Biotech Values

[iwfal]

RDTs - Does the FDA accept RDTs as a pivotal trial? There are good reasons that the FDA should NOT accept such a trial - i.e. if the treatment has moderate mortality (e.g. 5%), only works in a small fraction of the population (e.g. 20%) and then has only moderate efficacy (e.g. HR=0.70).

I guess this is another way of saying that part of any ph ii RDT had better be an exhaustive search for a biomarker. Either that or some way to prove that in the group for whom it is not efficacious that there are no excess deaths in the treated population.