Biotech Values

[exwannabe]

Re: "I’m not sure what you mean by invalidates—please clarify. "

Because it's a 2-sided test. If the curves have a significant area with placebo outperforming, the treatment arm gets a P benifit from those data points for being different, even though it's the wrong side of H/R.

My understanding was that in practice (i.e., FDA eyes) the 2-sided P value would be rejected for showing a benfit if the curves were not visually clear wrt the treatment arm being on the correct side throughout.

If the curves go as my guess (TNF doing worse for 12 months or so and better late), they are out of luck even if the log-rank number hits.

Oh yes, it is possible the curves have only some minor early crossing, gets much better at 12-18 months, and a continuation of the 12-18 month effect could provide a winner.

And it's possible that biologists will discover a species of airborn pigs.