$CRMD Here is why a Phase 4 post approval trial for oncology indication is more likely that a separate P3 trial: There are over 60 types of cancers and over 100 types of chemo agents that oncologists use to treat their cancer patients, so, how practical is it to test Defencath in a phase 3 study vs every oncology drug that oncologists use now and will be using in the future? There is no way FDA can ask for a phase 3 trial for oncology indication of Defencath against every single chemo agent that is being used now...all they can ask is P4 post marketing safety data review, that is all. Folks, label expansion it is!
1
27
27 Likes