Biotech Values

[biomaven0]

I think non-inferiority trials are always harder. They generally have to be bigger (because now there are two sources of variability), there's the standard fight with the FDA about the margin, and there are all the issues relating to use of ITT vs. completers.

It's not inconceivable that INCY will charge $100k/yr for their drug. So if they needed to do two 400-patient trials that lasted a year (the INCY trial actually continued as an observational trial for 2 years), that's another $40m on top of everything else just for comparator drug costs. Maybe they'd be able to get away with a smaller trial, but that has risk too.

Peter