Ann: Oncosil breakthrough device receives CE Marking approval, page-164

That's big talk re: FDA. Is the bullishness based on professional opinion and insight into FDA workings, or just hope? Unfortunately breakthrough doesn't mean approval, and unlikely FDA care about SOC from 20 years ago. The pivotal trial needs to have standard of care from present- probably gemcitabine plus abraxane, and/or folfirinox chemotherapy options. Otherwise if it were as easy as that OSL could file right now with panco and the "naïve" literature comparison and be approved for L.A. pancreatic cancer.
Can somebody educate me about the credibility of these forecasts from the likes of B-P, Wilson etc that seem to keep popping up. Are they based on rigorous analytical methods coupled with penetrating market insights, or just a few fellas with vested interests who every so often call up the CEO for some sales forecast projections and paste replies into their research reports then flick out?