When the investigators see evidence of response within months the next step would be to increase number of participants to have meaningful data (N must be 50). Then they report the meaningful data.
This is the path University of Washington took with PRGN-3005. It still boggles my mind that in the peak of covid initial scare in mid March they opted to increase participants from 41 to 71 and there were patients willing to participate (and not left to die). Why did they increase? Why did University of Washington launch a video? Why participate?
Now here is where I agree with you and normally JBWIN always responds to me with a post captioned "Reality check".
If, big caps IF, either ZIOP or PGEN can show that their platform can cure metastatic nearly dead patients could they apply for FDA approval immediatley forgoing a phase 3 trial?
If not the 5 years is needed. I side with you on this but reality could be otherwise.