Replies to post #45997 on Delcath Systems Inc (DCTH)

[Fisher Man]

I ask, only because if I were randomized to an arm I knew was inferior, I would not enroll, and I would go pay out of pocket to England, as did my friend, with my concurrence....the lack of a crossover will definitely affect enrollment, and with the incidence of uveal melanoma so low, how could the company design a trial without a crossover? I am late to the ballgame, and am all ears

[SAMNOTSAMUEL]

Well first it is interesting that FDA is not as much a terrorist group as in 2010 era. Also who knows whether each time for designs whether FDA pushed the choice or the company.

First time around delcath had a poor quality filter plus did not provide additional meds to counter side effects, so trying to get 6 treatments was probably near impossible, 3 max treatments in study.

In original study clearly OS was still better compared to those in the control group that did not cross. The Crossover folks though lived longer than CS only group, likely because they did not have an early pounding from CS, so were like fresh troops