Monday, August 15, 2022 2:20:14 PM
I guessed you missed the NYAS (and other) presentations that clearly disagreed with your post,
On the two endpoints you quoted, the EU/DE site says 3 analysis on each, while the NYAS asserted a single standard K/M on both.
The registries also have:
as an endpoint. The NYAS slides say no.
The entire point of the SAP is to nail down EXACTLY how an analysis is to be performed. And in this case there is clearly disagreement.
On the two endpoints you quoted, the EU/DE site says 3 analysis on each, while the NYAS asserted a single standard K/M on both.
The registries also have:
The fourth secondary objective, OS, is overall survival compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.
as an endpoint. The NYAS slides say no.
The entire point of the SAP is to nail down EXACTLY how an analysis is to be performed. And in this case there is clearly disagreement.
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