This is Whytee's reference point.
In addition, as described in the 2018 FDA guidance document for clinical trial endpoints, time-to-event measures such as overall survival aredifficult to interpret in single-arm trials, and Study 001 was not designed to detect differences in survival. And therefore, survival endpoints will not be discussed further by FDA.
Can anyone see reference to now " irrelevant future long term survival data"
Whytee refuses to acknowledge he took the above information and fabricated a story to suit his narrative .
Perhaps JB1975 concocting that Si has just made up the potency assays also fits a certain narrative .
How absurd
Reg
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-467
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