I am not clear on how you believe the primary or secondary will be successful as she explained that the primary is very confounding and the secondary is polluted hence the requested change.
To me this is much more messy and complicated than one would hope. I wonder how the announcement of results will come off?
The primary was not really effectively measurable. The secondary was confounded and therefore a different approach for measurement was needed and hence they asked for changes and received positive feedback from the health authorities, but won't it leave the announcement of results very confusing for people? It clearly wont be clean and definitive. It will be more like, we didnt meet the original trail endpoints, however we can demonstrate a clear survival benefit and we hope that folks agree that the benefit is worth carrying this forward? Hopefully???
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