PFS (progression free survival) was the clinical endpoint that was agreed to with the FDA under a special protocol assessment. Moreover, the FDA guided DCTH to limit their application to ocular melanoma. ODAC is a tough committee and they don't want to recommend approval of marginally efficacious drugs/devices. However, I would disagree with AF that overall survival (no significant difference with the controls) would be a cause for rejection. Overall survival has too many variables, especially with hepatocellular carcinoma's inevitable death sentence. Both melphelan and the kit have been around for decades, so I don't think there will be any safety issues. There are other skeptical biotech analysts who are betting on a positive outcome at the meeting. AF's article was based on polling, which is always skewed, especially among investors with a positive or negative bias. These polls are really for entertainment purposes only, but sometimes cause people to lose alot of money, both on the long and short side.
CLSN longs hated AF too.
They blamed him for being negative on clsn.
but now, he turned out to be a hero who had saved a lot of people from big losses on clsn's collapse.
AF is a biotech guru who protect small and naive investors from being scammed.