RE:FDA The data is actually better than it seems upon close examination. Numbers , especially the 270 days plus data is strongly impacted by anomalies such as the group of 4 from 1st set of 12 who were only given one Optimized treatment and the patient who died. When such a group represents 30-45% of your sample then you get numbers brought lower. Also we need more data from pending patients to get a better picture, as well as more patients treated. We should still keep our expectations realistic but optimistic that we will lead in efficacy and safety in the end. All IMO
enriquesuave wrote: The FDA can only like the Novel method used here which is basically a ONE and Done treatment with high efficacy and high safety. It is repeatable and can also be used in combination with Immunotherapy to enhance immune response and maximize efficacy if necessary.