Biotech Values

[iwfal]

It is bad science to analyze subset data from a trial, especially one with small patient enrollment numbers.

I agree. You can't look at xover survival vs placebo wo xover. Self selected subgroups are completely unreliable so saying that this data proves something is silly.

But by the same token Sher is essentially claiming that any trial with xover is unacceptable. And that is going against a LONG history of FDA precident. There is some truth to it - but the FDA long ago chose to say it was acceptable for ETHICAL reasons. Too bad. Get over it.

BTW - There is plenty of precident for survival being given its own alpha. And for single trials being acceptable. Is it mixed? Yes, more so than xover, but all of this sturm und drang is a little overdone. This is not ground breaking precident.