Senti,
I'm sure you know what you're speaking about, but what would you call the goals established in clinical trials may be what I'm thinking is what constitutes as the SAP. If the DSMB discusses the trial with the FDA it's those goals that they're discussing.
If in fact Overall Survival is the number 1 goal, if in fact how it's to be analyzed isn't established going into the trial, I don't see how it matters when results aren't a simple 10% or 20%, or whatever improvement on the SOC, they're a substantial multiple of what's found with SOC treatment. No product needs to multiply what's achieved by the SOC to be approved.
If the SAP isn't part of what's in what's provided to the regulators in the beginning, why were everyone so concerned about getting the regulators to accept what the company was proposing before the trial was locked. I'm certainly not knowledgeable about these things, but posters were all discussing it, as if it was highly unusual to do such things.
Gary
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