody could run an ECA based trial under these conditions.
What about the Medicenna P3 in rGBM ?
Cleared by the FDA, and it will use individual patient level data.
P.S.: Senti, MAIC has serious limitations.
The FDA says they want to see patient level data (not summary data) for ECAs. The JAMA paper notes lack of this as a limitation. LL bemoanes the fact that this lack of data creates an issue.
Yet you and Senti think the FDA is wrong because nobody could run an ECA based trial under these conditions.
What about the Medicenna P3 in rGBM ?
Cleared by the FDA, and it will use individual patient level data.
P.S.: Senti, MAIC has serious limitations.
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