I'm interested in 1) what the control to test arm split is to be. Is it going to be 30 (contol) and 30 (test or treatment) or 40 (treatment) and 20 (only control arm)?
Why does this matter - isn't it a small detail?
On one hand it looks like a small detail on the other hand CYP doesn't have a time machine and if is rubbery on the statistical design it could run a statistically invalid trial and no one will come out of left field to tell them not to do that. The ones that would be in a position to partner or be suitably impressed probably won't look at trial design except afterwards when they are considering what positive seeming (shareholders may hope) results actually mean.
One of the problems with MEND was trying to generalise from small samples where standard of care was changing from time to time (COVID and ARDS treatments) and place to place (different hospitals) - these vartiations can introduce confounding variables. We don't want confounding variables if we can possibly avoid them they reduce statistical confidence in any good result that is achieved.
The split of control arm to test arm not being fixed, the weakening of criteria for recruitment to increase the recruitment rate (eg DFU - these are additional variables -potentially confounding ones).
One, CYP shareholder, needs merely to look at Mesoblast for a cautionary tale on not controlling for confounding variables in trial design.
Most of the shareholders commenting on hotcopper don't understand most of what the Mesoblast announcements are saying and not saying because Mesoblast is speaking obfuscation much of the time.
CYP Price at posting:
13.0¢ Sentiment: None Disclosure: Held
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