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Thursday, April 28, 2022 4:56:21 PM
This is still a randomized trial blinded through data lock. It still has randomized endpoints. It also has an ECA controlled primary endpoint. Why do you persist in not acknowledging they retained the randomized and blinded aspect?
They could have just left OS between the randomized arms as the primary, they did not (all assuming the EU endpoints are what they have in the FDA SAP).
Trials are not formally analyzed by "here are a bunch of endpoints". They have a formal SAP that declares how the endpoints will be evaluated in order to insure the trial does not claim success just by saying some endpoint had a P <.05
This trial has two primaries that one would expect to be analyzed (with some alpha spend program) before they get to the randomized comparison (they do call them primaries after all). If so, then hitting either of those makes the trial a formal success, and they can PR that.
Given the actions by NWBO, there is no chance in hell the OS between the randomized arms was stat significant. So they instead spin the story so they can claim success on the historical comps,.
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